Article updated March 2024.
Enrollment is critical to timeliness and clinical trial success, but research indicates that in the US, studies enroll on schedule only about 10% of the time. The global picture is better, but not by much – just 14-17% of studies are on time outside the US.
Pharmaceutical organizations and research institutions continue to embrace digital transformation, and many companies are now looking to digital tools to upgrade and improve the clinical trial patient enrollment process, where tactics have remained static for some time.
According to Health Decisions:
“Drug and medical device developers need to assume current best practices as a starting point, but enroll patients much more efficiently by using an active, dynamic approach to manage everything that happens after site selection. Technology and processes should track enrollment progress in detail, identifying the strategies and tactics that are actually working in the field, and optimizing continuously based on what is learned.”
Let’s discuss what’s involved in patient enrollment, and how technology can impact patient engagement in clinical trials and improve other aspects of the process for overall more successful trials.
What is clinical trial enrollment?
Enrollment is simply registering or entering a patient into a clinical trial. According to the US FDA, the participant follows the clinical trial protocol once an eligible patient has been enrolled. Clinical investigations are designed to enroll a set number of clinical trial participants to increase the likelihood of answering the questions posed by the trial.
The National Center for Biotechnology Information reports that barriers to clinical trial participation can occur across a variety of factors, including:
- Patient factors or demographics (minority, age, rural location, poor access to care, socioeconomic status)
- Patient/community awareness or trust issues and history (mistrust of research or the medical system, fear of negative results or effects, lack of information on available trials
- Physician/researcher barriers (fear of losing patients, lack of awareness of clinical trial benefits, doctor-patient communication, lack of culturally appropriate researcher training to address patient concerns)
- Infrastructure or clinical trial design issues (lack of sufficient number of appropriate trials, disqualification of patients)
- Perceived or actual cost barriers (reluctance due to lack of insurance, fear of lack of reimbursement)
The New England Journal of Medicine characterizes poor enrollment as a missed opportunity – the opportunity to “advance scientific knowledge, develop therapeutic strategies, and ultimately improve care for everyone who will come next.” For this reason, it’s important to understand the potential barriers discussed above and create a strategy to address the lack of awareness or reluctance that prevents patients from pursuing enrollment and discourages physicians from encouraging it.
How can the pharma industry improve patient enrollment?
One of the most important steps toward improving patient enrollment in clinical trials is to take a more global approach. Health Decisions states that this reflects the growing number of investigators outside the US and a different attitude toward new or experimental treatments in areas other than the US. Expanding the patient pool to include other areas of the globe can also help increase diversity in clinical trials, which can help develop effective treatments for a wider selection of patients.
The American Society of Clinical Oncology has written extensively about strategies to prevent and alleviate the actual or perceived financial burden of cancer clinical trial participation:
“Historically, many of the efforts to address the financial burden of trial participation focused primarily on providing accommodations to children with cancer and their families. For example, programs associated with the Ronald McDonald House and the American Cancer Society Hope Lodge, as well as institutional support from St. Jude, have helped support children’s cancer treatment and clinical research. For adults with cancer, a National Institutes of Health program has helped support travel, meals, and lodging for participants in cancer clinical trials.”
“Although these efforts seek to address the financial concerns associated with clinical trial participation, evidence supporting these efforts as ways to enhance clinical trial enrollment and retention is lacking.”
Ongoing efforts to understand more about the financial impact of trial participation may reveal that the answer is more education and awareness or straightforward financial assistance that removes concerns around taking time off work, traveling, or paying for transit to investigation sites and the possibility of insurance coverage issues.
But the solution may also lie in eliminating some of those costly factors from the outset and making clinical trial participation more accessible, appealing, and simple to integrate into daily activities.
In early 2024, the National Cancer Institute (NCI) established a Virtual Clinical Trials Office to address declining participation in NCI-funded cancer studies. The Virtual Clinical Trials Office includes a centralized team of research nurses, clinical research associates, and clinical data specialists who will work remotely to assist NCI-Designated Comprehensive Cancer Centers and community practices with trial activities. This assistance could include screening patients for eligibility, enrolling patients into trials, educating patients about research protocols, and performing data entry.
How can virtual engagement increase enrollment in clinical trials?
When more than 1,000 clinical trials were paused in the early days of the COVID-19 pandemic, clinical research teams sought – and found – a workaround: digital tools that allowed remote monitoring and check-ins with investigators and physicians, or even fully virtual clinical trials. By leveraging telehealth and other online interactions, including virtual advisory boards, clinical teams were able to avoid even more extensive delays.
For pharmaceutical companies, lessons learned from this experience included more time at home or in the clinic, no risky or time-consuming travel, increased digital capabilities, and time and cost efficiencies gained through asynchronous engagement punctuated by live virtual interaction. It’s not a stretch to say that patients can enjoy the same benefits. Virtual trial participation allows patients more control over their schedule and the freedom to incorporate clinical study participation as a part of their lives – not something that disrupts or dictates their lives.
With these considerations in mind, pharmaceutical organizations should anticipate that offering virtual options can improve the process of patient recruitment in clinical trials. Online interaction may also help achieve an enrollment target and improve trial outcomes by giving patients a more private, secure venue to share sensitive medical information confidentially and reducing the likelihood of patients discontinuing participating.
Conducting patient interaction via an asynchronous virtual engagement platform also allows pharmaceutical teams to work toward better insights management, in which insight-gathering is a strategic business priority rather than a fragmented series of disconnected activities.
To learn more about why clinical teams prioritize virtual engagement, download our white paper.
