A clinical trial is a research study that determines whether specific healthcare interventions—such as investigational therapies, medicines and treatments—are safe and effective. An equitable and diverse clinical trial is a critical step toward getting a medicine or treatment approved by regulatory agencies, such as the U.S. Food and Drug Administration.
Before reaching the clinical trial stage, these investigational interventions may have already undergone other types of research and testing, depending on regulatory requirements, explains Rocio Lopez, Global Operations Head, Global Development, the Janssen Pharmaceutical Companies of Johnson & Johnson.
To confirm that the investigational intervention will consistently work as designed, various clinical trials are completed, and data is collected and submitted for approval to be used in patients with the condition being studied. This is the clinical trial process:
- Phase 1: Researchers test the investigational drug or treatment in a small group of people to learn about its safety, including how it is absorbed by the body, what dosage should be used and potential side effects.
- Phase 2: The intervention is given to a larger group of people to better understand ongoing safety, whether it works for a particular disease and the best dose.
- Phase 3: The intervention is given to an even larger group of people. The main objectives are studying safety and side effects in bigger populations, whether it works for a particular disease and how it compares to already existing standard therapies.
In some cases there may be a fourth phase after the intervention is approved where researchers will study long-term risks, benefits and side effects during day-to-day use in the population.
While these phases are standard protocol for clinical trials, the actual length of the study depends on the intervention itself, what the trial is evaluating and the end goal, adds Lopez.
The Importance of Diverse and Inclusive Clinical Trials
Often, participants find out about clinical trials from their doctor or patient advocacy organization. If a patient has a condition and there are no approved treatments for it or the available treatments are not proving effective, a clinical trial could be an option, explains Lopez.
Recruiting participants from a variety of demographics is crucial to ensure research is representative of the incredibly diverse communities served.
Yet “historically, most of the trials that have been conducted have produced data that underrepresents different demographics, such as Black and Hispanic patients,” says Kate Owen, Global Development Head, Janssen.
That’s why Johnson & Johnson has made diversity, equity and inclusion a top priority when designing and conducting clinical trials. Additionally, the company also works to drive health equity through Our Race to Health Equity, which aspires to eliminate health inequities for people of color and eradicate racial and social injustice as a public health threat.
“By incorporating diverse and inclusive practices into every stage of our clinical trial process, more patients will have the opportunity to participate in clinical trials,” says Owen. “Together, we are building a world where health equity is the norm.”
