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threatening and serious conditions to be registered on the
ClinicalTrials.gov databank, detailed analyses indicate that a
significant number of industry-sponsors do not comply with
the requirement 41 .
To support WHO’s initiative, funding agencies, academic
centres, philanthropic organizations, and supportive industrial
sponsors ought to develop strict compliance mechanisms.
Registration should be imposed as a requirement for research
ethics approval. Patient advocacy groups could attach
registration as a condition to support and advertise clinical
trials. The best approach would be for domestic governments
with control over existing primary registries to endow relevant
governing bodies with the necessary legal jurisdiction to enforce
compliance through sanctions. Given industry’s concern about
competitive advantage, it seems particularly important to
assure pharmaceutical companies that there is a level playing
field, by ensuring compliance with registration requirements.
Domestic regulations and state control can do that.
Even though the WHO minimal data set extends well
beyond information required to be registered in several other
registries, some have criticized the WHO initiative for providing
insufficient information. The Ottawa Statement, for example,
proposes that registration data further include information on
the full protocol and consent forms, details of ethics committee
approval and other trial design information 42 .
Registration of the WHO data set will indeed not resolve all
problems associated with manipulation of trial results 43 . It is
unclear how the accuracy of registration data that are not peerreviewed
as well as the scientific validity of statistical analyses
and interpretations could be validated using information from
existing registries or resources. The registration system does
not alleviate concerns associated with the fact that sponsors
with vested commercial interests still control how research is
designed, how subjects are recruited, how data are collected,
and how results are presented 44 . The data set does not provide
registry staff or researchers with access to protocols or raw
data, which significantly hampers independent scientific
review of database entries. Without the ability to
independently review and validate entries, selective reporting
of trial results may still occur. Finally, the basic principles of
evidence-based medicine require review of study design and
quality in addition to other relevant scientific data prior to
drawing conclusions from a single study 45 .
Finally, WHO’s clinical trials registration system does not
impose results reporting. It allows the public, researchers, and
governmental agencies to know that research is or has been
undertaken, which allows for further scrutiny and questions
when publications come out. But it does not provide them
with direct access to final outcomes. Several influential
organizations have called for public disclosure of results in a
manner analogous to clinical trial registration, including the
US Institute of Medicine, ICMJE, and researchers 46 . As noted
by the ICMJE in their most recent discussion statement on
mandatory registration 47 , the climate for results registration will
likely change dramatically and unpredictably over coming
years but is sure to go ahead in some form.
WHO has recognized that this is a next important step in the
promotion of research integrity. It has set up a Study Group on
the Reporting of Findings of Clinical Trials, which is looking at
the development of criteria and standards of disclosure of
results 48 . This new initiative will constitute another important
step towards more reliable and trustworthy clinical research.
Result reporting will only have success, however, if a coherent,
comprehensive, and mandatory registration system is in place.
It seems therefore crucial that national governments,
professional organizations, industry, and researchers commit
to such a registration system and fully support WHO in its
efforts. ❏
Trudo Lemmens is an associate professor at the Faculties of Law
and Medicine of the University of Toronto. His research currently
focuses on how law and regulation contribute to the promotion of
ethical standards in the context of medical research and
biotechnological innovations. Recent publications include the coedited
volume Law and Ethics in Biomedical Research: Regulation,
Conflict of Interest, and Liability and the co-authored book Reading
the future? Legal and Ethical Challenges of Predictive Genetic
Testing. In the last four years, Trudo Lemmens has been a member
of the Institute for Advanced Studies in Princeton, a visiting
professor at the KU Leuven and the University of Otago, and a
Fellow of the Royal Flemish Academy of Belgium for Science and
the Arts. Since 2006, he has been a member of the PAHO Advisory
Committee on Health Research.
Ron A Bouchard is a doctoral candidate in law and runs his own
consulting firm. His career has focused on the science, law and
policy of pharmaceuticals and biotechnology as well as strategic
planning for commercialization of innovative technologies. He
began his career as a scientist, obtaining a doctorate and working
in the field of membrane electrophysiology. He shifted focus to law,
and has been involved in the prosecution, acquisition, financing,
distribution, and litigation of intellectual property rights relating to
pharmaceuticals and biotechnology. He has appeared before the
Federal Court of Canada on trial and appeal matters and the
Supreme Court of Canada. He currently conducts research on drug
regulation and innovation from the perspective of systems dynamics
and complex adaptive systems.
Acknowledgements
Research for this chapter was funded by Genome Canada through
the Ontario Genomics Institute, by Génome Québec, the Ministère du
Développement Économique et Régional et de la Recherche du
Québec and the Ontario Cancer Research Network, as part of the
ARCTIC project. Ron Bouchard also received support from the CIHR
Health Law & Policy Program and the Lupina Foundation
Comparative Program in Health and Society at the Munk Centre for
International Studies. The authors thank Michelle Jackson for work on
the references.
Global Forum Update on Research for Health Volume 4 ✜ 043