Clinical Trials and developing Clinical trial Protocols.pptx

This document describes the detailed information of clinical trial protocol and protocol design. The protocol includes the key information of study designs. This document is downloaded as a PDF and viewed online.

1. Clinical Trials & Developing Protocols Prepared By - Shaikh Abubakar Pharmaceutics Department MPH12 Yash Institute of Pharmacy, Abad. 1

2. Clinical Trials A clinical trial is a research study conducted with human participants to evaluate the effects, safety, and effectiveness of a new treatment, drug, medical device, or intervention. Clinical trials follow a structured plan (protocol) and are designed to answer specific health questions while ensuring the safety and well-being of the participants. Clinical trials are an essential part of the process of evidenced based practice and can help guide treatment decisions for both health care professionals and patients. 2

3. Why Clinical Trials are important? Clinical trials are the best way to compare different approaches to preventing and treating illness and health problems. Health professionals and patients need the evidence from trials to know which treatments work best. Without trials, there is a risk that people could be given treatments which have no advantage, waste resources and might even be harmfull. Some types of clinical trial are designed to look at a treatment at an early stage of its development and some have serious side effects, it may not be developed further. 3

4. Phases of Clinical Trials Clinical trial phases are steps in the research to determine if an intervention would be beneficial to humans and include Phases 0, I, II, III, IV. In Phase 0, pharmacodynamics and pharmacokinetics are determined. In Phase 1, Safety studies are evaluated In Phase 2, Efficacy of drug determined. In Phase 3, Confirmation of Safety and Efficacy. In Phase 4, Post Marketing Surveillance. 4

5. Phases of Clinical trials Phase 0 Phase 1 This Phase is designed to explore Pharmacokinetics and Pharmacodynamics of the drugs particularly its oral Bioavailability. Doses are sub-therapeutic and patients are monitored by clinical researcher & it involves 10 patients. Phase 1 Clinical trials are the first stage of testing in human subjects. The aim of phase 1 trial is to determine the maximum tolerated dose (MTD) of the new treatment Normally 20-100 people are selected for clinical studies to evaluate the safety of the drugs, dose ranging . Phase 1 trials most often include healthy volunteers. Phase 2 Once a dose or range of doses is determined, the next goal is to evaluate whether the drug has any biological activity or effect. Phase 2 trials are performed on larger groups (100-300) and are designed to assess how well the drug works, as well as to continue phase 1 safety assessments. Phase 3 Phase 3 trials are the full scale evaluation of treatment and are designed to compare efficacy of the new treatment with the standard treatment. This is Pre-marketing phase of clinical trials . This phase have larger group i.e 100-3000 peoples. Phase 4 This Phase has been conducted when the drug has been marketed . It is also known as post marketing surveillance. This phase studies continue to collect data about effects in various populations & side effects From long term use. It helps to detect ADR's , Drug interactions. 5

6. Developing Clinical Trial Protocol Every clinical investigation begins with development of clinical research protocol. the protocol is a document that describes how a clinical trial will be conducted and ensures the safety of the trial subjects and the integrity of the data collected. the clinical trial should be carried out by a written protocol agreed and signed by investigator and the sponsor. The current regulator CDSCO (Central Drug Standard Control Organization), established in India by the D&C Act 1945, has provided guidelines regarding the contents of clinical trial protocol. The Actual writing of protocol is team effort with contributions from medical expert, a statistician, a pharmacokinetics expert, the clinical research coordinator and project manager, who all provide input to the medical writer to produce the final document. 6

7. After researchers test new drugs, therapies or procedurers in vitro and in animals (pre-clinical studies), the experimental treatments with the most promising laboratory results are moved into clinical trials The protocol describes what clinical trial experts will do in the study, what types of people may participate in trial, schedule of tests, procedures, medications, dosages and the length of the study. A protocol is carefully designed and controlled study plan to safeguard the health of the participants as well as to answer specific research questions. Health of the participants is checked before the commencement of the trial, specific instructions are given for participation, regular monitoring of the participant is done carefully during the whole study ans stay in touch is required even after the trial is completed. Clinical Trial Protocol 7

8. According to ICH good clinical practice guidelines, a trial protocol should include the following topics. General Information 9. Statistics 2. Background Information 10. Compliance with Protocol 3. Study trail protocol 11. Quality control and Quality Assurance 4. Study design 12. Ethics 5. Selection and withdrawal of subjects 13. Data management 6. Treatments of Subjects 14. Financing and Insurance 7. Assessments of Efficacy 15. Publication policy 8. Assessments of Safety Clinical Trial Protocol 8

9. General Information Title page introduced and documented, its title, precise number, sponsor(individual, company, firm, organisation)and author to reader. Protocol title, protocol identifying number, and datename & address of the sponsor. Name & Address of the investigator(s) who is responsible for conducting the trial, and the address and the telephones of the trial sites. Name, Title, address and telephone number of the qualified physician, who is responsible for all trial-site related medical decisions. 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. 9

10. The product name and description for the experimental product. List of the benefits if any and known risks to human subjects. An overview of results from clinical trials that are important to the trial as well as non-clinical research that may have clinical significance. An explanation and safety of the dosage, schedule, route of administration and duration of treatments. A declaration that the trial will be carried out following the applicable regulatory requirement, Good clinical practices (GCP) and protocol. An explanation of the population under study. Background Information 10

11. Study Trial Protocol 11 A detailed description of the Major (Primary) and minor (Secondary and exploratory), Objective, Purpose of trial

12. The scientific integrity of the study and the credibility of the dta obtained from the study largely depend on the study design This section of the protocols should describes, Primary and secondary endpoints to be measured A description of the type/design of the trial to be conducted (eg. double-blind, placebo-controlled, parallel design), procedures and stages. 3. Dosage and dosage rule, dosage form packaging and labeling of investigational product 4. Stopping rules or Discontinuous criteria for individual participants, parts of study and entire study. Study design 12

13. Procedure of withdrawal of subjects When and how to withdrawal of participants from study Type and timing of data to be collect for participants who withdraw from study Whether and how are to be replaced Follow up participants from trial treatment Selection and withdrawal of Subjects 13

14. The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group. Treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial. Procedures for monitoring subject compliance. Treatment of Subjects 14

15. This section describe the methods that will be used to determine the success of the treatment including : Criteria for determining the effectiveness of the treatment Methods and timing for assessing, recording and analyzing efficacy parameters Assessment of Efficacy 15

16. Specifications of safety parameter The method and timing for assessing, recording and analysing safety parameter Procedure for eliciting report of and for recording and reporting adverse events and intercurrent illness. The type and duration of the follow up of subjects after adverse events Assessment of Safety 16

17. A description of the statistical method to be employed, including the timing of any planned interim analysis. The number of subjects planned to be enrolled. The level of significance to be used Projected for each trial site should be specified. The selection of subjects to be included in the analyses (all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects). Criteria for the termination of the trial. Procedures for reporting any deviations from the original statistical plan. Statistics 17

18. The investigator/Institution should conduct the trial in compliance with the protocol agreed by the sponsor and, if required, by the regulatory authorities and which was given approval/favorable opinion by IRB/IEC. The investigator/institution and the sponsor should sign the protocol, or an alternative contract, to confirm the agreement. Compliance with Protocol 18

19. QC in clinical trials means the procedure which ensure the protection of human subjects form research risk, reliability of the data, and there by assures internal consistency. QA is clinical trial consist of planned, systematic activities that are conducted to ensure that a trail is performed and trail data are generate documented, and reported in compliance with the protocol, and all other applicable regulatory requirements. Quality Control and Quality Assurance 19

20. This section should describes ethical considerations relating to the study and measures taken to protect human participants and maintain confidentiality of the clinical trial study data management. Ethics 20

21. The data management plan describes the procedure that will ensure data integrity throughout study and at all study sites including. A description of data system design and development Data collection methods and activities Methods of data entry and editing Procedures for data monitoring reporting and transfer Recipient data and procedures for data publication. Data Management 21

22. Financing and Insurance 22 It must include financing and insurance if not addressed in a separate agreement. It may include funding source conflict of interest, subjects stipends or payment, subject insurance as per regulatory guidelines.

23. The policies and procedures relating to publication of findings from the study. In some research networks, policies and guidelines are established for research for the publications planning process. The trail results will also be published on public websites. The public websites will not identify participants, but will provide a resource for clinical trial participants and those seeking clinical trial involvement, to inform themselves. Publication Policy 23

24. Thank you! 24