Consumer health clinical trials aim to assess the safety, efficacy, and usability of health products that are available without a prescription. As a result, these studies typically face less stringent regulatory requirements, allowing for greater flexibility in study designs that improve participant experience and allow sponsors to achieve study milestones quicker. 

Effective trial design should consider the type of consumer health product under investigation. Whether it be a dietary supplement, cosmetic, over-the-counter medication, digital health application, or something else, their research can greatly benefit from unique variables related to trial design.

Consumer Health vs. Traditional Drug Trials

Consumer health and traditional drug trials can differ vastly in the way they are conducted across all facets. Key differences are summarized below.

Study Design

• Consumer Health: There is greater flexibility in study designs, allowing for observational studies, user surveys, and shorter-duration trials. These designs can adapt more easily to real-world consumer use.
• Traditional: Study designs are highly structured and must adhere to strict protocols. This includes randomization, control groups, blinding, and detailed statistical analysis to ensure reliable and reproducible results.

Duration & Scale

• Consumer Health: Tend to be shorter in duration and smaller in scale, focusing on immediate consumer feedback and short-term outcomes.
• Traditional: Often longer in duration and larger in scale, involving extensive follow-up periods to assess long-term safety and efficacy.

Data Collection

• Consumer Health: Can include more self-reported outcomes, user feedback, and real-world usage data.
• Traditional: More comprehensive and systematic, including clinical measurements, lab tests, imaging, and other objective assessments.

Regulatory Approvals

• Consumer Health: The approval process is often faster and less complex. Products like dietary supplements, wellness devices, and over-the-counter medications might only need to demonstrate basic safety and potential benefits without extensive clinical data.
• Traditional: The approval process is lengthy and complex, involving multiple trial phases and extensive data collection and analysis to obtain clinical validation.

Trial Design Variables to Consider for Consumer Health Clinical Trials

Study Model

Consumer health and wellness trials tend to allow for flexible research environments, focusing on patient experience and assessing product efficacy in settings where the products will actually be used. However, depending on the unique needs of the investigational product, it is important to evaluate which model is more appropriate to adopt to effectively evaluate the intervention: decentralized or in-person.

Decentralized Consumer Health Studies

Decentralized clinical trials (DCTs), or fully remote trials, leverage self-collection technologies, remote patient monitoring, and more to allow participants to engage in clinical research in their real-world environments. These trials promote participant convenience, eliminating the need for long study visits and travel to clinical sites. Even trials requiring sampling collection can now be executed from the comfort of individuals' homes’. 

For example, Lindus Health has just partnered with Tasso to enable blood collection without the need to travel to a physical site or have a mobile phlebotomist come in. In situations like these, ensure participants receive comprehensive instructions and all required materials for mailing their samples for analysis. In fully virtual trials, a research team member should always be available 24 hours if possible to address any questions or concerns that participants may have.

Hybrid Consumer Health Studies

If on-site visits are required to meet study objectives, in-person activities such as sample collection and blood draws should be combined whenever possible to minimize the frequency of patient travel. Prioritize at-home data collection to keep visit durations short. To further reduce participant burden, consider collaborating with multiple clinics or community centers, providing participants with options for where they can attend their visits. Additionally, ensure that all study-related travel expenses are fully reimbursed promptly after visits to support participant retention.

Study Duration & Population

The duration of consumer health studies can vary widely based on the specific product and study design, but they typically last anywhere from a few weeks to several months. Shorter studies, often lasting a few weeks to three months, are common for evaluating immediate consumer feedback and short-term outcomes. Longer studies, extending up to six months or more, might be conducted for products requiring more extensive safety and efficacy data.

The number of participants in consumer health studies can vary significantly depending on the study's objectives, design, and the nature of the product being tested. Typically, these studies enroll anywhere from a few dozen to several hundred participants. Smaller studies might include 50 to 100 participants, while larger studies could involve 300 to 500 or more participants to ensure a diverse and representative sample. The exact number often depends on the study's requirements for statistical power and the need to capture a wide range of user experiences and outcomes.

Data Collection Techniques

Self-Reported Data

Consumer health trials collect a large amount of subjective data related to user satisfaction, which can easily be captured via Electronic Patient Reported Outcome (ePRO) questionnaires. For products that aim to improve physical appearance in some way, contract research organizations (CROs) can employ their medical directors to collect photos from participants for remote medical evaluation. 

Wearable Technologies

Wearables enable continuous patient monitoring, delivering real-time biometric data that can capture fluctuations and trends in health metrics often missed during periodic study visits. This continuous data stream may even negate the need for physical sites, offering a more comprehensive view of a patient's health and enhancing the accuracy of results in consumer health studies.

Additionally, wearables are typically user-friendly and non-invasive, which can boost participant compliance. To ensure ease of data capture, select familiar technologies that are straightforward to use, as requiring participants to learn a new device may discourage study engagement. Apple Watches, FitBits, and similar devices are excellent choices for collecting biometric data, as they are already widely used and trusted for this purpose.

Conclusion

Embracing study designs that prioritize participant experience and real-world applicability is key to clinically validating consumer health products. By doing so, researchers can achieve faster and more reliable trial results from enhanced retention, ultimately contributing to the development of safe, effective, and user-friendly non-prescription therapies.

Lindus Health’s “All-In-One Consumer Health CRO” leverages a patient-centric approach to trial design that enables sponsors to provide greater convenience and flexibility in their health and wellness studies. Book a meeting with our team to learn more about how we execute faster and more reliable clinical trials for consumer health studies as a Consumer Health CRO.