The advancement of medical science, and the extent to which healthcare professionals (including pharmacists) can understand and treat medical conditions, depends in large part on reliable clinical trial results and outcomes.
Although the specific participants chosen for clinical trials varies depending on the study type, inclusion and exclusion criteria, and the situational research question at-hand, many clinical trials need healthy volunteers as a subset of study participants.
The definition of a healthy volunteer varies in the context of a clinical trial. However, an individual without a significant past medical history of certain condition(s) is a considered healthy volunteer. Per the National Institutes of Health (NIH), an official definition of this is described as “someone with no known significant health problems who participates in research to test a new drug, device, or intervention”.
Of note, a healthy volunteer is sometimes dubbed in the clinical trial world as a healthy participant. These terms are synonymous.
Whenever healthy volunteers are utilized in clinical trials, they are used to compare against a different subset of individuals that have a condition a medication or device is being used to treat. Alternatively, healthy volunteers can be used as a stand-alone group to test for safety and tolerability of a product at-hand.
For example, let’s say pharmaceutical company XYZ is conducting a phase 1 clinical trial in attempt to get a new drug for depression approved by the United States Food & Drug Administration (FDA). The coordinators of the clinical trial need healthy patients (defined in this case as patients without a diagnosis of depression). To be able to evaluate how the new drug performs in terms of safety tolerability, healthy volunteers are necessary.
FAST FACTS: FAQs about Clinical Studies
As a healthy volunteer in a clinical trial, there is typically no direct health benefit to the volunteer themselves. However, study participation helps adds to the wealth of medical knowledge available across various literary resources and guidances. As an added perk, a number of clinical trials compensate their healthy volunteer participants.
There are a variety of ways to search for clinical trials that a healthy volunteer may be eligible for. Although not an exhaustive list, below are four possible ways to gain insight about ongoing or recruiting clinical trials that are seeking healthy volunteers as study participants.
Once an interested individual finds a clinical trial that that they may be eligible for, they can reach out to the clinical trial coordinators to express interest. After interest is expressed, clinical trial coordinators then can screen the interested individual and set up potential next steps to initiate the process.
NIH Clinical Center
The NIH Clinical Center is a key resource for clinical trial information. This sentiment rings true for obtaining information about deducing which clinical trials are recruiting healthy volunteers.
Through the NIH Clinical Center, there are three primary avenues to take in order to find opportunities related to this topic.
The first of the three options is to enroll in the Clinical Research Volunteer Program by calling the NIH at +1 (301) 496-4763 to provide basic demographic and contact information.
The second of the three options is to visit the Find NIH Clinical Center Trials webpage to independently search for trials that are recruiting healthy volunteers. Whenever an interested individual goes to this webpage, it is recommended to use the keyword ‘healthy’ as a search term. It is acceptable to enroll in the Clinical Research Volunteer Program, aforementioned, while also utilizing this search feature.
The third of the three options is to visit Clinicaltrials.gov (via NIH/US Library of Medicine) to independently search for clinical trial volunteer opportunities. The process for this follows a similar process to the second option previously described.
For more information, disclaimers, and answers to frequently asked questions about participating in clinical research, visit http://www.cc.nih.gov/participate.shtml. Also, be sure to read the NIH Privacy Notice.
Contract Research Organization (CRO) Databases
In short, CROs are entities that work in conjunction with biotechnology/pharmaceutical companies to conduct clinical trials. Specifically, they often conduct many of the day-to-day logistics and nuances of the clinical trial process. By dealing with many of the preparatory and on-site logistic steps, this helps to reduce costs for biotechnology/pharmaceutical companies that are developing the study products.
Of the logistical functions that CROs perform, one of the common functions can be recruiting clinical trial participants on behalf, or in conjunction with, companies that are developing the products being studied.
For a list of CROs in the United States, there are many websites that summarize CROs in different locales while concurrently describing the type of research they tend to support. Of the websites available regarding this, one particularly helpful website is ICH GCP.
For example, a popular CRO in the United States is a company called Medpace. To research clinical opportunities through Medpace, an interested individual would navigate to their website and click on the “Study Volunteers” tab at the top of the page. Once on the page, interested individuals would learn that they can call the Medpace Call Center at +1 (513) 366-3222 to inquire about opportunities. Alternatively, they could fill out a study participant sign-up form online and wait for a Medpace representative to reach out.
Other CROs tend to follow a similar recruiting process to Medpace.
Pharmaceutical Company Databases
Although not quite as common of a mechanism compared to options 1 and 2, described above, it is also possible to gain insight about healthy clinical trial volunteer opportunities through investigating a biotechnology/pharmaceutical company’s website or by calling them and speaking to a representative.
For example, if someone lives in the vicinity of Boston, Massachusetts, United States and wanted to be a clinical trial volunteer for one of the many companies based out of the Greater Boston Metro Area, they could research specific companies available in the local area. Alexion Pharmaceuticals, for instance, is a company in Boston that commonly recruits volunteers for studies related to myasthenia gravis (MG).
Local Healthcare Institutions
Hospitals, outpatient clinics, and other healthcare institutions across the United States commonly participate in clinical research and concurrently recruit clinical trial participants. This recruiting process can be done independently by health institutions or it can be in conjunction with a CRO and/or biotechnology/pharmaceutical company.
To determine if a local healthcare institution in a specific geographic area is participating in clinical research, reach out to that specific institution.
References:
- Patient Recruitment. Department of Health and Human Services – NIH Clinical Center. https://clinicalcenter.nih.gov/recruit/volunteers.html. Accessed 9 November 2020.
- Spainhour CB. Contract Research Organizations. Science Direct.https://www.sciencedirect.com/topics/pharmacology-toxicology-and-pharmaceutical-science/contract-research-organization. Accessed 9 November 2020.
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