Informative and engaging participant materials are an important part of any clinical trial, especially during the recruitment process. Traditionally, many of those materials were produced and distributed on paper. Despite the increasingly remote conduct of clinical trials, virtual and digital participant engagement pieces have yet to be widely adopted.
Paper communications pose significant downsides: materials cannot be updated or corrected once produced, they must be physically distributed, printing and shipping is costly, and materials consume valuable resources. As the pandemic persisted, sponsors typically relying on printed materials have pivoted to digital platforms for patient communications. While it’s clear there are several environmental and economic benefits to digital communications as opposed to paper, it should be noted they can be more effective in conveying information. Thanks to the opportunities for multimedia and the use of interactive elements, digital materials can engage and capture interest in ways paper materials cannot. Additionally, in a world where telemedicine is taking hold and clinical trials are increasingly decentralized, digital communications are a must-have for researchers and healthcare providers who may never meet face-to-face with the participants they interact with. Printed materials have their uses and have served us well for many years, but it’s time to make digital communications our primary focus. With that in mind, how should we build and design these materials?
Follow the rules
Development of any content, print or digital, intended for clinical trial participants must adhere to strict ethical protocols. According to good clinical practice (GCP) guidelines:
- All information that is to be provided to enrolled/potential clinical trial participants cannot be coercive and requires review and approval by an independent ethics committee (IEC) or institutional review board (IRB)
- Any sponsor updates impacting participant materials must be made and need to be re-routed through the IEC/IRB
Ensuring compliance with these regulations is much simpler with digital communication, as updating digital source materials can be completed more efficiently, effectively, and at a fraction of the cost (both financial and environmental) of reprinting and redistributing hard copies.
Ensuring GCP in Decentralized Clinical Trial Conduct
Keep the customer satisfied
In the world of clinical trials, this translates to “keep the participant engaged.” As this 2016 study summarizes, a main factor contributing to trial efficiency and effectiveness is retaining participants throughout the study to meet sample size requirements. Effective education for potential and enrolled participants is paramount to trial success.
Keep in mind that today’s participants want to learn more, and often seek to understand the following:
- The disease studied
- The drug mechanism of action
- Trial locations
- Previous results from similar trials
When potential participants are considering your trial, it’s best to deliver these details in an engaging and accessible way. If participants do not have direct access to your informational materials, they will likely turn to internet searches and other digital or social platforms, and those may not provide factual information. Digital materials can be distributed widely – without any person-to-person contact – meaning better-informed participants before, during, and after the trial.
Make it personal
Digital delivery also provides the opportunity to personalize communications. Sponsors should not pass up this opportunity to personalize digital materials as much as possible. Consider the following regarding participants:
- Communication preferences (e.g., email, phone, text, social media, or video)
- Disease limitations
- Special needs
- Ethical guidelines
The more successful you are in aligning with the factors in this list, the more likely it is you will succeed in establishing a clear and compelling dialogue with participants.
Participants are the single most important part of clinical research. To conduct a successful study, commit to providing the information and resources they need to be informed, empowered, and appreciated, whether constrained by a global pandemic or not.