How to Rig Your Next Clinical Trial — and Why FundRx Will Catch You
With thousands of hours and millions of dollars at stake, early-stage healthcare companies live and die by the results of clinical trials. Even for mature pharmaceutical companies, around 30% of valuations directly relate to the results of Phase III clinical trials.1 So much like an Adderall-frenzied freshman with a term paper due or a German car company desperate to maintain high emission standards, you might be tempted to cheat. We thought we might calm those urges with some examples from the healthcare industry and a reminder that we’ll be watching.
Fabricate Data or Avoid Collecting It Altogether
What better way to guarantee a successful trial than to make up numbers? You’d be in good company. Aside from a handful of stories, including that of the infamous Dr. Reuben, manipulation of research data, whether out of laziness or desperation, pervades broadly. A 2005 study found that 17% of surveyed authors of clinical drug trials reported personal knowledge of research fabrication occurring within the previous 10 years.2 To guarantee no one will question your bunk data, why not fabricate your peer reviewers too? You could even start your own peer review and citation ring.
In circumstances where your product might not be subject to review by the FDA (such as health IT and laboratory-developed tests) you may opt to take the Theranos route and never publish any results despite marketing to consumers.
Report Your Success, Hide Your Failures
Say you run seven different trials of a drug called Reboxetine for treating clinical depression and get the following results:
A study published in the New England Journal of Medicine showed that despite ethical and legal obligations, most trials did not report results to ClinicalTrials.gov in a timely fashion. After the legal maximum of one year, only 17% of trials paid for by industry and 8% of those paid for by the NIH had published results.3
How FundRx Knows
Demand for Transparency. We at FundRx seek to fund effective products that transform people’s lives. FundRx stands alongside the 85 asset managers and pension funds, who manage over $3.7 trillion in assets, in demanding increased disclosure from the pharmaceutical industry. We expect the same levels of transparency from the companies we list on our platform. Not only does such transparency allow us to make more accurate decisions, it also empowers us as a true value-add investor. With full insights into a company’s trial efforts, FundRx can engage physician expertise and leverage its CRO partners to strengthen the trial process.
Data Tells All. Analyzing a study’s process and reported data alerts us to potential fraud. Signs of digit preference indicate that numbers have been warped. Improbable trends serve as another strong indicator. Excessive instances of perfect attendance, unusually high drug compliance, and unusually low adverse reports and withdrawals serve as indicators among other signals.4 Furthermore, analyzing research and citation networks for evidence of suspicious densities will help detect fraud and biases within the research community. Beyond fraud, we employ similar methods to assess the factors that contribute to trial success and provide those insights to our investor community.
We Run Our Own Peer Reviews. FundRx takes pride in being the only equity crowdfunding platform with a rigorous, independent peer review process. We depend on our own network of physicians and industry experts — through the FundRx Advisory Council and through the FundRx Specialist Network — to vet the companies and research we seek to finance through comprehensive surveys, independent reports, and direct consultations. Beyond vetting these companies for their scientific and therapeutic merit, our physician and expert community also provides insights into the viability of these novel products, exposing the one feature we care for the most: the capacity to change lives everywhere.
Faraz Yashar is a partner at FundRx, an equity investment platform that empowers physicians and investors to fund promising early-stage healthcare companies and advance meaningful medical innovation. Join us.