What Is the Clinical Trial Process Like?

When you join a clinical trial, you’ll work with a team of healthcare professionals and may need to visit a hospital or other location. The trial follows a detailed plan called a clinical trial protocol. A protocol is a detailed plan that explains how a clinical trial will be run. It ensures participants are safe while answering research questions. A protocol includes:

  • Tests, procedures, and treatments
  • Who can join the trial (eligibility)
  • How long the study will last
  • Goals of the study
  • Data to be collected
  • Ways participants will be protected

An Institutional Review Board (IRB) approves the protocol and makes sure the study is safe.

You’ll be told everything about the trial, including the procedures, how much time it will take, and other important details. After all your questions are answered, you’ll be asked to give your permission to join.

During the trial, doctors, nurses, and other staff will closely monitor your health. You might have more tests than usual and be asked to track your health or complete forms about how you feel. Sometimes, you may need to travel or stay in a hospital. For example, the NIH Clinical Center in Bethesda, Maryland, runs clinical trials. It is the largest research hospital in the world. If you decide the trial isn’t right for you, you can leave at any time. Leaving the trial will not affect your regular medical care.

Who is on the Research Team? 

A clinical trial team works together to monitor participants and ensure the study is safe and effective.

  • Principal Investigator (PI): Leads the study and is responsible for its safety and success. The PI also trains the research team.
  • Co-Investigator: Works with the PI to help manage and run the study.
  • Lead Research Nurse: Supports the PI and helps with patient care.
  • Research Nurse: Provides nursing care and helps with the study.
  • Lead Site Co-Investigator: Manages the study at a specific location.
  • Site Investigator: Runs the study at a specific site.
  • Study Coordinator: Helps organize and manage the study.
  • Regulatory Staff: Keeps track of important study documents.
  • Research Manager: Oversees the management and coordination of the research project.
  • Statistician: Analyzes and interprets the data collected from the study.
  • Other Staff: Includes students, scholars, or volunteers who help with the study but don’t usually get consent from participants.

Will It Cost Me Money to Join a Clinical Trial?

There may be costs involved with clinical trials, but often expenses are covered by the trial sponsor or your health insurance.

Examples of Costs Typically Covered by the Trial Sponsor:

  • Study medications
  • Lab tests done for the study
  • Extra imaging or doctor visits required for the trial
  • Travel help (gas cards, Uber rides, or lodging)
  • Meal vouchers or food during appointments
  • Childcare, eldercare, or parking costs

Ask the research team if they provide financial help or can connect you with organizations that offer support.

Before joining, learn what expenses you or your insurance might need to cover. Talk to the trial team, your doctor, and your health plan to get clarity.

If you’re worried about medical bills, ask about:

  • Payment plans
  • Reduced rates
  • Patient assistance programs
  • Support from charities

Some federal health programs also help:

  • Medicaid: Covers routine care costs during clinical trials for eligible individuals.
  • Medicare: May cover trial costs for certain treatments. Call 1-800-MEDICARE for details.
  • TRICARE: Covers certain trial costs for military families. Visit TRICARE’s website for more.
  • Veterans Affairs (VA): Offers access to trials for eligible veterans. Check the VA website or talk to your doctor.
  • Federal health insurance and programs for clinical trials

Can I Join a Clinical Trial? 

Anyone can volunteer for a clinical trial, but each study has specific requirements called inclusion and exclusion criteria. These ensure participants are the right fit and that the trial is safe and can measure the impact of treatment.

Eligibility requirements might include:

  • Age
  • Gender
  • Type or stage of a condition
  • Past treatments
  • Other health conditions

You can usually find out if you qualify by phone or through an online questionnaire. Clinical trials may be open to children, adults, patients with specific conditions, or healthy volunteers.