There are over 200,000 current clinical studies taking place in the United States. Over the course of a 10-year period of time, each clinical study costs tens or hundreds of millions of dollars. The clinical trial industry is projected to reach $65 billion by 2025 with a 5.7% CAGR (compounded annual growth rate). That’s NOT a good thing and platforms can help reverse this trend. Last week we wrote about how a healthcare platform can improve health outcomes for patients. This article focuses on how platform innovation can lower the cost of clinical trials while improving the process and quality of the trials.
Currently, clinical trials have a network problem.
The good news is that network problems can be deftly solved with a platform. Platforms benefit from network effects by connecting people around a common service or product (e.g. Uber riders and drivers who ride-share). In the case of the clinical trial platform, the network would connect three primary parties: researchers (CROs and pharma companies), investigator sites (doctors) and end-patients.
Of course, clinical trial participation isn’t as snazzy as ride-sharing and the incumbents are much more heavily entrenched. Currently, pharmaceutical companies work with CROs (contract research organizations) to conduct research studies about recruiting patients for a clinical trial. The data to find potential end-patients to participate in a new trial is siloed and highly fragmented. CROs need to recruit doctors to help run the study and check-in regularly with the end-patient as the trial takes place. There are a million doctors in the United States and tens of thousands of clinical trials take place every year. Unfortunately, almost no information is shared between all the parties. According to Clinical Leader, “forty-eight percent of sites miss their enrollment targets and 80 percent of trials are delayed due to recruitment.”
One of the only shared data initiatives is clinicaltrials.gov which does a good job sharing information about what studies are taking place and their results. However, this information doesn’t help solve the recruitment problem.
Initially, few patients would discover the platform organically and self-opt in. The network can be fed with an existing database of clinical trial patients and other patients whose data can be legally tapped for research purposes. The platform makes that database of patients accessible to a wider group of researchers, who are more likely to organically opt-in to this type of platform.
A platform for clinical trial recruitment democratizes the role of the CRO. Instead of a CRO working for just one pharmaceutical client, the platform CRO is matchmaking for all pharmaceutical companies. By centralizing investigator site and end-patient information, the platform CRO’s costs to the pharmaceutical client is drastically lower on a per trial basis.
The problem is that most doctors and end-patient don’t want to agree to allow a platform CRO to use their data across a variety of potential pharmaceutical clients. As most platforms do, they give away the technology in exchange for the network. So, what technology could be used by these two producer groups? A lot.
Companies like 23andme are now signing deals with pharmaceutical companies to help with clinical trials. These consumers pay for the test and have to opt-in to these broader studies to help advance medicinal research, without any monetary incentive. More advanced tests that catalog the whole genome can cost thousands of dollars which insurance doesn’t cover the full amount.
Another way to gain adoption is somewhat similar to what Oscar Health has done by partnering with Humana and Cleveland Clinic. By providing these two institutions with Oscar’s technology for telemedicine, claims management and content management, Oscar gets access to these two different markets. Come for the technology, stay for the network. Or, said another away, give away the technology to the older, traditional enterprises that struggle with technology and get access to their network in exchange. Platforms will make this trade all day long. In clinical trials, the software to conduct and monitor a trial is severely lacking.
An additional benefit to broadening the patient database is an improvement in diversity in patient samples. For example, a recent study of the Medisafe App revealed that 25% of the digital healthcare app’s patients were black, a group that is underrepresented in clinical trials and make up around 7% of patients in trials (and in some cases, as low as 1.6%).
Digital clinical trials is a new phenomenon. Typically, end-patients need to physically see their doctor at the investigator site regularly throughout the trial. This can be a big nuisance to end-patients and a big reason why they can’t participate. A communication and collaboration platform between the end-patient and doctors can lower the cost of conducting the trial and provide a key foothold to solve the recruitment problems mentioned above.
Medisafe was able to reach more black patients due to its remote, digital healthcare model. Remote, digital tools for clinical trial monitoring remove geographic and scheduling barriers that exclude certain segments of the population from participating in clinical trials.
Digital clinical trials are on the rise as researchers try to lower costs and improve adherence and data gathering. According to a Clinical Research.io, site monitoring, site retention, and site recruiting make up 30% of trial costs. Virtual clinical trials cut costs by eliminating the traditional brick-and-mortar set-up of multiple study sites.
Beyond cost-cutting, digital clinical trials improve adherence and engagement, another challenge for researchers. As many as 40% of Phase III trial subjects become disengaged and drop out of the study, largely due to breakdowns in communication, the complexity of data collection, and the inconvenience of traveling to trial sites for patients with mobility issues or who live in rural areas.
By offering digital healthcare to patients, the trial methodology is less onerous both during recruitment and in the later stages of the study when retention and engagement is critical to the study’s success. Furthermore, the patient-facing app could collect data remotely and more frequently, while also sending important notifications to patients, and improving subject feedback.
Many clinical trials grapple with the efficacy-effectiveness problem, wherein randomized clinical results don’t match up well with real-world results. We anticipate that by improving the patient sample, and allowing the study to take place remotely, that is, more in line with how the drug would be taken in a real-world setting, the clinical trial results should more closely mirror real life performance.
With digital therapeutic apps, patients integrate healthcare into their daily routine seamlessly. Furthermore, in the near future most drug usage, outside of clinical trials, may feature an app component. Thus, the difference between taking a drug for a trial or taking an approved drug on the market for an illness will be negligible, if at all possible to discern.
Contract Research Organizations (CROs) are well-positioned to launch a virtual clinical trial platform. CROs have operated as offline “platforms” for decades. They connect researchers to patients and sites by leveraging existing relationships and knowhow to improve outcomes for each pharmaceutical client. However, CROs are limited by the extent of their own reach. Their business models are linear, and their network expands with each new trial, and each new staff member who seeks sites and patients manually.
A platform business connects researchers and patients that join the platform’s network, whether or not the CRO made that connection manually. In other words, a CRO that innovates with a platform will benefit from network effects. Having grown its reach exponentially, the SaaS component – telemedicine and virtual healthcare – can be offered to a broader range of users.
However, CROs aren’t the only type of company that could potentially invest in a platform business for clinical trials. Pharmaceutical companies focused on differentiating itself as a leader in drug research could also lead this initiative. Ideally, a pharmaceutical company could acquire a CRO that has already advanced its linear virtual clinical trials substantially and only needs a gentle push to invest in a platform business.
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