Dr. Sachin Dighe, Associate Director, Claim Substantiation, Vedic Lifesciences

Participant selection can be an important part of achieving consistent outcomes across study population. Phenotype-based recruitment, for example, is one strategy that can help achieve clearer results compared to more heterogeneous populations.

Choosing design over proximity in clinical research. Why robust design, objective endpoints and clear biology outweigh geography in FDA and EMA reviews.

Competent and Reliable Scientific Evidence (CARSE) is a requirement set by the Federal Trade Commission, but how the agency defined "competent" is unclear. Let's unpack what makes a research team competent.

A long-held misconception that data generated in non-Caucasian populations has limited relevance for Caucasian markets continues to influence study protocol design despite the growing ethnic diversity of Western markets. However, trials designed around mechanism-driven end points do translate across populations, meaning that researchers can reliably study non-Caucasian populations, reducing cost and operational complexity of trials.

Best practices for clinical trial design to meet EFSA standards for scientific evidence. This means methodological honesty through clear hypotheses, proper controls, unbiased procedures, transparent reporting, and no manipulation of design or data to force an outcome.

How to design a study so that it passes EFSA's appraisal of biological relevance.