When you volunteer to participate in a clinical trial you start on a journey of scientific discovery. This is different than going to a normal doctor visit because in a clinical trial you will be following a research protocol with guidelines and restrictions to adhere to. You will be given personalized,one-on-one attention while completingregularly scheduled visits to your research doctor. Throughout the trial you will complete protocol required evaluations and assessments as well as share with the research team information about how you feel and inform them of any changes in health you have noticed.
Prior to participating the informed consent is completely reviewed with you by the research doctor and all your questions are answered to your satisfaction. The informed consent is a detailed description of your specific clinical trialand what is expected of you throughout the clinical trial. All areas of the clinical trial are fully discussed and transparent prior to and during your participation.
When you enter a trial you are usually assigned into a group. You may be in a group that receives the study medication or you may be in a group that receives a placebo or you may be in a group that receives an FDA approved, publically available treatment. You and the study team will not know which of the groups you will be in, but you and the study team do know the only options available in the clinical trial. This helps you and the study team to evaluate in a fair and objective way without bias.
Your visits are focused on your safety. We collect specific data before, during and after your participation to help us monitor and evaluate your safety. We also collect data for the goals of the trial and complete tests and questionnaires to help us determine the effectiveness of the investigational medications you are taking. You have exclusive access to your research team with allyour questions and problems addressed promptly.
Your primary care physician will be informed of your study participation and will continue to follow all of your non clinical trial related conditions. You will keep your research team abreast of all health and medication changes while you are participating in a clinical trial.When the trial and all the follow uphas been completed, your care will be returned to your doctorfor continuation of your health care needs.
You may volunteer to participate in one clinical trial at a time and in as many clinical trials, one after the other, as you are eligible for. Your PRC team will be happy to welcome you back for another clinical research trial.