The document discusses the importance of clinical trial registration to combat selective publication bias and enhance transparency in clinical research. It details the International Clinical Trials Registry Platform (ICTRP) and the Clinical Trial Registry - India (CTRI), emphasizing their roles in ensuring all clinical trials are publicly registered and accountable. Additionally, it outlines the registration process, requirements, and the benefits of maintaining a transparent trial record for patients and researchers.

1. Clinical Trial Registration
Dr. Shrish Bhatnagar
Dr. Pallav Singhal

2. Introduction
 Concerns regarding selective publication (bias in published
clinical trial literature in favor of positive or promising
results).
 Antidote to this problem- registration of all clinical trials,
results available publicly.
 Safeguarding of patient interests
 Greater transparency, accountability and accessibility of
clinical trials

3. International Clinical Trials Registry Platform (ICTRP)?
 Established by WHO in 2005, a network of Primary
Registers.
 ICTRP provide a unique identification number for clinical
trials from certified registers that meet standard criteria
for the exchange of essential trial data.
 Mission: to ensure complete view of research is accessible
to all those involved in health care decision making.
 International Committee of Medical Journal Editors
(ICMJE) committed that registration of clinical trials, a
prerequisite for consideration of clinical trial data
publication.

6. What is a Primary Register?
 A clinical trial registry with at least a national remit that
meets WHO Registry Criteria for
 Content
 Quality and validity
 Accessibility
 Unique identification
 Technical capacity
 Governance and administration
 Currently 11 Primary Registries in the WHO Registry
Network, including the CTRI.

7. Clinical Trial Registry - India (CTRI)
 Free
 Online public record system for registration of clinical
trials conducted in India.
 Hosted and set up by National Institute of Medical
Statistics
 Registration of clinical trials is now mandatory, as per
DGCI.

8. Impact :

9. Impact :

10. Goal and Objectives of the Registry
 Establish a authentic public record system all ongoing and
completed clinical trials
 Provide a corrective system against “positive result bias”
and “selective reporting”.
 Perform quality assurance on submitted entries
 Increase awareness and accountability of all the
participants of the clinical trials
 Deduplication
 Raise the standard of research.

11. What to Register?
 All trials conducted in India
 Involving human participants
 Any intervention-
 Drugs
 Surgical procedures
 Preventive measures
 Lifestyle modifications
 Devices,
 Educational or behavioural treatment
 Rehabilitation strategies
 Clinical trials undertaken by postgraduate students for their
thesis (separate section) in the CTRI website.
“When in doubt,
better register”

12. When to Register?
 Before enrolment of first participant.
 Also permits registration of ongoing trials.

13. Who Registers?
 Principal investigator
 Prime sponsor
 In multi-national trial, the Indian PI should register
(mentioning the relevant registration numbers in other
countries).

14. How to Register?
 Login to CTRI website: www.ctri.nic.in
 Register using “Username” and “Password” and create a profile.
 Add New trial, following dataset is submitted (next page)
 Reference number given by CTRI
 CTRI checks the dataset and sends back trial for
clarification/modification
 CTRI verifies the trial from “PI, contact person of scientific
and public query”
 Unique registration number is provided to the trial once found
complete and verified.*

18. CTRI Dataset (Information recorded in CTRI)
1. Public title of Study- Easy Language
2. Scientific title of Study- As in the protocol, (also include trial acronym)
3. Secondary IDs, if any (if registered in another Registry)
4. Principal Investigator’s name and address (not a mandatory field)
5. Contact person (Scientific Query)
6. Contact person (Public Query)
7. Source/s monetary or material support
8. Primary sponsor (responsible for ensuring that the trial is properly registered)
9. Secondary sponsor
10. Countries of Recruitment
11. Site/s of study
12. Name of Ethics committee and approval status.
13. Regulatory clearance obtained from DCGI

19. 14. Health condition/problem studied
15. Study Type
16. Intervention and comparator agent
17. Inclusion and exclusion criteria
18. Method generating randomization sequence
19. Method of allocation concealment
20. Blinding/masking
21. Primary outcome/s
22. Secondary outcome/s
23. Target sample size
24. Phase of trial (drug trial)
25. Date of first enrollment
26. Estimated duration of trial
27. Recruitment status of trial
28. Brief Summary

21. What is the UTN?
 Universal Trial Number (UTN)
 Unique number to facilitate identification of clinical trials registered
in WHO Primary Registries and displayed ICTRP Search Portal
 A UTN
 Permanently attached to the trial (part of the trial's identity)
 Used whenever information about the trial is communicated
 Documented in the trial protocol
 Submitted every time the trial is registered
 To obtain a UTN please go to http://apps.who.int/trialsearch/utn.aspx
, and enter in your name, email and organization.

22. Practical Tips for Registration
 For postgraduate thesis: The concerned guide of
postgraduate thesis should account as the PI while
registering.
 Scanned Ethics Committee approval letter is must for
submission.
 Public title- avoid medical jargon.
 If the study is an academic exercise (investigator-
initiated trials), the source of monetary/material support
should be acknowledged as “Institutional”
 A trial, already registered with another Primary Register,
is required to register again with the CTRI if done in India

23.  Primary sponsor may or may not be the funding agency, but
it is responsible for initiation, conduct, and management of
the study.
 It is the responsibility of the sponsor to ascertain
whether DCGI approval is required or not.
 International Non-proprietary Name (INN) is to be used if
possible (not brand/trade names).
 Must update the registry time to time.

24. Moving towards Results Disclosure
The following information is expected to be declared in
summary results of interventional trials
 Participant flow - A tabular summary at every stage of a
study.
 Baseline characteristics - A tabular summary of the data
collected at the beginning of a study for all participants
 Outcome Measures and Statistical Analyses - A tabular
summary for each pre-specified Primary Outcome and
Secondary Outcome and any appropriate statistical analyses.
 Adverse Events - A tabular summary of all SAEs and other
AEs

25. If a Registrant wishes to make changes in
the trial data set after trial registration?
 "Status of Trial" and sites with EC approval which are
"Under Review" may be updated at any point of time.
 Other data set fields are "locked" upon registration, and
may be "unlocked" after appropriate communication with
CTRI scientists and then edited.

26. Registration : Benefit to patients
 Transparency leads to Confidence Building
 Patients have started enquiring about possible enrolments
in clinical trials

27. Registration : Benefit to patients

28. Summary……

29. Common Causes of Delay in Trial Registration
Trial data uploaded but trial not submitted :
 Submit trial to CTRI at least 15 days before the anticipated date of first
enrolment with status as Not Yet Recruiting.
Ethics/DCGI approval is not uploaded.
 Make sure ethics approval and DCGI approval (if applicable) is uploaded at the
earliest.
Non-receipt of verification email.
 Ensure trial contact persons have responded to verification email sent by
CTRI.
Trial modifications :
 Make sure all requested modifications are incorporated or appropriate
clarifications provided
 Maintain regular contact with ctri@gov.in quoting REF number allotted to trial

30. Thank you