Clinical trials are research studies that examine whether new therapies, diagnostic techniques, or disease-prevention strategies are safe and effective in people. They’re considered the gold standard for determining if newly developed treatments produce better results and fewer side effects than standard therapies.
All proposals for clinical trials go through a rigorous review at the institution where they’re performed to ensure they’re well designed and protect the rights and welfare of participants. The Institutional Review Board and the Data and Safety Monitoring Board at the trial’s home institution track the progress of clinical trials once they’ve started to ensure that potential unexpected side effects are identified and shared with the participants.
Because they’re designed to answer specific questions — what percentage of patients benefit from a new therapy? which patients are most likely to benefit? what are the most common side effects and how severe are they? — clinical trials tend to be open to specific sets of patients. Each trial has detailed requirements for participation, referred to as eligibility criteria. Eligibility is based on the type or subtype of cancer that a patient has, and may be further limited based on age, gender, stage of disease, and co-existing health problems, plus the type of number of previous treatments.
Before enrolling, prospective participants are thoroughly briefed on the trial — its purpose, the potential benefits and risks of the therapy being tested, the schedule on which it will be administered — by a clinician. A detailed written informed consent is made available to patients for their review and consideration. Enrollment requires signing a formal consent document witnessed by their physician.
As a general rule, trials evaluating new treatments are open to patients who haven’t previously been treated or to those who have already received standard therapy for their disease. Some trials compare a standard regimen already shown to be effective to a newly developed regimen that clinical investigators believe may improve patients’ outcome, a process called randomization.
The National Institutes of Health maintains a website — clinicaltrials.gov —listing more than 300,000 trials in more than 200 countries. The site is searchable by type of disease and lists the eligibility criteria for each trial, along with detailed information on the treatment protocol, where the trial is available, and whom to contact for more information. People with questions about their eligibility for a particular trial can seek guidance from their oncologist. Because new trials are opening constantly, it makes sense to check the website regularly to see if a trial for which you are eligible has recently begun recruiting participants.
More information on clinical trial participation can be found here.