Participating in Clinical Trials
Clinical trials are designed to evaluate the effectiveness of new treatment interventions. Patients participate in clinical trials for several reasons, including but not limited to:
- The potential to benefit from a new drug or treatment
- Improved management of symptoms resulting from treatment
- Opportunity to directly contribute to discovering new therapies, which may ultimately benefit other patients.
Conducting Clinical Trials
Clinical trials are designed to test treatments under very specific scientific and ethical guidelines. Clinical trials use written protocols to define the purpose, design and conduct of a specific clinical trial. The protocol is written by either the physician investigator or another study sponsor and explains:
- What the trial will do
- How it will be conducted
- Where it will be conducted
- Who may participate
- How and when the participants will be evaluated
Every clinical trial has a principal investigator (PI), a doctor who is in charge of every aspect of the particular study.
All clinical trial protocols must undergo a review by a committee looking particularly at the ethics and safety of research called the Institutional Review Board (IRB). The IRB is responsible for overseeing all clinical trials that are performed in the specific healthcare institution where the clinical trial is offered. Committee members serving on Institutional Review Boards address these factors in reviewing protocols:
- Does this protocol have scientific value and validity?
- Are risks to subjects minimized?
- Are risks reasonable in relation to anticipated benefits?
- Is the selection of subjects equitable?
- Are additional safeguards in place for subjects likely to be vulnerable to coercion or undue influence?
- Will informed consent be obtained from research subjects or their legally authorized representatives?
- Is there adequate provision for monitoring the data collected to ensure the safety of subjects?
- Are there adequate provisions to protect the privacy of subjects and to maintain confidentiality of data?
The IRB also reviews all informed consent documents to make sure that they provide clear and complete information for those evaluating the merits of enrolling in a specific clinical trial.
Clinical Trial Safeguards and Informed Consent
Both standard care and clinical trials have risks, side effects and benefits that vary depending on the individual. Because of this, there are rigorous guidelines in place to protect the well-being and safety of clinical trial participants. Your physician and research nurse conducting the study will inform you of any known or anticipated risks ahead of time. Clinical trial participants are also constantly monitored to identify any changes in their condition.
Once a patient’s eligibility is established for the specific clinical trial, the research nurse will explain the informed consent process. Informed consent is one of the patient’s most important rights in the research process, as it outlines:
- The purpose of the study
- The exact treatments that will be administered
- All possible side effects
- The patient’s right to withdraw from the study at any point
Signing the consent form acknowledges that the trial was explained and is understood by the patient.
For more information on how clinical trials are conducted and/or your eligibility for participation, please discuss with your physician.