Clinical Research Participation Basics: What Should I Ask of, and Know About, the Study Staff?

Principal investigators, the people who supervise clinical trials, may only meet with you briefly to do a physical exam and required medical procedures. With the exception of dental studies, principal investigators are usually medical doctors. Research visits with physicians can seem like a routine doctor visit with added paperwork. But principal investigators do a great deal of behind-the-scenes work that study participants rarely see, including trial design and monitoring of results. Protocols that pharmaceutical companies and research consultants develop can be hard to qualify for and grueling to be in. Some principal investigators spend a significant amount of time reworking these trials to be more patient-friendly. Sub-investigators, including other doctors, graduate students, residents, and lab staff, may conduct study-related procedures under the supervision of the principal investigator.

With few exceptions, the professional with whom you will interact directly and frequently is the research nurse—called a study coordinator. Study coordinators are frequently registered nurses. They essentially run the clinical trial. Among their long list of duties are recruiting and screening patients, obtaining your written consent to participate in a study, monitoring your progress at home, and reporting any adverse drug reactions. Study coordinators are the individuals with whom you likely will first meet to discuss what you can expect during a clinical trial and the potential risks and benefits of the investigational therapy. Coordinators can, in many ways, make or break the clinical trial experience for you.

Both study investigators and coordinators usually make themselves available 24 hours a day to answer questions about the study and any unexpected reaction—or non-reaction– to the investigational medication. This also allows them to respond quickly to any adverse event that occurs. Many research centers will go to great lengths to assist you in feeling comfortable and well-cared-for. A number of studies have shown that the vast majority of study volunteers highly rate the level of professionalism and the quality of care that they received during their participation. The center may provide transportation services, onsite day care, after-hour appointment times, waiting rooms stocked with refreshments, friendly administrative staff, special dinners, and birthday cards. Some research centers even offer valet parking. Patients who repeatedly volunteer for drug trials targeting their particular illness are sometimes even supplied with free medications and treatments between studies.

For more information on clinical trials and making informed decisions about volunteering for clinical research, read “The Gift of Participation” by Ken Getz, Founder and Board Chair, CISCRP.