Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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3 Challenges in Clinical Research
3 Challenges in Clinical Research
Pages 14-28
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From page 14... ...
(left 2,000 100,00 text reset 0 1,000 50,000 landscape 0 0 Diabetes Depression CV Disease Cancer Diabetes Depression CV Disease Cancer FIGURE 2-4 Number of the 10,974 ongoing clinical trials and 2.8 million study subjects being sought by disease being studied. NOTE: CV Disease = cardiovascular disease.
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From page 15... ...
In 2007, 26,000 investigators registered this form with the FDA, 85 percent of whom participated in only one clinical trial. The issues facing clinical investigators were discussed throughout the workshop, and many participants echoed the theme of the Tufts data -- it is difficult to conduct clinical trials in the United States and establish a career as a clinical investigator.
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CAPACITY OF THE CLINICAL RESEARCH ENTERPRISE KMR data from 2006 for the 15 largest pharmaceutical companies show that the majority of patient visits associated with an industry-sponsored clinical trial occur outside the United States. According to Krall, this statistic speaks to the costs and difficulty associated with conducting clinical research in the United States.
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Investigator performance in the United States and the rest of the world is similar in that 75 percent of investigators fail to enroll the target number of subjects; also, 90 percent of all clinical trials worldwide fail to enroll patients within the target amount of time and must extend their enrollment period. Krall commented that these data on patient enrollment are from one pharmaceutical company but that, based on his industry experience and conversations with colleagues from other companies, he believes the data are generally consistent with the pharmaceutical industry as a whole.
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Some workshop attendees suggested that efficiencies could be gained by streamlining the clinical trials infrastructure so that those investigating new research questions could quickly draw on resources already in place instead of reinventing the wheel for each trial. This chapter summarizes workshop presentations and discussions focused on the challenges facing clinical research today.
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Reflecting the diversity of stakeholder value judgments, and in the absence of a broad national agenda, clinical trials are conducted in a "one-off," narrowly focused fashion. Because clinical trials are necessary to obtain regulatory approval in the United States, they are a high priority to companies.
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-- a nonprofit institution positioned outside the federal government to define and execute comparative effectiveness research methods. Several speakers and workshop participants raised questions about the ability of the current clinical trials system, which is already showing signs of strain, to absorb a substantial amount of the anticipated CER studies.
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The limited involvement of community physicians in clinical research reduces physician referrals of patients to clinical research studies, as well as the total number of investigators available to conduct the research (see the discussion of narrow incentives for physician participation in clinical trials below)
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approvals, establishing clinical trial and material transfer agreements with sponsors and medical centers, recruiting patients, administering complicated informed consent agreements, securing protected research time from medical school departments, and completing large amounts of associated paperwork. As a result of these challenges, many who try their hand at clinical investigation drop out after their first trial.
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In addition to confronting potentially undesirable interruptions in care, it is understandably difficult for many patients to justify the physical and emotional strain of leaving their regular provider to volunteer for a clinical trial. If a patient reaches the point of enrolling in a clinical trial, the extensive paperwork associated with the informed consent process can be confusing and burdensome.
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The overall cost associated with gathering the necessary resources to conduct a clinical trial is an important factor in the choice of a trial site. For instance, physician salaries in a number of countries are lower than in TABLE 3-1 Global Research Costs: Relative Cost Indexes of Payments to Clinical Trial Sites Cost of Clinical Trials Relative to Country the United States United States 1.00 Australia 0.67 Argentina 0.65 Germany 0.50 Brazil 0.50 China 0.50 Russia 0.41 Poland 0.39 India 0.36 SOURCE: Califf, 2009.
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Some also argue that clinical trials conducted outside of the United States are of higher quality because of better adherence to trial protocols and better patient follow-up. THE COST OF CLINICAL TRIALS Clinical trial costs can vary widely depending on the number of patients being sought, the number and location of research sites, the complexity of the trial protocol, and the reimbursement provided to investigators.
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institutions in the level of clinical trial support they provide makes it difficult for NIH to determine how its payments to research sites should be adjusted to take CTSA support into account. NARROW INCENTIVES FOR PHYSICIAN PARTICIPATION IN CLINICAL RESEARCH As discussed earlier, the current clinical research enterprise in the United States is largely separate from traditional clinical practice.
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From page 28... ...
Thus, the capability of the health care system to implement or act on research findings can be an important consideration in conducting clinical trials to test alternative treatments for a condition. SHRINKING CLINICAL RESEARCH WORKFORCE Research involving human subjects has become an increasingly complex environment in which to work and be successful.
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