Examination of Clinical Trial Costs and Barriers for Drug Development. 4.7 Disconnect Between Clinical Research and Medical CARE


Janet Woodcock, director of CDER, identified the separation between clinical research and clinical practice in the United States as one of the most serious problems with the current clinical research enterprise (English, Lebovitz, & Giffin, 2010). The problem is a multi-faceted one that also serves to reinforce many of the barriers discussed in other sections, such as shortages of investigators and patients, high costs, and lengthy timelines.

One aspect of this problem is the lack of involvement of community physicians in the clinical research process (English, Lebovitz, & Giffin, 2010). Most U.S. health systems and clinical practice sites do not include research as part of their mission (Kramer, Smith, & Califf, 2012); thus, there are fewer physician referrals of patients to clinical research studies and fewer investigators available to conduct the research than there might be otherwise. This also means that research findings are less likely to be adopted by such physicians in their regular practice (English, Lebovitz, & Giffin, 2010). Many health care professionals do not receive training in research methods (Bonham, Califf, Gallin, & Lauer, 2011) and have difficulty understanding research results and therefore applying them (Kramer, Smith, & Califf, 2012) (discussed in greater detail in Section 4.8).

Apart from issues of mission and training, there exist some disincentives for clinicians to participate in research. The U.S. system is one that encourages physicians to focus on efficiency and profitability, and discourages clinical research for being risky, time-consuming, and costly (Kramer, Smith, & Califf, 2012). Furthermore, although participation in pharmaceutical industry-sponsored clinical trials can be an attractive way for physicians to supplement their incomes (Ashar, Miller, Getz, & Powe, 2004), there is a great deal of scrutiny of doctors who work with pharmaceutical companies, due in part to media attention to conflict of interest cases. Any gifts or other “freebies” doctors receive from drug companies must be reported according to the Physician Payment Sunshine provision under the Patient Protection and Affordable Care Act, and several states have additional rules governing physicianindustry relations (Milne C. , 2012). While these safeguards against conflicts of interest are important, they have the unfortunate side effect of contributing to what some industry representatives described as a prevailing attitude of suspicion toward physician involvement in industry-sponsored clinical research. Such an atmosphere can dampen the appeal of the financial incentives provided by pharmaceutical companies and discourage physicians from participating in trials.

The separation between clinical research and clinical care in the United States also produces data collection inefficiencies, as some of the data that are routinely collected in the course of clinical trials overlap with data collected for the purposes of clinical care. Integration of clinical care and clinical research datasets would eliminate redundancies in data collection, help researchers to identify potential study participants, and offer other efficiency gains. However, at present, such integration is hindered by the lack of standard nomenclature and blend of incompatible paper and electronic data collection systems used in clinical care/billing and clinical research (Kramer, Smith, & Califf, 2012; Califf & Muhlbaier, 2003).

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