How Do Clinical Trials Work?

Overview

A clinical trial is a research study that tests how well a medical treatment—like a new drug, therapy, or device—works in people. Researchers run clinical trials to see if the treatment is safe, what side effects it might have, and whether it actually helps the condition it's meant to treat.

Trial Phases

Each new treatment goes through multiple trials, numbered as phases. The trial for each phase builds off of the previous one.
  1. A Phase 1 trial provides researchers with the first-ever opportunity to test a new drug in human patients and collect safety data. (Before this point, it's likely that the drug has been tested on only animal subjects.) Typically 20–100 participants.Find Phase 1 trials near you.
  2. A Phase 2 trial is to confirm the effectiveness of the drug in treating the target condition. Typically 100–300 participants.Find Phase 2 trials near you.
  3. A Phase 3 trial is the final step before approval by the FDA for mass production. The purpose is usually to establish the precise dosage guidelines, as well as confirm that the treatment's benefits outweigh the risks. Typically 300–3,000 participants.Find Phase 3 trials near you.
  4. A Phase 4 trial happens after a treatment is FDA-approved and available to the public. The goal is to monitor long-term safety, rare side effects, and real-world effectiveness. Typically multiple thousands of participants.Find Phase 4 trials near you.
When you apply to a clinical trial, here on Power or anywhere else, you're signing up to join a trial for a particular phase.

Working with Clinics

Sometimes, trials run at a single research site (such as at a research university). But more often, phase 2–4 trials are run across many different clinics throughout the country. When you apply to a trial on Power, we help to match you to the clinic closest to you. Each clinic has a Principal Investigator (PI), who oversees trial operations at their clinic, ensuring that the study follows the precise study protocol and that all participants stay safe.

Trial Duration

From the patient perspective, trials often last between a couple of months and a couple of years, comprising the following periods:
  1. Screening: Interviews and lab tests with the trial clinic to ensure that you're a fit.
  2. Treatment: The period during which you receive the study drug or, if you're placed into the Placebo group, a Placebo.
  3. Open Label Extension: After the treatment period, some trials let participants stay on, with 100% guarantee that they receive the active drug (as opposed to receiving only a Placebo).
  4. Follow-Up: All trials follow up with patients after treatment to ensure that they're okay.
Read More: What to Expect During a Clinical TrialGiven that trials enroll anywhere from a few dozen to a few thousand people, it may take the researchers several years to get all participants through the process.

Study Results

Once all patient results are collected, the sponsoring biomedical company publishes any successful results in a peer-reviewed medical journal. Some trials end with the decision not to continue developing the drug. But hopefully, the trial data demonstrates high promise, and the researchers can continue to move the drug on the path for mass production.