Clinical trial enrollment

A clinical trial is a research study that tests how well new medical approaches work in people. Clinical trials are the primary way that researchers determine whether new treatments, drugs, devices, or procedures are safe and effective.

42 steps across 12 sections

1. Identify Your Interest and Goals

  • Understand why you are considering a clinical trial (access to new treatment, standard treatments haven't worked, desire to contribute to research)
  • Discuss with your primary doctor or specialist

2. Search for Trials

  • Use ClinicalTrials.gov, NCI, disease-specific organizations, or ask your doctor
  • Identify trials that match your condition, location, and treatment goals

3. Review Eligibility Criteria

  • Read the inclusion and exclusion criteria carefully
  • Compare your medical history, current health, and medications against the criteria
  • Note any questions or areas of uncertainty

4. Contact the Research Team

  • Reach out to the trial coordinator listed in the study record (phone number or email is usually provided)
  • Ask initial questions about the study
  • Request the informed consent document to review

5. Pre-Screening

  • Answer preliminary questions about your health and medical history (often by phone or online questionnaire)
  • The research team will determine if you are a potential fit before scheduling in-person screening

6. Formal Screening and Evaluation

  • Visit the research site for medical exams, lab tests, imaging, or other evaluations
  • The research team reviews your medical records
  • This step confirms whether you meet all eligibility criteria
  • Screening may take one visit or multiple visits depending on the trial

7. Informed Consent

  • Review the informed consent document thoroughly
  • Ask every question you have — no question is too small
  • Take the document home if you need more time
  • Sign the consent form when you fully understand and agree to participate

8. Randomization and Assignment

  • In randomized trials, you will be assigned to a treatment group (new treatment, standard treatment, or placebo)
  • You may or may not know which group you are in (blinding)
  • The research team will explain your specific assignment process

9. Begin Participation

  • Attend scheduled trial visits (frequency varies by study — weekly, monthly, etc.)
  • Follow the trial protocol (take medications as directed, attend all appointments, report symptoms)
  • Maintain open communication with the research team

10. Ongoing Monitoring and Follow-Up

  • Regular check-ups, lab tests, and assessments throughout the trial
  • Report any side effects or changes in health promptly
  • The research team may adjust your treatment or remove you from the trial if safety concerns arise
  • Follow-up visits often continue after the active treatment phase ends

11. Phase 1: Safety and Dosage

  • Purpose: Test the safety of a new drug or treatment for the first time in humans; determine safe dosage range and identify side effects
  • Participants: Small group of 20-80 healthy volunteers or patients
  • Duration: Several months
  • Key question: "Is this treatment safe? What dose should we use?"
  • Success rate: About 70% of drugs pass Phase 1
  • What to know: These are the earliest-stage trials. You may be among the first humans to receive the treatment. Monitoring is extremely close and frequent

12. Phase 2: Effectiveness and Further Safety

  • Purpose: Determine whether the treatment actually works for a specific disease or condition; continue evaluating safety
  • Participants: 100-300 volunteers with the condition being studied
  • Duration: Several months to two years
  • Key question: "Does this drug improve the disease or condition?"
  • Success rate: About 33% of drugs that pass Phases 1 and 2 move to Phase 3
  • What to know: Randomization may be introduced (you might receive the treatment or a placebo). Side effects are more thoroughly evaluated at this stage

Common Mistakes

  • Not telling your primary doctor
  • Not reading the informed consent document carefully
  • Assuming you will definitely get the new treatment
  • Ignoring eligibility criteria
  • Not asking about costs upfront

Pro Tips

  • Start with your doctor
  • Search multiple databases
  • Use specific search terms
  • Filter by "Recruiting" status
  • Look at the trial location map

Sources

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