How Do You Participate in a Clinical Trial?

How Do You Participate in a Clinical Trial?

How Do You Participate in a Clinical Trial?

Clinical trials set out to prove the effectiveness and safety of medical treatments, such as medicines, devices, or biologics like gene therapy before it can get the Food and Drug Administration's (FDA) approval and be used by the public.  How do you participate in a clinical trial?

Clinical trials require human volunteer participation. Study volunteers have the disease or condition that the new medical therapy has been developed to treat. To ensure proper scientific protocol and controls, some volunteers may get the treatment being tested while others may get a placebo.

Clinical studies can also be used to find new ways to prevent, detect, and diagnose diseases. They each have their own rules with some studies needing only healthy volunteers or are gender-based, etc.

Before a treatment gets to clinical trials, there is first a long process that begins in a research laboratory. Scientists work for many years to understand the disease or medical condition, etc. they are studying to develop new treatments. Before trials begin on humans, treatments are first conducted on laboratory animals.

Principal Investigator

The principal investigator in a clinical trial is a doctor or scientists with a Ph.D. This person oversees and manages the study. A protocol is a plan the principal investigator organizes before the start of the trial and includes information about it such as:

  • The reason for the clinical trial

  • Who is eligible to join it

  • The number of people who will participate

  • The population type, i.e., all men, children, an ethnic group, etc.

  • What medical tests will be done before, during, and at the conclusion

  • Medicines or therapies that will be given/performed, how often, dosage, etc.

  • What kinds of information participants will need to provide


Who Pays the Patient Costs?

Participants in clinical trials may have additional medical costs in addition to their regular therapy. Expenses can include costs for medicines, doctor visits, lab tests, and any others required by the trial. Often costs are either covered by the sponsor of the trial or health insurance. In some states, such as California, Medicare and most HMO health insurance plans are legally required to cover clinical trials for cancer patients.

However, it's crucial for participants to clearly understand what costs the study covers and what if any are their responsibility. Usually, the study's sponsor will help volunteers determine what their health insurance will cover.

Risks Involved in Clinical Trials

There are federal rules that govern clinical trials to ensure the well-being of study participants. Clinical trials are professionally reviewed and approved by scientific experts who are members of the Institutional Review Board (IRB). The IRB also makes sure the study is ethical and balances the risks against potential benefits. Trials are also continuously monitored by the IRB, the trial's sponsor, and the research team.

However, while efforts are made to ensure safety, there is some risk due to the nature of clinical trials testing new medical products. Those thinking about participating in a research study need to fully understand not only potential risks but also understand the purpose of the research. Before joining a clinical trial, potential volunteers need to ask their doctor or the principal investigator questions about the study. Some questions to ask are:

  • What are the risks involved?

  • What are the costs to me?

  • Who is overseeing patient safety?

  • How is patient safety being ensured?

  • What is the clinical trial trying to discover or answer?

  • How much time do I need to devote to the study?

  • Can I back out of the study at any time?


Clinical Trial Database

The National Institute of Health's (NIH), U.S. National Library of Medicine, maintains a database of both privately and publicly funded clinical studies currently being conducted around the world. The database contains 294,540 clinical trials.

While NIH maintains the database, the studies listed have not been evaluated by the U.S. government. They state: "The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating."[i]

The database can be searched by the status of the study, the health condition or disease, country, and other terms. Among additional information, database entries include a summary of the research, recruitment status, contact information, and eligibility requirements. Here is the link to the database: clinicaltrials.gov

Clinical trials are a vital process in the development of new medical technologies, pharmaceuticals, and medical products. We often take for granted how well a medical product works. However, without human volunteers, it would be difficult to know the efficacy and safety of new treatments and even whether old therapies are still a viable medical solution.

References

Clinical Trials. Retrieved from https://medlineplus.gov/clinicaltrials.html

Clinical Trials Information for Patients and Caregivers. Retrieved from https://www.cancer.gov/about-cancer/treatment/clinical-trials

Conducting Clinical Trials (June 15, 2016). Retrieved from https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ConductingClinicalTrials/default.htm

The Cost of Clinical Trials. Retrieved from http://www.pamf.org/cancercare/trials/cost.html

[i] Clinical Trials, Disclaimer, September 2017. Web.

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