Patient Recruitment: The Biggest Barrier to Product Development in Healthcare
May 20, 2023
Clinical trials are key to breakthrough advances in healthcare and to addressing important unmet treatment needs for patients. And, while we are living in the golden age of innovation, it however often feels as though we are still in the dark ages when it comes to clinical trial recruitment.
Finding enough qualified participants willing to commit to a clinical trial within a short timeframe is a persistent challenge. Additionally, there may be reluctance on the part of a patient to volunteer for a clinical trial because of potential health risks or side effects. These obstacles and others can make it difficult for sponsors to recruit enough people to test a product, which in turn can impede or delay a therapeutic’s development.
Clinical trials are a critically important requisite to successful drug development. They are also costly; clinical research makes up a significant share of total drug development costs, approximately 40% according to estimates. And while more than 300,000 clinical trials are conducted annually, only about 20% of them are completed on time, mainly due to lack of study participants, making patient recruitment one of the most daunting challenges in the drug development process.
Retaining patients is another significant challenge. Reports show that from 15% to 40% of patients enrolled in studies drop out before they are completed, significantly affecting trials’ timelines, and jeopardizing their success.
The impact of patient recruitment and retention challenges is clear; only 37 novel drugs were approved by the FDA last year, a drop of 26% from the 50 novel drugs approved in 2021, and 33% less than the 55 novel drugs the FDA approved in 2017.
We cannot keep approaching clinical trial recruitment in the same way expect different outcomes. Our response to the COVID-19 pandemic actually showed us how quickly we can collaborate to advance treatments. It also made it possible for us to explore new communications strategies, which we can now deploy to improve patient recruitment to ensure product development success and deliver on our collective promise to patients.
Based on our recent experience, three key strategies focusing on new top of the funnel communications approaches can help enhance clinical trial recruitment success:
- Activate the broadest range of patient recruitment strategies right from the start.
Don’t wait to see the recruitment numbers come in and hope that they will get better over the next few weeks or months. Adding activities to catch up is always more difficult and costly. Be decisive, think outside the box and embrace doing things differently – it will be worth it and actually could save time and money in the end.
- Focus on driving high-quality leads, not quantity.
Targeting is king – so go narrow, not wide! The good news is that recruitment and retention strategies have significantly evolved, especially with digital solutions that can more efficiently target the right patient population and therefore yield a narrower pool of higher-quality potential participants.
- All healthcare is local and deeply personal.
Most patients access their health care locally. COVID somewhat blew up the traditional clinical trial recruitment model and forced the drug development industry to turn to more decentralized tools including telehealth, decentralized clinical studies or hybrid trials to address barriers and limitations and increase access to care. Regardless of the mix, we recommend deploying a program that reaches patients by strategically mining the important local network of referrals and awareness. This allows patients to be seen locally and enhance their personal connections with the team, and their commitment to the study.
On May 20, as we honor Clinical Trials Awareness Day, we should remember all the patients who have, by taking part in clinical trials, contributed to advancing the scientific process and making it possible for patients everywhere to benefit from the medications they helped validate. At this time, we should be reminded just how much more work we need to do to reach and successfully engage patients and continue finding strategies that remove barriers to patient recruitment on which therapeutic innovation depends.