NIH Clinical Trials:

Various Factors Affect Patient Participation

HEHS-99-182: Published: Oct 30, 1999. Publicly Released: Nov 1, 1999.

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Pursuant to a congressional request, GAO reviewed patient access to clinical trials sponsored by the National Institutes of Health (NIH), focusing on: (1) how health insurers' coverage policies and practices affect patient participation in clinical trials; (2) researchers' experience in enrolling patients for trials sponsored by the National Cancer Institute (NCI) and factors that may explain this experience; and (3) whether NIH has evidence of recent difficulties in enrolling patients in clinical trials.

GAO noted that: (1) despite policies that generally exclude coverage for clinical trials, nearly all the insurers that GAO interviewed allow for exceptions following case-by-case reviews by the insurers' medical personnel; (2) if coverage is approved, insurers generally agree to pay the standard, nonexperimental care costs associated with a trial; but because there is little agreement on which trial services constitute standard care, payments can vary from insurer to insurer; (3) given the uncertainty about approval and payment levels, patients and physicians can be discouraged from seeking prior approval from insurers; (4) most cancer research centers GAO contacted said that they did not experience what they considered to be serious difficulties enrolling adequate numbers of patients for NCI-sponsored clinical trials; (5) but all the centers described clinical trials enrollment as challenging because of the significant administrative burden incurred in dealing with health insurers about trial coverage and payment issues; (6) paperwork requirements can be labor-intensive and time-consuming when staff physicians and nurses must document the necessity of enrolling each patient and negotiate the specific services and amounts to be paid as standard care; (7) center representatives also cited an array of physican- and patient-related factors that affect the availability of patients for NIH-sponsored clinical trials; (8) NIH has expressed concern that trial enrollment is declining, but the data provided to GAO by several of the largest institutes did not document the basis for NIH's concerns; (9) patient enrollment in the NIH-sponsored clinical trials for which GAO could obtain data appeared to be meeting the goals of those trials; (10) in 1998, NIH officials reported to the Office of Management and Budget that patient participation in trials was a substantial problem, particularly for cancer trials; (11) they cited 1996 testimony from clinical investigators that managed care seemed to have affected patient participation in cancer clinical trials; (12) beyond such anecdotal information, however, NIH does not have quantitative data that indicate that patient enrollment has slowed or that trials have been delayed or prematurely closed because of patient enrollment problems; and (13) NCI is in the process of converting its existing clinical trial reporting systems to a new consolidated electronic system, which should support improved trial monitoring.

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