Clinical trials present a daunting undertaking for fledgling companies developing novel healthcare products. While scientifically validating a product through clinical trials can provide a major edge against competitors, most startups lack the infrastructure and resources to steer the multifaceted process.
For budding enterprises, carefully weighing the advantages against the potential hurdles and risks of clinical trials is imperative.
Brenden Dougherty, the CEO of MDbio, a company combating gaps in the pharmaceutical industry by creating botanical alternatives for sleep, anxiety, and pain, is well-versed in clinical trials. MDsleep just went through the largest non-melatonin clinical trial in history, proving it’s efficacy.
The results after taking MDsleep for four weeks demonstrated substantial improvements across all measures compared to placebo:
57% of participants reported improvement in sleep disturbance, which was 35% greater than the placebo group. 38% reported less stress, a 50% greater improvement versus placebo. 14% had higher well-being scores, 64% greater than placebo. And 60% experienced less anxiety, a 17% greater improvement than a placebo.
While the clinical trial was complex, the results demonstrate it was worth the effort to prove the efficacy of the product.
The Burdensome Documentation Requirements
One initial challenge is the expansive product documentation mandated. Firms must furnish comprehensive details about their product, including testing of ingredients, sourcing, and safety protocols. Verifying the integrity and safety of components is paramount, often necessitating collaboration with a certified cGMP (Current Good Manufacturing Practice) facility. cGMP standards ensure consistent, quality production and control of pharmaceuticals, mitigating risks.
The Pivotal Role of QA/QC in Manufacturing
Quality assurance (QA) and quality control (QC) are integral in manufacturing, especially for products with active ingredients. These components must be rigorously tested for potency and contaminants, with a very narrow variance threshold under 8%. For example, a Johns Hopkins study found a striking 76% of retail hemp goods mislabeled, with CBD levels diverging markedly from claims. Such discrepancies are impermissible in clinical trials, where permissible margins of error are virtually nil. Standards imposed by testing agencies typically eclipse those of governing bodies like the FDA.
Understanding Regulatory Guidelines and CRO Expectations
Grasping and adhering to regulatory standards is vital in clinical trials. While USP 561 is the FDA-sanctioned contaminant level, clinical research organizations (CROs) may impose even loftier benchmarks. Companies often only learn of these heightened CRO expectations after manufacturing a clinical trial product batch, potentially causing QA/QC failures and rejection. This squanders time and resources, underscoring thorough preparation and understanding of CRO requirements.
The Uncertain Outcomes of Clinical Testing
Also noteworthy is that most products tested clinically fail to demonstrate statistical significance exceeding a placebo. This means that after investing substantially and awaiting results for 8-12 months, a firm may find its product no more effective than a placebo, barring efficacy claims. This reality spotlights the inherent clinical trial risks and the need for companies to judiciously gauge alignment with their capabilities and aims.
Navigating the Intricacies of Clinical Evaluation
While clinical trial therapeutic significance can set a product apart, the process brims with uncertainties and hurdles. Startups, in particular, must consider the substantial resources entailed, the rigorous standards imposed, and the potential for unfavorable outcomes.
By thoroughly assessing the risks and benefits and ensuring adequate internal resources, companies can make informed decisions about undertaking the complex clinical trial journey.