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See all Premium member Presentation Transcript CLINICAL TRIALS : CLINICAL TRIALS Sameena A khan 1 Acronyms : Acronyms GCP: Good Clinical Practices CFR: Code of Federal Regulations ICH: International Conference on Harmonisation CRF: Case Report Form FDA: Food and Drug Administration IRB: Institutional Review Board IND: Investigational New Drug SOP: Standard Operating Procedure 2 Definition : Definition A clinical trial is a research study in human volunteers to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects. 3 TYPES OF CLINICAL TRIAL : TYPES OF CLINICAL TRIAL 4 Treatment Prevention Early detection/screening Diagnostic Quality of life/supportive care 1.TREATMENT TRIAL : 1.TREATMENT TRIAL 5 Trials that test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. 2. Prevention Trial : 2. Prevention Trial 6 Trials to find out better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. 3. Early detection/screening : 3. Early detection/screening Trials to test the best way to detect certain diseases or health conditions. 7 4. Diagnostic Trial : 4. Diagnostic Trial 8 Trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. 5. Quality of life/supportive care : 5. Quality of life/supportive care Trials that explore and measure ways to improve comfort and the quality of life for individuals with a chronic illness. 9 Phases of clinical trial : Phases of clinical trial Phase I Phase II Phase III Phase IV 10 1.Phase–I(Human pharmacology) : 1.Phase–I(Human pharmacology) 11 In Phase - I researchers tests a new drug or treatment in a small group of people [20-80] for the first time to evaluate its Safety Determine a safe dosage range Identify side effects 2.Phase II(Therapeutic Exploratory) : 2.Phase II(Therapeutic Exploratory) 12 In Phase II, the study drug or treatment is given to a larger group of people [100-300] to see if it is EFFECTIVE. And to further evaluate its Safety. 3.Phase-III(Therapeutic Confirmatory) : 3.Phase-III(Therapeutic Confirmatory) 13 In Phase III, the study drug or treatment is given to large groups of people [1000-3000] to confirm its Effectiveness Monitor side effects Compare it to commonly used treatments Collect information that will allow the drug or treatment to be used safely. 4.Phase IV (Therapeutic Use) : 4.Phase IV (Therapeutic Use) 14 Phase IV trials are done after the drug or treatment has been marketed. These studies continue testing the study drug or treatment to collect information about their effect in various populations and any side effect associated with its long term use. Clinical Trials - Phases : Clinical Trials - Phases 15 Trial Design:Measurements : Trial Design:Measurements Safety Efficacy Primary endpoint/objective Secondary endpoint/objective 16 Key Players in a Clinical Trial : Key Players in a Clinical Trial 17 Sponsor Investigation Site Team IRB/IEC Regulatory Authority/Competent Authority (e.g FDA in US,DCGI in India etc) Subject/Participant Contract Research Organization Standards Governing Clinical Research : Standards Governing Clinical Research Declaration of Helsinki,1964 The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving subjects. Medical research involving subjects includes research on identifiable human material/identifiable data. 18 The Belmont Report,1979 : The Belmont Report,1979 The Belmont Report is a report created by the former United States Department of Health, education,& welfare entitled” Ethical principles and guidelines for the protection of human subjects of Research”and is an important historical document in the field of medical ethics. The report was created on April 18,1979 and gets its name from the Belmont Conference Centre where the document was drafted. 19 GCPs Defined : GCPs Defined GCPs are generally accepted, international best practices for conducting clinical trials . They are defined as an international ethical and scientific standard for designing, conducting, recording and reporting trials that involve the participation of human subjects 20 Slide 21: 21 They are NOT statutes or regulations and do not have the force of law Compliance with GCPs provide public assurance that the rights and safety of participants in human subject research are protected and that the data that arises from the study is credible The Thirteen Principles of GCP Guidance : The Thirteen Principles of GCP Guidance 22 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society The available non clinical and clinical information on an investigational product should be adequate to support the proposed clinical trial Slide 23: 23 Clinical trials should be scientifically sound, and described in a clear, detailed protocol. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks Slide 24: 24 Freely given informed consent should be obtained from every subject prior to clinical trial participation All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation, and verification .The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirements Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol Systems with procedures that assure the quality of every aspect of the trial should be implemented How to comply with ICH GCP : How to comply with ICH GCP Use qualified support staff Obtain informed consent Record information appropriately Protect confidentiality Handle investigational products appropriately Implement quality systems 25 Essential documents : Essential documents 26 Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Importance of Essential Documents : Importance of Essential Documents Demonstrate compliance of the Investigator, Sponsor/CRO, Monitor with GCP standards and applicable regulatory requirements. Timely filing greatly assists in successful management of a trial by the Investigator, Sponsor/CRO, Monitor. These files are vital in the audit/inspection process to demonstrate validity of trial conduct and integrity of the data. 27 List of essential documents : List of essential documents The various documents are grouped in 3 sections: Before the clinical phase of the trial commences During the clinical conduct of the trial After completion or termination of the trial 28 Before the clinical phase of the trial commences : Before the clinical phase of the trial commences Investigator’s Brochure Signed protocol and amendments Case Report Form (CRF) Informed Consent Form Financial aspect of the trial Insurance statement 29 Before the clinical phase of the trial commences, …..cont…. : Before the clinical phase of the trial commences, …..cont…. Signed agreement between involved parties Dated, documented approval of IRB/IEC IRB/IEC composition Investigator and sub-investigator’s curriculum vitae Laboratory normal range and certification 30 Slide 31: Before the clinical phase of the trial commences, …..cont…. Signed agreement between involved parties Dated, documented approval of IRB/IEC IRB/IEC composition Investigator and sub-investigator’s curriculum vitae Laboratory normal range and certification Before the clinical phase of the trial commences, …..cont…. : Before the clinical phase of the trial commences, …..cont…. Instruction for handling of investigational product Decoding procedures for blinded trials Randomization list Pre-trial and initiation monitoring report 32 During the clinical conduct of the trial : During the clinical conduct of the trial Investigator’s Brochure (update) Any revision to protocol, ICF, CRF etc. and IRB/IEC approval Update investigator’s curriculum vitae Update laboratory normal range and certification Monitoring report Relevant communication 33 During the clinical conduct of the trial,….Cont…. : During the clinical conduct of the trial,….Cont…. 34 Signed informed consent forms Source documents Signed, dated and completed CRF Documentation of CRF correction Signature sheet Notification of SAEs and related reports Interim or annual reports During the clinical conduct of the trial,….Cont…. : During the clinical conduct of the trial,….Cont…. 35 Subject screening log Subject enrolment log Subject identification code list Investigational products accountability After completion or termination of the trial : After completion or termination of the trial 36 Investigational products accountability Documentation of Investigational products destruction Completed subject identification code list Audit certificate Final trial close out monitoring report Treatment allocation and decoding documentation Final report to IRB/EC Clinical study report THANK YOU ALL : THANK YOU ALL 37 You do not have the permission to view this presentation. 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