A review of EFSA’s recent opinions on Health Claims applications reminds us of the importance of rigor and objectivity in the clinical trial design. We studied three such opinions to identify trends in EFSA’s approach and learnings from there.
PaCRAN: A proprietary cranberry ingredient, was recently evaluated by EFSA for a health claim around recurrent UTIs based on 2 human studies. While one study demonstrated beneficial effects, the other one failed to confirm the same. There were concerns pertaining to misreporting of eligibility criteria, issues relating to study design and stats (including post-hoc analysis). EFSA expects more transparency and consistency in the reporting of studies supporting a health claim. EFSA concluded that the evidence of PaCRAN’s MoA v/s bacterial pathogens in the lower urinary tract was also inconclusive.
Citicoline: EFSA concluded that the evidence presented for this submission was insufficient to support a health claim for memory improvement. In weighing the evidence, one RCT indicated improved episodic memory. However, another RCT using a higher dose failed to reproduce the effect. A third study had significant methodological deficiencies (no blinding, no information on subjects’ compliance or randomization, no wash-out period, possible confounding of meds affecting memory… Even the stats analysis wasn’t appropriate for the study design). In the absence of sufficiently consistent evidence, technical robustness or a pattern that could help formulate a rationale, EFSA rejected this claim.
Olive Oil Polyphenols: EFSA did not find sufficient substantiation for the health claim of maintaining normal HDL-cholesterol levels. While one study described a dose-dependent increase in HDL-C over a three-week period, similar changes were not seen in other studies and populations. These studies suffered from design flaws such as variable study durations, unclear quantification of polyphenol intake, lack of randomization or washouts and high attrition rates.
Vedic Lifesciences has been supporting health claim applications globally for last 25 yrs. We’ve faced similar scenarios in the past for studies ordered by clients. In one of our studies for eg, we were asked to rely on subjective PROs, with no objective recruitment criteria. This design decision possibly undermined study credibility. Subsequently, we revamped our trial design SOPs, strengthened our internal processes, ensuring evidence-based recruitment and objective measures wherever feasible.
While most CROs are happy to just complete the promised sample per protocol, Vedic has always gone beyond.
In our 25th year, we invite our large network of clinical trial customers to share feedback on data that we helped generate. Whether for submissions, approvals, marketing, or patenting, your insights are invaluable to us. Please reach out to us at connect@vediclifesciences.com. We look fwd to our collaboration & thank you for your trust!
