clinical trial Management with ethics committee

clinical trial approaches with clinical trial management under ethics committee

1. Clinical Trial Management Clinical trial flow activities

2. Contents Introduction of Clinical trial 01 How to approach a Clinical trial 02 Application of Clinical Trial 03 Essential documents for Clinical trial 04

3. Keywords for Clinical trial 01 02 Experimental Unit Treatment & Evaluation An experimental unit is usually referred to as a subject from a targeted population under study . To analysis a result of study. Experimental Unit In clinical trials a treatment can be a placebo or any combinations of a new pharmaceutical identity (e.g., a compound or drug), a new diet, a surgical procedure, a diagnostic test, a medial device, a health education program, or no treatment. Evaluation of effectiveness and safety of the test treatment and all activities belongs to human begin Like cost , quality of life , genetic factor Treatment and Evaluation

4. Approach of clinical trial 1.Principal Investigator 2. Drug Feasibility 3. Possibility to check all data & Information Trial Approach 1.CDA from PI 2. PI Approach the Protocol to EC Feasibility Questionnaire & Sponsor Protocol Ethics committee Protocol, Safety, PI Eligible, Site checking , lab facility, Molecule / dosage, QT checking , ICF , INSURANCE If EC approval letter get , START CT. before get approval from CTRI EC Approval Letter After register CTRI get approval to start CT Approval from CTRI

5. SMO – Site Management Organization TO Feasibility Principal investigator Sponsor Agent Adverse event 1.To conduct a Clinical trial by initiation of PRINCIPLE INVESTIGATOR’S drug 2. Protocol development 1.A Person that is retained as an independent contractor of the principle investigator 2.A CRO may perform SMO function 3.Research site to provide administrative support of the conduct study, such as recruitment of subjects, collection and prepare study data like all. . To check all the data about the drug molecule details and ADHERSE EVENTS SMO To check the new drug feasibility and all the information about that drug

6. Feasibility Questionnaire's and Sponsor Protocol In the feasibility questionnaire belongs to all question about the PI details and site tracking details . 2. Feasibility Questionnaire 3. Details about PI experience in clinical trials CDA is deals with Sponsor and PI 1. Confidentiality Disclosure Agreement 4. PI approach the study to Ethics committee

7. Ethics Committee An IRB/IEC review the appropriateness of the clinical trial protocol as well as the risks and benefits of the study participants . A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected EC is mainly formed to find the safety of subjects 1.Protocol 2. Safety 3. PI Eligibility 4. Site Checking 5. Lab facility 6. Staff eligibility 7. Clinical research staff 8. Molecule / dosage data 9. QT checking 10. ICF 11. Insurance

8. EC Approval & CTRI Registry 4. To register the CTRI with all documents properly 2. Another important flow of study was to register the CTRI 3. Without the CTRI approval letter, study can start. Because the EC approval letter was enough to start the study If EC approves the study after the committee discussion, Approval letter was issued to start the study

9. ICF & Screening ICF was furnished about all the details about the study. Include the pre clinical trial details also. ICF and Screening Screening Before enroll the patient, to find the history of that health status and personal approval Before the patient enrollment, PI wants to explain all the risks and benefits about the study . All details are cleared and if patient was willing to participate means get sign from ICF And also explain about the AE and cleared all the details in ICF

10. Randomization Another one was TREATMENT GROUP + ( STANDARD + PLACEBO ) PLACEBO – Which is identical to new drug but does not contain active ingredient Single blind and double blind study Randomization Computer to randomized a patient whether an treatment group or Control group B Control group Standard Standard treatment only Standard New drug Treatment Group A

11. After Randomization End of the visit has to taken all the lab test for the safety procedure End of the visit In these section was performed by analysis of all clinical data and move to CDSCO for further more process Analysis and Marketing Follow up of subject was a challenge task And it should note all data and fill the logs and CRF Follow up Documentation is the important procedure to maintain the study. Which should clear and all data was noted Documentation After Randomization

12. During the Randomization process:

13. 3 TEXT Application of Clinical trial

14. Clinical trial Application in India Form 44 for clinical trial application 04 Recent regulatory reforms initiated by CDSCO 05 1. Fast-tracking approval timelines 2. Single-window clearance for export No Objection Certificate (NOC ) 3. Mandatory registration with Clinical Trials Registry- India ( CTRI) Drug and cosmetic act, 1945 & Schedule Y 01 Regulatory Requirement for clinical trial 02 Flow of application for clinical trial 03

15. Drug and Cosmetic Act ,1945 & Schedule Y The history of various regulatory aspects related to drug import, manufacture and sale are covered under the Drugs & Cosmetics Act of 1940 and Drugs & Cosmetics Rules of 1945 The Act’s main objective is to ensure that available human drugs are safe and efficacious and conform to prescribed quality standards, and marketed cosmetics are safe for use. Currently clinical trials in India are regulated by Schedule Y of the Drug and Cosmetics Rules , 1945. Schedule Y defines the requirements and guidelines for import and/or manufacture of new drugs for sale or for clinical trials which is governed by CDSCO (Central Drug Standard Control Organization ). A B C D

16. Regulatory requirement for clinical trial Regulatory processes are being harmonized with US and international standards. Drugs Controller General of India(DCGI) has the prominent role in overseeing clinical trial in India along with Ethics committee (IEC/IRB: Institutional Ethical Committee/Institutional Review Board). Apart from DCGI, different agencies such as Department of Biotechnology (DBT) Indian Council of Medical Research (ICMR) Central Bureau of Narcotics (CBN) Review Committee on Genetic Manipulation (RCGM) Genetic Engineering Approval Committee (GEAC) are involved in clinical research regulation in India . Regulatory Body for clinical Trial

17. Flow of Application for Clinical Trial Primary permission for clinical trial Importing drug for clinical trial Sponsor should provide all data regarding drug molecule Applicant has to submit all Suspected or Unexpected Serious Adverse Reactions (SUSAR) if any. Sponsor has to submit affidavit stating that study has not been discontinued in any country(If any reason should be provided ) Approval time of application in India is 10-12 weeks A B C D

18. Institutional Ethics Committee / Review Board IEC / IRB IEC / IRB In case of BA/BE study for new drug, the anticipated timelines for DCG(I) approval would be 6-8 weeks . For the BA/BE study, the regulatory requirement for the study depends upon the study drug molecule. Approval process is conducted in parallel with DCGI. If the study drug molecule is old drug, then approval from the DCG(I) won’t be required and only the approval from the EC committee will suffice.

19. Form 44 for CT application: Application for permission to initiate specific phase of clinical trial sponsor is required to submit application (Form 44 and Appendix-01) for the purpose of conducting clinical trial in India and submit documents as per Schedule Y of the Drugs and Cosmetics Act 1940 and Rules. FORM 44: Form 44 is an application for grant of permission to undertake for conducting Clinical Trial . The document design is as per the International submission requirements of Common Technical Document (CTD) and has five Modules . Module 1: Administrative / Legal Information Module 2: Summaries Module 3: Quality Information ( Chemical, Pharmaceutical, Biological ) Module 4: Non- Clinical Information Module 5: Clinical information

20. A clinical trial application utilizes Form 44 , accompanied by documents. – Chemical and pharmaceutical information, – Animal pharmacology, – Toxicology data, – Clinical pharmacology data . Other trial-related documents that must be submitted for approval include the – Investigator’s Brochure, – Trial protocol, amendments – Case report form, – Informed consent form , – Investigator’s undertaking. – Trial’s regulatory status of the trial in other countries must be reported .

21. Recent regulatory reforms initiated by CDSCO: Fast-tracking approval timelines: • If the application is complete, first response from the DCGI office can now be expected within 30 days . Single-window clearance for export No Objection Certificate (NOC ): • Earlier, after obtaining permission from the DCGI for conducting a trial, an applicant had to apply separately to the Directorate General of Foreign Trade (DGFT) for an export NOC . This process has now been simplified and fast tracked, so that an applicant can apply for trial permission as well as export NOC to DCGI , without the need for a separate application to DGFT. • As per revised timelines, export NOC can now be expected within 10 working days , in contrast to the previous 2-4 weeks timeline for DGFT approval

22. Mandatory registration with Clinical Trials Registry-India (CTRI ): • The National Clinical Trial Registry ( www.ctri.in ) launched by National Institute of Medical Statistics (NIMS) under the Indian Council of Medical Research (ICMR) has been operative for the last two years . • CTRI ensures accountability and transparency in conducting trials that are the two essential demands of globalisation .

23. IMPORTANCE OF THE ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL • Essential documents are important for: – Evaluation of the conduct of a trial and the quality of data produced – Successful management of the trial by the investigator, sponsor and monitor – Validation by regulatory authority( ies ) and sponsor’s audits • Depending on the stage of the trial, essential documents are grouped in three sections: – before the start of clinical trial – during the conduct of the trial – after the completion or termination of the trial

24. ESSENTIAL DOCUMENTS THAT A MEDICAL WRITER SHOULD KNOW A medical writer must know about the following essential documents that are required during a clinical trial

25. ESSENTIAL DOCUMENTS REQUIRED DURING A CLINICAL TRIAL

26. ESSENTIAL DOCUMENTS REQUIRED AFTER THE COMPLETION OF A CLINICAL TRIAL

27. Thank You