Trial Participant Behavior

Safety First

The top priority of initial drug testing is to assess the safety of the proposed treatment. This must be done in a way that minimizes the risk of causing harm to trial participants. Typically Phase I/II trials use a careful approach that involves a small number of participants participating in several groups or stages. Usually some participants will be on active drug, and some will be on a placebo (doses with no active drug ingredient). The placebo group is necessary to ensure the only difference between the groups is whether or not they are exposed to drug, in order to allow for the best evaluation of the effects of the drug. Often Phase I/II trials are double-blinded controlled studies, meaning that information on active versus placebo recipients will be hidden from both participants and personnel at the clinical trial sites in order to protect the objectivity and quality of the trial results.

Do's and Don'ts of Communicating

When you join a clinical trial, you become part of a community of scientists and fellow participants who agree to protect and promote the accuracy and reliability of the data collected. While it is usually appropriate to confidentially tell your immediate family and friends that you are a participant, it is important that you avoid sharing details about your participation online, including on Facebook or in any other social media or online forums. Why? Because these online comments can distort the results of the study and essentially cause the trial to fail.

Do:

  • Do discuss your experience confidentially with your family and other people who are close to you.
  • Do talk with your family doctor and other healthcare providers. It’s important to let them know that you are in a clinical trial.
  • Do ask your clinical trial team to provide guidance about where to obtain reliable educational material online.
  • Do keep a journal or take notes on your cell phone so you can make a list of things to talk about with your clinical trial doctor and study team at your clinical trial.

Don’t:

  • Don’t talk publicly, including online, about your participation in a clinical trial.
  • Don’t post about your experience in the trial, including about side effects or about how you think the drug is working.
  • Don’t solicit trial advice or information from online friends or people other than the clinical coordinator or primary investigator at your clinical trial site.
  • Don’t respond to questions or comments online related to the trial you’re involved in. If you do see trial posts online, please tell MDF or your trial site.
  • Don’t share or take anonymous advice from “experts” online.