GCP for clinical trials in India

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Publication Issues

• GCP for clinical trials in India

R.Raveendran Chief Editor Indian Journal of
Pharmacology
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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?
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Why should ethics committee members bother about
publication of study results?
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• 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.

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Do publication issues come under the purview of
the ethics committee?
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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
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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

1. 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
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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 domain so 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.
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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.
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Ethical Guidelines for Biomedical Research on
Human Subjects INDIAN COUNCIL OF MEDICAL RESEARCH
NEW DELHI 2000
VII. RESEARCHERS 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
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What issues (of publication) concern the ethics
committee members?
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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
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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 dont penalise
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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

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Issues concerning the ethics committee members

• After submission or publication of trial results
  
• Fraud
• Data fudging
• Data fabrication
• Data falsification
• Authorship

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

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

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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

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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.

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• 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.