If you’ve ever contemplated joining a clinical trial but were wary of the process and commitment, you’re not alone. Many people spend time deciding whether to join a clinical trial — but few know what actually happens once they say “yes.”
You may have a multitude of questions: “Will I need frequent doctor’s appointments?” “Who will oversee my care?” “What happens if I experience side effects or decide the study isn’t right for me?”
While every clinical trial is unique, most follow a similar process. Knowing what to expect can help you feel more prepared and confident if you choose to participate. Clinical trials are founded on patient consent and safety, and you should know that you’re in control of your choice to participate.
While the steps may vary by trial, most clinical trials begin with a pre-screening process, which happens before any consent forms are signed. This is usually a quick phase consisting of a few basic health questions that you’ll complete either over the phone or via an online form.
During this stage, some participants may not be approved to move forward based on various factors such as age, condition, health risks, etc. If you are approved, the research team will contact you with next steps, which include informed consent.
One of the most important steps of the clinical trial process is reviewing the informed consent form before signing. You should receive information about the study from the research team, and they should be available to review it with you. You can also take the form home to discuss with your primary care provider and family. This ensures you fully understand the trial and have time to ask any questions. Remember that participation is completely voluntary, even after you’ve signed the informed consent form.
After the preliminary pre-screening and informed consent, you will undergo an official screening. Even after signing your consent, getting enrolled in a clinical trial isn’t always an immediate process. You will most likely receive an initial phone call or online inquiry from the study team, which may include a review of your medical history and whether you meet the eligibility criteria. This includes factors such as age, diagnosis, and medications. You may also undergo various tests, such as blood work, imaging, a urine test, a physical exam, and additional questionnaires.
Mark McKenzie, M.D., the chief medical officer at EmVenio Clinical Research, explained how the screening process prioritizes patient safety.
“Each study protocol includes detailed inclusion and exclusion criteria that are established to protect participant safety and ensure the study can accurately answer its scientific objectives,” Dr. McKenzie told BlackDoctor. “To qualify, a participant must meet all of the inclusion criteria and cannot meet any of the exclusion criteria.”
Depending on how well you meet the trial’s inclusion or exclusion criteria, you may or may not be approved to move forward with the study.
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For your first study visit, you can expect to meet the study’s healthcare provider or coordinator and complete baseline health assessments, such as blood samples, vital signs, imaging, and other tests. You may be asked to complete additional surveys or questionnaires as well as receive your study medication and instructions. The length of this visit will vary by study, but it is typically more comprehensive than a standard office appointment.
“Additional evaluations depend on the focus of the study,” Dr. McKenzie says. “For example, a liver disease trial may include an ultrasound, while a respiratory study for COPD or asthma may involve spirometry, breathing assessments, or chest imaging.”
Throughout the study, a patient’s participation, though it may vary by trial, will typically include:
While some studies require only a few visits, others can last months or years.
Taylor Adjei, MPH, is the manager of Patient and Health Equity at Lupus Therapeutics, the clinical affiliate of Lupus Research Alliance. Adjei works with lupus-specific clinical trials and explained how the participation can vary even within her specialty.
“For example, some studies may require a monthly infusion, whereas others may require taking a pill,” Adjei told BlackDoctor. “Some studies may require more upfront treatment, and then longer-term follow-up. During these visits, the research team monitors the participant’s health and lupus symptoms, looking for changes such as joint pain, fatigue, skin rashes, or hair loss.”
According to Dr. McKenzie, most trials involve a combination of clinic visits and remote monitoring. “Virtual visits and home health visits are increasingly common and help make participation more convenient while supporting study retention.”
Patient safety is of the utmost priority during clinical trials. Participants’ health is consistently monitored for side effects through clinic visits, routine lab work, lab testing, and physical exams. Participants are encouraged to report any new symptoms to the study team immediately.
“Any reported health changes are reviewed promptly and followed closely by the study team,” Dr. McKenzie says.
For some trials, Adjei explains, health monitoring can continue for several years. “Ongoing monitoring is a critical part of clinical research because it helps researchers evaluate both participant safety and how well the treatment is working.”
While this is a common concern for many potential clinical trial participants, the answer is usually yes — but it may depend on your specific study. With your permission, the research team may coordinate care with your regular doctor. You’ll continue seeing your primary care provider unless instructed otherwise, and they should be made aware of any trials you take part in.
“Clinical trial teams and treating physicians often work together to support the participants,” Adjei says. “For example, the participant’s doctor may receive updates on lab results, study findings, and any significant changes in health status. They may also review medications to help ensure there are no safety concerns or potential interactions. This collaboration helps provide comprehensive care while allowing participants to safely take part in the research study.”
While not every participant will experience side effects, the risk will depend on the study. Subjects should promptly report any symptoms to the research team, which will monitor for expected and unexpected effects. The team will also explain what to do and when to seek emergency care. In some cases, the study treatment may be paused or stopped.
Yes, participation is voluntary, and you can withdraw from a study at any time, even after you’ve signed informed consent. The research team may ask to conduct a final safety visit, but this is typically optional. Know that leaving a study should not affect your regular medical care.
RELATED: Can I Leave a Clinical Trial? What Every Patient Needs to Know
While you may have heard what happens before and during a clinical trial, more often than not participants are left with questions about what happens after a study. Most studies will conclude with a final health evaluation and return of any study materials. You may also attend follow-up visits or calls.
“[The final health evaluation] includes many of the same health assessments as the screening visit, and may also include a physical exam, blood work, and urine testing,” Adjei says. “This gives the research team a clear picture of the participant’s health at the end of the trial and allows them to compare those results to the baseline assessments collected during the first study visit.”
Participants who were taking medication may need to undergo an additional step of adjusting for other medications.
“If medications were stopped or adjusted during the trial, the participant may need to wait until the study drug is fully cleared from their system before starting or restarting certain treatments,” Adjei says. “This decision is made by the healthcare team based on the participant’s individual situation.”
While it depends on the study, not every trial participant will automatically receive study results. You may be able to request results from your research team. Some studies allow post-trial access, also known as continued access, after the study for patients who benefit from the treatment. This, however, is not guaranteed and will vary by trial. Not all studies offer ongoing access to the investigational treatment after the trial ends.
While you should ask questions before joining a clinical trial, you are also encouraged to do so throughout the study.
Here are some common questions participants are encouraged to ask throughout the process:
When searching for clinical trials to join and researching their various goals, know that no two studies are exactly alike. First, the condition being studied will determine the trial itself, the study location, the type of treatment, and length of follow-ups. Some studies may use virtual or decentralized visits, which are appointments that take place somewhere other than the study site. You also may be participating in a specific phase of the trial, which can have different timelines. It is always encouraged to discuss the details of any specific study with the research team.
Joining a clinical trial doesn’t mean navigating the process alone. Research teams are there to answer questions, monitor participants’ health, and explain each step along the way. Understanding what happens after enrollment can help you feel more prepared and make informed decisions about whether participation is right for you.
“At the end of the day, clinical trials are a partnership, and patients should never hesitate to ask questions and advocate for what they need throughout the process,” Adjei says.
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