Finding a Clinical Trial

Patients who choose to participate in a clinical trial can do so with their own research and/or through the referral of their physician. In addition to those approaches, clinical trials can also be found through a matching service. Clinical trial matching services facilitate patient enrollment in clinical trials by identifying potential trials for interested patients and their caregivers and providers, and in some cases by providing other support services such as educational materials or personnel who can answer questions or assist patients. While all services involve providing a list of trials to those using them, the actual goals of the services vary significantly. If you are considering a matching service, be sure to check the terms and conditions and whether there is a fee for the service. Matching services that are specific to a disease are usually free of cost. A few free clinical trial matching services include: Fox Trial Finder(Parkinson’s)Breast Cancer Trials, and ResearchMatch.

For patients who would like to find a clinical trial through personal research, there are general registries including any medical condition and trial registries for specific medical conditions. The International Committee of Medical Journal Editors has a policy that as a condition of publication, clinical trials would be required to be listed in a public registry. Regulators around the world therefore require the posting of clinical trial information and, in some cases, the submission of summary results to a publicly accessible registry. The World Health Organization (WHO) created a set of criteria to ensure that clinical trial data is handled properly and that patient safety is maintained. The WHO recommends that clinical trial registries include this criteria so that patients can be well informed about helpful indicators for a safe and regulated trial. Listed below are clinical trial search engines and registries that use the WHO’s recommended best practices:

Good Clinical Practice 

Your safety should always be the trial team’s top priority. Along with the World Health Organization’s set of criteria, The Guideline for Good Clinical Practice includes safeguards for patient rights. The guidelines were established by the International Conference on Harmonization, whose main goal is to protect participants and ensure the integrity of the data that is being collected. Since most of the safeguards regulate the way studies are performed, it can be difficult to recognize how the safety measures are meant to protect you. Indicators of a clinical trial that practices the guidelines can include, but are not limited to:

  • Number of participants: as the trial continues in phases, the number of participants usually increases. Does the trial have a large number of participants?
  • Transparency: participants should have access to clear and understandable information. The participant should also be able to ask questions. Is the information written in clear and simple terms?
  • Access to patient advocate: the participant should be given the choice to have a patient advocate if they desire. Does the study provide a patient advocate/representative for participants? Can the participant bring in their own advocate?
  • Beneficence: the possible benefits of a trial should outweigh the risks. Will this trial improve the patient’s health outcome or quality of life? Are the adverse side effects being documented and reported?
Enrolling in a Clinical Trial May 2019

Benefits and Risks

Clinical trials can benefit patient volunteers, patients with conditions similar to the volunteers, and many others. Trials offer early access to the latest treatments at little to no cost to patients (the device or treatment is usually provided by the investigator). Clinical trial staff are trained specifically on the patients’ condition so that they can provide optimal care. Another benefit is that patients get the opportunity to learn more about their health condition while contributing to research that could save lives. In some clinical trials, patients may find that the new treatment can lead to remission or improve the quality of their life. However, these outcomes are not guaranteed. There are risks associated with participating in a clinical trial. 

The majority of treatment trials are randomized, so patients may be placed in a control group and not receive the new treatment. Also, the trial design may conceal or ‘blind’ both the patient and the local care team as to which specific treatment is being administered. This can eliminate any inherent biases by those measuring and reporting outcomes. For example, vials of trial medication may only be identified by code numbers-not drug names. If a patient does receive the new treatment they may experience adverse side effects or find that it is not as effective as their current treatment. Trial organizers have access to the coded data. In this situation the central leadership of any blinded, randomized clinical trial bears responsibility to closely monitor trial progress and intervene if unexpected outcomes or hazardous trends emerge. Participating in a clinical trial can also be time consuming and costly. Each trial has risks and benefits specific to its topic of study; the trial team should make these known to participants before they decide whether to enroll in the trial. 

General Process

The process of enrolling in a clinical trial varies from trial to trial. Here is a general outline for what it may look like:

  1. Search for clinical trials that are recruiting patients (some trials are invitation only so you may be recommended by your physician).
  2. Consider the inclusion/exclusion criteria to make sure you are eligible.
  3. Consult your physician and contact the trial team member listed on the posting. With the help of their physician and/or patient advocate, the patient volunteer should determine which clinical trials are the most appropriate.
  4. Review the trial and its structure keeping in mind the Good Clinical Practice criteria. 
  5. Qualify to participate. In order to join a study a patient must receive approval from their primary care physician and the trial investigator.
  6. Enroll in a study.
  7. Verify your health status. Before being fully accepted into a trial you will need a physical exam and screening tests.
  8. Pre-assignment. In this stage a participant is enrolled in a trial, but has not been assigned to a specific treatment pathway, or treatment arm, group.
  9. Arm group assignment. Arm types are categories that determine whether a patient receives treatment and what type. Depending on the specific condition being studied, the arm types can include a no intervention arm, a placebo/sham comparator arm, or an experimental arm.
  10. You may withdraw from the study at any point without penalty. You will likely resume a recommended ‘standard of care’ treatment protocol.