A Clinical Trial Advisory Board:
Weaving through the Clinical Trial Maze

By Bruce Shriver, PhD
Editor-in-Chief, ESUN

At some point in their journey with sarcoma, some patients need to consider the possibility of participating in a clinical trial. It is common for several Phase 1, Phase 2, and Phase 3 clinical trials to exist for each particular type of sarcoma. The trials often use different agents and protocols and have different eligibility requirements. The question immediately arises, "Which is the 'best' study for an individual to participate in?" The patient’s treatment history may limit the choices of trials for which they are eligible. But how does one select from the remaining trials available?

The choice of a clinical trial, even if a Phase 3 trial is an option, is not always obvious. Participating in a particular clinical trial (e.g., Study A), may eliminate a patient from participating in other trials (e.g., Studies B and C) at a later time. This may happen because the eligibility requirements of Studies B and C rule out patients who had been treated with the agent used in Study A. These eligibility dependencies, coupled with the patient’s response to previous treatment regimens (surgery, chemotherapy and radiation) and the patient’s current state of disease progression, often sets up a complex decision making process. Thus, the decision is sometimes guided by anecdotal information known about the responses of patients in the candidate studies (in this example, Studies A, B and C).

Patients may also encounter an additional level of complexity when choosing a clinical trial. In some Phase 3 studies, patients are randomized to receive either the new experimental treatment or the best existing treatment option. These Phase 3 studies are designed to determine which treatment is actually better, the new experimental treatment or the best existing option. Patients who choose studies like these in the hopes of receiving a specific experimental treatment may not receive it at all, but at least they would receive the best current treatment option.

Although a person diagnosed with sarcoma is strongly encouraged to be treated at a sarcoma center,¹ not everyone is able to do so because of where they live or because of other family, financial or job-related reasons. It would be extremely useful to have a Clinical Trial Advisory Board of several sarcoma clinicians who, given a patient’s medical history, records and a set of candidate studies, would recommend to the patient and the patient’s medical team a suggested order in which the studies should be undertaken. This board could be international in scope, taking advantage of the insights of sarcoma clinicians around the world. It could consist of perhaps five clinicians who would volunteer their services for one month each year to participate on the board. A second set of five clinicians would take over the next month, etc. throughout the year.

This board could be a valuable resource to patients and their medical teams as well as a valuable experience to the clinicians serving on it. The discussions leading up to making a set of recommendations could prove very useful in increasing knowledge about the trials among clinicians. A shared research database could be formed that would contain relevant parts of the patient’s medical history (anonymously), the trials considered, the recommendations, and follow-up information such as the outcome of the patient’s participation in the recommended studies.

The formation of such a board is not without some important issues that must be addressed. Standards would need to be established as to what information the patient’s physician would submit to the board and in what form it would be submitted. There must be a mechanism in place to accommodate for the medical liability of the rotating members of the board. Many clinical trials are limited to countries within a given continent. What is the patient to do if the "best" clinical trial is being conducted on another continent? For many, the financial hardships of travel, housing, and related costs and impact of the time spent away from home and family may be too much to bear. There may be instances where the board needs a consultation or review by an outside expert (e.g., a sarcoma pathologist or a radiologist) who also needs access to the relevant medical data. Accommodations need to be made to allow this review to happen in a timely manner. Further, because of the patient’s medical history and disease progression, there may be situations in which there does not appear to be a "best" answer.

If a Clinical Trials Advisory Board proves too difficult to establish, perhaps an alternative mechanism such a s a Clinical Trials Forum could be initiated where a patient’s medical case would be presented and discussed with the intent of helping guide the patient and the patient’s medical team to the "best" trial. An identified group of sarcoma experts would have access to participate in the forum for a given period of time, as in the case of the board. In fact, a Clinical Trials Forum might be a potential stepping stone to forming a Clinical Trials Advisory Board.