Patient Recruitment Case Study: Bladder Cancer

A phase 2 clinical trial evaluating TAR-200 in combination with cetrelimab for muscle-invasive bladder cancer

THE CLINICAL TRIAL
Bladder cancer is the tenth most common malignancy worldwide. Approximately 25% of all new bladder cancer participants present with muscle invasive bladder cancer (MIBC) at the time of diagnosis, and roughly 50% will ultimately develop distant metastases. The SunRISe Clinical Trials was a suite of three clinical studies anti-tumor effects of TAR-200 – an intravesical drug delivery system – in combination with intravenous (IV) cetrelimab and IV cetrelimab alone.

THE PROJECT
The Sponsor set out to establish a global brand identity for the suite of SunRISe Studies and enlisted the patient recruitment team at Stark / Raving Health to deliver. The program included four unique global clinical studies, each with specific criteria for both study participants and clinical teams. Our approach emphasized the significance of inclusivity, striving to represent a diverse patient population and providing accessible information across a range of study materials to assist patient in their clinical trial journey.

Clinical trial for bladder cancer patient recruitment branding

Streamlining processes to deliver a large-scale clinical study.

To guarantee prompt and precise delivery of patient and site-facing materials, the extensive scope and scale of this project required thorough upfront planning. Before initiating the development of creative concepts, our project management team partnered with the CRO to formulate a comprehensive plan that considered every aspect of study material development, review cycles, IRB/EC approvals, translations, printing, and distribution. Setting up this process at the project’s outset ensured agreement on roles and responsibilities among all parties involved.

Clinical trial for bladder cancer patient recruitment project management

SunRISe Clinical Trial Study Content Development

Creating a brand identity system to support multiple clinical trials.

Our primary focus was to develop a robust umbrella brand identity that could stand alone and adapt easily to encompass three different clinical studies. To achieve this, we concentrated on establishing a comprehensive set of brand standards that outlined how the visual identity would transform with the activation of each study. These standards encompassed all visual elements such as the logo, color, and photography, along with a defined messaging strategy for each individual study.

Developing patient-friendly content focused on health literacy.

The SunRISe studies shared a common trait – a complex study design that presented daunting requirements to the study participants. Our content development team tackled this challenge by devising a messaging strategy and matrix for each study, ensuring that the content created for the study materials matched the precise requirements of each protocol. The team also simplified the complex information into easy-to-understand language to empower study participants with the necessary knowledge without feeling intimidated. This approach facilitated the team’s ability to make quick adjustments to the study materials in response to multiple protocol amendments.

Clinical trial for bladder cancer patient recruitment content creation

SunRISe Clinical Trial Study branding and Content Development

Adding safeguards with version control and document management.

Like all studies, the SunRISe studies underwent protocol amendments over a two-year period. These changes necessitated significant updates to the study content. Our content and production teams implemented strict version controls and document management processes to facilitate easy tracking, review, and approval of revisions. In addition, study sites received updated study materials that replaced previous versions, which they could discard with ease.