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Scouting Report-Castor: Bringing the Clinical Trial Process into the 21st Century



The Driver:


Castor, a provider of clinical trial software to empower decentralized clinical trials, recently raised $45M in a Series B funding led by Eight Roads Ventures and F-Prime Capital with additional investments from existing investors Two Sigma Ventures and Inkef Capital. With offices in New York and Amsterdam, Castor is attempting to disrupt an antiquated clinical trials process that is often not digitally driven and which results in approximately 40% of trials being halted due to slow enrollment.


The Takeaways:


  • Less than 5% of patients participate in clinical trials and trial diversity is a persistent problem, particularly for certain disease populations.

  • According to data from IQVIA, 49% of patients drop out of clinical trials before completion and 48% of trial sites miss their enrollment targets.

  • On average new therapies take approximately 10 years to reach the market and cost approximately $3B to develop.

  • A typical travel requirement is for patients to visit a trial site 15-20 times over a 6 month period.


The Story:


Founded in 2012, while CEO Derk Arts was doing his final medical internship in an intensive care unit in the Netherlands and had to assist with a clinical trial. As part of the trial, Arts had to input case report forms into each individual patient's case report file which then had to be combined in order to get results for the study. Upon using this system, Derk soon realized it would not scale easily. Building upon the programming experience he had used to help support himself while at school, it took him two weeks to build a prototype for use in the ICU, according to the company’s website. After doing a little more research Arts states that he came to find out “that almost all unfunded investigator initiated studies used Excel or SPSS for data collection” as colleagues noted open source software was too complicated to build and professional systems were too costly. According to the company, Derk soon partnered with a friend who was a PhD student and within two months they had built what was to become the Castor Electronic Data Capture system. Castor states that the EDC offers a “modern, self-service clinical research platform which enables every researcher worldwide to design studies and integrate data from any source in real-time.” Castor is attempting to use human-centered design to improve the speed, efficiency and patient experience of the clinical trial process.


The Differentiators:


Traditionally clinical trials are based around a physical trial site around which trial participants are recruited and to which they periodically report to have their blood drawn and other lab tests to evaluate the efficacy of the drug candidate. Often the process was very paper intensive and manually based. Castor is attempting to modernize this legacy process through the use of digital technology. Castor’s enrollment portal allows organizations to recruit, screen and obtain electronic informed consent forms in an automated fashion. This is extremely important as trials often have a difficult time recruiting diverse populations, in part because of the difficulties that many underrepresented communities have in accessing trial sites. For example, according to Pharma Voice, patients often have to travel an average of 50 miles to reach a trial site. In addition, Castor’s platform allows “participants to easily provide data, and stay up-to-date from the comfort of their own homes”. As noted above almost 40% of trials are halted due to missing enrollment targets, in part due to the burdens trials place on their participants such as manually having to keep records of medication administration, efficacy and side effects. By allowing trial participants to keep records and communicate through its app, Castor’s platform streamlines and simplifies the process for patients. In addition, with the average cost to successfully develop and bring a drug to market equaling approximately $3B, Castor’s products empower companies to drive down trial costs and speed delivery of new products helping to drive competitive advantage. This is achieved via real time visibility into trial data which facilitates monitoring patients and incorporating trial amendments (if necessary), and flexible remote data capture which provides an API that allows data collection from other systems.


The Big Picture:

As noted by Castor co-founder and CEO Derk Arts, prior to COVID, clinical trials were “stuck in a rut”, the process was cumbersome, required heavy manual input from both patients and trial personnel and did not allow for easy monitoring of side effects or changes in trial protocols. However, due to the need for social distancing and to limit exposure to COVID, digital clinical trials gain new popularity, By reducing travel time and expense for participants, which often spans several times per week over a six-month span, tools like Castor helped increase recruitment of more diverse trial panels and the recruitment of sub-populations which can be critical in certain diseases. In addition, as illustrated by a number of short trial stoppages during COVID vaccines development, rapid tracking and monitoring of drug candidate side effects can be crucial in helping speed products to market and in investigating potential issues or the need for changes in protocol. Moreover, the pace of pharmaceutical innovation relative to the amount spent on R&D is largely unchanged since the 1950’s, in part because of the difficulties encountered with recruiting, retaining and completing trains, Castor and products like it, which bring the process into the digital age, should help speed the pace of innovation.



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