One of the strongest trends in clinical trials is patient centricity, which is to say, making the patient experience as easy and accessible as possible. During the height of the COVID-19 pandemic, this became even more of a focus because of limitations on patients visiting clinics and healthcare institutions for non-urgent care. This led to an increase in decentralized clinical trials (DCT),¹ where some or all of a trial was conducted outside a trial site via telehealth visits, remote monitors/sensors, patient-reported outcomes, and in-home visits. The trend has continued and emphasizes the importance of communicating with patients effectively and efficiently using a variety of modes, including print, email, texts, web-based portals, and more.
Communicating With Patients in Their Preferred Way
Not all clinical trials, because of the types of diseases being studied, can be fully decentralized. Trials that use a mix of clinic visits and sensors and telehealth are referred to as hybrids. Either way, the focus is to make participation — including communication — as convenient to the patient as possible. And that means using whatever method of communication they prefer, and often multichannel approaches.
Strategic Use of Print Communications
Through all phases of drug development, from preclinical through post-approval and marketing, there is a strong need for dynamic communications internally and externally. Although digital is one mode, there is still a significant need for dynamic, flexible print communications.
John Sullivan, national account manager at FedEx Office, said, “For example, a biopharma client wants to target a specific group. Once the messaging from the client is refined, we can create, for example, direct mail where we can develop a different image and message on each piece of mail and have that delivered to a target of one.”
For example: delivering patient-recruitment materials to a specific demographic audience. Sullivan noted that FedEx Office can search zip codes and demographic data and target materials for delivery not just to a particular zip code but also to specific audiences within those regions. “We’re searching out where those people are likely to reside in what zip codes and what density. The mailings are then going out to those specific areas.”
Communication Vendor’s Expertise in Regulated Document Generation
If patients need to fill out paperwork, whether in print or online, it needs to be accurate, compliant, and secure. FedEx Office has technology with centralized, secure platforms for compliant printing.
Kevin Kaiser, national account manager with FedEx Office, said, “FedEx Office has solutions in place to manage compliance for your print communications, including a cloud-based, customizable suite of products designed to help ensure compliance for content management. This intuitive web-based interface manages all customer-facing communications, including automated marketing, print-on-demand, upload-to-print, client reporting, and ordering pre-printed, warehoused documents. Through this portal, our customers can create documents by selecting from pre-approved content, templates, and themes that adhere to brand identity standards. The system also allows for custom reporting as well.”
Sullivan added, “A lot of compliance information goes into these materials, or even more importantly, there are things that are not allowed to go into some of these materials that are all housed and captured within the platform. The materials are, in essence, reviewed by the system, and data is flagged that should or should not be there.”
Regional and International Considerations
Drug development and clinical trials are rarely limited to local sites. And in fact, many countries require clinical trials to be conducted in their populations before a drug can be approved in that country.² Japan, for example, adopted ICH E5, Ethnic Factors in the Acceptability of Foreign Clinical Data. Until 2019, China did as well, although, since July 2019, it evaluates the data to determine if it meets various criteria for ethnic sensitivity. If it doesn’t meet those criteria, it may require additional data from Chinese trial participants.
And, of course, different countries have different regulatory bodies and requirements for clinical trials. Kaiser noted, “FedEx Office is fully integrated within the FedEx platform, providing final mile, white glove solutions to ensure your communication materials are available for your trial by leveraging the FedEx logistics network. There are specific healthcare and pharma sectors within our network that specialize in moving information in a very secure fashion, and we have developed specialized workflows for it. You can safely say we get the materials where they need to be and as quickly as possible.”
Before the COVID-19 pandemic, biopharma companies were pushing toward patient-centric clinical trials, particularly with DCT and hybrid studies. The pandemic accelerated an existing trend. According to a report by McKinsey & Company,³ in mid-2021, remote participant interactions are expected to increase threefold in the coming years. The demand for communicating and reaching trial participants where they live in the most convenient and effective fashion is growing daily, and having a dynamic print solution can help make that happen.
To learn more about how FedEx Office can help your business communicate important messages through print, visit fedex.com/businesssolutions today.
1. “Practical approaches to operationalizing decentralized clinical trials.” BioPharma Dive. August 5, 2021. https://www.biopharmadive.com/spons/practical-approaches-to-operationalizing-decentralized-clinical-trials/604513/
2. Bancroft, C. “Meeting Clinical Trial Data Requirements in Asian Markets.” Clinical Leader. January 3, 2020. https://www.clinicalleader.com/doc/meeting-clinical-trial-data-requirements-in-asian-markets-0001
3. Agrawal, G.; R. Moss; R. Raschke; et al. “No place like home? Stepping up the decentralization of clinical trials.” McKinsey & Company. June 10, 2021. https://www.mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials