Table 1

Informed Consent:

It is the opinion of the Review Group that the informed consent process is onerous and overly cautious. In many cases it has become a disclaimer for institutions rather than information for the participant. As a result, true informed consent is not being obtained and the informed process itself may be inappropriately deterring individuals from participating in clinical trials ... Simplified informed consent documents will assist both trial participants and physicians ... and are essential.

Trial eligibility criteria

[There are] far too many exclusion criteria in the current clinical trials system. Potential enrollees are disqualified for seemingly arbitrary reasons from trials for which they would otherwise qualify ... The eligibility criteria for all cancer clinical trials should be simplified in order to require minimal input at the time of registration of individuals, and to substantially reduce the workload for the individual conducting the registration.

Protocol development

Rapid protocol development is critical to the ability to implement new ideas and concepts in an expeditious fashion. Groups should develop a common algorithm for protocol development in order to minimize the time necessary to develop and obtain a letter of intent or concept to NCI for consideration and review.

Data collection

Data collection should be reduced so that only data pertinent to the study endpoints and patient safety are accrued. In addition, NCI-funded efforts should include some large, uncomplicated trials in common cancers with minimal data requirements and accrual goals large enough to establish treatment differences definitively.

Use of information technology to facilitate clinical trials management

Forms required for trial randomization do not take advantage of computer systems creating even more work for the investigator. The resulting enrollment system is slow, inefficient and costly. The money that could be saved through a more uniform and streamlined process could be used to enroll more patients in trials. A single informatics system for the NCI, all cancer centers, and all cooperative groups is important to the success of the clinical trials program.