Understanding Clinical Trials
Clinical trials are at no expense to the patients participating in the trial. The therapy under evaluation, the investigational product (IP), is provided along with the needed laboratory test and colonoscopies at no charge to the patient. This is provided for the length of the trial. Trials can range from 1 year to greater than 5 years in length. Any additional medication and hospitalization expenses are not covered by the clinical trials.
Clinical trials are governed by the Food and Drug Administration ( FDA) and carried out under strict guidelines and regulations. These trials involve new medications aimed at treating ulcerative colitis and Crohn’s disease. Clinical trials are designed to go through three phases. Phase 1 , phase 2 , and phase 3 trials. Phase 1 and 2 trials are more exploratory in nature and seek to determine if a new medication has potential therapeutic benefit, study dosing of drugs and drug safety. If a new medication passes through phase 1 and 2, it will undergo extensive testing at a much broader scale in the phase 3 trial which determines if the FDA will approve the drug for its use in ulcerative colitis or Crohn’s disease. The vast majority of clinical trials conducted by TRI are phase 3 trials.
Participation in any clinical trial is voluntary and must be done with each patient’s informed consent prior to any involvement in a trial. Participants in clinical trials are given the investigational product (IP) in a blinded manner. This means that neither the patient or the staff at TRI know who is getting IP or placebo therapy. The placebo therapy is given only to a small percentage of patients (control group) in a given trial. If the patients in the control group continue to experience symptoms of active disease then they are rolled over into the other side of the trial to receive the IP. Therefore, if patients with active symptoms of disease remain in the trial they will ALL receive the IP during the course of the trial. The control group is needed to demonstrate that the IP has a defined benefit in patients with active disease and is required in all new clinical drug trials. The majority of patients who get randomized to the control group are in this group for about 2-3 months before being rolled over into the treatment group who receive the IP. At any time in the study if the patient is not doing well, they can be withdrawn from the study and other therapies can be pursued.
To learn more about our research into Crohn’s disease and ulcerative colitis, or to see how you can become involved in a clinical trial to help find a cure for these diseases, contact Tyler Research Institute today.
