Risks of Trial Participation

Patients should not expect a miracle cure on a research trial.  Certainly, there are risks to participating in clinical trials.  A cancer trial participant voluntarily accepts the added risk that a new experimental agent may not benefit their condition and/or may even cause unanticipated negative side effects. 

Trial participants are monitored closely for any side effects that might occur and are notified if other patients experience significant side effects.   If side effects do occur, generally it may be reversible and mild.  Depending on the study drug, some side effects may be irreversible or require hospitalization.  FDA oversight of trial safety monitoring prevents further study drug administration if multiple significant side effects or hospitalizations occur.   Inconveniences of participation include extra time commitment to adhere to strict protocol schedules and potentially extra blood draws or an extra voluntary tumor biopsy.  

Although many trial participants may not survive cancer themselves, the medical knowledge gained from the trial results can save lives in the future, including possibly their own. Whether they participate for the hope of success or altruism for others, clinical research volunteers are all “heroes.”  By understanding and participating in clinical cancer research trials, you, too could become a hero, and save lives.