Navigating Clinical Trials: Patients, Subjects, Volunteers, or Participants? Why Our Language Matters (2024)

As we start 2024, our post-pandemic culture is well versed as to why clinical trials play a crucial role in advancing medical research and improving healthcare outcomes. We experienced firsthand the best of the research industry, the ability to quickly build on and expand the mRNA research we had at hand, and the community outreach and education to save lives through FDA's emergency use authorization (EUA) for vaccines and antiviral medications.

During the pandemic and now post-pandemic, the question I often received from family and friends seems simple; what do you call someone taking a study drug? Each reporter and article seemed to use different terminology, and the inconsistent use of patient, subject, volunteer or participant in clinical trials can be confusing, especially to those outside the industry.

To clarify the terms patients, subjects, volunteers, or participants all refer to the heroes among us who selflessly participate in clinical research to advance medicine. These heroes rarely get the recognition they deserve. Volunteering to participate in research is pivotal to medicine, technology, and medical device innovations.

Now, let’s explore the common terms to use and why it matters.

1. Patients: Patient is used to refer to individuals receiving medical care. In the context of clinical trials, this term is most appropriate starting at Phase II trials and beyond, trials which involve individuals with a specific medical condition or disease. Referring to the volunteers as patients acknowledges their existing health status and the fact that they are seeking treatment through clinical research.

2. Subjects: Subjects, while widely used in the past to refer to individuals participating in clinical trials, this term has gradually fallen out of favor due to its passive connotation. It implies that individuals are merely a number, making up the subset or population sample, devoid of their humanness, agency or active involvement.

3. Volunteers: This term applies to individuals who willingly and without coercion choose to participate in a clinical trial. Using the term, volunteer, highlights the selflessness and altruism of those individuals who offer their time, effort, and even their bodies for the advancement of medical research. It is important for us to remember that ALL medication comes with risk, even an over-the-counter medication as commonly used as ibuprofen has side effects and cannot be used by all people.

Using the term volunteer emphasizes their active decision to participate, contribute to scientific knowledge, and potentially help others in the future.

4. Participants: Participant is the term increasingly preferred in the field of clinical research and most often read in medical protocols. It recognizes the active role individuals play in clinical trials. By referring to them as participants, we acknowledge their voluntary involvement, active engagement, and contribution to the research process. This term emphasizes the partnership between researchers and individuals, promoting a sense of empowerment and collaboration.

Why terminology matters:

As we look to increase diversification in clinical trials the choice of terminology reflects our evolving understanding of the role individuals play in clinical trials. Using the appropriate term is not just a matter of semantics; it can shape the perception of volunteers and influence their sense of involvement in the research process.

By using the terms such as volunteer or participants, we foster a positive and respectful relationship between researchers and individuals involved in clinical trials without specifying if the individual requires medical treatment. It acknowledges their autonomy, decision-making capacity, and willingness to contribute to medical progress. This seemingly small inclusive approach can lead to increased trust, better recruitment rates, and improved retention in clinical trials.

While "patients" is appropriate when referring to individuals with a medical condition and/or seeking medical treatment, the terms “volunteers” & "participants" don't specify medical need and are increasingly preferred due to the recognition of their active involvement and agency. This shift in language reflects a more #inclusive and #collaborative approach, fostering a positive research environment.

Let's embrace the power of words to ensure the everyday heroes in clinical research feel valued, respected, and empowered on their journey towards advancing medical knowledge.