People who are in a clinical trial or are thinking about joining a clinical trial have the right to ask the study staff any questions they may have about the study.
The questions below are useful for patients, potential study volunteers, and their family members and/or friends, to ask the research staff – which can include doctors, nurses, study coordinators, and other people who help conduct the clinical trial.
1. What is the main purpose of the study?
The main purpose of any clinical trial is to determine if the drug is safe and effective at treating the illness for which it was created. This process takes several years with results being reported to the FDA for final approval before the drug can be marketed as a treatment.
2. Does the study include a placebo or an already approved medication?
It depends on the clinical trial. A placebo, which is a pill with no active medication, is used to compare the actual medication to the placebo and record the contrasting results. An already approved medication can be used in conjunction with the study medication to determine how effective the study medication is with the approved medication.
3. If the treatment works, can I still use it after the study?
There are two ways to use the study medication after the study. The first way is if there is another clinical trial using the same study medication for which the participant can qualify for. The other way is when the study medication gets approved by the FDA and becomes available for marketing to the public.
4. What are the credentials and experience of the doctors and their staff regarding clinical trials?
Clinical trial sponsors look for certified and/or licensed doctors who have experience in the indication similar to the study medication indication (i.e. – a board-certified oncologist would be a good physician for a cancer clinical trial). Clinical researchers need to have Good Clinical Practice certifications and be qualified by training and education to conduct the trial.
5. What happens if I want to stop the study or the study medication before the study ends?
Clinical trial participants can stop the study or the study medication at any time. However, for safety purposes, the participant should schedule an early discontinuation appointment with the clinical trial site to return the drug and receive any final exams or procedures as directed by the clinical trial protocol.
At Fellows Research, we are happy to answer all your questions long before you decide to participate in a trial and will continue to answer your questions throughout your participation.