GCP for clinical trials in India

1. Publication Issues GCP for clinical trials in India R.Raveendran Chief Editor Indian Journal of Pharmacology

2. What is this talk about? Why should ethics committee members bother about publication of study results? Do ‘publication issues’ come under the purview of the ethics committee? What issues (of publication) concern the ethics committee members? What can ethics committee members do when guidelines are violated?

3. Why should ethics committee members bother about publication of study results?

4. Patients agree to participate in clinical research because of an • “understanding that the research could help future patients in a similar situation to them” • Failure to report results of completed trials, whether positive or negative, negates the notion of social value. • Non-publication of research results can harm future patients. • Misreporting can cause considerable harm to patients and researchers.

5. Do ‘publication issues’ come under the purview of the ethics committee?

6. Operational Guidelines for Ethics Committees That Review Biomedical Research, World Health Organization, Geneva, 2000 6.2 Elements of the Review 6.2.1.8 the manner in which the results of the research will be reported and published;

7. Indian Council of Medical Research Guidelines for preparing Standard Operating Procedures (SOP) for Institutional Ethics Committee for Human Research • 10. Documentation: • For a thorough and complete review, all research proposals should be submitted with the following documents : • Plans for publication of results – positive or negative- while maintaining the privacy and confidentiality of the study participants. 12. Elements of the review m. Plans for data analysis and reporting

8. Ethical Guidelines for Biomedical Research on Human Subjects INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI 2000 STATEMENT OF GENERAL PRINCIPLES X. Principles of public domain whereby, the research and any further research, experimentation or evaluation in response to, and emanating from such research is brought into the public domainso that its results are generally made known through scientific and other publications subject to such rights as are available to the researcher and those associated with the research under the law in force at that time.

9. Ethical Guidelines for Biomedical Research on Human Subjects INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI 2000 SUBMISSION OF APPLICATION The researcher should submit an appropriate application in a prescribed format along with the study protocol at least three weeks in advance. The protocol should include the following : - 13. Plans for publication of results – positive or negative – while maintaining the privacy and confidentiality of the study participants.

10. Ethical Guidelines for Biomedical Research on Human Subjects INDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI 2000 VII. RESEARCHER’S RELATIONS WITH THE MEDIA AND PUBLICATION PRACTICES “Researchers have a responsibility to make sure that the public is accurately informed about results without raising false hopes or expectations ……………………. …………… …………………… ……………………………… …………… ……………… …………………… …………….. .…………………………………………………………… that considerable time has to pass before these findings can be translated into human use”

11. What issues (of publication) concern the ethics committee members?

12. Issues concerning the ethics committee members Review of Application / Protocol : • 1. Statement of plans for publication/ dissemination of results : • Peer reviewed journals – print or electronic • Websites • Open Access policy / institutional archives • 2.Freedom to publish : • Data ownership – Sponsor or Researcher ? • Veto power by sponsor – Unacceptable • Multicentric trial 3. Authorship :

13. Issues concerning the ethics committee members • Beginning of trial : • Registration of clinical trials • Trial Registry – Facility to register ongoing trials • When to register? - before commencing enrollment • Where to register? – Govt body or private agencies • Why register? - advantages • Problems –No national registry Non-registration does NOT violate guidelines Advise & Insist but don’t penalise

14. Issues concerning the ethics committee members • Completion of trial : • To publish or not to publish? • Negative results • Journals - Publication bias • Website – link to the registry • Archives – self, institutional • Electronic data banks • Exploratory studies – may not be published • Major flaws in the study – invalid data • Failed trial • Confidentiality • Media relationship • Duplicate / Redundant publication – multicentric trial

15. Issues concerning the ethics committee members • After submission or publication of trial results : • Fraud • Data fudging • Data fabrication • Data falsification • Authorship

16. Violation of guidelines / publication ethics What can ethics committee members do?

17. Violation of guidelines / publication ethics • What can ethics committee members do? • Review of Application / Protocol : • Return the protocol • Researcher to correct & resubmit

18. Violation of guidelines / publication ethics What can ethics committee members do? • Ongoing trial: Registration • Ask for registration details • Advise/insist the researcher to register • Completed trial: Publication • Ask for publication details (e.g. reprints; website URL etc.)

19. Nature 435, 737-738 (9 June 2005)

20. Unethical publication practices • Conducting research without ethics committee permission / Retrospective permission • Authorship – Ghost writing • Fraud • Plagiarism • Redundant or duplicate publication • Not declaring conflict of interest Violation / misconduct may be reported by a reader or colleagues

21. Violation of guidelines / publication ethics What can ethics committee members do? • If any violation detected / reported : • Take up the issue for discussion • Action : • recommend the head of the institute to initiate punitive measures • ban further submission of protocols by the researcher • ask the journal to withdraw the article and publish retraction

22. Violation of guidelines / publication ethics What can ethics committee members do? • Issues may be reported but not brought to the notice of the ethics committee • SOP – for dealing with publication issues and violation of publication ethics • Unnecessary delay in taking a decision to be avoided • Recommendations may not be implemented. • Ask the journal to withdraw the paper.

23. HANK OU

24. The investigator should be asked to clarify : • whether the research sponsor has contractual rights to review and amend the content of the results before submission for publication; • the extent of any declared sponsor-review period between completion of the report and its submission for publication • whether the sponsor retains a veto power over results' dissemination.