ASCO Surveys Demonstrate Problems with Clinical Trials System

The three most comprehensive surveys to date of the cancer clinical trials system, commissioned by the American Society of Clinical Oncology, reveal a high level of oncologist participation in clinical research, despite severe underfunding and a lack of research resources. Patient paticipation, however, remains dismal. These separate surveys examined:

• oncologists' experiences and perceptions associated with clinical trial participation;
• pharmaceutical industry participation in clinical trials;
• the costs associated with clinical trials; and
• patient paticipation in clinical trials.

The surveys, begun in September 1998, queried more than 9,000 oncologists and 116 companies.

Patient enrollment

Not as many patients are being enrolled in cancer clinical trials as could be: while it is estimated that 20% of patients are eligible, only about half of hose are approached by oncologists to participate in clinical trials, and less than half of that latter group (approximately 3% of all oncology patients) are actually enrolled.

The single greatest barrier identified by oncologists to enrolling patients was strict eligibility criteria for participation, cited by 65.7% of the 3,550 respondents; additional barriers included administrated burden and inadequate data management staff

A total of 40,000 - 45,000 patients are enrolled in clinical trials at any given time: 20K in trials sponsored by the NCI, 13K in industry trials; and 7-12K in investigator-initiated cancer center trials. This represents approximately 5% of all cancer patients.

Survey of the Pharmaceutical Industry

It was difficult to obtain data from industry: 116 companies received the survey; 32 responded; 19 companies were evaluable.

The pharmaceutical industry survey found that only 9% of industry clinical trials are devoted to finding new anti-cancer agents, compared to 25% examining heart disease,17% investigating neurologic diseases, and 14% addressing respiratory diseases. The costs survey found that investigators are substantially subsidizing the costs of trials, and that NCI-sponsored trials - which represent half of all cancer clinical trials - reimburse only a quarter of the actual costs of conducting research.

The top five cancers being investigated in pharmaceutical industry trials are, in order: prostate, colon, melanoma, breast, and lung

It is estimated that 115 companies are conducting clinical research in cancer, and that 267 anti-cancer compounds are being tested in 647 different trials

Survey of Oncologists

"The encouraging news is that most oncologists view clinical research as fundamental to their jobs, despite significant disincentives to participate," said Allen S. Lichter, ASCO President, who has made increased participation in clinical research a primary focus of his tenure. "The bad news is that a lack of trained personnel, inadequate funding, increased pressure to do reimbursable work, and a lack of dedicated research time serve as powerful deterrents to conducting such research."

Specific points of the survey of oncologists included the following:

• A large majority of oncologists (85%) view clinical trials as the essential means of discovering new therapies to improve patient care
• 80% of oncologists reported having participate in clinical research within the last three years.
• The key barriers to participation in trials were excessive paperwork, inadequate financial support for data managers and research nurses, and strict eligibility requirements
• Overall, 20% of oncologists' time is protected for research - this is lower in private practice than in the academic setting
• There are 15 separate activities required to enroll patients and conduct a clinical trial; the most time-consuming of these included recruiting patients, seeing patients in the physician's office, and completing forms; overall, 200 hours of work are required to see one patient through the clinical trial process.
• Nurses and data managers take a significant amount of time: 1800 hours and 1500 hours per trial, respectively.

Oncologists reported cost estimates for enrolling patients that are significantly higher than current NCI reimbursement. The average cost of patient enrollment in government or industry trials is $2000 per patient (with a range of $581 - $5,028 for government trials and $569 - $6,567 for industry trials). Current NCI reimbursement is $750 per patient; average pharmaceutical reimbursement is $2,500 per patient.

Despite the higher industry reimbursement, oncologists report preferring to work on NCI- sponsored trials. There is a reservoir of good will for cooperative group trials, which many physicians consider to be exceptionally well-designed to respond to critical goals in oncology, and are intellectually challenging.

"These surveys tell us that we must better target resources to manage clinical trials, increased the amount of protected research time physicians, have, and loosen the eligibility criteria for some trials," said Dr. Ezekiel Emmanuel of the National Institutes of Health and primary author of the oncologist survey. "Without these actions, our continued ability to find better cancer treatments will be compromised."

"If trials were adequately funded and supported, we could shorten the time it takes to complete patient accrual, and thus the time it takes to complete research. This would allow us to undertake more trials, and learn the results faster," said Dr. Lichter. "This is critical because in oncology the majority of what we know to be effective has come to us through the clinical trials process."