How Do Clinical Trials Work?
Some aspects of clinical trials may vary, but most follow the structure outlined below:
- The Idea: most clinical trials are rooted in laboratory or patient care settings and begin with an idea to test a new medication or treatment to determine its effectiveness and/or limitations.
- The Protocol: a medical team then designs a protocol to help establish specific study guidelines to ensure patient safeguards and provide drug or treatment safety, dosage and efficacy. A principal investigator and/or coinvestigators are typically identified to monitor and manage the study.
- Protocol Review: the protocol is sent to the Institutional Review Board (IRB) for approval and periodic monitoring to ensure that the benefits outweigh any potential risks to participants.
- Sponsors: once the protocol is approved by the IRB, it is ready to be submitted as a clinical trial. Most trials receive funding from various federal agencies and organizations, such as the National Institute of Health, pharmaceutical companies or privately by individuals.
- Clinical Trial Sites: various types of institutions establish and host clinical trials, including hospitals, physician’s offices, universities, clinics, etc. Often, clinical trials are administered and managed from multiple sites to increase patient accrual.
- Enrollment in the Clinical Trial: a patient will work with their medical provider to determine which clinical trials are available to meet their specific needs and to find out if they meet the inclusion/exclusion criteria. Once it is established that the patient is an appropriate candidate for the trial, they then complete the informed consent process prior to officially joining the trial. Informed consent is the process where the main facts about the clinical trial are provided with a document that addresses all aspects of the trial, the risks and benefits and any other related details. Informed consent will continue throughout the trial.
Depending on the medication or treatment being used in the trial, there may be a prescreening process involved that may include such things as a history and physical. Sometimes, additional procedures/imaging studies are required.
Once the items above have been completed and approved, the patient is ready to join the clinical trial.