Although many industries have been negatively impacted by COVID-19, the dietary supplement and health product market has experienced an upswing in recent months.
As demand for these products skyrockets, clinical research is increasingly needed to commercialize products while supporting safety, efficacy, and label claims.
However, the mandated closures and safety measures necessitated by COVID-19 have ushered in new challenges for Sponsors with current studies underway or those planning upcoming clinical trials.
In this article, you will learn:
- How dietary supplement clinical research has changed due to COVID-19
- Challenges Sponsors face for current and upcoming clinical trials
- Decentralized clinical trials (remote/virtual studies) as a viable solution
Barriers to Executing Clinical Research in the Age of COVID-19
Constraints that have traditionally impacted trial timelines and execution have been exacerbated by the pandemic landscape.
Participant recruitment is still a top challenge given regional differences in COVID-19 cases> There is also uncertainty about “hot spots” and potential second and third waves, as well as concerns about prioritizing patient safety, meeting enrolment targets, and minimizing drop-out rates.
Staff safety and providing proper Personal Protective Equipment (PPE) has become a priority amidst medical supply shortages. Many additional considerations come into play for both participant and staff safety. At minimum, the average study visit duration is likely to increase due to additional safety measures due to COVID-19 precautions (e.g., temperature checks, contact tracing measures, PPE requirements, etc.).
Site closures and reduced capacities have also forced Sponsors to re-select sites, extending study timelines and, in some cases, increasing budget. The fact that COVID-19 vaccine and therapeutic trials are ongoing further compounds the issue, affecting site network capacities globally.
It is clear that clinical research must continue, but many Sponsors are unsure how to successfully execute their trials without compromising the quality or integrity of the research while trying to avoid unwanted budget increases and longer timelines.
Decentralized Studies as a Solution to Current Research Restrictions
Virtual or remote clinical trials—more accurately known within the industry as “decentralized” clinical trials—are showing promise as a viable, often beneficial, solution to the barriers brought on by COVID-19.
A Decentralized Clinical Trial is one that allows patients to take part in a study within their home environment. This concept was already trending in certain study types, more commonly in the pharmaceutical space. COVID-19 has only accelerated the trend and its acceptance with regulators and ethics boards within certain parameters.
How does a decentralized trial differ from a traditional one? Comparatively, there is greater focus and time spent during the planning and startup phase to ensure the trial runs smoothly. This includes more focus on the logistics, both from a trial management perspective as well as participant training.
Another option is hybrid trials, which combine in-person and virtual visits. A hybrid model may be required in some trial designs to obtain biological samples or have specific medial assessments performed. This reduces the burden of the participant to travel to the site for every visit and can result in improved participant retention for longer studies. Decreasing the number of in-person visits helps reduce potential viral transmission and exposure during the pandemic.
Risks are different between the standard in-clinic, hybrid, and virtual approaches to clinical research. Ensuring an effective risk management process is in place is key to success of any clinical trial.
Additional considerations for a decentralized trial pertaining to study product include a greater focus on stability data (to ensure it can withstand longer shipping times, or variable shipping temperatures) as well as adding data loggers for storage at the participant’s home, if the product requires specific storage temperatures.
The way participants are compensated may also become virtual, such as through e-gift cards, money transfers, or other methods.
Overall, the new necessity for decentralized trials has posed challenges for Sponsors with traditional studies underway or those in the planning phase. Knowing how to pivot effectively without compromising study quality and integrity has been the biggest hurdle. Moving to a decentralized model or using a hybrid approach will force Sponsors to change study designs and, in some instances, re-visit their regulatory and research ethic board approvals.
Awareness and understanding will be key to using decentralized trials to advance dietary supplement research, including probiotics, vitamins/minerals, CBD, nutraceuticals, botanicals, omega-3s, and more.
Potential Advantages of Decentralized Clinical Trials
Challenges aside, decentralized clinical trials have produced surprising benefits for Sponsors, including but not limited to:
- Wider participant recruitment pool for improved recruitment
- Recruitment no longer limited to regional sites
- Maintained trial quality
- Increased flexibility for conduct
- Flexibility to work around participant’s schedule
- Improved patient retention in studies with long follow-up periods
- Improved long-term follow-up
- Potential for more real-time data collection from participants
Given these potential advantages as well as the evolving digital landscape, it is highly likely we will see a shift toward hybrid and virtual models even when in-person trials can resume.
That’s not to say that decentralized studies are an ideal solution in all instances. Factors like study phase, product type, patient population, patient indication, and study endpoints may make it difficult to conduct a trial exclusively virtually, and in such cases a hybrid approach or standard in-clinic approach may be more appropriate. However, with proper planning and diligence, it is becoming a viable solution for the dietary supplement industry.
Success Tips for Conducting Decentralized Clinical Trials
Running a successful decentralized study for dietary supplements requires experience in risk management, participant management including conduct of remote patient visits, effective data capture (i.e., proper tools), as well as understanding of privacy and regulations around data and protected health information (PHI).
Below are key success factors that should be firmly in place operationally if considering a decentralized or hybrid trial.
For best results, your clinical site should have patient kitting down to a science. This includes ensuring high professionalism with necessary paperwork, test product, and non-invasive sample collection materials (e.g., saliva, urine, stool) with clear and concise sample collection and submission instructions as required for the study. Patient kits should include supplies that are simple, easy to use/ship elsewhere, can be tracked/are traceable through their life cycle, and may involve a variety of instructional media (tactile, visual, audio, etc.).
Failure to effectively plan and execute patient kits introduces risk to the study quality, given that these steps are not conducted in the clinic and may be more difficult to oversee. Automated notifications and a plan to monitor participant compliance with kits will help ensure quality study data is obtained through the trial life cycle.
Electronic Data Capture and Processing
Another area critical to minimizing study risk and ensuring a smooth trial is data collection and processing techniques. The digital systems and tools such as telemedicine often accelerate screening and pre-screening into the study (compared to traditional recruitment methods like phone interviews), leading to faster and more efficient study timelines.
Using a contract research organization (CRO) that is well-versed in eConsent, remote electronic data capture, and medical coding will safeguard data integrity and pool-ability. Also important to study success is making sure remote data capture tools are calibrated and validated while standing up to regulatory and privacy protection scrutiny.
If participants are to complete diaries or questionnaires remotely, easy-to-use tools and proper training is imperative. Training should involve a variety of aids (written, oral, visual instructions) to ensure participant compliance and retention.
Virtual Patient Visits
Patient visits done offsite through virtual means can introduce inefficiencies and risk if not done correctly. Virtual patient visits should have proper structure and process based on CRO expertise and operational systems.
In some cases, the clinical team can walk patients through completion of online surveys and answer questions, making it a smooth and convenient experience for participants.
Though virtual studies allow for a wider participant pool, this can also mean inclusion of multiple time zones. Offering 24/7 support to participants will help with compliance and retention so participants can have their questions answered in a timely manner, particularly if the participant needs to report an adverse or serious adverse event. Participants may not always speak the primary language of the study staff, which should be taken into consideration if the study extends over multiple regions or countries.
CRO Team Expertise and Experience
Above all, the most important success factor is finding and vetting a CRO with experience in decentralized dietary supplement trials. Your clinical research partner will work with you to design and conduct the trial based on your strategy and end goal for commercialization.
For optimum results, look for a CRO with extensive expertise and a robust in-house clinical team encompassing data management, biostatistics, medical writing, pharmacy management, pharmacovigilance, quality assurance, monitoring, and project management, claims substantiation, regulatory (both clinical and product), as well as expertise in biomarkers, and bioanalytical and analytical research.
The bottom line is that decentralized trials will be expected to play an increasing role in the future of clinical research. If you are currently running a study that has been impacted by the pandemic or are planning an upcoming one that has now become unfeasible, look for a CRO with experience conducting these types of studies in the dietary supplement space, as well as a strong and experienced team with specialties in your specific indication or product area.