Examination of Clinical Trial Costs and Barriers for Drug Development. 4.8 Barriers at Academic Institutions

07/25/2014

There are cases in which drug sponsors might find it appealing or necessary to use academic institutions as trial sites. For instance, sponsors might seek to employ key opinion leaders who are affiliated with a particular institution, or they may be studying a very specialized disease area for which patients can only be found in sufficient numbers at certain universities, medical schools, or other academic sites. Despite these benefits, many aspects of academic institutions are not conducive to efficient and successful clinical research.

Academic institutions have a reputation for taking their ethical and regulatory oversight responsibilities to extremes and creating bureaucratic entanglements that add months to clinical trial timelines (Kramer, Smith, & Califf, 2012; Dilts & Sandler, 2006). A recent study found that the number of steps necessary to open a clinical trial at academic centers was over 110, in contrast to fewer than 60 steps at non-academic centers. The number of approval signatures needed ranged from 11 to 27, compared to a maximum of 11 at non-academic centers (Dilts & Sandler, 2006). For multi-site trials, sponsors and CROs must negotiate contracts individually with each participating institution, and, in a study of 218 trials at academic institutions, the mean time taken for grants and contracts approval was 100 days (which is even longer than IRB review takes, at 69 days) (Kramer, Smith, & Califf, 2012; Dilts & Sandler, 2006).

Though it does not take up as much time as the grants and contract approval process, obtaining ethical approval is another source of frustration for drug sponsors working with academic institutions. As discussed in Section 4.5, use of central IRBs can greatly improve the efficiency of this process; however, academic institutions are often unwilling to defer to these central IRBs. While one pharmaceutical company representative was optimistic that this reluctance was beginning to fade for the sake of staying competitive with other sites, there are other factors that might be difficult to overcome. For one thing, academic institutions have already invested in developing their own internal IRBs (as well as the electronic systems required for protocol submissions to those IRBs), so officials at those institutions will likely be hesitant to let those investments go to waste and lose financial support to a central IRB (Kramer & Schulman, 2011). Another interviewee explained that academic institutions are concerned about relinquishing their responsibility without also being relieved of some of their liability.

Aside from the regulatory and administrative roadblocks, many academic medical centers undervalue or fail to provide incentives for clinical research. There is a perception that clinical research is less intellectually rigorous than basic research. Moreover, many academic institutions do not inculcate in their students, trainees, and faculty a sense of professional obligation to generate new medical knowledge as part of clinical practice. As a result, faculty engaged in clinical research struggle for resources in the academic setting and face special challenges in achieving academic promotion and tenure. Students observing their struggle are less likely to choose the clinical research career path (Kramer, Smith, & Califf, 2012).

A related issue is the failure of academic medical curricula at the graduate and undergraduate levels to encourage fundamental principles of clinical research. Even training designed for investigators neglects research principles in favor of an emphasis on strict compliance with standard operating procedures (Kramer, Smith, & Califf, 2012). Those studying to be physicians are not adequately trained in advanced statistical methods to interpret clinical trial results (even at the level at which they are reported in medical journals), impairing their ability to use such results to inform their clinical care and practice evidence-based medicine (Kramer, Smith, & Califf, 2012; Horton & Switzer, 2005). For example, in a survey of 367 residents from 11 programs, only 37.4 percent knew how to interpret an adjusted odds ratio from a multivariate regression analysis. Seventy-five percent of survey respondents said they did not understand all the statistics they saw in journal articles, but the vast majority felt it was important to be familiar with the concepts in order to understand the literature (Kramer, Smith, & Califf, 2012; Windish, Huot, & Green, 2007).

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