By Joel Morse, CEO & Co-Founder
“In science, there are no shortcuts to truth.”
— Carl Sagan, Astronomer
The same holds true for clinical trials.
Yesterday the FDA’s June 2024 draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” seems to have been removed from the FDA website with no explanation. I will let you draw your own conclusions as to why.
At Curavit we believe in Science. This particular guidance underscores that enrolling participants from underrepresented populations enhances the strength and applicability of clinical evidence. It highlights that diverse participation can reveal potential differences in treatment responses among subgroups, thereby informing safer and more effective use of medical products. The document also discusses the necessity of considering demographic characteristics—such as race, ethnicity, sex, and age—when setting enrollment goals, aligning them with the disease’s prevalence in the intended use population. This approach ensures that the clinical study population reflects the real-world patient population, thereby improving the scientific validity of the study outcomes.
I am proud to have spent three decades in the clinical research industry, an industry defined by its commitment to ethics, study participant safety, and science. Our collective mission is to find solutions that enhance the human experience. I am confident that the industry will continue to prioritize science and safety as its guiding principles, including the critical work of enrolling the right study participant populations. At Curavit, we commend the FDA’s efforts to incorporate data-driven insights into science-based policies. Science informs our enrollment plans and we remain committed to collaborating with our clients to enroll based on science.
@FDA
Curavit’s Virtual Clinical Trial Site has proven results
Faster Recruitment: Enroll 2-3x faster than traditional site based trials.
Diverse Study Subjects: Meet the target enrollment for underrepresented populations.
Higher Retention: Provide your study subjects with the convenience of participating from home.
Lower costs: Reduce costs by eliminating site based screening, startup and closeout fees.
Learn more about Curavit by visiting www.curavit.io
