Improving patient recruitment is one of the top challenges drug developers, research sites and CROs face when managing clinical trials. To find, enroll and retain more patients, many pharmaceutical and biotechnology companies have adopted best practices driven by a patient-centric approach.
According to a recent report from the Economist Intelligence Unit, commissioned by Parexel, drugs in development using a patient-centric design were 19% more likely to launch compared to a control group. In addition, patient-centric trials took almost half the time to recruit patients into neurology and oncology trials. Recruitment into rare disease trials was even faster, taking one fifth the time compared to non-patient-centric trials.¹
While it makes both business and ethical sense to design clinical trials with the patient top of mind, sponsors must also consider another critical part of the equation—study sites.
If investigators and clinical staff are too overwhelmed by technology, paperwork and other tasks to effectively communicate with patients and caregivers before and during the trial, patient-centric benefits dissipate. Many prospective sites decline to participate in clinical research altogether, as the extra time and labor involved exceed the capacity of resources, diverting staff from front-line patient care or outweighing financial benefits.
To get the enrollment numbers needed for a successful study, pharmaceutical companies and CROs must consider sites as business partners—not for one clinical trial only, but as part of a long-term program. In other words, they must become both patient-centric and site-centric.
Why sites matter
Hospitals, research centers and clinics serve as the venue for most patient-centric clinical trials. With a few online exceptions, patients review informed consent and undergo screening, tests and procedures at sites. Just as sponsors benefit from reducing patient burden, they can also benefit from reducing site burden.
"Patients and sites don't act in isolation," says Tom Ruane, Parexel's global head of patient recruitment. "Doctors and nurses serve as air traffic control of patient care.
Site staff will have a vested interest in the realization of benefits to patients that Patient Centric initiatives are now affording. That's why we recommend a combined site-centric and patient-centric approach."
Sponsors and CROs typically engage investigators based on their historical performance, knowledge and experience. A site-centric approach equally emphasizes where investigators practice. "Sites determine how investigators are supported and how the trial is managed," says Agnieszka Gackowska, Parexel's global head of clinical feasibility and site alliances.
Multiple studies cite a lack of adequate resources, including the absence of support staff and uncompensated research costs, as physicians' greatest barrier to participation. Clinical practice commitments also factor high on the list.²
When sponsors and CROs prioritize sites, investigators receive the support they need, which makes them more willing to participate. Site staff and project managers work effectively together, which allows studies to run more smoothly, mitigating delays and cost overruns. Greater transparency allows for a more accurate estimation of the number of patients and sites needed to meet defined targets.
"Collaborating with sites on the right level, understanding their processes and being a partner are factors to clinical trial success," says Gackowska.
How to implement site-centricity
To develop a productive, long-term relationship with sites, Ruane says, drug developers and CROs must start from a foundation of "operational empathy." Ask them about their burdens and frustrations and find ways to reduce them.
To align the needs of sponsor, CRO and site, consider expanding the traditional clinical research associate role to that of a site relationship manager. At Parexel, a single site relationship manager serves as the point of contact with the site at any time and triages all communications with the site.
In addition to site relationship manager, consider the following:
Test before implementing new technology.
About 66% of the top 50 pharmaceutical companies use or plan to use eConsent3. While many study coordinators and other site staff may also support eConsent, the process of moving toward the technology involves preparation and education. Before pushing for eConsent, consider whether the site has the resources to integrate it into their workflow. If possible, perform a short-term test run to see how a new program works in actual practice.
The same consideration applies to any new technology—wearables, advanced risk-based monitoring systems and study-specific web portals, to name a few. Ask for site staff's opinion. If they don't have the resources to manage the technology, help them acquire the staff and provide the training needed.
Bridge the communication gap.
Investigators, nurses and hospital administration staff often have different views on running a clinical trial than the sponsor or CRO. Even the most patient-centric CRO has data points and timelines to consider. Caregivers are concerned with the administrative and patient burden.
Having a single point of contact engenders a close and trusting relationship. The site relationship manager is also trained in recruitment strategies so they can better support the site. This close level of support represents another approach to reducing the site's burden.
By forming an established relationship through a single point of contact, CROs can activate sites more efficiently. They also develop a level of trust you can't get from a short-term relationship.
Physicians, nurses and hospital staff already spend too much time on paperwork. Don't add to the paper pile unnecessarily.
A site-centric approach is a relationship-based approach. Consider contracting with sites on specific terms up front, for a fixed-term, to reduce paperwork on recurring programs with those sites. For example, if sponsors and CROs build confidentiality into their agreement, they can mitigate duplicative paperwork from multiple Confidentiality Disclosure Agreements.
Parexel in addition to the sire relationship manager role has also developed long-term strategic relationships with experienced healthcare institutions across the globe under the name of the Alliance Site program. Parexel's 20-plus fully dedicated Site Alliance Managers serve as the liaison between the CRO and the institution where are located project sites, providing support not only while studies are active but also between studies, facilitating protocols assessments, site start-up activities, patient recruitment strategies and data quality. They utilize in-depth knowledge of site capabilities to support feasibility during the -site selection process to lower the administrative and logistical burden. Today the Site Alliance network includes more than 360 institutions covering more than 15,000 investigators. And these long term relationships are having a meaningful impact - based on current Parexel internal data, project sites located in Alliance institutions recruit on average 62% more patients than non-alliance sites.
"They're successful because they are the best institutions with many experienced investigators and access to patients, and what is even more important, they are willing to implement new solutions to improve their standards. Having close relationships with such institutions, we’re prepared to support them at the right moment, not at the last moment and help to be even more successful," Gackowska says.
What about the patient?
An efficient process between site and sponsor means a higher-quality experience for the patient. Patients feel more engaged when they participate in a streamlined, efficient process. A better informed, less-stressed staff can better communicate information patients’ need about the study, the drug and the process.
"The site is a true game-player," says Ruane. "Inform them much earlier to recruit patients more successfully in the future."
1. The Innovation Imperative: The Future of Drug Development, Part I: Research Methods and Findings, The Economist Intelligence Unit, 2018.
2. Dev AT, Kauf TL, Zekry A, et al. Factors influencing the participation of gastroenterologists and hepatologists in clinical research. BMC Health Serv Res. 2008;8:208. Published 2008 Oct 8. doi:10.1186/1472-6963-8-208
3. McNair, Lindsay, MD et al. Electronic Informed Consent: A New Industry Standard. WIRB Copernicus Group.