| INTEGRATIVE INSIGHTS ON EMERGING OPPORTUNITIES |
Integrative research means our extensive company research informs every thesis and perspective. The result is deep industry knowledge, expertise, and trend insights that yield valuable results for our partners and clients.
jmunda@firstanalysis.com
- Recruiting patients for clinical trials is challenging and often the rate-limiting step in bringing a new drug to market, and recruitment delays are costly, resulting in lost potential revenue ranging from $600,000 to $8 million per day per drug.
- COVID-19 only amplified the challenges of patient recruitment, ultimately forcing trial sponsors to rethink and improvise on their trial strategies, typically by leaning more heavily on digital solution providers to enable decentralized clinical trials. In decentralized trials, patients and clinical trial staff use technology to interact and share data remotely, thereby expanding the pool of potential trial participants by enabling patients anywhere to participate with few or no visits to a centralized trial site.
- One of the keys to realizing the full potential of decentralized trials is digital patient recruitment technology that identifies and attracts the largest possible pools of candidates for clinical trials, taking maximum advantage of the fact that decentralized trials eliminate or reduce the constraints of geography and related factors on trial participation. We profile several companies that have developed innovative technology solutions for identifying, attracting, and retaining high-quality pools of patients for clinical trials.
TABLE OF CONTENTS
Includes discussion of CERN, INF, SYNH and eight private companies
It takes a village
Finding a needle in a data stack
Strength in numbers
Faster. Better. Cheaper.
eClinical index overtakes Commercialization Index in Q1
Pharma IT M&A continues resurgence in Q1
Pharma IT private placements rebound in Q1
Introduction
The drug R&D process is inefficient, complex, bureaucratic and, above all, expensive. According to the Tufts Center for the Study of Drug Development, it takes an average of $2.6 billion, including cost of failures, and 10-15 years to discover, develop and win approval for a new drug. Additionally, only one of every 10 drugs that starts trials ends up being approved by the FDA. Patient recruitment is often the rate-limiting step in the process.
Historically, recruitment has been largely dependent on physician referrals and patients' ability to successfully navigate clinicaltrials.gov, a database of privately and publicly funded clinical studies. Challenges to recruiting patients include making patients aware of trial opportunities, overcoming patients' fears about participating or mistrust of trials, and accommodating patients' time and economic constraints. In normal times, about 50% of clinical trials need to extend their recruitment period, resulting in lost potential revenue ranging from $600,000 to $8 million per day. Additionally, 11% of trial sites fail to recruit any patients, and 37% under-recruit and fail to meet their enrollment targets.