[Ip-health] Large-Scale Analysis Finds Majority of Clinical Trials Don't Provide Meaningful Evidence
Riaz K Tayob
riaz.tayob at gmail.com
Thu May 3 05:39:59 PDT 2012
[Let us just forget the ethics of some of BigPharma in Africa, like
Pfizer and meningitis in Nigeria... perhaps the push to not hold
companies liable for shoddy work will gain more momentum... ]
Large-Scale Analysis Finds Majority of Clinical Trials Don't Provide
ScienceDaily (May 1, 2012) --- The largest comprehensive analysis of
Clinicaltrials.gov finds that clinical trials are falling short of
producing high-quality evidence needed to guide medical decision-making.
The analysis, published May 1 in the/Journal of the American Medical
Association/, found the majority of clinical trials is small, and there
are significant differences among methodical approaches, including
randomizing, blinding and the use of data monitoring committees.
"Our analysis raises questions about the best methods for generating
evidence, as well as the capacity of the clinical trials enterprise to
supply sufficient amounts of high quality evidence to ensure confidence
in guideline recommendations," said Robert Califf, MD, first author of
the paper, vice chancellor for clinical research at Duke University
Medical Center, and director of the Duke Translational Medicine Institute.
The analysis was conducted by the Clinical Trials Transformation
Initiative (CTTI), a public-private partnership founded by the Food and
Drug Administration (FDA) and Duke. It extends the usability of the data
in Clinicaltrials.gov for research by placing the data through September
27, 2010 into a database structured to facilitate aggregate analysis.
This publically accessible database facilitates the assessment of the
clinical trials enterprise in a more comprehensive manner than ever
before and enables the identification of trends by study type.
The National Library of Medicine (NLM), a part of the National
Institutes of Health, developed and manages Clinicaltrials.gov. This
site maintains a registry of past, current, and planned clinical
"Since 2007, the Food and Drug Administration Amendment Act has required
registration of clinical trials, and the expanded scope and rigor of
trial registration policies internationally is producing more complete
data from around the world," stated Deborah Zarin, MD, director,
Clinicaltrials.gov, and assistant director for clinical research
projects, NLM. "We have amassed over 120,000 registered clinical trials.
This rich repository of data has a lot to say about the national and
international research portfolio."
This CTTI project was a collaborative effort by informaticians,
statisticians, and project managers from NLM, FDA and Duke. CTTI
comprises more than 60 member organizations with the goal of identifying
practices that will improve the quality and efficiency of clinical trials.
"Since the Clinicaltrials.gov registry contains studies sponsored by
multiple entities, including government, industry, foundations and
universities, CTTI leaders recognized that it might be a valuable source
for benchmarking the state of the clinical trials enterprise," stated
Judith Kramer, MD, executive director of CTTI.
The project goal was to produce an easily accessible database
incorporating advances in informatics to permit a detailed
characterization of the body of clinical research and facilitate
analysis of groups of studies by therapeutic areas, by type of sponsor,
by number of participants and by many other parameters.
"Analysis of the entire portfolio will enable the many entities in the
clinical trials enterprise to examine their practices in comparison with
others," says Califf. "For example, 96 percent of clinical trials have
?1000 participants, and 62 percent have ? 100. While there are many
excellent small clinical trials, these studies will not be able to
inform patients, doctors, and consumers about the choices they must make
to prevent and treat disease."
The analysis showed heterogeneity in median trial size, with
cardiovascular trials tending to be twice as large as those in oncology
and trials in mental health falling in the middle. It also showed major
differences in the use of randomization, blinding, and data monitoring
committees, critical issues often used to judge the quality of evidence
for medical decisions in clinical practice guidelines and systematic
"These results reinforce the importance of exploration, analysis and
inspection of our clinical trials enterprise," said Rachel Behrman
Sherman, MD, associate director for the Office of Medical Policy at the
FDA's Center for Drug Evaluation and Research. "Generation of this
evidence will contribute to our understanding of the number of studies
in different phases of research, the therapeutic areas, and ways we can
improve data collection about clinical trials, eventually improving the
quality of clinical trials."
An analysis-ready copy of the ClinicalTrials.gov
<http://ClinicalTrials.gov> database is now available at
/Specialists from numerous therapeutic areas are now scrutinizing the
contents to better understand how the number and characteristics of
clinical trials match the perceived needs of the research communities.
This dataset will be useful for academic institutions and also for
pharmaceutical and device companies to produce reports showing the
completeness of their data entry compared to other institutions.
Advocacy groups can chronicle the number and types of trials in their
area of interest.
Data quality is likely to improve as a function of the accountability
fostered by this transparency.
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