The Clinical Trial Crisis That’s Pushing BioTech Companies Into a New Era

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A typical drug takes over a decade and billions of dollars just to hit a pharmacy’s shelves. The primary culprit for this lengthy and expensive process is Research and Development — namely, finding, recruiting, and studying the drug’s effects on the right patient population. The associated costs with pharma trials have only increased as demand for larger and more diverse pools of participants also increases. In fact, two-thirds of clinical trial sites fail to meet their enrollment goals for any given trial.  

The issue is so problematic, that many smaller biotech companies have begun turning to overseas populations, where competition for participants is less steep, and the average patient is less likely to have already trialed a clinical drug. This has created a surge in companies using innovative methods to address clinical trial participant sourcing, eligibility screening, and administrative paperwork. From siteless trials to streamlined software, NewtonX surveyed the top solutions to clinical trial barriers by issuing a survey to 500 pharma executives involved in the clinical trial process. The results of this survey informed the data and insights in this article.

Dropouts, Transportation, and Paperwork: How Pharma Companies Are Solving Clinical Trial Barriers

There are three primary issues with pharma trials:

  1. Sourcing patients
  2. Dropout rate (keeping patients)
  3. Communicating with patients

The solutions for each are siloed from one another — there are no industry leaders for providing end-to-end pharma trial solutions.

We’ll start with the first issue: In the U.S. there are so many clinical trials that finding treatment-naive participants (people who haven’t developed a resistance to other treatments) are rare and difficult to find. In fact, respondents to the NewtonX survey indicated that it can regularly take between 7 months and two years to fill a single patient cohort in the U.S. However, in other parts of the world with fewer pharma companies and clinical trials, finding these same cohorts is significantly faster (and therefore cheaper). Moleculin Biotech, a cancer treatment research firm, is one such company that opted to conduct parts of clinical trialing abroad. The company said that in Poland it was able to fill the cohort within a month and a half, as compared to the year that it took in the U.S.

To make matters even more complicated, once a cohort has been filled, that does not necessarily mean it will remain filled. The average dropout rate for clinical trials is 30% — a number that adds years to getting a drug to market. Organizations such as Janssen Clinical Innovation, part of Janssen Research & Development, LLC, have implemented incentives to keep participants coming back, including patient data sharing. The company found that giving patients access to lab results and other health data collected throughout the trial contributed to lower drop-out rates.

Siteless trials have also become increasingly popular. These typically function through a combination of telemedicine and IoT devices that monitor patient vitals to send real-time data on patients without requiring them to leave their homes (but while still ensuring compliance). Several companies including Science 37, Clinical Trials Arena, and the above mentioned Janssen Clinical have employed this model to decrease costs and improve patient drop-out rates. Big Pharma has also experimented with the approach: both Pfizer and Merck have piloted virtual trials, to mixed results (Pfizer’s 2014 experiment with the approach was ineffective due to the company’s laborious online portal). Of the companies that have piloted remote trials in the past year, reports indicate that online recruitment improves speed, dropout rates are lower than expected, and compliance is only slightly worse than in-person trials.

Inherent to success for remote trials, however, is the third challenge in pharma drug trials: communicating with patients. The medical industry in general is incredibly paper-heavy, and this is no less true for clinical trials. Because of this, many companies have turned to SaaS solutions that can track patient activity, digitize contracts, transmit data through e-adherence tools, and automate immediate intervention when patients aren’t compliant.

The Results: Will Streamlined Pharma Trials Cut Costs?

At the heart of challenges facing pharma trials is a shortage of qualified patients who are willing to not only participate initially, but continue participating in trials. Each of the solutions above help lessen the effects of this problem, but there is still currently no end-to-end market leader in the space. Considering the costs involved, this is likely to change over the next five years, with more and more companies offering solutions to capitalize on the booming pharma drug development market.

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About Author

Germain Chastel is the CEO and Founder of NewtonX.

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