Clinical research involves investigating investigational products in human subjects to discover or verify their clinical, pharmacological, and toxic effects. Clinical trials help translate basic scientific research into better ways to prevent, diagnose, or treat disease. Conducting clinical research in pediatric populations requires special considerations due to important developmental differences compared to adults. Key areas of difference include organ maturation, drug absorption, distribution, metabolism, and elimination, which can vary significantly across pediatric age groups from neonates to adolescents. Informed consent from parents or guardians is required. Clinical trials in pediatrics aim to establish safe and effective treatments while minimizing risk.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
Pharmacogenomics is new science about how the systematic identification of all the human genes, their products, interindividual variation, intraindividual variation in expression and function over time affects drug response/metabolism, etc.
Improve drug safety and reduce ADRs. The presentation explained the advantages of pharmacogenomics. Explained Goals of Pharmacogen(etics)omics.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
Pharmacogenomics is new science about how the systematic identification of all the human genes, their products, interindividual variation, intraindividual variation in expression and function over time affects drug response/metabolism, etc.
Improve drug safety and reduce ADRs. The presentation explained the advantages of pharmacogenomics. Explained Goals of Pharmacogen(etics)omics.
Guideline on patient safety and well being in clinical trialsTrialJoin
Patient safety is and should be the number one priority in clinical research. Human participants in a clinical trial are necessary in order to improve and develop new therapies for certain conditions and advance the understanding of how a condition can be treated. Such medical advancements wouldn’t be possible without human subjects as participants. However, even though we all know the importance of clinical trials in the advancement of medicine, most people still have some misconceptions regarding this topic.
The feeling of being treated as a ‘’guinea pig’’ and fear of potential risks and side effects are still common among patients who suffer from a certain condition. Such misinformation and misconceptions regarding clinical trials can unnecessarily prevent patients from finding a potential cure or relief, and can also decrease the number of enrolled patients in studies.
In order to clarify these misunderstandings, we’ve decided to tell you everything there is to know about patient safety in clinical trials. We hope that with this information we can help you to better understand patient safety in clinical trials so that you gain more insight and start considering clinical trials as valid options that can help you improve any condition.
FDA 2013 Clinical Investigator Training Course: Clinical Discussion of Specia...MedicReS
FDA 2013 Clinical Investigator Training Course: Clinical Discussion of Special Populations
Ryan P. Owen, Ph.D.. Office of Clinical Pharmacology, Office of Translational Sciences,CDER
Clinical, ethical and legal considerations in the treatment of newborns 2008Dominique Gross
Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy.
The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient.
The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.
2008 Elsevier Inc
Iacapap workshop on PRESCRIBING FOR CHILDREN AND ADOLESCENTS: PERSPECTIVE FR...Devashish Konar
Discusses the best way to reach the minimum important information to professionals who deal with mental health of children and adolescents and prescribe psychotropic medicines to them.
Screening Tool for Developmental Disorders in ChildrenApollo Hospitals
Developmental problems are a diverse group of conditions that affect and limit children and their life-chances. A ready reference for a Paediatrician would be the first six chapters of the latest edition (18th) of the Nelson Textbook of Pediatrics (The Field of Pediatrics, Growth & Development, Psychological Disorders, Social Issues, Children with Special Health Needs and Nutrition and Human Genetics and Metabolic Diseases).
DNP- TRANSLATIONAL RESEARCH AND EVIDENCE- BASED PRACTICE 2DNP.docxmadlynplamondon
DNP- TRANSLATIONAL RESEARCH AND EVIDENCE- BASED PRACTICE 2
DNP- TRANSLATIONAL RESEARCH AND EVIDENCE- BASED PRACTICE 2
DNP-Translational Research and Evidence-Based Practice
DNP-820-O501: Translational Research and Evidence-Based Practice
Grand Canyon University
September 26, 2019
DNP-Translational Research and Evidence-Based Practice
Introduction of the Identified Subtheme
The role of medical administration has advanced lately and become more demanding and time-consuming task leading to high possibility error due to the complexity of the medication administration. The fact remains that the patient relies on other people who control their life to keep them alive. It has led to the significant impact of young children suffering from leukemia when physicians administer the wrong drugs or cause an error on prescriptions.
Medication administration error is not a unique thing according to the review articles. Upon review of the identified items, most of the research concentrated on the after effect of the wrong administration while others focus on the process that leads to incorrect prescriptions leading to more sickness and problem on the children. One of the significant contents is the damage to the cognitive development of the children even after successful treatment. It shows that the moment a child is given the wrong drug other than the one to treat leukemia, it led to slow development of motor skills even after the change of the medication.
Another content identified is the ability to cope with pain due to medication error. The articles focus on the panic caused to the children under five-year old now changing the medication and prolonged time to take the actual drug. Another significant effort of error in drug administration include an increased rate of fungal and bacterial infection on young children developing a life-threatening disease. It shows that medical error on young children suffering from leukemia lacks enough blood cell, especially white blood cell to fight other the wrong drug in the blood leading to high risk of additional infection. Another impact includes difficult in developing adaptive function compared with other children of the same age group. It led to the loss information process even after recovering from leukemia.
Error in the administration of the right medication in children suffering from leukemia is highly associated with cancer. Wrong medicine administers to children mostly led to cancer since the children have no capabilities of fighting the drug on their own leading to worsening of the leukemia conditions. Given the presence of a parent in raising the children, medical administration error also leads to post-traumatic stress to the parents and guardian since they fear the children may fail to recover or lead to other mental problems.
Summary of the Research Question Posed by the Studies
Some issues include the process of prescribing, dispensing, and parental administration of these dru ...
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
1. What is a Clinical Research?
1;Any investigation in human subjects intended to discover or verify the
clinical, pharmacological and other pharmacodynamic/kinetic;;adr;;toxicity
& efficacious effects of an investigational product(s)
Clinical research may need to conduted in certain study subjectsgroups
includes;; childern;; women;;the elders to gain drug development approch
in these groups.
1
2;Clinical trials translate results of basic scientific research into better
ways to prevent, diagnose, or treat disease
The more people take part, the faster we can:
- Answer critical research questions
- Find better treatments and ways to prevent disease
3;This process of stating must consider a series of
questions.
-What data / decision is neede
-Is a specific trial required?
-Which trial design will deliver what is required?
-What use will be made of the results?
-What hypothesis is being tested or what are the precise
objectives?
2. Children are not just “little adults,” and lack of data on
important pharmacokinetic and pharmacodynamic difference
has led to several effectable situations in paediatrics .
The rate and extent of organ function development and
thedistribution, metabolism, and elimination of drugs differ not
only between pediatric versus adult patients but also among
paediatrics age groups .
The effectiveness and safety of drugs may vary among various
age groups and from one drug to another in pediatric versus adult
patients
3. PEDIATRICS AGE CLASSIFICATION ;
Preterm newborn infants
Term newborn infants {neonates}
(0 to 27 days)
Infants and toddlers (28 days to
23 months)
Children (2 to 11 years)
Adolescents [12 to 16/18 years )
3
4. PRE-TERM NEW BORN INFANTS
The study of medicinal products in pre-term
newborn infants presents special challenges
because of the unique pathophysiology
and responses to therapy in this population.
The complexity of and ethical considerations
involved in studying pre-term newborn
infants suggest the need for careful protocol
development with expert input from
neonatologists and neonatal pharmacologists.
4
5. Important features that should be
considered for these patients include ;
Gestational age at birth and age after birth (adjusted age)
Immaturity of renal and hepatic clearance mechanisms
Protein binding and displacement issues (particularly bilirubin)
Penetration of medicinal products into the (CNS)
Unique neonatal disease states (e.g., respiratory distress
syndrome of the newborn, patent ductus arteriosus, primary
pulmonary hypertension)
Unique susceptibilities of the preterm newborn (e.g., necrotizing
enterocolitis, intra-ventricular hemorrhage, retinopathy of
prematurity)
Rapid and variable maturation of all physiologic and
pharmacologic processes leading to different dosing regimens
with chronic exposure; and
Transdermal absorption of medicinal products and other
chemicals.
5
6. NEONATES (O TO 27 DAYS )
Although, term newborn infants are developmentally
more mature than preterm newborn infants, many of the
physiologic and pharmacologic principles also apply to
term infants.
Vd of medicinal products may be different from
those inolder pediatric patients because of
different body water and fat content and
high body-surface-area-to-weight ratio.
BBB is still not fully mature and medicinal
products and endogenous substances
(e.g., bilirubin) may gain access to the CNS with
resultant toxicity.
6
7. ;;;;;;;;Cntnu
Oral absorption of medicinal products may be less
predictable than in older pediatric patients.
Hepatic and renal clearance mechanisms are
immature and rapidly changing; doses may need to
be adjusted over the first weeks of life.
Many examples of increased susceptibility to toxic
effects of medicinal products result from limited
clearance in these patients (e.g., chloramphenicol grey
baby syndrome).
On the other hand, term newborn infants may be less
susceptible to some types of adverse effects
(e.g.,aminoglycoside nephrotoxicity) than are patients in
older age groups.
7
8. INFANTS AND TODDLERS
(28DAYS TO 23MONTHS) ;
Oral absorption becomes more reliable.
This is a period of rapid CNS maturation, immune
system development and total body growth.
Hepatic and renal clearance pathways continue to
mature rapidly.
By 1 to 2 years of age, clearance of many drugs on
a mg/kg basis may exceed adult values.
The developmental pattern of maturation is
dependent on specific pathways of clearance.
8
9. CHILDREN (2 TO 11 yrs):
Most pathways of drug clearance (hepatic and renal)
are mature, with clearance often exceeding adult
values. Changes in clearance of a drug may be
dependent on maturation of specific metabolic
pathways.
The onset of puberty is highly variable and occurs
earlier in girls, i.e. as early as 9 years of age.
Puberty can affect the apparent activity of enzymes
that metabolize drugs, and dose requirements for
some medicinal products on a mg/kg basis may
decrease dramatically (e.g., theophylline).
9
10. ADOLESCENTS:12 TO 16-18yr ;
This is a period of sexual maturation; medicinal products may
interfere with the actions of sex hormones and impede
development. In certain studies, pregnancy testing and review
of sexual activity and contraceptive use may be appropriate.
This is also a period of rapid growth and continued
neurocognitive development.
Many diseases are also influenced by the hormonal changes
around puberty (e.g., increases in insulin resistance in
diabetes mellitus, recurrence of seizures around menarche,
changes in the frequency and severity of migraine attacks and
asthma exacerbations). Hormonal changes may thus
influence the results of clinical studies.
10
11. Major Physiologic Variations In
Pediatrics
Generally, in children and elderly people, drugs and biological
products behave similarly than in 18-65 year-old population.
The important pharmacokinetic variables such as immature or
aging enzyme metabolism systems as well as elimination rates
affected by immature or aging organs of excretion must be
properly adjusted.
In neonates, the gastric pH is biphasic- High in first few days
of birth and decreases by 30th day, but takes 5-12 years for
the adult pattern and a constant value to emerge.
On the other hand, methylation pathway, which is not
important in adults, is well developed in children.
Furthermore, Acetaminophen is less toxic to children than
adults, because it utilizes sulphate metabolic pathway.
11
12. The informed consent process is the foundation ofany ethical
research.Researchers should have a clear understanding of the
process on a theoretical and practical level to conduct ethics
studies, to improve parents’/patients’ understanding and
expectation, and to improverecruitment rates.
in accordance with the Declaration of Helsinki on ethical principles
In any research on human beings, each potential subject must be
adequately informed of the aims, methods, anticipated benefits
and potential hazards of the study and the discomfort it may
entail. He or she should be informed that he or she is at liberty to
abstain from participation in the study and that he or she is free
to withdraw his or her consent to participation at any time.
As a rule, a pediatric subject is legally unable to provide informed consent.
Therefore, pediatric study participants are dependent on their
parent(s)/legal guardian to assume responsibility for their participation in
clinical studies.
Fully informed consent should be obtained from the legal guardian in
accordance with regional laws or regulations. All participants should be
informed to the fullest extent possible about the study in language and
terms they are able to understand.
12
Informed consent
13. Phase I studies are usually avoided in paediatrics because the risk to a
child is more than minimal. The chance of having a significant clinical is minimal.
Institutional Review Board/Independent Ethics Committee
(IRB/IEC):
The roles and responsibilities of IRB’s/IEC’s as detailed in ICH E6 are critical to
the protection of study participants. When protocols involving the pediatric
population are reviewed, there should be IRB/IEC members or experts consulted
by the IRB/IEC who are knowledgeable in pediatric ethical, clinical, and
psychosocial issues
When studies are conducted in the pediatric population, an attempt should be
made to include individuals representing the demographics of the region and the
disease being studied, unless there is a valid reason for restricting enrollment.
Investigators should be fully aware before the start of a clinical study of all
relevant preclinical and clinical toxicity of the medicinal product.
To minimize risk in pediatric clinical studies, those conducting the study should
be properly trained and experienced in studying the pediatric population,
including the evaluation and management of potential pediatric adverse events.
14. Types of paediatric clinical trials
•Paediatric formulation studies.
•Pharmacokinetic studies
•Pharmacodynamics studies
•Efficacy & safety study
•Cohort study
•Case control study
•Trail design for rare diseases;;{ involves open
protocol design;;Cross over design;;suurogate end
point study;;meta analysis }