This document summarizes a study that surveyed 505 people in Chennai, India about their awareness of clinical trials. The study found that about 60% of participants were not aware of what a clinical trial is or why they are conducted. Only around 35-45% of participants correctly answered questions about clinical trials. Awareness was higher among those with more education. The study concluded that there is lack of awareness about clinical trials among the general population in Chennai and that education level plays a role in knowledge.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.
The Indian Dental Academy is the Leader in continuing dental education , training dentists in all aspects of dentistry and
offering a wide range of dental certified courses in different formats.
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Assignment on Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional, Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT
A full proof presentation on Clinical Trials and its Phases. This presentation contains clear description of clinical trials and its phases with suitable examples. All key points have been tried to be covered. After going through this presentation, one should be able to discuss about clinical trials and its phases.
Overview of Pharmacovigilance by Yash Dhikale | Zumbar Pote | Santosh Ghuge |...ijtsrd
Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
the ppt describes in detail the translational research and path of the drug from lab to bed side, CONSORT guidelines, DCGI guidelines, CTR-I, the GCP principles, medical ethics, sample size estimation for RCT, RCT designs including cross over design and factorial design, Randomized permuted blocks, blinding and matching.
Assignment on Experimental Study- RCT and Non RCT, Observation Study: Cohort, Case Control, Cross sectional, Roles and responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor, Contract Research Organization and its management Guidelines to the preparation of documents, Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study Report Clinical Trial Monitoring-Safety Monitoring in CT
A full proof presentation on Clinical Trials and its Phases. This presentation contains clear description of clinical trials and its phases with suitable examples. All key points have been tried to be covered. After going through this presentation, one should be able to discuss about clinical trials and its phases.
Overview of Pharmacovigilance by Yash Dhikale | Zumbar Pote | Santosh Ghuge |...ijtsrd
Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry. There are more than 2, 50,000 positions unemployed in global Pharmaceutical industry.
Clinical Aspect of Drug Discovery and Development PCO 413.pptxCoutyNess
Clinical trials helps in the discovery and development of drugs which helps to improve health, drug discovery and development is a key aspect of medicine which ensure more improved drugs are been developed to improve health in the society
In these slides you can get the information of clinical trials which have four phase I,II,III, IV. before clinical trials, Pre-clinical studies should be completed.
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.
Chapter 19Clinical Trials Clinical TrialsThe history EstelaJeffery653
Chapter 19
Clinical Trials
Clinical Trials
“The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”
— Sidney M. Wolfe
Lecture Overview
Research and Development Investments Fund a Complex Multistage Pathway
Clinical Trials of Generic Drugs
Health Risk Assessments
Expanded Access Protocols
Termination of Clinical Trials
Observational Studies
International Clinical Trials
Informed Consent in General
Transparency and Full Disclosure in Clinical Testing
Financial Conflicts of Interest
Commitment to the Life Sciences
Source: Hammaker, D. K., & Knadig, T. M. with Tomlinson, S.J. (2017). Clinical trials. In Health care management and the law: Principles and applications (pp. 389-412). (2nd Ed.) Burlington, MA: Jones & Bartlett Learning.
Research and Development Investments Fund a Complex Multistage Pathway
Some major expenses are research materials, advanced computers, and other highly sophisticated machines that support research activities, and salaries of scientists. Stage specific activities include:
Drug discovery
Preclinical testing
Clinical trials
Approval by the FDA
Post marketing surveillance
Research and Development Investments Fund a Complex Multistage Pathway
Drug Discovery:
While most compounds will never be approved for use, each one is evaluated to determine its potential value compared to existing therapies, complexity of large scale manufacturing, and other factors.
Preclinical Testing:
Candidate drugs from the discovery stage receive 1 to 3 years of extensive testing to assess safety and show biological activity against a disease.
Chemical tests establish the purity, stability, and shelf life of a compound.
Manufacturing tests determine mass production of the drug.
Pharmaceutical development studies explore dosing, packaging, and formulation of the drug.
Research and Development Investments
Fund a Complex Multistage Pathway: Clinical Trials
For drugs in development, there are low odds of reaching the market.
While Phase I, II, and III of studies are taking place, research investigators are also conducting toxicity tests and other long-term safety evaluations, evaluating dosage forms, planning for mass production, designing packaging, and preparing the extensive application required for FDA approval.
One out of five drugs that enter clinical testing is never approved by the FDA:
20% of the drugs that enter Phase I are approved to enter Phase II
30% of the drugs that enter Phase II are approved to enter Phase III
60% of the drugs that enter Phase III are approved for a new drug application
80% of the new drug applications are approved by the FDA for market entry
Research and Development Investments Fund a Complex Multistage Pathway
Approval by the U.S. Food and Drug Administration
According to the FDA, the documentation required in a new drug application is supposed to tell the whole story of a ...
Clinical trials are divided into several phases to ensure the safety and effectiveness of new medical interventions, such as drugs, treatments, or medical devices, before they are approved for widespread use. Here are the typical phases of clinical trials:
Phase 0: Exploratory Study
Phase 0 trials are relatively new and not always a part of the clinical trial process. They involve a small number of participants and aim to gather initial data on how the drug or treatment behaves in the human body. These trials help researchers decide whether to move forward with larger Phase 1 trials.
Phase 1: Safety and Dosage Study
Phase 1 trials involve a small number of healthy volunteers or patients and focus on assessing the safety of the intervention and determining the appropriate dosage range. Researchers closely monitor participants for any adverse effects, evaluate how the intervention is metabolized, and gather initial data on its efficacy.
Phase 2: Expanded Safety and Efficacy Study
Phase 2 trials involve a larger number of patients who have the condition the intervention is intended to treat. These trials continue to assess safety, evaluate dosage regimens, and gather more data on the intervention's efficacy. Researchers may also explore different patient populations, dosages, or combinations with other treatments.
Phase 3: Confirmatory Study
Phase 3 trials are large-scale studies involving a significant number of patients to confirm the intervention's safety, effectiveness, and monitor any side effects. These trials often include a randomized and controlled design, comparing the new intervention against existing standard treatments or placebos. Phase 3 trials provide critical data for regulatory agencies to evaluate whether the intervention should be approved for widespread use.
Phase 4: Post-Marketing Surveillance Study
Phase 4 trials take place after the intervention has received regulatory approval and is available to the general public. They aim to monitor the intervention's long-term safety, effectiveness, and identify any rare or long-term side effects. Phase 4 trials may involve a larger and more diverse population than earlier phases.
Patient compliance: Challenges in management of cardiac diseases in Kuala Lum...pharmaindexing
Background
The objective of this study was to investigate the degree of compliance among cardiac patients who attend the health facilities in Kuala Lumpur and Perak, Malaysia. The reasons for non-compliance and recommendations from healthcare professionals were also evaluated.
Method
A cross-sectional study of 400 patients and 100 healthcare professionals was carried out. This study utilizes variables on external factors and internal factors as the measurement tools. The questionnaire which consists of Morisky self-reported medication adherence questions was administered to patients and causes for non-compliance sought. Questionnaire for healthcare professionals was used to determine strategies that can improve compliance rate.
Results
The study revealed a 15.8% of high adherence rate, 54.3% of moderate adherence rate and 30% of poor adherence to cardiovascular disease medications. The chi-square tests showed the strong association between dependent and independent variables. The model chosen for testing the patient compliance through external and internal factors gives an R2 value of 85.0% with an adjusted R2 of 84.7%. The F value (317.187) was also significant (p=0.000) which means that the variables have better fit in the multivariate model. The major reasons determined for non-adherence were attitudes and beliefs, lifestyle, side effects and cost of medications. The study recommends that pharmacists and dispensing technicians should be adequately qualified to provide proper counselling to cardiac patients on their medicines and disease conditions.
Conclusion
The result of this study is of value to health care providers. Compliance to cardiovascular medications will avoid treatment failures encountered in therapy.
Overview on Recurrence Pregnancy Loss etiology and risk factorspharmaindexing
Recurrent pregnancy loss (RPL) can be defined as more than two to three consecutive miscarriages before 20 weeks’ gestation; it affects approximately 1% to 2% of women. RPL is a multifactorial disease. It is very important to study the etiology and risk factors of RPL to find the best diagnostic tests and suitable therapeutic intervention. This article will discuss the current understanding etiologies and risk factors of RPL.
Novel treatments for asthma: Corticosteroids and other anti-inflammatory agents.pharmaindexing
Asthma management is a challenge due to the prevalence of disease in the world. Based on the immunological and inflammatory mechanisms of asthma, corticosteroids and anti-inflammatory participate greatly in the treatment plan. Due to different reasons, there is still an unmet need to develop new agents in this field. A lot of compounds with anti-inflammatory effect are investigated in both pre-clinical and clinical studies.
A review on liver disorders and screening models of hepatoprotective agentspharmaindexing
The liver is a vital organ present in vertebrates and some other animals. It has a wide range of functions, including detoxification, protein synthesis, and production of bio chemicals necessary for digestion. The liver is necessary for survival; there is currently no way to compensate for the absence of liver function long term, although liver dialysis can be used short term.
Carbamazepine induced Steven Johnson syndrome: A case reportpharmaindexing
Drugs are the most common cause that induces Steven Johnson syndrome (SJS) and includes antiepileptic drugs, antiretroviral drugs, anti-tuberculosis drugs, Sulphonamides, fluoroquinolones, penicillins, non-Steroidal anti-inflammatory drugs, Multivitamins. The genetic markers are also the cause for carbamazepine induced Steven Johnson Syndrome. In our study, the antiepileptic drug (Carbamazepine) is the cause for Steven Johnson Syndrome. A female patient aged 25 years came to the hospital with the complaints of bubbling over the skin and all over the body with papillary vesicles associated with pain and irritation, fever, myalgia, and nausea. The patient is known case of Phenytoin induced Steven Johnson Syndrome. In this case the patient developed the Steven Johnson Syndrome approximately after one month after starting the carbamazepine.By the withdrawal of the drug, the condition of the patient was improved.
Monoherbal formulation development for laxative activitypharmaindexing
The Ayurvedic Pharmacopoeia specifically approves flaxseed as a poultice for boils externally and demulcent or laxative internally. In this study monoherbal formulation development for laxative activity of flaxseed was undertaken. The plantLinumusitatissimumhasshowed higher percentage of total ash as well as alcohol soluble extractive values. The aqueous extract of Linumusitatissimumwas prepared by using pilot scale extraction plant and spray drying unit. The qualitative phytochemical studies reveal the presence of amino acids, carbohydrates, vitamins and proteins. From the available literatures it was found that Linumusitatissimum contains more number of amino acids. The formulated tablets showed acceptable pharmacopoeial limits and complies with specifications for thickness, hardness, friability and weight variation. The formulation has showed better laxative activity indicating additive property of the combined phytoconstituents of the plant.
Monoherbal formulation development for laxative activitypharmaindexing
The Ayurvedic Pharmacopoeia specifically approves flaxseed as a poultice for boils externally and demulcent or laxative internally. In this study monoherbal formulation development for laxative activity of flaxseed was undertaken. The plantLinumusitatissimumhasshowed higher percentage of total ash as well as alcohol soluble extractive values. The aqueous extract of Linumusitatissimumwas prepared by using pilot scale extraction plant and spray drying unit. The qualitative phytochemical studies reveal the presence of amino acids, carbohydrates, vitamins and proteins. From the available literatures it was found that Linumusitatissimum contains more number of amino acids. The formulated tablets showed acceptable pharmacopoeial limits and complies with specifications for thickness, hardness, friability and weight variation. The formulation has showed better laxative activity indicating additive property of the combined phytoconstituents of the plant.
Pneumonia and respiratory failure from swine origin influenza H1n1pharmaindexing
Swine influenza (swine flu) became alarming health concern when World Health Organization declared as “public health emergency of international concern” on April 25, 2009. After documentation of human-to-human transmission of the virus in at least three countries of two WHO regions, the WHO raised the pandemic level to 6.1 During the 1918, flu pandemic infected one-third of the world's population (an estimated 500 million people) and caused approximately 50 million deaths.2 In 1976, an outbreak of swine influenza occurred in New Jersey, USA, which involved more than 200 cases, some of them severe, resulting in one death.3 In 1988, another fatality was reported as a complication of swine influenza.
A descriptive study on newborn care among postnatal mothers in selected mater...pharmaindexing
The newborn health challenge faced by India is more formidable than that experienced by any other country in the world. The newborn health is inevitably affected by the traditional care practices of the mothers causing high infant morbidity and mortality.The aim of the study were determine the knowledge, attitude and practice of postnatal mothers regarding new born care and find out the association between knowledge, attitude and practice of postnatal mothers regarding new born care and to determine the association between these as well as with the selected demographic variables. A descriptive study was conducted to assess the knowledge, attitude and practice of postnatal mothers regarding new born care in selected maternity centres in Madurai. Survey approach was employed to select sample and it consisted of 100 postnatal mothers. Data was collected using structured interview schedule. Findings of the study showed that 65% of postnatal mothers had moderate knowledge; 61% had favourable attitude and 57% of them had high practice of new born care. There was a significant association between knowledge and attitude (r=+0.567), knowledge and practice (r=+0.388), attitude and practice (r=+0.321) .There was a significant association between knowledge and education, monthly family income and obstetrical score at p<0.05. Findings of the study indicated the need to conduct frequent assessment of knowledge, attitude and practice of postnatal mothers regarding new born care. Awareness and attitude of the mothers towards new born care still has lots of lacunae especially in those who belong to the lower socio economic statusand poorly educated postnatal mothers. So it is imperative to provide comprehensive training in the field of new born care for mothers during pregnancy
Late 19th century was evident of intelligent biomaterial; which has changed researcher’s perspective towards science and technology. This intelligent biomaterial are envisioned to have huge impact on Healthcare from sequential signalling of biomedical molecule, mimicking natural gene, an effective drug carrier, to high resolution diagnostic tool.From drug discovery aspect many of NCE fail to reach therapeutic potential due to PK/ PD profile. Nanotechnology has changed the face of drug discovery form chemical evaluation to structure of proteins in signalling pathways and development of chemical antibody. Nanotechnology from lab to market approval is long process due to regulatory evaluation. Though it seems to be bright future market it has to go through a long process from being innovation to complete market product. This makes whole process expensive making investor reluctant to invest in big projects.Western world is aware of dramatic potential of nano-projects; which has its limitation in financial investments; with major challenge of transforming nano science to commercial pharmaceutical product.
The Flaws in health practice in post-operative management of a patient in ter...pharmaindexing
Introduction
Congenital urinary tract obstructions are common cause of kidney damage sometimes which sometimes presents itself without symptoms leading to abnormalities in blood filtration and consequently retarded kidney function. A cohort study was conducted in such patient to find out the short comings in treatment strategy.
Case presentation
A four years old child, weighing 14 kg was brought with severe constipation, fever, chest congestion and cough later developed left eye disorientation after admission to hospital, diagnosed with urinary tract obstruction, indicating acidosis and loss of electrolytes due to excessive loss of water. His therapy management included surgical treatment, dialysis and to improve his electrolyte levels within the normal with the treatment chest congestion and fever.
Conclusion
This case study reports the post operative treatment of congenital urinary tract obstructions in a tertiary care hospital and highlights the discrepancies observed. Antibiotic rationality and irrational prescribing was observed. The case study highlights the need of a clinical pharmacist in the health care team.
Corticosteroid induced disorders – An overviewpharmaindexing
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders, and the toxicity of glucocorticoids is one of the commonest causes of iatrogenic illness associated with chronic inflammatory disease.Glucocorticoid-induced muscle atrophy is characterized by fast-twitch or type II muscle fiber atrophy. Corticosteroid (CS) therapy is widely used in the treatment of rheumatic diseases.Osteoporosis remains one of its major complications.Steroid induced glaucoma is a form of open angle glaucoma occurring as an adverse effect of corticosteroid therapy. Glucocorticoids induce hepatic and extrahepatic insulin resistance.Glucocorticoid treatment impairs both glucose transport in fat and muscle cells. Corticosteroid-induced psychosis represents a spectrum of psychological changes that can occur at any time during treatment. Cushing’s syndrome describes the signs and symptoms associated with prolonged exposure to inappropriately high levels of the hormone cortisol. Physicians must be aware of these adverse effects and be equipped to manage them.
Anti-inflammatory activity of pupalia lappacea L. Jusspharmaindexing
Pupalia lappacea (L) Juss is an erect shrub used in folklore medicine to treat bone fractures and in inflammatory conditions. Methanolic extract of aerial parts shown is claimed in traditional medicine that the leaves of the plant are used in the treatment of inflammation. In the present study, the methanolic extract of Pupalia lappacea was screened for its anti-inflammatory activity using carageenan induced rat paw edema egg white induced paw oedema models. The methanolic extract at the dose of 200 mg/kg p.o exhibited significant anti-inflammatory activity in carrageenan induced paw edema model (p<0.01). In egg white induced model, methanolic extract at the dose of 200 mg/kg inhibited paw oedema significantly (p<0.01) indicating that both test samples inhibit the increase in number of fibroblasts and synthesis of collagen and mucopolysaccharides during prostaglandin formation during the inflammation. These experimental results have established a pharmacological evidence for the folklore claim of the drug to be used as an anti inflammatory agent. HPTLC analysis of the extract shows the presence of gallic acid 1.24mg/ml, ferulic acid 2.00mg/ml, chlorogenic acid 46.25mg/ml and rutin 7.02mg/ml of the extract which were responsible for the claimed anti-inflammatory action in the animal models studied.
Lucinactant: A new solution in treating neonatal respiratory distress syndrom...pharmaindexing
Lucinactant is a novel synthetic surfactant, approved by the FDA on March 6th 2012, for use in treatment of RDS. It’s superiority as compared to the previously approved surfactants lie in containing sinapultide, a 21-amino acid peptide also known as KL4 peptide, which has been designed to mimic the activity of human surfactant protein. Lucinactant is completely devoid of any animal derived components. It is the fifth drug approved by the FDA for the treatment of RDS. It has shown immense efficacy in phase two clinical trials and animal model studies and exhibited better efficiency when compared to other surfactants in both 24 hour and two week mortality rates of infants in RDS. Lucinactant tends reduce the surface tension at the air-liquid interface of alveolar surfaces and allows lungs to function normally. It was observed that the side effects were lesser with Lucinactant when compared with other naturally derived surfactants.
Bioactivity screening of Soil bacteria against human pathogenspharmaindexing
Microorganisms have a profound effect on medical science as they not only infect & cause disease but also produce metabolic products that can cure infections. Soil happens to be a source for a variety of microorganisms. Most of the bacteria, particularly actinomycetes produce biologically active secondary metabolites. Though there are a number of antibiotics available, there is a pressing need for the discovery of new source for antimicrobials against the pathogens due to the development of drug resistance of the pathogenic microorganisms. In addition to, new pathogenic strains are also developing and causing infection to human beings. Bioactive compounds are compounds that are produced by any living organism and are known to exhibit various biological activities both in-vitro & in-vivo. Bioactivity may be antimicrobial, antineoplastic, anticancerous, immunomodulation, antifertility & others. Soil bacteria were isolated by standard technique and by making use of selective media. The isolates were identified and subjected for preliminary screening to look for their ability to produce bioactive materials. A total of 96 strains were isolated from three different soil samples. 14 of them were found to have antibacterial activity against the human pathogens like Staphylococcus aureus, Streptococcus faecalis, E.coli, Klebsiella aerogenes, Proteus vulgaris, Pseudomonas aureginosa and Salmonella typhi by preliminary screening. Further the selected (3) bacteria were grown in the suitable culture media for the production of bioactive metabolites by using rotary shake flask. The active metabolites was isolated by solvent extraction and concentrated by evaporation under reduced pressure. The antimicrobial screening of the active metabolites showed prominent effect against the clinical pathogens under the study.
A study on sigmoid Volvulus presentation and managementpharmaindexing
A study on sigmoid volvulus presentation and management was a 2yr retrospective study done at RMMCH.The diagnosis of sigmoid volvulus was made from a history of large bowel obstruction (constipation, abdominal distension, and abdominal pain), which were often recurrent and plain abdominal radiographs.The morbidity associated isSuperficial wound infection occurred in four patients. All the infected wounds eventually healed with conservative measures. Clinical anastomotic dehiscence was noted in 1 patient for which during relaparotomy proximal colostomy and mucous fistula was done. The mortality associated is shown is there were 9 deaths of which 7 were due to sepsis and 2 were due to comorbid illness. Two out of eight patients for whom a colopexy was done had a recurrent attack of sigmoid volvulus. The duration of hospital stay ranged between 10 and 21 days. Use of sigmoidoscopic detorsion for viable colon should be encouraged. Sigmoidopexy, which is associated with a recurrence rate of 20% in our series of patients, should be used selectively.Hartmann’s procedure is a safe option in sigmoid volvulus with gangrenous bowel. Primary anastomosis in emergency situation can be carried out with morbidity and mortality in patients with viable colon
Evaluation of Preliminary phytochemical on various some medicinal plantspharmaindexing
The present study was carried out to evaluate the physical status and percentage yield of methanolic extract and its fractions of whole plant of Leucas cephalotes, leaves of Hiptage benghalensis and leaves of Kydia calycina were recorded for future references and Preliminary phytochemical screening of MLC, MHB and MKC revealed the presence of carbohydrates, glycosides, saponins, flavonoids, steroidal and phenolic compounds. MLC revealed the presence of all the above mentioned phytoconstituents except saponins and also MKC steroidal compounds. The fractions of MLC, MHB and MKC revealed the presence of glycosides, phenolic compounds, steroids and flavonoids.
Comparision of in vitro antibacterial activity of cefoperazone and levofloxac...pharmaindexing
Cefoperazone (a third generation cephalosporin) has effective in vitro activity against majority of pathogens. Levofloxacin (a flouroquinolone) is one which prescribed more due to its increased antibacterial activity against Gram-positive, Gram-negative, and atypical bacteria. Microbial resistance to antibiotics is now prevalent and poses a serious clinical threat. An attempt has been made to evaluate sensitivity of Cefoperazone and Levofloxacin against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Salmonella typhi. A total of 120 isolates were collected from different pathological laboratories and medical centers in Karachi, Pakistan. The above stated clinical isolates were extracted from urine/stool, skin, blood and sputum samples. Results show least resistance of Levofloxacin as compare to Cefoperazone against Escherichia coli (32.5% and 42.5%) and Pseudomonas aeruginosa (36% and 48%) while Staphylococcus aureus is still susceptible towards Cefoperazone and least sensitive to Levofloxacin by showing 26.6% and 50% resistance respectively. Study concluded that the prevalent pathogens are still susceptible towards Levofloxacin and Cefoperazone but the gradual increase in resistance is alarming to the general practice of prescribing antibiotic which require routine evaluation and surveillance to ensure the effectiveness of the antibacterial agents.
Concept of srotas from ayurvedic perspective with special reference to neurologypharmaindexing
Ayurveda is a life science. The researchers of ayurveda could rule out the presence of srotas (channels) spreading throughout the human body. These srotas (channels) are governed by vayu which is using all the srotas (channels) of the body to carry out the functional and physiological activities of the human body without which the human society will not exist. Several synonymous words have been described by the ayurvedicacharyas for srotas. Some are micro and some are macro in structures and they adopt the same colour of the particular dhatus of the body to which it belongs. The aim of the study is to justify that srotas are nothing but innurmerable channels or pathways of the nervous system governed by electric current without which no functional and physiological activities of the human body will develope.
Health promotion survey in overweight and obese students of universities in n...pharmaindexing
Introduction
Overweight and obesity is one of the major health problems in the UK and worldwide. Approximately two-thirds of the population in the UK is either overweight or obese. Overweight and obesity is an important issue that causes distress to most women. Health promotion is the best method to educate overweight and obese women. It is defined as the process enabling people to increase control over and to improve their health by Ottawa Charter for Health Promotion. It is aimed to enhance the well-being of the individuals and their positive attitudes towards prevention of various diseases. In order to make any improvement to the health promotion for overweight and obesity, the risk factors and the opinions from the public should first be identified and addressed.
Methods
Cross-sectional survey design was selected with a questionnaire that consisted of 20 open and close ended questions. A sample size of 196 was determined. The data thus gathered was analyzed using SPSS V20 (Statistical Package for Social Science version 20). Descriptive statistics (fx) and (SD) were used and Chi-square X2 test for association was employed.
Results
Out of the total 196 responses, only (40%) of the students had normal weight (SD 1.1), (25%) students had a good understanding of health promotion (SD 1.6), half (50%) appeared concerned about their weight (SD 0.5), (60%) had an obese family member (0.5). The BMI of students was associated with the presence of an obese member in their family and their weight as a concern for them. (P-value <0.05).
Conclusion
The health promotion service is beneficial as it was found to have raised concerns in the mind of the students regarding over weight and obesity. However it was observed that the understanding of health promotion service was different among students and this is the root of the problem.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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A questionnaire based survey on awareness of clinical trials among general population.
1. ~ 8 ~
* Corresponding author: Balasubramanian J
E-mail address: jvbalpharm@yahoo.co.in
IJAMSCR |Volume 1 | Issue 1 | Oct - 2013
Journal Homepage: www.ijamscr.com
Research article
A Questionnaire based Survey on Awareness of Clinical Trials among
General Population.
*,1
Balasubramanian J, 2
Rukmani A, 2
Rajesh kumar R, 3
Purushothaman K.
1
Shield Health Care Pvt Ltd, Chennai-600095, Tamil Nadu, India.
2
Chettinad University, Kancheepuram-603 103, Tamilnadu, India.
3
Vels University, Chennai-600117, India.
ABSTRACT
The aim of the questionnaire based survey was to find the extend of awareness of clinical trials among general
population among the different category of people in Chennai. The project was carried out among the general population
living in and around Chennai. While recruiting the subjects care was taken to include different strata of the society and
the informed consent was obtained from each subject before starting the study The participants was provided with the
“Evaluation tool to assess the perception of clinical trials among general population”.
KEY WORDS: Clinical trial, History of clinical research.
INTRODUCTION
Clinical trial is a research work conducted in
human subjects intended to study the safety,
efficacy and pharmacokinetic parameter of a new
investigational product, procedure or a device.
History of clinical research
The fundamental tools of modern medicine are
research and the clinical trials in fact, the clinical
trial has contributed to nearly all the life saving
medicines available today The evolution of clinical
research dates back to 3000 years. The ancient
Egyptians (1500BC) regularly documented their
prescriptions. It wasn‟t until 600 BC in the Book of
Daniel the Bible describes what might be the first
comparative trial. Daniel tested two diets to see
which was healthier, a vegetarian diet or a diet rich
with meats and wine. After a 10-day test, the
vegetarian diet was judged most healthy. The first
modern clinical trial was conducted in 1946.
British epidemiologist, Sir Austin Bradford Hill put
patients into experimental and control groups at
random. This eliminated any bias that only the test
medicine would account for differences seen in the
health of the two groups. With the establishment of
guidelines for ethical clinical trial conduct and
regulations for drug development, more than 1019
novel drug therapies have been approved by the
Food and Drug Administration – that‟s virtually all
the medicines used today [1].
Phases of clinical trials
Phase I
Phase I trials are the first stage of testing in human
subjects. Normally a small (20-50) group of
healthy volunteers will be selected. This phase
includes trials designed to assess the safety,
tolerability, pharmacokinetics, and
pharmacodynamics of the investigational agent.
Phase II
The initial safety of the study drug has been
confirmed in phase I trials. The primary objective
of phase II trials is to explore therapeutic efficacy
in patients. Phase II trials are performed on larger
International Journal of Allied Medical Sciences
and Clinical Research (IJAMSCR)
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groups (20-300) and trials are usually randomized
and controlled to evaluate the efficacy of the drug
and its safety for a particular therapeutic indication.
Phase III
Phase III studies are randomized controlled
multicenter trials on large patient groups (300-
3000). Primary objective of this study is to confirm
therapeutic benefit. Phase III trials assess the
effectiveness of the drug and are compared with
current „gold standard‟ treatment. Because of their
size and comparatively long duration phase III
trials are expensive, time consuming and difficult
trials to design and conduct the trial. Certain phase
III trials will continue while the regulatory
submission is pending this will allows the patients
to receive possibly lifesaving drugs until the drug
can be obtained in the market. Other reasons for
performing trials at this stage are to obtain
additional safety data or to support marketing
claims for the drug.
Phase IV
Phase IV trials are also known as Post marketing
surveillance trial. Phase IV trials involve the safety
surveillance and ongoing technical support of drug
after it receives the approval for marketing. This
studies include additional drug-drug interaction,
dose-response or safety studies and studies
designed to support use under the approved
indication. The safety surveillance is designed to
detect any rare or long term adverse effects over a
much larger population and longer time period than
was possible during the phase I – III clinical trials
[2,3].
Development of Clinical Trials
The first clinical trial of a novel therapy was
conducted unintentionally by the Renaissance
surgeon Ambroise Pare in 1537. He used a
concoction of turpentine, rose oil and egg yolk to
prevent the infection of battlefield wounds, noting
that the new treatment was much more effective
that the traditional formula. James Lind
documented the fact that citrus fruits in the diet
could prevent scurvy. From 1800 onwards, clinical
trials began to proliferate and more attention was
paid to study design. Placebos were first used in
1863, and the idea of randomization was
introduced in 1923. The first trial using properly
randomized treatment and control groups was
carried out in 1948 by the Medical Research
Council, and involved the use of streptomycin to
treat pulmonary tuberculosis [4].
Global Scenario in Clinical Research
Clinical trials market now witness a paradigm shift.
A Naïve heterogeneous patient population in the
developing nations is opening up new avenues for
the clinical trials market. Developing countries also
offer faster go to market which is triggering major
pharmaceutical companies to direct their
investment in these regions. Apart from this,
stringent regulations and tight R&D budgets in the
Pharma-Biotech industry are also forcing
companies to move to east. This scenario has
further boosted the alliances between the Pharma-
Biotech companies and the clinical research
organizations, with the latter accounting for major
chunk of the trials conducted [5]. Over the years
the cost of inventing new drugs (NCEs) or
biological is increasing due to global inflation and
this is increased from $ 802 million in 2003 to $
~1.2 billion in 2010. Due to this high cost incurred
the companies around the world are focusing more
on development of existing drugs with new dosage
forms [6].
Indian Scenario in Clinical Research
Till 1990, India was not the preferred destination
for major global pharmaceutical companies, even
though some of them were conducting clinical
trials here. In the last 10 years however, there has
been a steep rise in the global demand for world
class clinical trial management capacity and
productivity. The international biopharmaceutical
sector now finds India‟s pool of highly skilled
doctors, trained medical personnel, investigators,
and the support research infrastructure to be highly
attractive and as a result, large numbers of
international companies are now viewing India as a
potential center of knowledge, skills and resources,
and are hoping to derive expertise-based synergies
from Indian partners [7].India presently occupies
only a small quiche of the global market. The total
numbers of clinical trials conducted in India were
221 in 2007 and had increased to just over 700
trials in 2008. Although there was an increase of
65%, it associates to only single digit percentage of
the global clinical trial market. The country is
projected to conduct nearly 5% of the global
clinical trials by 2012. However, to achieve its goal
of becoming a global center of clinical trials, the
country has to overcome few challenges [8].
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Challanges in Clinical Research
Information flowing from the clinical research
enterprise directly influences over the cost, quality,
and efficiency of our health care system. The
pressure for our clinical research enterprise to
produce high quality information and to speed the
translation of advances from basic science to
clinical care, and then to better health, will continue
to grow [9]. Even more serious is the lack of
confidentiality. Unlike China, India does not yet
grant protection for data gleaned from clinical
trials, which makes it easy for generic drug makers
to copy the drug under trial. Under India's existing
laws, only those drugs that have already passed
Phase 1 safety trials in the country of their origin
can be tested on Indians. In India, opportunities
will become limited unless there is a very strong
patent law and mechanism to enforce it. Drafting
patent laws with the help of industry experts and its
implementation is highly essential [10].
METHODOLOGY
A preliminary version of the questionnaire was
assembled using information from the literature. It
was then reviewed by experts not directly involved
in the study design, tested in a small independent
sample of health consumers, then administered
twice to a small group of students. Debriefing
interviews to test face validity and formally
evaluate reliability showed which were the most
valid and reliable questions. The final version was
regarding awareness and opinions about general
issues pertaining to clinical research and regarding
the attitude towards participation in clinical trials.
Briefly, the questions were about the awareness of
clinical trials
Perception of clinical trials
Yes /
No
1. Have you heard “clinical trial”?
2. Do you know what clinical trial is?
3. Do you know why Clinical trials are conducted?
4. Is a clinical trial, an experiment in humans?
5. Do u think will the clinical trials benefit the society?
6. Are clinical trials unethical?
7. Is there risk involved in participating in a clinical trial?
8. Is it necessary for a company to get approval from the government for conducting a
clinical trial?
9. Will the participant be paid money to participate in a clinical trial?
10. Should India allow pharmaceutical companies to conduct clinical trials in India?
Describe clinical trial in your own words.
RESULTS & DISCUSSION
A total group of 505 participants were participated
in this survey. Among them 272 were males and
the remaining 233 were females. Their age,
educational qualification, annual income are
provided in Tables 1.2, 1.3 & 1.4 and also in
Figures 1.2, 1.3 & 1.4. The mean age, annual
income, education qualification was 33.22,
157582.18 and 63.12.
The knowledge of clinical trial was assessed
through the evaluation tool given in annexure 1
TABLE 1: Gender distribution
GENDER DISTRIBUTION
NO %
MALE 271 53.66
FEMALE 234 46.34
TOTAL 505 100.00
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FIGURE 1. Male and Female
Among the participants 61% were in the age group of 26-35 and 29% in 36-50, 7% in 18-25 and the remaining
4% were 50 years and above.
TABLE 2 Age distribution
AGE NO %
18-25 35 6.93
26-35 307 60.79
36-50 145 28.71
50 ABOVE 18 3.56
TOTAL 505 100
FIGURE: .2 Age distribution
Among the participants 23% of participants were 12th
standard and below, 35% of them were undergraduates,
16% were postgraduates, 4% of participants were diploma holders, 4% were paramedical workers and the
remaining 1% was from medical personnel.
TABLE: 3 Educational qualifications
Categories NO %
12TH BELOW 193 38.22
DIPLOMA 20 3.96
MEDICAL 9 1.78
PARAMEDICAL 18 3.56
UNDERGRADUATES 175 34.65
POSTGRADUATES 79 15.64
OTHERS 11 2.18
54%
46%
MALE AND FEMALE
Male
Female
7%
61%
29%
3%
AGE
18-25
26-35
36-50
50 ABOVE
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FIGURE: .3
All the 505 participants responded to all the
questions and response rate was 100%. Maximum
number of correct answers was obtained for the
questions 6 and 10 and both the questions were
related to general information regarding clinical
trials. 79% of participants reported that clinical
trials are ethical and 59% stated that regulatory
authorities should allow pharmaceutical companies
to conduct clinical trials in India.
58% of participants responded correctly to the
question on the necessity to get government
approval to conduct clinical trials. More than 50%
of participants were reported that the clinical trials
benefit the society and there is no risk in
participating in trials. 46% of participants quoted
that clinical trial is an experiment conducted in
human. 44% of them reported that they will get
compensation for the participation in clinical trials.
Around 60% of participants reported that they
don‟t know what clinical trial is and why it is
conducted. 64% of people are not aware of the
term clinical trial.
TABLE: 4 Response from participants
CORRECT INCORRECT
QUESTION % %
Q1 35.84 64.16
Q2 40.2 59.8
Q3 42.97 57.03
Q4 45.54 54.46
Q5 54.46 45.54
Q6 79.01 20.99
Q7 48.71 51.29
Q8 58.22 41.78
Q9 43.76 56.24
Q10 59.21 40.79
38%
4%
2%3%
35%
16%
2%
EDUCATION
12TH BELOW
DIPLOMA
MEDICAL
PARAMEDICAL
UNDERGRADUATES
POSTGRADUATES
OTHERS
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Figure 4.Response from participants
Table 5. Education
Education
Question
10th
and 12th
Medical and
Paramedical
Diploma &
UG
Post
Graduate
CHI-
SQUARE(P-
Value)
Q1
NO
YES
159(77.9)
45(22.1)
4(14.8)
23(85.2)
115(59.3)
79(40.7)
46(57.5)
34(42.5)
.001*
Q2
NO
YES
151(74.0)
53(26.0)
4(14.8)
23(85.2)
103(53.1)
91(46.9)
43(53.8)
37(46.3)
.001*
Q3
NO
YES
132(64.7)
72(35.3)
7(25.9)
20(74.1)
100(51.5)
94(48.5)
48(60.0)
32(40.0)
.001*
Q4
NO
YES
121(59.3)
83(40.7)
5(18.5)
22(81.5)
112(57.7)
82(42.3)
36(45.0)
44(55.0)
.001*
Q5
NO
YES
111(54.4)
93(45.6)
7(25.9)
20(74.1)
87(44.8)
107(55.2)
25(31.3)
55(68.8)
.001*
Q6
NO
YES
172(84.3)
32(15.7)
23(85.2)
4(14.8)
142(73.2)
52(26.8)
61(76.3)
19(23.8)
.040*
Q7
NO
YES
128(62.7)
76(37.3)
8(29.6)
19(70.4)
93(47.9)
101(52.1)
29(36.3)
51(63.8)
.001*
Q8
NO
YES
95(46.6)
109(53.4)
4(14.8)
23(85.2)
80(41.2)
114(58.8)
31(38.8)
49(61.3)
.016*
Q9
NO
YES
121(59.3)
83(40.7)
6(22.2)
21(77.8)
109(56.2)
85(43.8)
48(60.0)
32(40.0)
.003*
Q10
NO
YES
90(44.1)
114(55.9)
8(29.6)
19(70.4)
71(36.6)
123(63.4)
37(46.3)
43(53.8)
.193
0
20
40
60
80
100
RESPONSES
CORRECT INCORRECT
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The chi-square table for education when compared
with questions reveals a significant difference
when compared with education level. The major
contributors to the significant chi square test are
based on the percentages. It was identified that the
cells “10th
&12th
”column and the “medical &
paramedical” column show a significant difference
with 55.8(77.9-22.7) for “10th
& 12th
” column and
70.4 difference for “medical & paramedical”
column.
For Q2, Q3, Q4, Q5, Q6,Q7,Q8,Q9 the p –value is
significant, hence education is a major contributor
for perception of clinical trials. The probability of
chi square test statistic is 4.76 with the p=0.193,
greater than α level of significance of 0.05.
Table 6: Age
AGE
Question
18-25 26-35 36-45 ABOVE 46 P- Value
Q1
NO
YES
23(65.7)
12(34.3)
189(61.6)
118(38.4)
106(71.6)
42(28.4)
6(40.0)
9(60.0)
.040*
Q2
NO
YES
25(71.4)
10(28.6)
173(56.4)
134(43.6)
99(66.9)
49(33.1)
4(26.7)
11(73.3)
.004*
Q3
NO
YES
20(57.1)
15(42.9)
160(52.1)
147(47.9)
101(68.2)
47(31.8)
6(40.0)
9(60.0)
.006*
Q4
NO
YES
24(68.6)
11(31.4)
153(49.8)
154(50.2)
88(59.5)
60(40.5)
9(60.0)
6(40.0)
.068
Q5
NO
YES
18(51.4)
17(48.6)
128(41.7)
179(58.3)
78(52.7)
70(47.3)
6(40.0)
9(60.0)
.135
Q6
NO
YES
27(77.1)
8(22.9)
240(78.2)
67(21.8)
121(81.8)
27(18.2)
10(66.7)
5(33.3)
.527
Q7
NO
YES
23(65.7)
12(34.3)
141(45.9)
166(54.1)
88(59.5)
60(40.5)
6(40.0)
9(60.0)
.011*
Q8
NO
YES
14(40.0)
21(60.0)
128(41.7)
179(58.3)
63(42.6)
85(57.4)
5(33.3)
10(66.7)
.915
Q9
NO
YES
22(62.9)
13(37.1)
162(52.8)
145(47.2)
89(60.1)
59(39.9)
11(73.3)
4(26.7)
.186
Q10
NO
YES
13(37.1)
22(62.9)
116(37.8)
191(62.2)
69(46.6)
79(53.4)
8(53.3)
7(46.7)
.221
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Figure 5: Education
Figure 6: Age
Figure:7 Gender
0
20
40
60
80
100
Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10
EDUCATION
10TH AND 12TH MEDICAL AND PARAMEDICAL DIPLOMA AND UG PG
0
20
40
60
80
100
Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10
AGE
18 TO 25 26 TO 35 36-45 ABOVE 46
0
20
40
60
80
100
Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 Q10
GENDER
FEMALE MALE
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GENDER
ANNUAL
INCOME
Question
BELOW
1,00,000
1,00,001-2,00,000 2,00,001-
3,00,000
ABOVE
3,00,001
P- Value
Q1
NO
YES
177(76.6)
54(23.4)
106(54.1)
90(45.9)
9(33.3)
18(66.7)
32(62.7)
19(37.3)
.000*
Q2
NO
YES
167(72.3)
64(27.7)
101(51.5)
95(48.5)
5(18.5)
22(81.5)
28(54.9)
23(45.1)
.000*
Q3
NO
YES
145(62.8)
86(37.2)
104(53.1)
92(46.9)
12(44.4)
15(55.6)
26(51.0)
25(49.0)
.077
Q4
NO
YES
139(60.2)
92(39.8)
94(48.0)
102(52.0)
13(48.1)
14(51.9)
28(54.9)
23(45.1)
.078
Q5
NO
YES
122(52.8)
109(47.2)
77(39.3)
119(60.7)
13(48.1)
14(51.9)
18(35.3)
33(64.7)
.017*
Q6
NO
YES
193(83.5)
38(16.5)
146(74.5)
50(25.5)
20(74.1)
7(25.9)
39(76.5)
12(23.5)
.120
Q7
NO
YES
143(61.9)
88(38.1)
86(43.9)
110(56.1)
7(25.9)
20(74.1)
22(43.1)
29(56.9)
.000*
Q8
NO
YES
102(44.2)
129(55.8)
77(39.3)
119(60.7)
6(22.2)
21(77.8)
25(49.0)
26(51.0)
.094
Q9
NO
YES
141(61.0)
90(39.0)
100(51.0)
96(49.0)
15(55.6)
12(44.4)
28(54.9)
23(45.1)
.224
Q10
NO
YES
98(42.4)
133(57.6)
74(37.8)
122(62.2)
11(40.7)
16(59.3)
23(45.1)
28(54.9)
.707
One of the important players of clinical trials is the
volunteers. Volunteers, either patient or healthy,
are recruited from the general population. Hence
awareness of clinical trial among the public,
especially its importance in new drug development
would help them take part in clinical trials. But it is
not known to what extent the public are aware of
clinical trials. Hence this study was under taken to
find out whether the public know about clinical
trials. The evaluation tool used was a questionnaire
containing questions regarding general knowledge
about clinical trials. From the evaluation tool, it
was observed that majority of the participants have
not heard the term clinical trial. A few of them
have heard the term but they do not know about the
clinical trials. Many participants did not know why
clinical trials are conducted and whether it is tested
in humans or not. But majority of them had said
that clinical trial is an ethical one and it benefits the
society. Both the male and female participants
have responded almost equally. But the level of
education and the age of the participants have
influenced the response. The medical and para
medical graduates have responded better than the
others. The older participants (above 50 years) and
those between 26 to 35 have scored better than the
rest of the participants.
10. Balasubramanian J et al / Int. J. of Allied Med. Sci. and Clin. Research Vol-1(1) 2013 [8-17]
www.ijamscr.com
~ 17 ~
CONCLUSION
The older participants would have had the chance
to participate more than one trial and that would
have improve their performance. It can be stated
from the present study that specific knowledge
pertaining to clinical trials among the general
populations is inadequate hence conducting
awareness program is essential in order to improve
both the public participation and the current status
of clinical trials in India. According to this expert
group, the most important forms of scientific
misconduct in clinical trials are selective reporting
and the opportunistic use of the play of chance.
Fraud and misconduct in clinical research can be
overcome only by proper education to participant.
REFERENCES
[1] http://www.clinicalresearch.com/Research/Pages/HistoryofClinicalResearch.aspx
[2] Brater DC, Daly WJ. Clinical pharmacology in the Middle Ages: principles that presage the 21st
century. ClinPharmacolTher. 2000 May;67(5):447-50.
[3] Drugs from Discovery to Approval (second edition), Rick NG, PhD, MBA-A-Bio Pharmapte Ltd,
Singapore, WILEY-BLACKWELL ( A John Wiley & sons ltd, publication)
[4] SurbhiSarafDeodia ,G. R. Soni , V. K. Kashyap and N. K. Jain. Overview of Global Standards and
Indian Scenario,Indian J. Pharm. Educ. Res. 44(2), Apr-Jun, 2010
[5] http://www.researchandmarkets.com/reports/1884753/
[6] Amrit B Karmarkar.. Current Trends in Clinical Research: Indian Perspective. WebmedCentral
CLINICAL TRIALS 2012; 3(3):WMC002996
[7] http://www.researchandmarkets.com/reports/339460/
[8] D. Sreedhar, Manthan D Janodia, Virendra S Ligade, Ajay Pise and N. Udupa Clinical Trials in India:
Current Scenario and Future Outlook Article: THE PHARMA REVIEW (MAY 2009)
[9] Horacio Murillo, MD, PhD, E. Albert Reece, MD, PhD, MBA, Ralph Snyderman, MD, and
[10]Nancy S. Sung, PhD: Meeting the Challenges Facing Clinical Research: Solutions Proposed by Leaders
of Medical Specialty and Clinical Research Societies. Academic Medicine, Vol. 81, No. 2 / February
2006
[11]http://www.docstoc.com/docs/49827286/FICCI-white-paper-on-clinical-trial-scenario-in-India
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