- While there has been a downward trend in COVID-19 clinical trial starts, these trials maintain strong momentum into 2022.
- Enrollment remains at the top of the list of challenges facing clinical trials.
- Virtual trial companies have seen exponential growth over the past two quarters.
It’s been about two years since the life sciences industry became aware of COVID-19 and shifted focus toward vaccine and treatment development. Since Jan. 1, 2020, over 21,000 clinical trials have been registered with the clinicaltrials.gov database. Of these, over 5,600 were related to COVID-19. Approximately 33% of these COVID-19 trials started in 2021, indicating a downward trend but not yet extinction.
Vaccines were not the primary intervention studied. Approximately 64% of these trials related to drug interventions, while 30% related to biological interventions, where vaccines reside. The remainder related to other interventions, such as treatments for mental health-related issues spurred by the pandemic.
As is the case for other indications, universities and medical institutions earned the bulk of COVID-19 clinical trials funding, making up approximately 73% of all COVID-19-related studies. Industry researchers represented approximately 15% of all such studies, with the remainder representing some combination of government funding and the aforementioned buckets.
COVID-19 clinical trials have fared better than non-COVID-19 trials as relates to enrollment. While less than 20% and 4% of phase 3 clinical trials starting in 2020 and 2021, respectively, report having met enrollment needs, approximately 34% of COVID-19 trials have been completed or terminated and 13% are active, having met enrollment requirements. The remaining 53% have not met enrollment requirements, signaling an ongoing, significant enrollment challenge for COVID-19 trials; however, the challenge is less pronounced than for other indications.
Contract research organization executives note that COVID-19 trials generally make up less than 10% of their contract backlog. They do not expect COVID-19-related clinical trials to go away but rather to continue in lower numbers going forward. We tend to agree with this stance. While there has been a downward trend in COVID-19 clinical trial starts, these trials maintain strong momentum into 2022. As COVID-19 transitions from a pandemic into an endemic disease, we anticipate that clinical trials will continue, though at a lower volume.
Clinical trials continue to struggle with enrollment deadlines
Enrollment remains at the top of the list of challenges facing clinical trials. No matter how great a study’s design or its flexibility in virtual versus in-person participation, participants need to be identified and recruited for the study to be successful.
Enrollment challenges are not a symptom of the COVID-19 pandemic but rather a challenge exacerbated by it. Less than half of the phase 3 clinical trials started in 2017 to 2019 report having met enrollment needs. Of phase 3 clinical trials starting in 2020 and 2021, less than 20% and 4%, respectively, report having met enrollment needs. Cumulatively, 31% of phase 3 clinical trials over the past five years report having met enrollment needs.
Companies are looking for strategies to improve clinical trial enrollment. Most are turning to patient-centric design, in which the patient experience is emphasized in all aspects of protocol development. Examples of this approach include easing participant burden through the implementation of new technologies and improving patient diversity.
More calculated approaches to resolving enrollment issues, such as machine learning algorithms, are also making inroads. Services are now available that use such an algorithm to parse electronic health records and identify potential participants. However, challenges with this approach include gaining patient consent to obtain records and maintaining patient confidentiality.
Virtual trial companies see exponential investment growth spurred by longer clinical trials
Catalyzed by the need for virtual technologies during the COVID-19 pandemic and an emphasis on improving the patient experience, virtual trial companies have seen exponential growth over the past two quarters. In contrast with traditional CROs, virtual trial companies have been purpose-built for the decentralized clinical trial and virtual clinical trial movement. Most companies in this space have a proprietary SaaS platform built to standardize site methodologies, enabling clinical trial sites to operate virtually anywhere.
One value proposition for virtual trial companies, beyond flexibility in where and how patients participate, is their effort to reduce clinical trial durations. In 2010, phase 3 clinical trials took approximately two years to complete; 2021 duration increased to 3.25 years. Many virtual trial companies are aiming to reduce duration to as short as one year, representing a tremendous value proposition to the industry.
Over the past two quarters approximately $1.4 billion has been invested in these trial companies, leading to hefty valuations, including $2 billion for Medable and $1 billion for Science 37. Cumulative investment over the past two years totaled approximately $1.9 billion.
This calculation of investment does not include the numerous partnerships between virtual trial companies and CROs—nor the investment made by CROs into the virtual trial space. In the ICON acquisition of PRA Health Sciences on July 1, 2021, ICON executives mentioned that a key benefit of the acquisition was PRA’s technology capabilities. On quarterly earnings release calls, it seems like every other question relates to decentralized or virtual clinical trials.
In response to this growing trend of virtualization, the FDA recently released draft guidance titled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. The guide describes practical and regulatory considerations related to the use of technology to accumulate clinical trial data.
We are cautiously optimistic that investment in this market will continue, given the industry’s emphasis on this space, market interest on the topic and regulator acknowledgment.
