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Recruiting patients for real-world studies – the power of a digital campaign

By Will Maier

Increasingly, real-world evidence – information gathered as a product to be used in clinical practice – helps regulators, payers, providers and patients make informed health decisions.

Research conducted outside randomised controlled trials (RCTs) can be used to monitor patient safety and measure drug utilisation
as well as to fill in evidence gaps with respect to a treatment’s value and durability.

Yet, for all their useful applications, it is difficult to enrol patients in real-world studies via traditional means. Treating physicians have other higher priorities, one of which is to recruit patients into RCTs. And, since the onset of the pandemic, fewer patients are visiting healthcare professionals in person.

Plus, there’s the need to include a representative sample of a large and diverse patient population; whereas pivotal clinical trials typically seek to enrol hundreds of patients, real-world studies often aim to enrol thousands, if not tens of thousands, of patients.

So, how can study sponsors reach such a large body of prospective study participants? One solution is to use digital channels for inbound, or ‘pull’ marketing.

Using digital media, sponsors can put relevant study opportunities in front of people based on their geography, demographics and/or interests. Because the approach is automated, it takes place around the clock, affords broad reach, which speeds enrolment timelines, and reduces start-up costs.

The basic format

Digital recruitment campaigns involve three key components that may be integrated with other tactics:
1. Search engine optimisation (SEO) is the process of using key words within a website to improve its position in results returned by search engines such as Google and Chrome. With careful SEO, a study website will appear in a higher position for patients who’ve searched for terms related to the therapeutic area and study opportunity.

2. Micro-targeted advertisements on social media platforms. Social media platforms collect a wealth of information about their users that they can use to identify characteristics, opinions and behaviour that can be used in targeted advertising.

3. Target lists created from consumer and other information databases. Particularly in the US, these databases hold a wide variety of information about individuals’ demographics, purchasing patterns, income, etc. By applying an inferential identification algorithm, it is possible to map data based on such characteristics against a probability matrix to understand the best places online to reach potential study participants.

The ads direct patients who are interested in learning more to a landing page on the study website. A carefully orchestrated pathway then ushers patients through an introduction to the study, a self-screening step, an invitation to join the study if appropriate and, finally, to an electronic consent form.

Keys to success

Although digital recruitment is a fairly new approach, it has already been well tested, and best practices around its implementation have emerged. The most successful digital campaigns: * Develop a comprehensive recruitment

strategy before the study protocol is finalised, as one will influence the other. Decisions made around the recruitment methodology could, for instance, influence the parameters of the study population.

  • Understand the volume metrics. Online recruitment leads to a very high screen failure rate, so it is important to cast a wide net; with typical enrolment rates of less than 1%, it will likely take millions of views of the study website to generate a single enrolled patient.
  • Aim for a representative sample of the patient population. This involves identifying the characteristics of subgroups that will be important for data analysis and drawing scientific conclusions. Will it be important, for example, to analyse the results by patient age and gender? If so, the recruited sample should reflect the age and gender of the patient population in the therapy area.
  • Find ways to keep patients engaged. One drawback of digital recruitment (and more broadly of real-world research) is that it can be far less personal than site-based recruitment and studies. Direct-to-patient contact teams can help to overcome that by welcoming patients to the study, providing compliance reminders and coordinating events with the treating physician.

A case in point

One company sought to conduct a natural history study of a condition, while also building a database of patients who may be interested in participating in a clinical trial in the future.

A total of 8,320,000 patients viewed the targeted online ads, 9,900 completed the online screener, 6,000 patients were eligible based on the screener, and 3,000 patients actually enrolled in the study. The study met its enrolment target in under six months.

As real-world studies gain importance, study sponsors must turn to the most efficient and cost-effective means of recruiting thousands of patients. Digital recruiting is one proven answer.

William Maier is VP, Rare Disease, Drug Development Sciences at ICON

In association with

28th July 2021

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