Who decides whether you get into a clinical trial?
One may choose to participate in a clinical trial for many reasons. Volunteering often has multiple benefits, from advancing medical research to gaining access to cutting-edge medical care. However, deciding to enroll in a clinical trial is only one part of the process.
Based on study-specific inclusion and exclusion criteria, medical research teams determine who can join a clinical trial. These criteria exist to accurately determine whether a potential new treatment is safe and effective in treating symptoms in a controlled population subset. Typical exclusion criteria include taking specific medications, having other health conditions, and experiencing certain disease symptoms.
How to get into clinical trials
Understand the different types of clinical trials
Because any medical treatment must first go through a clinical trial to prove it is safe and effective, there are different types of studies depending on the purpose of the research. The types of clinical trials include:
- Prevention trials that look for better ways to prevent a disease from occurring or returning
- Screening trials testing new ways of detecting health conditions
- Diagnostic trials which study tests and procedures for diagnosing a condition
- Treatment trials that look at new treatments, drugs, or approaches to therapies
- Behavioral trials evaluating or comparing ways to promote behavioral changes
- Quality of life/supportive care trials measure ways to improve the comfort of people with a particular condition
Learn about the phases of a clinical trial
As more is learned about a new treatment, therapy, or other medical technology being studied, it will progress through the phases of a clinical trial. This begins in Phase 1, where the intervention is tested for human safety, often with fewer than 100 volunteers. About 70% of drugs then move to Phase 2, where safety and efficacy are tested in several hundred patients over many months or even a few years. If this is successful, Phase 3 begins — this is where a potential treatment is tested in hundreds to thousands of people, and the research will typically last for several years.
Search for clinical trials
After understanding the types and phases of clinical trials, the process of searching for a study can begin. Searching for a clinical trial can be done directly through ClinicalTrials.gov or simplified by using a tool such as Antidote Match.
When searching via Antidote Match, individuals can enter their location, age, and gender and answer a few questions tailored to the condition they are searching for. This patient-centric process makes finding studies that may be a good fit easier. From the results page, it’s possible to see essential information about the study, including where the study site is located, the inclusion and exclusion criteria, and how to take the necessary steps to proceed.
Complete any prescreener requirements
Getting screened for a clinical trial is unique to each study and depends on the inclusion and exclusion criteria. Sometimes, the first step is to contact the site directly. However, to make the process easier for patients, research teams may use an online questionnaire as a first screening step, followed by asking patients additional questions over the phone. This can help determine whether a patient may or may not qualify for a trial while reducing the time commitment from both the patient and the site.
How to participate in clinical trials
Sign an informed consent form
After choosing a clinical trial and proceeding through any prescreener requirements, individuals can then officially enroll in a clinical trial. The first step for this is reviewing and signing an informed consent form. This form is designed to educate volunteers about the details of the study, the potential risks and benefits, and all the requirements for participating. Before signing, potential participants are encouraged to ask questions and get clarification on any details that remain unclear.
Complete the required study visits
Every study will have different requirements for participants to complete during the duration of the trial. Some studies may require regular, in-person visits for testing and monitoring, while others may allow participants to complete check-ins with site staff from home or at satellite locations at a local doctor’s office.
Keep track of any take-home assignments
Whether the trial is conducted as a fully virtual experience or requires in-person site visits, it will likely still have some component of at-home record keeping. Often, patients will be asked to keep a record of their lifestyle habits, any symptoms they experience, and any interactions with the study drug. Additionally, many trials are now including the data collected from wearable fitness trackers, such as resting heart rate and sleep duration.
Are you ready to learn more about the clinical trials you may be eligible for? Click the button below to answer a few questions and see what studies are available in your area.
