Ctri

CLINICAL TRIAL REGISTRY OF INDIA

1. Clinical Trial registry- India PRESENTED BY - N ISHA YADAV MSc Nursing 1 st year NINE, PGIMER Chandigarh

2. Outlines Clinical Trial- Introduction, Definition, and India scenario Clinical Trial Registry India- Introduction, Mission, Vision, Access and Stages How to register Clinical Trial Datasets used in the clinical trial Advantages of CTRI Summary

3. Introduction Clinical trail is an ancient concept is a medical research study conducted to find answers to health questions and is often conducted to evaluate new medications, a combination of medications, or new ways to use current treatments. They are also conducted to evaluate new tests, equipment, and procedures for diagnosing and detecting health conditions and to find vaccines to prevent illnesses. Before an experimental treatment can be tested in a clinical trial, it must have shown benefit in laboratory testing, animal research studies, or research in a small group of humans. Clinical trials are required to follow the same ethical and legal guidelines as standard medical practice to protect the safety of participants .

4. Clinical trial ? Any research study that prospectively assigns human participants or groups of humans to one or more health related interventions to evaluate the effects on health outcomes. Interventions- Drugs Cells and other biological products Surgical procedures Radiologic procedures Devices Behavioral treatments Process of care changes Preventive care, and others

5. Why conduct a clinical trial ?? Some of the questions answered by doing a clinical trial are: How helpful the treatment is? How does the experimental drug or new type of treatment work? If it works better than already existing treatment options? What are the side effects that occur as a result of the new treatment/ drug? How serious the side effects are when compared to standard treatment options? Do the benefits outweigh the side effects? Which groups of people are most likely to benefit from the new drug / treatment

6. India scenario From 2008 and 2011, around 2,000 patients died during trials, but no  action  has been taken against any pharma company or  the Ethics Committee that oversees clinical trials. Pharmaceutical companies claimed that other deaths occurred due  to  other  reasons,  such  as patients  being  terminally  ill  or suffering  side effects  from  an  unrelated  cause. Drug trials in India Almost 2,000 trials  in past seven years.  Tests include drugs  made by well known companies  such as  Biogen Idec, Astra Zeneca and Glaxo  Smith Kline. • 288 deaths in 2008 • 637 deaths in 2009 • 668 deaths in 2010 • 438 deaths in 2011

7. Clinical Trial Registry- India Introduction Mission Vision Access to CTRI Stages of CTRI

8. INTRODUCTION The CTRI hosted at the ICMR, National institute of medical statistics(NIMS), is a free and online public record system for registration of clinical trials being conducted in India. It was launched on 20 July, 2017. Initiated as a voluntary measure, since 15 th June 2009, trial registration in the CTRI has been made mandatory by the drugs controller general, India

9. MISSION To encourage all clinical trials conducted in India to be prospectively registered i.e. before the enrolment of the 1 st participant Trials where patient recruitment has started or even completed are also being registered. Post marketing surveillance studies as well as BA/BE trials are also expected to be registered in CTRI.

10. VISION Improve transparency and accountability Improve the internal validity of trials Conform to the accepted ethical standards Reporting of all relevant results of registered trials

11. Which clinical trials are required to be registered?? Any research study that assigns human participants to one or more health related intervention to evaluate the effects on health outcomes. Health related interventions include any intervention used to modify a health outcome and include drugs, surgical procedures, devices, vaccines, herbal compounds, behavioral treatments. In addition observational trials, bioavailability, bioequivalence & post marketing surveillance trials – should be registered

12. When should a clinical trial be registered ?? To register all clinical trials prospectively i.e. before the enrollment of the 1 st patient Currently, ongoing and completed trials are also being registered

13. Access to CTRI There are 3 levels of access to CTRI Public Registrant CTRI Administrator From the homepage of CTRI the public can perform a no. of functions Can search the registered trials and view details of registered clinical trials View and download trial registration dataset Contact administrator for queries None of these functions require registration in CTRI Now we will understand how these 3 functions can be performed www.ctri.nic.in

14. How to register First login to CTRI website: www.ctri.nic.in Register here: obtain username and password New trial is then added using the CTRI registration: filling data set A reference number of the trial is given by CTRI CTRI checks the dataset and sends back trial modification: incomplete/inappropriate A unique registration number is provided to the trial valid for submission of the study in any journal

15. Stages of trial registration in ctri Stage 1: Opening a new account for filling the trial dataset STAGE 2: Trial submission to review by CTRI scientist STAGE 3: CTRI clarifications to assign CTRI number STAGE 4: Regular update about the trial and submission of final brief summary

16. Part 1: Title of the study Public title : study title in a simple language to be understood by lay people Scientific title : study title as mentioned in protocol submitted for ethical committee (and DCGI) approval or funding Part 2: Principal investigators and contact person details Secondary IDs : universal trial number earlier known as UTRN may be obtained from http://apps.who.int/trialsearch/utn.aspx If there are no secondary IDs, nil can be selected Principal investigator : name official address, affiliation and designation, contact telephone and fax numbers and email ID of PI Contact person(for scientific study ): name, official address, affiliation and designation, email, telephone no., fax no. and postal address and affiliation of the local person to contact for scientific queries about the trial Contact person(for public study ): name, official address, affiliation and designation, email address, telephone no., fax no. and postal address of the contact who will respond to general queries including information about current recruitment status STAGE 1: OPENING A NEW ACCOUNT TO FILLING THE TRIAL DATA SET After submission of the initial profile, a confirmation mail along with username and password is sent to registered email id. The CTRI dataset has eight parts including 28 items Clinical Trial Registry- India Dataset Items For Trial Registration

17. Part 3: Details of funding and recruitment country Sources of monetary : major sources of monetary or material or infrastructural support Primary sponsor : name and address of individual taking responsibility for securing the arrangements to initiate and manage a study, in investigator initiated trials, PI is primary sponsor Secondary sponsor : name and address of additional individuals/ organization if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship Countries of recruitment: name of (intended) counties of participants recruitment Part 4: Details of study approval status and health condition Sites of study : list all sites within India including the site address Name of ethics committee and approval status Regulatory clearance obtained from DCGI Health condition/ problem studied Part 5: Details on study design Study type : PG thesis or not type of trial: interventional trial, observational trial study design: single arm trial, nonrandomized placebo controlled trial,etc .

18. Part 6: details on measures of internal validity Intervention and comparator agent : intervention- specific name of the interventions and the comparator/ controls being studied. list all several separate treatments in the intervention package if there are more than one intervention, in one line separated by commas Comparator agent: name of the intervention, placebo or no treatment. Inclusion criteria : for participant selection, including age, sex, health condition and other criteria Exclusion criteria : for participant selection, including age, sex, health condition and other criteria Method of generating randomization sequence : used to generate the random allocation sequence Method of allocation concealment : allocation concealment methods used Blinding/ masking : type of blinding used in the study Part 7: details on outcome measures and duration of the study Primary outcomes : main outcome used to determine the effect of the intervention in prespecified time Secondary outcomes : outcomes measured at time-points of secondary interest Target sample size : total no. of participants that the trial plans to enroll Phase of trial : phases of investigation, usually applies to drug trials Date of first enrollment : anticipated or actual date of first enrolment of participant Estimated duration of trial : expected time duration of trial, starting from first enrolment to final submission of report

19. Part 8: details on recruitment status and summary Recruitment status of trial : recruitment status of the trial separately for global and Indian site Not yet recruiting Open to recruitment Closed to recruitment Completed Suspended Publication details : details of publication if any Brief summary : short description of the primary purpose of the protocol, including a brief statement of the study hypothesis.

20. STAGE 2: Trial submission to review by ctri scientists Once the trial is submitted, a ref number is assigned, but CTRI number will show as pending. Now, the trial details are visible to both registrants and CTRI. After review of the trial details, CTRI seek clarifiactions / modifications along with unlocking the respective fields for further editing. T he trial can be resubmitted addressing all the clarifications sought by CTRI satisfactorily . The registrant should update CTRI regularly, regarding the trial recruitment status, change in registrant or investigators, study site, protocol amendm ents, change in contact persons and any other change O nce the trial is completed the registrant will be asked by CTRI to submit the final brief summary of the trial. STAGE 3: CTRI CLARIFICATIONS/MODIFICATIONS TO ASSIGNMENT OF CTRI NUMBER STAGE 4: REGULAR UPDATE ABOUT THE TRIAL AND SUBMISSION OF FINAL BRIEF SUMMARY

21. To enter data field online & can be saved Submission of form Verification by CTRI Changes required Request to register for online correction Amended data received, EC/DCGI permission uploaded Applied for username and password Satisfactory changes Complete dataset Incompete dataset Changes required Trial registered FULL CTRI NUMBER ASSIGNED PROVISIONAL CTRI NUMBER ASSIGNED CTRI REGISTRATION PROCESS

22. Advantages of ctri Increases transparency and accountability Improves internal validity of the trial Increases the chance of publishing in high impact journal Avoid duplication of work A source of information for future studies Reduces publication bias

23. SUMMARY Ctri establishes an unbiased, scientific public record of clinical trials and also ensures transparency, accountability and accessibility of clinical trials conducted. Clinical Trial Registration is an easy process and is completely an online system. trial registration costs nothing in monetary terms. registration of clinical trials also increases the internal validity of the trial and also increases the chance of publishing in a high impact journal. Trial Registration should be part of the routine research and should be practiced fully as a part of good clinical practice for the benefit of the scientific and general community.

24. Quiz time ? Q1.What do you mean by prospective registration? Q2.. How many stages are involved in registering clinical trial? Q3. What is CTRI?

25. references Clinical Trials Registry- India (CTRI) [Internet]. [cited 2020 Sept 20]. Available from: http://ctri.nic.in/Clinicaltrials/cont.php Kaur S, Singh A. Nursing Research in 21 st Century: clinical trials registry- India. CBS Publishers & Distributors Pvt Ltd; 2019;185-193 Pandey A, Aggarwal AR, Maulik M, Seth SD. Clinical Trials Registry- India: raising the veil. Natl Med J India. Jan;23(3):187 https://www.who.int > topics > clinical_trials. WHO | Clinical trials. World Health Organization. Accessed on Sept 2020.