Comments on the Department of Health and Human Services’ Inspector General’s Study on Recruiting Human Subjects: Pressures in Industry-Sponsored Clinical Research”(HRG Publication #1523)
HHS Inspector General’s Study Recruiting Human Subjects:
Pressures in Industry-Sponsored Clinical Research
Comments by Sidney M. Wolfe, M.D. and Peter Lurie, M.D., M.P.H.
Public Citizen’s Health Research Group
“Somewhat buried in the middle of this highly disturbing report, the authors mention “the transformation of clinical research into a traditional business model.” As a result of the shift to this business mindset, the often highly unethical and possibly illegal recruitment practices documented in the Report appear to be increasing rapidly. The rise of separate (from the drug companies themselves) for-profit Human Experimentation Corporations (HECs), a more accurate name for the more benign-sounding name currently in use–Contract Research Organizations (CROs)–has introduced new techniques for rapidly recruiting patients. When combined with the appallingly inadequate Federal regulation of human experimentation in general, and recruitment practices in particular, and the failure (as usual) of the medical profession to police itself, the risk of abuse of patients increases dramatically.”
“In concordance with a New York Times investigation documenting doctors getting paid as much as several thousand dollars per patient to recruit patients from their own practices, the policy of recruitment by physicians of patients from their own practices is further documented in the Report. The vulnerability of a doctor’s own patients to be persuaded to become an experimental research subject because of their trust in their doctor, combined with signing bonuses which the doctor pockets for the referral sets up a toxic situation where some doctors are literally selling their own patients into human experiments. In a gross commercialization of this practice, one large family practice group advertised its “computerized patient data base of 40,000 patients” to HECs and others running clinical trials as one from which “We can actively recruit patients for any study…”
“Seeking Additional Patient Bases
In addition to plumbing their own files for potential experimental subjects, some researchers pay “finder’s fees” to other doctors who do not even conduct the research: “Occasionally, investigators offer fees to encourage referrals from other physicians or nurses,” such as an offer of $75 to physicians or nurses for each subject referred, according to the Report. The use of patients reached through patient advocacy groups, also described in the Report, similarly has the taint of using a relationship of trust to recruit patients who might otherwise not be interested in participation in such experiments.”
-Is HSR known as “human capital”?
CRO’s Regulatory Aspects-Wiki
“Specifically pertaining to CROs providing clinical-trials services, the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH-GCP) (E6 1.20) defines a Contract Research Organization (CRO) as: “A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.”
Furthermore, it states that:
* (5.2.1) A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
* (5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing.
* (5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
* (5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.
In spite of this statement of principles, at least one publicly traded biopharmaceutical company that makes use of CROs has stated in investor filings:
Due to our reliance on third party contract research organizations to conduct our clinical trials, we are unable to directly control the timing, conduct, expense and quality of our clinical trials.(emphasis added)”
*Recuitment though patient advacacy groups? This might explain the information black hole in such groups.
CROs exposed in India…
Posted on Sunday 21 April 2013
links to his take on CROs most info is about CROs abroad
So we can almost see where CROs and HECs fit in here:
This would probably cover medical devices as well.
HHS Office of Inspector General-keyword search HSR results