Dietary supplement and food advertisers often tout the number of clinical trials conducted on their products, but the quality of these trials is neither evident nor questioned. International standards for research planning, conduct and reporting help ensure that nutraceutical clinical science is globally accepted and the sponsor’s research investments are protected. Consumers are often sensitive about research conducted on animals, but what about the ethics of research conducted on humans? While independent review boards (IRBs) approvals add to the quality of clinical trial protocols, IRBs are unable to control how the study is conducted and reported.
Begin with the end in mind
Brands may start with a “dream publication” in mind for its clinical study’s circulation. Overwhelming evidence shows researchers’ quality of reporting on randomized controlled trials (RCTs) is not optimal. Without transparent reporting, the reliability and validity of study results may be questioned by the journal reviewers. RCTs are designed to reduce bias, but in the absence of transparent reporting, authors may be inadvertently introducing bias, thus defeating the purpose of RCTs. It is also good to consider in advance the expected outcomes in terms of effect size, onset of action and the claims that may be supported by the study.
Three excellent resources are available to guide high-quality clinical study reports (CSR) or manuscripts for food and supplement clinical studies.
- The Structure and Content of Clinical Study Reports (ICH E3, January 2013) is a critical contribution of the International Council on Harmonization (ICH).
- While the ICH E3 guideline is for developing credible study reports, the CONSORT 2010 Statement provides a checklist and flow diagram to improve a study’s chances of acceptance of papers in top journals. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement, and some have made it mandatory. This checklist facilitates critical appraisal and interpretation of RCTs.
- While the guidelines in CONSORT 2010 apply to nutraceutical clinical studies, natural product studies have additional reporting requirements.. Hence in June 2004, an international group of clinical researchers and pharmacognosists met for a consensus meeting in Toronto that led to the development of recommendations for the reporting of herbal medicine trials – the CONSORT for herbal clinical trials.
A good start is a job half done
Good clinical practice (GCP) or ICH E6 R2 (November 2016) is a comprehensive guidance to sponsors, IRBs, planners, monitors, investigators and all other participants on their roles and responsibilities in clinical research. Compliance to this gold standard for any food supplement or natural product research involving human volunteers is mandatory, but due to lack of cost-effective alternatives, companies are not fully aware of the true meaning and value of GCP. FDA adopted GCP as a standard in April 1996. The United States, along with EU and Japan, is a member of the ICH, which sets mutually agreeable research quality standards for these regions and much of the rest of the world.
‘Trust, but verify’
This wisdom from former U.S. President Ronald Reagan is good to apply to nutraceutical studies and the selection process of service providers. Most contract research organizations (CROs) talk about ICH-GCP compliance, but its best to invite them to demonstrate the preparedness of their systems and trained personnel early in the discussion. Clinical service provider (university or CRO) can provide non-confidential information from past trials to show how these guidelines will be followed for a future clinical study. GCP compliance is profitable and can support differentiated marketing copy for the brand. Yet, compliance to GCP is rarely mentioned in dietary supplement clinical study papers. However, as the quality of supplements is increasingly under scrunity, journal editors and reviewers are more aware of GCPs .
Facts are stubborn things, but statistics are pliable
Consumers deserve to be told the truth. The ICH E9 guidance from February 1998 is a standard for the statistical principles for credible analysis of clinical study data. ICH E9 helps harmonize the statistical methodologies that may be used for analysing clinical efficacy and safety of all human use products.
Late to start
Most of these guidelines have been around for the better part of the last two decades. Some health care sectors (drugs, devices and vaccines) have adopted them in practice, to a greater extent and much early whereas others are late to start (dietary supplements, sports nutrition, functional foods, medical foods, ayurvedic medicine traditional Chinese medicine, yoga and other alternative health approaches).
None of the leading standards organizations, instrumental in raising the bar on dietary supplements quality, have proposed a standard for clinical safety and efficacy evidence of nutraceuticals. May be someone will soon. It is better to develop consensus and self-regulation for clinical study quality from within our industry rather than wait for external scrutiny or regulation to decide the rules of the game. Complementary and alternative health solutions will not remain faith-based forever. As health care costs and concerns are rising globally, consumers and media have started asking questions. The time has come.
Jayesh Chaudhary is CEO of Vedic Lifesciences, a provider of clinical trial services for nutraceuticals
Read other articles by Chaudhary on clinical trials: