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Written by Adam Chasse, Vice President, Corporate Development at RxTrials
Source:HHS cutting red tape to speed clinical trials
American Medical News
HHS’s proposal to require protocol approval by a single central IRB could trim study startup timelines, particularly for indications more likely to be studied in academic and hospital settings. If enacted, this will be one critical step in accelerating drug development. But as with all new policies, there will be benefits to some stakeholders and detriments to others – all of which may make for some interesting lobbying.
Consider –
Academic research is still considered by many in the medical establishment to be the “gold standard” for research due to its noncommercial focus – whether or not that is always true, one reason for this school of thought is the rigor with which local IRBs review protocols – could the HHS proposal dilute that in the eyes of ethicists, and more importantly, the public?
Local IRBs would still be able to provide advisory services – will academic investigators still look to their local IRBs to be de facto reviewers, negating any time savings? Will pharma be willing to pay for such advisory services?
Will the types of studies that migrated to the private site industry in the 1980s and 90s migrate back to academia?
That last question is thought-provoking… it is easy to envision sponsors trying to achieve more consistent site quality by placing more studies within institutions (i.e., 20 studies at X University should have more predictable delivery and quality than 20 studies at 20 random private sites), not to mention the positive PR that could result – and which is sorely needed by industry. But academic centers don’t enroll, right? Truth be told, that varies by institution, by department, by PI, and by study coordinator – same as with private practice sites (which as a group, by the way, fail to enroll at an alarmingly high rate, and have plenty of quality problems).
Bear in mind that universities are buying or partnering with outpatient clinics regularly these days… if/when they figure out how to extend their research missions to those doctors’ offices, and how to accelerate the contracts process… the clinical trials landscape could look very different in 5 years.