Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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7 Clinical Trials in Diabetes
7 Clinical Trials in Diabetes
Pages 56-67
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From page 56... ...
In designing clinical trials, it is customary for researchers to look to prior experiences with similar trials in the medical literature to determine how to power the study statistically and develop a target sample size. When there is such dramatic variability in placebo response rates across studies, researchers are left with little information with which to construct an informative, adequately powered study.
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From page 57... ...
In the end, the measurement tools varied significantly based on individual trial site characteristics and were determined to be too imperfect for practical use. Accelerating Depression Research Potter suggested that, despite the importance of creating new therapies for depression, investment in this area is no longer a top priority for some in the pharmaceutical industry because no path forward exists for obtaining clear, interpretable answers to essential research questions.
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From page 58... ...
Kalali suggested that more pharmaceutical companies should share their data regarding the rate at which the placebo response diverges from the response to active medication (i.e., placebo separation data) in clinical trials.
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From page 59... ...
Trivedi noted that in a chronic, long-term illness such as depression or diabetes, clinical trials that follow patients for a significant length of time are important. Long-term studies for chronic diseases require successful patient retention strategies to be effective since significant dropout rates over time can jeopardize the validity of trial results.
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From page 60... ...
D) study was a large, federally funded clinical trial that tested the effectiveness of antidepressants in a population diagnosed with major depressive disorder.
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D clinical trial results: remission rates by treatment level (monotherapy or combination treatment)
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62 TRANSFORMINg ClINICAl RESEARCh IN ThE UNITEd STATES Finally, Potter explained that intention-to-treat analysis is useful and can be especially effective in depression research.2 According to Potter, this methodology allows outcome measurements to be continued at the end of the study even if the intervention does not continue. 2 Inan intention-to-treat analysis, subjects who started in the trial are included in the final analysis regardless of whether they finished the treatment (i.e., dropouts are treated as if they finished the trial)
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From page 63... ...
At the same time, the participation rate in trials among adult cancer patients is extremely low. Questions arise, then, as to who will study all of these drugs, who will prioritize their study, and how enough patients will be identified to study them, especially given limitations in the infrastructure necessary to conduct clinical trials, including investigators and patients, discussed in Chapter 3.
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From page 64... ...
CLINICAL TRIALS IN CANCER: A PATIENT PERSPECTIVE According to data presented by Margaret Mooney, Chief, Clinical Investigations Branch, Cancer Therapy Evaluation Program within NCI, and Musa Mayer, breast cancer advocate of AdvancedBC.org, approximately 3 percent of adult cancer patients participate in clinical trials. An analysis of more than 500 NCI Cancer Therapy Evaluation Program (CTEP)
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From page 65... ...
Conversely, recently diagnosed patients who are frequently sought for clinical trials are attempting to cope with the news of their diagnosis and tend to follow the standard treatment protocols prescribed by their doctor rather than participating in clinical trials. On the other hand, as noted in Chapter 3, patients who participate in trials 1 As noted in Chapter 3, equipoise is the point at which a rational, informed person has no preference between two (or more)
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From page 66... ...
THE NATIONAL CANCER INSTITUTE'S CLINICAL TRIALS COOPERATIVE GROUP PROGRAM The federal government plays a large and important role in funding and organizing clinical research in oncology. NCI funds approximately half of all cancer trials in the United States.
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From page 67... ...
Mooney explained that the search for rare patient subsets is one reason why clinical trials have become increasingly global -- enough patients cannot be found in the United States. Streamlining NCI's Clinical Trials Process Despite differences in research focus, the NCI system shares with industry and all medical disciplines the growing pressure to reduce research costs in the face of declining budgets.
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