Clinical reaserch 112070804001


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Clinical reaserch 112070804001

  1. 1. GUIDED BY:- PRESENTED BY:-Mr. Mushir Mansuri PARTH PATEL M.Pharm Sem:-1 Quality Assurance 1
  2. 2. TABLE OF CONTENTS1. Clinical research Introduction2. Protocols,3. Objectives,4. design. 2
  3. 3. Clinical Research:“ Clinical research is the key to the discovery oflatest diagnostic method and to develop moderndrugs for the treatment of diseases.’’ 3
  4. 4. The Way We Make Progress Against Disease 4
  5. 5. What Are Clinical Trials? According to WHO:- It is systemic study on pharmaceutical product in human subject in order to discover the effect & identify any AR/to study ADME of product for their safety and efficacy. There are interventional and observational types of studies.1. Interventional studies :- Are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured.2. Observational studies :- Are those in which individuals are observed and their outcomes are measured by the investigators. 5
  6. 6. Why Are Clinical Trials Important? 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 6
  7. 7. What are the benefits and risks of participating in a clinical trial? Benefits:- Clinical trials that are well-designed and well- executed are the best approach for eligible participants to: Patients will receive, at a minimum, the best standard treatment (if one exists) If the new treatment or intervention is proven to work, patients may be among the first to benefit Patients have a chance to help others and improve patient care 7
  8. 8. Risks:- There are risks to clinical trials. There may be unpleasant, serious or even life- threatening side effects to experimental treatment. The experimental treatment may not be effective for the participant. The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements. 8
  9. 9. Types of Clinical Trials1. Treatment2. Prevention3. Early detection/screening4. Diagnostic5. Quality of life/supportive care 9
  10. 10. Treatment Trials What new treatments can help people with a particular disease? What is the most effective treatment for people with that disease? 10
  11. 11. Prevention Trials Evaluate the effectiveness of ways to reduce therisk of a particular disease Enroll healthy people at high risk for developingthat disease Include medicines, vitamins vaccines, minerals orlifestyle change. 11
  12. 12. Screening and Early-Detection TrialsFind test for detecting a particular disease. Detecting disease at an earlier stage, resulting in improved outcomes SUPPORTIVE CARE TRIAL To improve comfort and quality of life for individual with chronic illness. 12
  13. 13. Diagnostic Trials Develop better tools for diagnosing particular condition or disease. Possible benefits:  New technology may be better and less invasive  Earlier detection of recurrences Possible risk:  May require people to take multiple tests 13
  14. 14. Clinical Trial PhasesConducted in four phases. PHASE-1 How does the agent affect the human body? What dosage is safe? It is undertaken to find out –  The safety and toxicity  Biological activity and tolerability  Pharmacokinetic parameters Researchers test a new drug or treatment in a small group of people(20-80) for the first time. 14
  15. 15. PHASE-2 Phase 2 trials continue to test the safety of the new agent, and begin to evaluate how well it works against a particular disease. In phase 2 trials, the new agent is given to groups of people with the disease in question, using the dosage found to be safe in phase 1 trials. If a new agent has demonstrated that it works against the disease and is safe for people in phase 2 trials, it enters a phase 3 trial. Phase 2 trials usually have less than 100 participants. 15
  16. 16. PHASE-3 It include controlled clinical trials where a new drug therapy is compared with the previously established therapy or placebo, under standardized conditions. In this drug/treatment is given to a large group of peoples (1000-3000) to conform its effectiveness monitor side effect, compare it to commonly used treatment and collect information that will allow drug or treatment to be used safely. 16
  17. 17. PHASE-4 POST MARKETING STUDY PHASE The real clinical status and the nature and frequency of adverse reaction often becomes apparent only the drug is released for general use. It include additional information like drug’s use , benefits and optimal use. 17
  18. 18. Further trials Clinical research continues throughout the lifetime of the test article to include post marketing surveillance where a periodic progress report is submitted to the regulatory authorities once every 2 years after the test article is released into the market, and such as pharmacovigilance where the safety of marketed drugs, biologics or medical devices are monitored. The focus of clinical research is wide enough to include important items such as data management, medical writing, regulatory consultation, and biostatistics. The clinical trials are regulated by country specific Health Regulatory Agencies such as the Food and Drug Administration (FDA) in the U.S. and the European Medicines Agency (EMEA) in the European Union. 18
  19. 19. Summary of Phases I-III # Length Purpose % Drugs Successfully Subjects TestedPhase 20 – 100 Several Mainly Safety 70%I monthsPhase Up to Several Short term 33%II several months- 2 safety; mainly 100 yrs. effectivenessPhase 100s – 1-4 yrs. Safety, dosage & 25-30%III several effectiveness 1000
  20. 20. Stage/Phase Time to CompletePre Clinical 4 YearsPhase I 1.3 YearsPhase II 2.1 YearsPhase III 1.5-Several YearsPhase IV Total Time to Complete Testing 15 Years
  21. 21. Key Players in a Clinical Trial Sponsor Investigation Site Team IRB/IEC Regulatory Authority/Competent Authority Subject/Participant Contract Research Organization 21
  22. 22. Clinical Trial Protocol The contents of a trial protocol should generally include the following topics:-General Information:-1. Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).2. Name and address of the sponsor and monitor (if other than the sponsor).3. Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor.4. Name, title, address, and telephone number(s) of the sponsors medical expert (or dentist when appropriate) for the trial. 22
  23. 23. 5. Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).6. Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator).7. Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial. 23
  24. 24. Background Information:-1. Name and description of the investigational product(s).2. A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.3. Summary of the known and potential risks and benefits, if any, to human subjects.4. Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).5. A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).6. Description of the population to be studied.7. References to literature and data that are relevant to the trial, and that provide background for the trial. 24
  25. 25. Protocol- Relevant components General Information Objectives and Justification Ethical considerations Study design Inclusion, Exclusions & withdrawal of subjects Handling of products 25
  26. 26. Protocol- Relevant components Assessment of Efficacy Assessment of safety Statistics Data handling & management Quality control & quality assurance Finance and Insurance Publication policy Evaluation Supplementaries & Appendices 26
  27. 27. Protocol- General Information Protocol Title, identifying number & date. Amendment number Contact names, addresses Name and title of Authorized signatory Contact medical expert Contact investigator(s) Institution(s), Laboratories, department contact 27
  28. 28. Protocol- Objective & Justification Aims & objectives, phase of study Name & description of Inv product Summary of non clinical & clinical studies Summary of risks & benefits Description of route of administration, dosage Statement of GCP compliance 28
  29. 29. Protocol- Study Design A Description of trial Design should include,1. A description of design of trial to be conducted, Double blind Placebo control Parallel design2. A description of measure taken to minimize or avoid Bios Randomization Blinding 29
  30. 30. Protocol- Study Design3. Packing/labeling description4. Proposed date of initiation of study5. Discontinuation criteria for subjects6. Instructions on suspending or terminating the study7. Procedures for monitoring compliance 30
  31. 31. PLACEBO CONTROLLED STUDY: A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition. Endpoint: A primary or secondary outcome used to judge the effectiveness of a treatment. 31
  32. 32. Clinical Trial Design Randomization: A method used to prevent bias in research; a computer or a table of random numbers generates treatment assignments. Participants have an equal chance to be assigned to one of two or more groups: One gets the most widely accepted treatment (standard treatment) The other gets the new treatment being tested, which researchers hope and have reason to believe will be better than the standard treatment 32
  33. 33. Randomization So all groups are as alike as possible Provides the best way to prove the effectivenessof a new agent or intervention 33
  34. 34. Clinical Trial Design Stratification: Categorizing subjects into subgroups by specific characteristics  Enables researchers to look into separate subgroups to see whether differences exist 34
  35. 35. Protocol- Inclusion Exclusion criteria Specifications of the subjects to be included (age, gender, ethnic groups, prognostic factors, diagnostic criteria) Specify exclusion criteria Subject withdrawal criteria & procedures Protocol- handling of products Safe handling and storage measures System to be followed for labelling Labeling specifications 35
  36. 36. Protocol- Efficacy assessment Specifications of efficacy parameters Descriptions of how these are measured and recorded Time & periodicity of recording Description of special analysis/ tests(PK, clinical, lab, radiology) 36
  37. 37. Protocol- Safety assessment Specifications of safety parameters Procedures for eliciting reports of and reporting ADR Time &method of recording Type, duration of follow up after adverse events) 37
  38. 38. Protocol- Statistics Description of statistical methods employed Details of enrollment plan Significance level, power Selection of subjects to be included in final analysis Procedure for reporting any deviation from original plan should be described & justified in protocol. 38
  39. 39. Protocol- Finance & insurance Budget, financial aspects Sources of economic support Subject payments Reimbursement to team members Insurance details of study subjects 39
  40. 40. How Are Patients’ Rights Protected?1. Informed consent2. Scientific review3. Institutional review boards (IRBs)4. Data safety and monitoring boards (DSMBs)Informed Consent:• Purpose• Procedures• Potential risks and benefits• Individual rights 40
  41. 41.  Scientific review Institutional review boards (IRBs) are required by federal law for trials that are: --Federally funded --Subject to FDA regulationData and safety monitoring boards: Ensure that risks are minimized Ensure data integrity 41
  42. 42. Why Do So Few People Participate in Clinical Trials?Sometimes patients: Don’t know about clinical trials Don’t have access to clinical trials May be afraid or suspicious of research Can’t afford to participate May not want to go against health care provider’s wishesHealth care providers might: Lack awareness of appropriate clinical trials Be unwilling to “lose control” of a person’s care Believe that standard therapy is best Be concerned that clinical trials add administrative burdens 42
  44. 44. Where to Get More Information1. H.P. Rang, M.M. Dale, J.M. Ritter, R.J. Flower, Rang and Dale’s Pharmacology, 6th edition, pp 92-96.2. Understanding Clinical Trials, 063. involved-in-pharmacovigilance-and-drug- safety 44
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