From Lab to Launch: How Clinical Trial Management Systems are Keeping Discovery Moving
When investors and innovators think of the digital approaches to life sciences, it’s often the dramatic “hacking” of biology leveraging technologies such as AI, CRISPR, and now mRNA, that get the limelight. While these innovations are groundbreaking, their impact is supported by an ecosystem of equally important behind-the-scenes players that make bringing new treatments to market possible. In this article, we’ll explore some of the companies that make clinical trials successful and how impactful they are for the medical research space and, ultimately, for improving patients’ lives. We’ll review the clinical trials ecosystem and its segments, define trends in the space today, and note what we think winners in this space will look like.
Clinical Trials: A Brief Overview
Most of us are now familiar with clinical trials, at a minimum from watching and cheering on the COVID-19 vaccines as they passed through various rounds of approvals before going to market. Clinical trials are a lengthy and necessary process for any type of new drug or device to gain approval for human use. Trials involve four major steps before approval, as well as post-approval analysis, as indicated below. Overall success rate for clinical trials are relatively low, at about 14% from start to finish. And the prize for success is massive. A “blockbuster” drug can earn its sponsor (typically a pharma company) in excess of $1B per year in sales. As a result, innovations to improve the clinical trial process can have a real monetary incentive. It goes without saying that this, coupled with the health benefits of improving the types of care we can offer those suffering from diseases, makes for a highly compelling value proposition.
There are four key stakeholders involved in clinical trials:
- Sponsors — as noted above, these are the parties that want to run and pay for trials; typically pharmaceutical, biotechnology, or medical device companies.
- Contract research organizations (“CROs”) — these companies help execute the clinical trials, and act as an outsourced services arm for research.
- Sites — organizations that conduct the clinical trials and study the results, this includes hospitals, academic institutions, and independent providers.
- Patients — the people that participate in trials.
Trends in clinical trials today: expensive and slow, but COVID brings new hope
With the revenue potential of successful breakthrough innovations being so massive, it’s no wonder that sponsors spend heavily on clinical trials. However, the irony is that despite massive budgets and resources, only 5% of clinical trials finish on time*. The value of finishing on time is significant — patents are issued before drugs or devices are in market, meaning that each extra day in trials means one less day selling under patent protection — a cost of on average $2M-$3M per day*. As a result, many of the solutions Wittington Ventures has looked at help alleviate the pain points that cause trials to run inefficiently. This can include more effectively recruiting and retaining patients, operating decentralized trials that are more convenient for patients, maintaining efficient operations and supply chains, or other value-add services. COVID-19 has illustrated how fast clinical trials could go and thus put pressure on the industry to optimize its slow and sometimes analog process. We are also seeing an increased interest in patient-reported outcomes, driven by technological advances such as data interoperability, machine learning, and sophisticated wearables that make real-world evidence more practical.
The clinical trials technological value chain
Clinical trial management systems (“CTMS”) are broadly defined as the technological systems that underpin the various aspects of clinical studies. From Wittington Ventures’ perspective, this is the sector within clinical trials where we see the most promise for future growth. As we dove deeper into the CTMS space, we identified 6 different segments on the basis of function: study design, patient recruitment, operations and supply chain, data collection and analysis, decentralized trials (DCT), and real-world evidence/data (RWE/D). Some of these segments are required at various stages in a clinical trial (pre-, during, or post) and some segments are engaged throughout. Some of the key pain points that drive sponsors to use outsourced tools are highlighted below:
Which segments have the most potential?
After categorizing the various segments in the CTMS space, we identified how each differed in its value proposition (i.e. unmet need addressed), market potential and level of competition. This served as our basis to help prioritize which segments we saw as having highest potential from an impact, and thus investment, perspective.
Based on the analysis above, we found that startups working in the Real-World Evidence / Data (e.g. Unlearn, Aetion) and Operations & Supply Chain (e.g. Slope, Florence) segments were poised for high growth. These startups are followed closely by companies operating in the Decentralized Trials (e.g. Medable, Elligo) and Patient Recruitment (e.g. Clara, Subjectwell) segments, each of which is a somewhat crowded market but hosts effective technology-enabled solutions.
What does a winner look like?
After prioritizing the segments within CTMS, we then drilled down one level further to define what we believe the prerequisites for successful companies would be in each space.
In the RWE/D segment, a track record of completing studies with the FDA is very helpful because it validates the regulatory acceptance of a solution. This helps de-risk a purchase decision for sponsors who are typically focused on creating the highest possible chances for their drug or device candidates to succeed. A broad variety of ways to commercialize is also valuable, given that most datasets can be monetized multiple times. And finally, the more high fidelity the data is, the more valuable it is for sponsors in studies. Data pipelines that are dynamic versus static (e.g. real-time window into an EHR database), tend to be more useful and valuable.
In the ops & supply chain segment, sites are your key stakeholder. Products and services must be designed to make lives easier for investigators, whether it’s seamless delivery tracking, active inventory management or easy record-keeping. Being able to tie back shifts in operational metrics to the speed of a trial is imperative (e.g. carrying an extra days inventory allows a site to see 5 more patients). Since many supply chain items are commoditized, an ideal system should aim to alleviate “bottlenecks” in a process versus becoming one itself. Established traction with large sites will be key , especially with those that conduct a lot of research and have more complex operations.
For decentralized trials, having a focus on technology instead of labor is critical to scaling a profitable business. The more that companies in this space can leverage technology to ensure trials are delivered effectively, the more successful they’ll be. We prioritized solutions that have full integration across the value chain over those that simply offer point solutions.
Finally, in the patient recruitment space, it is worth underscoring that getting high quality patients (e.g. those that ultimately enrol and complete trials) quickly is really the highest currency credential a company can have. Additional factors include solving for multiple therapeutic areas / patient populations and having a living patient pipeline that is engaged and willing to convert (and still in the desired therapeutic state) months or even years after joining a platform.
The table below summarizes our perspective on what defines a winner in each of our four prioritized segments.
The value of innovation in clinical trials is undeniable and the timing is right for technology to upend the slow and expensive way we bring drugs and devices to market. At the forefront of these changes, we expect players in the RWE/D, patient recruitment, DCT, and operations and supply chain space to drive the most innovation. Over the next little while, we believe that the CTMS sector will garner more attention from emerging startups and investors alike, and are thrilled about the impact that will have on the universe of treatments available to patients.
Please let us know if you have thoughts on how clinical development is being shaped by technology. If you are building a CTMS business or technology that meshes with our Connected Health Landscape, we’d love to connect! Megh, Katie, and Curtis from the WV Healthcare team can be reached at email@example.com.
A big thank you to our MBA intern Chris Biondi for his research & insights that went into this piece.
*Source: Expert interviews conducted by Wittington Ventures