What You can Learn About Clinical Trials from Recent Event

Saturday, October 3, 2015
Hosted by the Center for Information & Study on Clinical Research Participation (CISCRP)
Supported by the Lupus Research Institute and other national sponsors


We learned so much about clinical trials at the October 3 AWARE for All event in New York City, and wanted to share some highlights with those who couldn’t attend.  We especially found the analogy speakers drew between clinical trials and sports helpful in understanding the clinical trial process.  We can’t have new treatments without all the members of the team – including the patients!

What is a clinical trial?

  • Scientific study conducted according to a carefully designed plan that needs volunteers to help answer a specific medical question such as: is a treatment safe? Does it have side effects? Is it better than existing treatments?

Who’s on the research team?

  • The principal investigator is like the head coach of a team who follows a ‘play book’ called the study protocol and makes sure the plan is carried out.
  • Trial participants often have the most interaction with the clinical research coordinator who is like an assistant coach who handles day-to-day activities.
  • Volunteers are the players – the heroes out on the field.

How are volunteers protected?

  • To carry the analogy further, every trial is governed by referees -- the Institutional Review Boards who make sure every trial is ethical, fair and not too risky for the volunteers. And they make sure everyone follows the rules! They can even stop the trial if safety becomes an issue for the volunteers.
  • Then there are the higher referees – the Food and Drug Administration which approves the trial, makes sure that research centers are well equipped and has the final say whether or not a treatment is approved for patient use.

Why is diversity so important?

  • You can’t win a basketball game with just shooters or a football game with a team of quarterbacks. Everyone contributes a different skill.
  • In a clinical trial, you can’t find out if a new treatment works by testing it on just one group of people. Characteristics like sex, age, race and ethnic background affect how people respond to diseases and treatments. That’s why scientists need all different types of people to volunteer for research!

How can friends and family help?

  • They are your fan base!  They can help you ask the right questions to decide whether you want to be recruited for a study. And they are there to cheer you on along the way!
  • Sometimes friends and family can join the team themselves – some studies need healthy volunteers to serve as a control or provide genetic information.

Why are clinical trial participants heroes?

Many people take part in a clinical trial with hopes of taking back control over their disease and getting better treatment than they would otherwise. And that is often the case – every aspect of your care, every question is carefully attended to as the assistant coaches make sure that the rules of the trial protocol are followed exactly.  In some studies you may be treated with an investigational therapy in addition to your regular standard of care that may make a difference in how you feel.

But many people also want to make a difference for future generations. So while the trial results may not change their own treatment, the knowledge gained can advance research so others may benefit in the future. No matter the motivation, volunteers are an absolutely essential part of clinical research. Without them, there are no trials and there are no new treatments. In the world of clinical studies, trial volunteers deserve no less of a hero status than the greatest pro athlete!

One of the speakers, lupus patient Kaamilah Gilyard, has become a passionate advocate for participation in clinical research.  She told the audience, “You can choose to be hopeful or hopeless.  I need something to be hopeful about. Being in a clinical trial is not just a way to help myself; it’s a chance to help thousands of people. That’s enough to convince me to participate.”

More information about trials is available on the CISCRP website. And learn about lupus trials at LupusTrials.org.  The next AWARE for All event is Thursday evening, October 22 in Chapel Hill, North Carolina.