Case Study: Managing and developing a comprehensive, successful subject recruitment campaign for a global immune-oncology study

Introduction

A large global, Phase 3 trial of an immunotherapy for patients with minimally symptomatic metastatic castrate-resistant prostate cancer (mCRPC) was failing to meet initial enrollment expectations and so a comprehensive subject recruitment plan, developed early on in the study as a proactive measure versus a rescue endeavor, was launched. The strategies, all of which had been ‘branded’, included both patient- and provider-facing tactics, web-based tactics including social media, with the call-to-action being patients, caregivers, family members, patient advocates, and healthcare providers either going to a clinical trial website or contacting a staffed call center. The prostate cancer space is somewhat unique in that both oncologists and urologists treat these patients; thus, provider-facing tactics targeted urologists, oncologists, and oncology nurse navigators. The tactics and how they were deployed are described below:

1. Patient-facing (Direct-to-Patient)

• Appointment card (for potential subjects in a site’s practice)
• Patient letter (for participating centers to send to patients in their own practice)
• "Point of Purchase" Display – acrylic display/holder for brochures that could be placed in waiting areas or consultation / examination rooms; 4 inserts (one for each of four different ethnicities)
• Patient Brochure
• Study Visit Guide
• Advertisements (both print and web-based)
• PSA Progression Tool – educational tool on the course of ‘typical’ disease progression
• PSA Flyer – debate on PSA as the best marker to use

2. Provider-facing (Direct-to-Provider)

Database searches (both medical reimbursement and prescription) combined with a multipoint ‘touch’ strategy targeting providers from searches (the search elements were based upon diagnoses or specific prescription medications but also highlighted physicians that were currently prescribing a marketed immunotherapy for patients with mCRPC).

• Letter of introduction from Sponsor
• Letter of introduction from proximal clinical trial site (sent either by the sponsor or by the site to both their existing referral network as well as relevant providers within their geographic area)
• Invitation to attend local seminar (hosted by proximal clinical trial site)
• Invitation to visit clinical trial booth at international medical congresses
• Invitation to request a copy of recent White papers or other relevant articles

Key Opinion Leader(KOL) White papers / short interviews for broadcast – KOLs that either were clinical trial sites or were well-known within the mCRPC space were asked to :

• Write white papers on topics such as immunotherapy, immune-oncology, or the sequencing of prostate cancer treatments that were then made available to both existing sites as well as the broader provider community
• Both KOLs and other clinical site investigators were interviewed on key topics and these short interviews were released on a private YouTube channel for viewing by existing site personnel

A clinical trial booth was developed for exhibition at global, regional, and local medical congresses, oncology nurse navigator congresses, and patient-centered congresses. The booth hosted printed materials as well as electronic equipment and videos that described the study and provided a site lookup function based upon postal codes.

Medical Science Liaisons (MSLs) – An international team of medical science liaisons (MSLs) was developed whose responsibilities included:

• Attending congresses where the opportunity to have a booth was not an option. Here, the MSLs would engage investigators from existing sites, KOLs, and other health care providers that might be interested in either referring patients for study participation or becoming clinical trial sites themselves.
• The MSLs also promoted study awareness within sites by scheduling one-on-one meetings with pharmacists, nurses, and other physicians within existing clinical trials sites to promote study awareness within large multispecialty practices or within large institutions.

3. Site support materials were developed to help existing sites promote study awareness by their staff and to facilitate potential subject engagement. These tools included:

• Appointment cards (for potential subjects in a site’s practice)
• Laminated inclusion / exclusion criteria cards
• Slide deck for use at internal or external presentations (grand rounds, e.g.)
• Triage flyer (to help identify qualified patients)

4. Web-based

• Clinical Trial Website (including clinical trial center search by patient zip code & International Landing Pages translated into main language(s) of countries were the study was being conducted)
• Facebook Page (can friend, like; cannot post)
• LinkedIn Page – link to oncology, urology specialty groups
• Discussion boards – discussion threads were posted and monitored; if the thread was fading, another (similar) discussion thread would be posted
• Paid keyword searches on popular search engines
• Banner advertisements on select websites and search engines
• Search engine optimization with metatags

5. Patient advocacy organization outreach

• Relationships were developed with a number of patient advocacy groups many of which had niche audiences. Several of these groups have local chapter meetings where the distribution of recruitment materials is permitted. Additionally, several groups had sponsorship opportunities available (e.g., have the clinical trial branded logo embedded into their monthly newsletter).

6. Radio / TV ads

• Both 30-second and 1-minute radio ads were developed but in two formats: one where the call-to-action was contacting the call center or the clinical trial website; the other where the local sites could input the contact information for their study coordinator or intake coordinator
• Although storyboards were developed for a TV, they were not developed for this campaign. However, short TV spots were developed locally by some sites for their local cable TV station and in these instances, the sites used the script from radio ads

Ongoing evaluation
The most ideal way to track, and thus optimize, your return on investment is to have unique URLs, ‘landing pages’, and toll-free numbers for each initiative. Landing pages are transparent to the internet user but allow monitoring of how patients are getting to the clinical trial website. When combined with subject recruitment and enrollment metrics from a traditional enrollment ‘funnel’ (screened, screen failure, enrolled, dosed), it is possible to assess which tactics are generating more screen failures versus which tactics generate more dosed subjects, for example.

Conclusions
By identifying all possible points at which a patient may enter the medical or support communities subsequent to diagnosis, it was possible to promote study awareness at the majority of those touch points between patients, family members, patient advocates, and medical providers thus greatly enhancing study enrollment. The goal of the campaign was to create a menu of options from which clinical sites could chose tactics that have a proven track record in their area; that, coupled with the centralized campaigns, facilitated entry of pre-qualified potential subjects into the top of the subject recruitment funnel.