There are many reasons people decide to take part in clinical research trials. Some patients are able to utilize new treatments before they are released to the general public. Others may receive certain types of medical care without going through insurance, and others may be passionate about contributing to medical advancements.
We wanted to write a blog for those who may not be familiar with research or who are curious to learn more. Clinical trials and the volunteers who participate in them are the heart of medical advances. Here’s why:
What is a Clinical Trial?
Clinical trials involve evaluating the safety and efficacy of potential new medications and devices. These medications and devices could be newly created or previously approved to treat another condition. The Food and Drug Administration (FDA) is a government agency responsible for regulating and overseeing the creation and distribution of medications, medical devices, food, and other products to ensure public health and safety. Clinical trials are a large part of the process required to receive FDA approval for new devices or medications. Before moving to human trials, a product undergoes an exhaustive assessment in a lab environment. Though we can recreate most scenarios in this environment, evaluating how these interact in the intricacies of a human body is necessary for defining how effective and safe they are.
General Participation Information
Clinical trials have four phases they go through. Once a phase is complete, the FDA evaluates all the data and determines if they move to the next stage. Trials start with generally healthy volunteers, and as the trials move through the phases, they focus specifically on the condition or disease the device or medication is designed to target.
- Phase I: Dose-ranging on healthy volunteers for safety. At this stage, a clinical trial evaluates a few different dose levels of medication to determine which dose(s) optimize the efficacy and safety in generally healthy participants.
- Phase II: Assessing the efficacy and side effects. Based on the findings from Phase I, clinical trials evaluate the safety and effectiveness of the new treatment on patients with a specific medical condition.
- Phase III: Assessing the effectiveness and safety of various ages, ethnic groups, genders, etc. Based on the findings from Phases I and II, clinical trials continue to evaluate the safety and efficacy of the treatment while examining a larger, more diverse participant population over a longer period of time.
- Phase IV: Surveillance in public after marketing. Once the product has been approved by the FDA and released to the general public, the organization that created the product can continue monitoring safety and efficacy. If the product is approved for a specific type of treatment or medical condition, the organization will need to repeat the clinical trial process to have the product approved for a different medical condition or type of treatment.
Individuals interested in participation go through an initial telephone screening process to determine if they meet pre-determined criteria. Qualified individuals are then seen at the research center and need to review a consent form. The consent form explains the trial purpose, medication or device being evaluated, potential benefits and risks to participation, visit schedule, and any other information needed to make an informed decision. Depending on the specific study, the visit may include lab tests, imaging, questionaries, physical examinations, and other procedures.
Multiple agencies need to review the details of a clinical trial before any participants are involved. For example, the FDA reviews applications for medications and devices set to undergo clinical trials and examines whether there are protections for patients involved in the trials. Other organizations that look out for patient protections include Institutional Review Boards (IRBs) and Data Safety Monitoring Boards (DSMBs), and each research facility has a primary study doctor, or Principal Investigator, that oversees the safety of the facility’s study participants.
Patient protections include:
- Informed Consent: To ensure patients understand the study purpose, potential benefits and risks to their participation, alternative treatments available, what their involvement in the study looks like, etc.
- Respect and autonomy: Patients receive respect in their participation and health decisions and understand they have control over the treatment they choose. This also includes understanding their participation is a choice and is not required.
- Beneficence: Clinical trials should be designed in a way such that the potential benefits outweigh the potential risks, and any harm should be limited.
- Justice: Clinical trials need to “equally distribute” potential benefits and risks, which is to say that clinical trials cannot target vulnerable populations and must fairly select participants. Vulnerable populations are groups that may be more susceptible to coercion or manipulation to participate.
Participation is 100% voluntary, and patients are informed they can stop their involvement at any time.
Why are Clinical Trials Important?
Health officials, researchers, and scientists work continuously to improve how we manage existing conditions and provide treatment. They strive to offer treatment options for medical conditions, more information on conditions not well understood, and improved devices to make healthcare easier for patients and providers. Clinical trials help to bring these possibilities closer to patients.
Participant diversity can ensure stronger trial results that allow for safe and effective treatment to be used in a larger population. Volunteers are vital to this process and make medical advances possible. If you’re looking for a way to give back or want to get involved in advancing treatment for health issues, consider becoming a research volunteer with Seattle Women’s. For more information, call us at (206) 522-3330, or visit our website today!