"Why Don't More Oncologists Refer Patients to Clinical Trials "

All oncologists understand the critical importance of participating in trials, but we are also largely responsible for the poor participation in clinical trials.  The main reason an oncologist may not discuss trials is that he or she may presume that patients are not interested in trials as an option.   If trials are not discussed, we may never know if patients are interested or not.  For this reason it may be important for the patient to initiate interest in clinical trials.  Often times, patients become aware of cancer trials opening before their oncologist.   Since trials open and close on a weekly basis, oncologists may not be aware of the rapidly changing pipeline and eligibility of new trials. 

            It is important for oncologists to keep handy an updated listing of open trials and eligibility criteria.  A simple question to your oncologist “what trials am I eligible for?” hopefully may prompt a discussion of available trial options if any are available.   If a trial is available, oncologists may sometimes differ on the trial’s equipoise and believe that another treatment is better.  This may occur when older trials remain open greater than 5 years in the face of shifting standards of care.  The trial sponsor, IRB and DSMB have an ethical obligation to revise outdated trials to include new treatment standards or close the trial.

            Another reason oncologists may not refer patients to trials is limited time.  In a busy practice, oncologists may not have time to explain the mechanics or review the entire purpose of the trial, a process that may take more than an hour to fully review informed consent and all aspects of a clinical trial.  

            Symptoms and timing may affect the patient adversely as well.  For example, if a patient goes to the hospital Emergency Room on Friday afternoon with severe pain from cancer; radiation or chemotherapy may be warranted over the weekend to control pain.  On this emergency basis, there isn’t the time or resources to register patients on trials, thus patients may become ineligible for certain trials once treatment is already started.  Most adjuvant trials have a window of 30-60 days after surgery or diagnosis to register, and this deadline can be easily missed.   Patients conditions sometimes dictate starting therapy as soon as possible without delay, such that a few extra days delay to register for a trial is unacceptable.

            Other reasons for not referring to trials include administrative burdens and “loss of control”.  The physician may feel strapped by protocol stipulations, such as frequent documentation, extra physical exams, and detailed grading of side effects.  Some oncologists do not refer patients to trials simply because of lost revenue if a study drug provided free and is not billable.  This “lost revenue” is an oncologist’s misperception, because trial sponsors pay investigator fees to compensate for the oncologists expertise, time, and effort.