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Chad Moore, MBA, President, Elligo Health Research
Overcoming patient recruitment challenges is one of the most complex and competitive investments for today’s drug developers. Despite using various recruitment tools and technologies and spending heavily on patient outreach, there continues to be a shortage of study-participating patients. In fact, as many as 86 percent of trials do not reach their enrollment goals within their targeted timeline (Huang, et al. 2018) (Christel 2015). Missed last-patient-in deadlines are not only costly — resulting in up to $8 million in lost revenues each day (ePatientFinder 2016) — they are generally unsuccessful and often result in lengthened, suspended or terminated studies.
When more patients are needed to fill a trial, the industry typically uses traditional recruitment methods. Generally, these approaches target patients and caregivers through geofenced advertising online, or locally on billboards, radio and television and in the newspaper. Although these tactics can reach a wide audience, recruiting in this manner is limited, expensive and largely inefficient. Study sponsors often experience delays because large numbers of responding patients do not qualify for study participation after they are evaluated against trial inclusion and exclusion criteria.
Alternatively, study sponsors have seen some success with direct-to-patient outreach. Several methods to access patient pools exist, including social media, newsletters, blogs and advocacy through physician investigators at known central research sites. But even this more-targeted style of patient recruitment has its drawbacks: Patients, in most cases, must participate in a study at a research facility and under the care of a medical professional who is unfamiliar to them. This often requires lengthy travel, and the patient may endure additional costs to attend appointments and receive treatment that causes them to reconsider joining or perhaps to drop out of a study.
Today, numerous companies are working on new approaches that address the most common downfalls to these outdated recruitment methods. Through these efforts, we are learning that the closer we can work with protocol-eligible patients, the better recruitment becomes. The most successful approaches are evolving traditional service offerings and patient outreach tactics to make them more patient-centric. The outcome of this approach is accelerated study timelines and improved trial quality due to quality patient recruitment and retention.
Innovation plus service to reach patients
According to Tufts Center for the Study of Drug Development, patient-centric initiatives improve trial feasibility, enhance patient convenience, improve treatment relevance and create higher ownership and participation among physicians and their patients (Getz 2015). To be successful, it won’t be enough to use technology to identify patients: Interaction with physicians and patients is also essential to make participation more convenient and comfortable.
To understand how the industry can better reach eligible patients, we look at some of the technologies and services that companies are implementing and how innovations — combined with the service necessary to reach patients and physicians — can make a difference.
Maintaining the physician-patient relationship
Research shows that patients prefer to receive clinical research information from their primary or specialty care physician (The Center for Information & Study on Clincal Research Participation 2013). Study sponsors and CROs are recognizing this and have begun improving patient enrollment and retention by taking research directly to patients and their health care provider. By using electronic health record information, providers can identify patients under their care that meet a specific trial protocol. In some cases, these health care providers are partnering with integrated research organizations to deliver a comprehensive suite of services and technologies that allow physicians and their patients to participate in a more convenient manner.
Improving trial feasibility
One of the core reasons sponsors miss recruitment deadlines is because they rely on estimates for the number of patients that will be enrolled at a research site. In most cases, these estimates are simply guesses and not supported by data. Some companies are enabling sponsors to better gauge enrollment timelines, estimate budgets and pinpoint the best geographies for their studies using datasets to run protocol simulations and assess feasibility. Other companies are deploying real-time analytics and predictive technologies with good results, allowing sponsors to avoid unproductive sites.
Enhancing patient convenience
Keeping enrolled patients engaged for the full length of a trial can be just as challenging as recruiting them. To combat this, trial sponsors are beginning to incorporate new technologies — like Bluetooth devices and digitally based studies — to gather data. These tactics often make participation easier for patients and keep them informed and engaged; some studies using electronic devices even make it possible for patients to get real-time information about their participation and health.
Patients need a voice
Patient recruitment begins with identifying qualified patients, but success lies in our ability to educate them on the benefits of clinical trials, remove barriers to participation and engage them throughout the duration of the trial. The key is finding opportunities to give patients a voice. The most successful companies will not only increase awareness of research opportunities among patients, but will allow them to participate closer to home and under the care of their own physician. With this approach, we will find success in filling clinical trials and see improvement in patient compliance and retention as well.
Chad Moore is president and co-founder of Elligo Health Research which offers the only platform that brings clinical research direct to clinical health care. Since Elligo’s inception, Moore has helped concept and build the approach that is innovating and diversifying clinical trial participation.
Applied Clinical Trials. 2015. New Approaches to Speeding Up Clinical Trials – What Works and What Doesn’t. May 27.
ePatientFinder. 2016. “epatientfinder.com.” ePatientFinder. Accessed July 18, 2018.
Getz, Ken. 2015. Clinical Trials Transformation Initiative. January. Accessed July 17, 2018.
Huang, Grant D, Jonca Bull, Kelly Johnston McKee, Elizabeth Mahon, Beth Harper, and Roberts N Jamie. 2018. “Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative.” Contemporary Clinical Trials 66: 74-79.