Small Companies Can Face Challenges When Conducting Clinical Trials

For startup companies developing new health care products, clinical trials pose a massive undertaking full of risks and uncertainty. While scientifically validating a product through clinical trials can provide a huge competitive advantage, most startups lack the resources and infrastructure to effectively manage the process. For emerging companies and startups, it is crucial to weigh the benefits against the potential risks and challenges associated with the clinical trial process.

The Daunting Task of Product Documentation

One of the initial hurdles in the clinical trial process is the extensive product documentation required. Companies must provide detailed information about their product, including ingredient testing, sourcing, and safety measures. Ensuring the integrity and safety of the ingredients is paramount, and this often necessitates collaboration with a certified current Good Manufacturing Practice (cGMP) facility. The cGMP standards ensure that products are consistently produced and controlled according to established quality standards, minimizing the risks associated with pharmaceutical production.

The Critical Role of QA/QC in Manufacturing

Quality assurance (QA) and quality control (QC) play a vital role in the manufacturing process, particularly when it comes to products with active ingredients. These ingredients must be tested for potency levels and potential contaminants, with a very narrow variance threshold of under 8%. For instance, a study conducted by Johns Hopkins revealed that a staggering 76% of retail hemp products were mislabeled, containing significantly different levels of CBD than claimed. In the realm of clinical trials, such discrepancies are unacceptable. The margin for error is virtually nonexistent, and the standards set by clinical testing agencies are often more stringent than those of regulatory bodies such as the FDA.

Navigating Regulatory Standards and CRO Expectations

Understanding and adhering to regulatory standards is a critical component of the clinical trial process. USP <561> is the FDA-approved level for contaminants in products, but clinical research organizations (CROs) may impose even higher standards. Companies often only discover these heightened expectations after manufacturing their clinical trial product run, leading to potential QA and QC failures and product rejection. This not only results in wasted time and resources but also underscores the importance of thorough preparation and understanding of CRO expectations.

Uncertain Outcomes of Clinical Trials

It is also important to acknowledge that the majority of products subjected to clinical testing do not demonstrate statistical significance above a controlled placebo. This means that after investing considerable resources and waiting 8 to 12 months for results, a company may find that their product is no more effective than a placebo. This reality highlights the inherent risks of clinical trials and underscores the need for companies to carefully assess whether this path aligns with their resources and business objectives.

Navigating the Complexities of Clinical Trials

While achieving therapeutic statistical significance in a clinical trial can set a product apart from its competitors, the journey is fraught with challenges and uncertainties. Emerging companies in particular must be mindful of the substantial resources required, the rigorous standards imposed by regulatory bodies and CROs, and the potential for unfavorable outcomes.

By thoroughly evaluating the risks and benefits, as well as ensuring that the necessary internal resources are in place, companies can make informed decisions about whether to embark on the complex and demanding journey of clinical trials.

Clinical Trial Investigating Non-Melatonin Sleep-Aid Supplement

The largest non-melatonin clinical trial for a botanical-based sleep-aid supplement (Mdsleep; Mdbio) was recently conducted, and the results after taking the supplement for 4 weeks demonstrated substantial improvements across all measures compared to placebo. During the trial, 57% of participants reported improvement in sleep disturbance (35% greater than placebo), 38% of participants reported less stress (50% greater than placebo), 14% had higher wellbeing scores (64% greater than placebo), and 60% experienced less anxiety (17% greater than placebo).

The largest non-melatonin clinical trial for a botanical-based sleep-aid supplement (Mdsleep; Mdbio) was recently conducted, and the results after taking the supplement for 4 weeks demonstrated substantial improvements across all measures compared to placebo. Image Credit: © Yulia Panova - stock.adobe.com

While the clinical trial was complex, the results provided clinical evidence that demonstrate the supplement is effective. Because of the lack of transparency present for many supplements and pharmaceutical alternatives, investing in clinical trials that investigate claims of safety and efficacy can support greater patient wellness.

About the Author

Brenden Dougherty is the CEO of Mdbio.

Reference

Spindle TR, Sholler DJ, Cone EJ, et al. Cannabinoid Content and Label Accuracy of Hemp-Derived Topical Products Available Online and at National Retail Stores. JAMA Netw Open. 2022;5(7):e2223019. doi:10.1001/jamanetworkopen.2022.23019