HomeInsights
Insights

Increasing Clinical Trial Enrollment Through Innovative Digital Techniques

June 16, 2021

Current limitations in clinical trial enrollment

Once the planning and start-up procedures for a clinical trial are completed, the most critical part of the trial begins, patient enrollment. Unfortunately, this is when many clinical trials can encounter difficulty. Patient recruitment is one of the primary challenges in clinical trials, and can often lead to increased costs due to trial delays and the efforts needed to increase enrollment. 

Traditionally, there are three primary patient recruitment strategies used by CROs, pharmaceutical companies, and biotechnology companies to increase clinical trial enrollment. First is to add study sites, especially in different countries, which can increase the geographic reach of patient recruitment efforts. Second is to produce patient-facing advertising materials, such as posters to be placed in healthcare settings. And third is to generate patient referrals from general practitioners, specialists, and other satellite sites. There is a limit to the efficacy of these traditional techniques, and thus a need for new innovative techniques for enhancing clinical trial enrollment.

How to increase enrollment through innovative digital enrollment techniques

The clinical trial industry is changing and looking for new solutions - facilitated by the Covid-19 pandemic, digital transformation has been happening at an unprecedented rate\(^1\). One of the examples is an innovative enrollment technique, developed in response to the need for a more robust clinical trial enrollment strategy. This technique employs a special digital environment that promotes collaboration between clinical trial sites and a clinical data aggregator. Such an environment is achieved through the implementation of a universal toolkit, in general containing:

  • an ecosystem wherein partners are connected with data publishers to initiate collaboration\(^2\)
  • digital patient consent management tool that is compliant with ICH,\(^3\) GCP,\(^4\) CFR part 11,\(^5\) and GDPR.\(^6\) This module enrolls patients into research activities via centrally-managed auditable and transferable permissions
  • a digital patient-facing tool that facilitates patient education regarding their health and promotes their proactive involvement in research initiatives. This module adheres to the NIH and NSF guidelines concerning the implementation of digital technologies in clinical trials.\(^7\)

Digital enrollment technique strategy

This new digital enrollment technique for clinical trial enrollment is realized via two primary strategies. The first is social media advertising, using such platforms as Facebook and Instagram. Social media allows for precise targeting of potential study subjects, based on demographic and behavioral parameters related to the specific clinical trial.\(^8\)

The second is search engine enrollment, on platforms such as Google. This is uniquely valuable because it can leverage key search terms that patients are using while actively searching for information about their health condition. These are usually based on a pay-per-click strategy, and as with the social media advertising for clinical trials, can be tailored to target specific patient populations. These combined digital enrollment strategies are critical components to the advancing digital era of clinical trials.\(^5\) Research has shown that such techniques effectively contribute to increased patient recruitment and are a cost-effective option for increasing clinical trial enrollment.\(^9\)

Digital enrollment technique during trial start-up

An effective strategy for digital enrollment optimization begins during the clinical trial start-up phase. First, the recruitment strategy is discussed alongside the development of the study design and determination of the study objectives. Then, these details are incorporated into the clinical trial protocol, consent form, and related patient documents. The FDA considers direct advertising to study subjects as the start of the informed consent process.\(^10\) Then a trial-specific questionnaire should be developed, which can be completed digitally and remotely by potential study participants, especially those with the highest potential for screen-failure at the screening visit. This tool is a unique advantage of the digital enrollment technique, as it saves time and effort for both the patient and the study site. 

The protocol, consent form, and questionnaire, along with all study documents, must adhere to regulatory requirements and best practice guidelines, even as guidance shifts during the current pandemic.\(^{11, 12}\) The regulatory assessment in this process also accounts for the evolving regulatory landscape for social media advertising and search engine marketing in countries of interest. This is especially important because the use of social media in clinical trials is relatively new, and developments to reporting standards and regulatory and ethical guidelines are expected.8 Appropriate adjustments are then made to adhere to specific content regulations of each country, and to maintain reasonable expectations of ethics committee (EC) and institutional review board (IRB) timelines.

Finally, the feasibility assessment, which begins during the start-up phase but continues throughout the trial, involves the assessment of site-specific digital enrollment needs. Prior to sites opening to enrollment, an initial feasibility assessment informs the specific digital marketing needs of that site for their pre-screening process. Then, as study enrollment proceeds, the feedback from their recruitment efforts is used to iterate upon the initial digital enrollment strategy, and adjust according to the site’s evolving needs. This provides a distinct advantage over the traditional approach to patient recruitment, which is not as flexible or adaptable.

Digital enrollment technique during enrollment

Once the clinical trial has opened and enrollment begins, this innovative digital strategy for patient recruitment continues. During this phase, patient awareness of the clinical trial via social media and search engines enables the patients to participate, even if their primary physician is not conducting the trial. This is not only of benefit to study enrollment, but also permits patients to access more investigative treatment options, which is especially important in diseases with few approved treatment options.

Patients are targeted with digital parameters according to the protocol criteria, such as age, demographics, and geography. Then patients can undergo digital pre-screening with the approved questionnaire, which further specifies protocol criteria, such as medical condition and lab values. When a patient completes the pre-screening and meets the criteria, they are referred to a participating study site for confirmation of eligibility, completion of informed consent, study enrollment, and then study-specific procedures. 

Working with Dokumeds for digital enrollment

The digital enrollment study activities detailed here are implemented and managed by a specialized member of the Dokumeds patient recruitment CRO team, called the Enrollment Liaison Manager (ELM). The ELM tailors the digital enrollment techniques to each specific clinical trial, and ensures their successful implementation, adjusting as needed throughout the study start-up and enrollment phases. As such, the ELM plays a pivotal role in clinical trial success, serving as the central communicator between the sponsor, the CRO, the patients, and the sites. Their role involves seeking feedback to further optimize the digital enrollment technique with the help of our partners, who provide a special environment that promotes collaboration between clinical trial sites and a clinical data aggregator.

At Dokumeds, the digital enrollment strategy is a key component of our clinical trial success and strong track record of subject recruitment success. Our ELMs contribute to our personalized approach to each project, with each sponsor. We have years of experience implementing this strategy, with different indications and different patient populations, and we look forward to applying our expertise to new clinical trial opportunities.


References

  1. https://www.clinicaltrialsarena.com/sponsored/digitalization-trends-shaping-outpatient-clinical-trials-in-2021/
  2.  https://link.springer.com/article/10.1007/s12525-019-00377-4 
  3. https://www.ich.org/
  4. https://www.fda.gov/files/medical%20devices/published/Presentation--Good-Clinical-Practice-101--An-Introduction-%28PDF-Version%29.pdf
  5. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
  6. https://gdpr.eu/compliance/ 
  7. Inan OT, Tenaerts P, Prindiville SA, et al. Digitizing clinical trials. npj Digit. Med. 2020;3:101. https://doi.org/10.1038/s41746-020-0302-y
  8. Reuter K. Social media for clinical trial recruitment: how real is the potential? EMJ Innov. 2020;4(1):34-39. 
  9. Juraschek SP, Plante TB, Charleston J, et al. Use of online recruitment strategies in a randomized trial of cancer survivors. Clin Trials. 2018;15(2):130-138. https://doi:10.1177/1740774517745829
  10. US Food and Drug Administration (FDA). Use of Electronic Informed Consent Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors. https://www.fda.gov/media/116850/download 
  11. US Food and Drug Administration (FDA). Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards. https://www.fda.gov/media/136238/download
  12. European Medicines Agency (EMA). Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic. https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf 

Tags
No items found.

FREQUENTLY ASKED QUESTIONS?

No items found.