Clinical trials: the balance between protecting participants and promoting drug and product development by ProQuest

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									  CMAJ                                                                                                                        News
Clinical trials: the balance between protecting participants
and promoting drug and product development

T
         hey have been called bureau-
         cratic, cumbersome, a liability
         to the drug and research indus-
tries, and even harmful to patients. In
fact, so maligned have research ethics
boards been in Canada that they have
spurred demands for the introduction of
national accreditation centralized re-
view for clinical drug trials involving
multiple sites.
    The purpose is straightforward — to
protect human research subjects (as de-
fined by granting council guidelines).
Research ethics boards are groups of
          volunteers — doctors, lawyers,
              scientists, community mem-
               bers — that review clini-
                cal trial protocols to deter-
                mine whether the risks of
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               a study are “reasonable”
             and whether there’s “undue”
pressure on individuals to participate.
                                                               Research ethics boards exist to protect patients in clinical trials, but some researchers
    Because of the growth of clinical trials                   claim they actually harm more patients than they help by delaying novel projects that
in Canada, research ethics boards seem to                      could lead to life-saving discoveries.
be proliferating across the nation. Busy
teaching hospitals have created multiple
boards to streamline and professionalize                      deride research ethics boards for their         Another time she abandoned a trial af-
the process, as well as teams of research                     lack of scientific expertise and com-           ter waiting nearly 2 years for approval
staff to support their work. Smaller hos-                     plain of waiting up to 2 years to win           from several hospitals, while watch-
pitals, however, typically cannot afford                      approvals for multisite clinical trials.        ing from afar as a European group
such efficiencies.                                            Meanwhile, the pharmaceutical indus-            nearly completed its study. “That was
    Of late, though, research ethics                          try takes trials to other countries, in part    just so painful.”
boards have increasingly come under                           to avoid delays in ethics review.                  To cut through the red tape, a
fire for delaying the process by which                                                                        Health Canada-sponsored group, the
new drugs are tested for human use.                           Review delays                                   Experts Committee for Human Re-
Critics even say the system of boards                         There’s little question that delays have        search Participant Protection in
and committees that now protects indi-                        become altogether common.                       Canada, recently asked the federal
viduals who volunteer for scientific re-                         Dr. Laurie Morrison, a University            government to create a new council to
search actually harms more patients                           of Toronto, Ontario, professor who              accredit research ethics boards that
than it helps — by delaying novel proj-                       runs resuscitation trials funded by the         meet a set standard of performance.
ects that could lead to life-saving dis-                      US National Institutes of Health and               Alberta, Quebec and Newfoundland
coveries, and by clogging the system                          the Canadian Institutes of Health Re-           and Labrador have gone further, man-
by approving studies that have already                        search (CIHR), has become accus-                dating centralized ethics reviews for all
been done.                                                    tomed to waiting more than 18 months            human research. A recent draft of a re-
    As Sir Iain Chalmers, a United                            for sign-off from research ethics               vised version of the Tri-Council Policy
Kingdom clinical trials expert, wrote in                      boards at the 40 or more hospitals in-          Statement: Ethical Conduct for Re-
2007, research ethics boards contribute                       volved in her trials.                           search Involving Humans includes a
to “the avoidable suffering and deaths                           “One of my studies never got off             new section recognizing the role of
of millions.”                                                 the ground because a European coun-             specialized or multi-institutional boards
    Frustrated Canadian scientists often                      try could move faster,” Morrison says.          for collaborative research.


                                                              CMAJ • MARCH 17, 2009 • 180(6)                                                         603
                                                © 2009 Canadian Medical Association or its licensors
News

    But researchers in most provinces            Koski recommends that clinicians                  section of the survey that asked for
still must approach each hospital sepa-       who do research receive extra training,              comments, the scientists wrote of “con-
rately for approval of a multisite proj-      which would eventually lead to better                flicting recommendations from differ-
ect, respond separately to each research      research ethics applications. But he ac-             ent REBs at different hospitals” and
ethics board’s questions, and provide         knowledges that ethics boards also need              “nit-picky details for consent forms that
each with ongoing reports about               to become
								
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