Clinical Trial Data: Fit for Public Consumption
- From: MarilynMann <mannm@xxxxxxxxxxx>
- Date: 19 May 2007 06:00:38 -0700
originally appeared on the Alzheimer Research ForumFrom Schizophrenia Research Forum -- Adapted from a news story that
17 March 2007. This week, two independent groups of academic
researchers call for more transparency in the conduct of clinical
trials. One focuses on the structure of industry-academic partnerships
in clinical trials, while the other argues for a more open airing of
safety results from large-scale clinical trials that are submitted to
the United States Food and Drug Administration (FDA). The reports, one
in Nature and one in the journal Health Affairs, highlight the fine
line which investigators, patients, pharmaceutical companies, and
federal regulators walk while trying to balance the sometimes
competing, and always compelling, interests of all parties in the
complex task of assuring that new drugs are safe, effective, and
available.
Academic independence is essential to the proper conduct of clinical
trials and to safeguard patients' interests, Martine Piccart of the
Jules Bordet Institute in Brussels, Belgium, and Aron Goldhirsch of
the University of Bern in Switzerland write in their commentary in the
March 8 Nature. The authors belong to the Breast International Group,
a consortium of 38 groups of breast cancer researchers who oversee
clinical trials involving 60,000 women, and the article is coauthored
by eight other international researchers.
Given that large trials require financial and other support from
pharmaceutical companies (including the provision of the drugs
themselves), academia and industry are obligated to collaborate to
bring new therapies to patients. However, the authors note a "push" by
pharmaceutical companies for greater control of clinical trials and
data, which marginalizes the role of academics. This trend, they
write, does a disservice to patients and may actually deter some from
participating in trials. When companies control the studies and the
data, study design can suffer. Company control of data can also result
in withholding or delayed reporting of unwelcome findings, as has
happened in several recent cases.
The alternative, Piccart and coauthors write, is a more equal
partnership, where the clinical trial database is held by independent
researchers while the trial is ongoing, with limited access by the
sponsoring company. Once the primary endpoints have been reached, the
data is transferred to the company to use in their application for
marketing approval. They cite four large and prominently published
studies on breast cancer recently conducted in this way (Goss et al.,
2003; Piccart-Gebhart et al., 2005; Thurlimann et al., 2005; Coombes
et al., 2004), but the model would clearly be applicable to other
diseases and treatments.
In their view, this academic independence and openness with the data
is the key to successful clinical investigation. "Only by ensuring
untrammeled access to long-term data, both good and bad, can we
conduct clinical trials in a credible manner," the authors conclude.
"This access will ensure that those patients who consent to
participate in them maintain faith in the clinical trial process."
That theme of the importance of open access to data is echoed in the
second report, from Aaron Kesselheim from the Brigham and Women's
Hospital and Michelle Mello of the Harvard School of Public Health,
both in Boston, Massachusetts. In the March/April issue of Health
Affairs, they argue that the FDA practice of treating all clinical
data as confidential may not be appropriate, especially where safety
data is concerned.
When companies conduct a trial, all the safety and efficacy data is
submitted to the FDA. The primary data stays under wraps, with the
results presented in a summary report, which is often written by the
applicant company. The presumption behind this scheme is that
releasing the raw data could harm the business interests of the
company by helping their competitors.
The case of nonsteroidal anti-inflammatory drugs, where safety issues
emerged long after drugs were on the market (see Alzheimer Research
Forum news story and Alzheimer Research Forum news story), and the
incomplete disclosure of dangers related to antidepressants, have
raised concerns about the confidential treatment of safety data.
Kesselheim and Mello question whether the FDA's default policy of
keeping safety data secret is consistent with public's interest in
disseminating the information, which not only protects people using
existing drugs, but also can help efforts to make future drugs safer.
While it may be true that the release of some kinds of information,
such as data on chemical composition and formulation, and sometimes
efficacy, can put companies at a disadvantage, this is rarely the case
with safety data, the authors write. "The legal question is whether
the information will give other drug companies an unfair advantage,"
Mello said in a press release accompanying the study. "But it is
strange to argue that evidence that a drug is harmful will enable
others to develop a similar drug."
In their analysis, the authors cite several examples where the FDA had
data indicating safety issues with drugs in clinical trials or on the
market, but had no way to act on the confidential information. For
example, when approved drugs are tested in unapproved indications, new
safety issues can sometimes emerge. By existing policy, these
discoveries cannot be revealed to people who are using the drug as
labeled.
The data is not always lost to public scrutiny. Consumers can sue to
have data released under the Freedom of Information Act. Sometimes
this approach is successful, and sometimes not, but getting data this
way is always inefficient. This mechanism may not satisfy the public
interest in a full accounting of safety data. Lawsuits are expensive
and take a long time.
Kesselheim and Mello suggest changes in current policy that would both
protect pharma's trade secrets and allow a fuller evaluation of drug
safety. As a first step, they propose that sealing safety data should
not be the default mode: companies should have to show why the data
should be kept confidential by demonstrating how its release would
harm their interests. They suggest replacing the summary document with
a full accounting of safety data for all new drugs. If the FDA will
not act to change these policies, Congress may need to step in and
pass new laws requiring the disclosure of safety data. The goal, they
write, is to let external researchers better help the FDA, physicians,
and consumers make appropriate medication choices, while balancing the
commercial interests of drug companies.-Pat McCaffrey.
References:
Piccart M, Goldhirsch A, Wood W, Pritchard K, Baselga J, Reaby L,
Kossler I, Kyriakides S, Norton L, Coates A. Keeping faith with trial
volunteers. Nature. 2007 Mar 8;446(7132):137-8. Abstract
Kesselheim AS, Mello MM. Confidentiality laws and secrecy in medical
research: Improving Public Access to Data on Drug Safety. Health
Affairs. 2007 March; 26(2): 483-491. Abstract
* * *
Senate legislation just passed would set up a public database of
results of clinical trials. I have only read the NYT article on this;
I don't know the details.
Marilyn
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