What Does Joining a Trial Involve?
This is the initial step in joining a clinical trial and occurs over the phone. During the call, one of our experts will speak with you. She/he will first describe the clinical trial that might suit you. She/he will ask you a series of questions to determine if the trial might be right for you. You of course are encouraged to ask any and all questions you may have. If you and the expert believe you are a good candidate for the trial, you will schedule a visit at our site.
Second, Screening at our site:
After an initial greeting, you will be asked to complete an intake form concerning your particular medical conditions, including medications. We may request that you complete a medical release form to enable us to communicate with your personal physician. This will enhance your safety when joining the trial.
Then we move to the informed consent. Informed consent is something we take extraordinarily seriously at Excel Medical Clinical Trials. This form details all aspects of the trial. Any reported study-drug side effects will be detailed. Informed consent also plainly states your rights. If, after you read the informed consent, discuss it with our research staff, and have all your questions answered you then determine that you would like to join the trial, you will sign the document together with our expert present. This process establishes the fact that you have been informed of potential risks and benefits of participating in the study, and that your questions have all been addressed to your satisfaction. After informed consent has been discussed and signed, we will move on to complete other steps in the process. This might include a physical examination by our physician investigator, obtaining blood tests, and taking a more extensive medical history. We may also perform an ECG.
Third, Following the Protocol and Scheduling visits:
It is imperative that we follow the trial’s protocol. If after the screening has been completed and you are deemed eligible for enrollment in the trial, you will be asked to return to our site for randomization. This means that you will be placed in a particular “arm” of the trial, independent of the influence of you or the site’s investigators. Study visits will then be scheduled. The goal is for each trial participant to:
- Complete all scheduled study visits as detailed in the informed consent.
- Honestly answer all questions regarding potential side effects
- Take the Investigational Product (IP) as agreed
After you complete all scheduled visits, you will have successfully completed your part in the research trial. Often a final physical examination as well as blood tests will be performed on your completion of the trial.
At times you will be offered an opportunity to enter an “Extension” trial. This enables participants in the trial to continue taking the study medication for a longer time period. This is an excellent opportunity for trial participants, especially when the trial medication has been effective for you.
Sign up with your name and email address to obtain ongoing updates. Please know that you can ‘opt out’ at any time.