Leveraging Print and Digital Communications for Patient-Centered Clinical Trials

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One of the strongest trends in clinical trials is patient orientation, that is, making the patient experience as easy and accessible as possible. At the height of the COVID-19 pandemic, this has become even more important due to limitations placed on patients visiting clinics and health facilities for elective care. This has led to an increase in decentralized clinical trials (DCT),1 where part or all of a trial has been conducted outside of a trial site via telehealth visits, remote monitors / sensors, patient reported results, and 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, text, web portals and more.

Communicate with patients the way they prefer

Not all clinical trials, due to the types of diseases studied, can be fully decentralized. Trials that use a combination of clinic visits and sensors and telehealth are called hybrids. In all cases, the goal is to make participation, including communication, as convenient as possible for the patient. And that means using whatever method of communication they prefer, and often multi-channel approaches.

Strategic use of print communications

At all phases of drug development, from preclinical to post-approval and marketing, there is a significant need for dynamic communications internally and externally. Although digital is a fad, there is still a great need for dynamic and flexible print communications.

John Sullivan, National Account Manager at FedEx Office, said: “For example, a biopharmaceutical customer wants to target a specific group. Once the customer’s message is refined, we can create, for example, a direct mail where we can develop an image and a message on each piece of mail and have that delivered to a target of one. “

For example: providing patient recruitment materials to a specific demographic audience. Sullivan noted that FedEx Office can search postal codes and demographics and target documents for delivery not only to a particular postal code, but also to specific audiences in those regions. “We are researching where these people are likely to reside in what zip codes and what density. The shipments are then sent to those specific areas.”

Expertise of the communication editor in the generation of regulated documents

If patients are to complete documents, whether on paper or online, they must be accurate, compliant and secure. FedEx Office has technology with centralized and secure platforms for compliant printing.

Kevin Kaiser, National Account Manager at FedEx Office, said: “FedEx Office has solutions in place to manage the compliance of your print communications, including a suite of customizable cloud-based products designed to ensure compliance. content management. This intuitive website management-based interface handles all communications to customers, including automated marketing, print-on-demand, download-to-print, customer reports, and ordering of pre-printed documents and stored. – Approved content, templates and themes that meet brand identity standards. The system also allows the creation of personalized reports. “

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 hosted and captured in the platform. Materials are, in essence, examined by the system, and data is flagged as it should or shouldn’t 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, has adopted ICH E5, Ethnic factors in the acceptability of foreign clinical data. Until 2019, China has done the same, although since July 2019 it has been evaluating the data to determine whether it meets various criteria for ethnic sensitivity. If it does not meet these 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 with the FedEx platform, providing white glove solutions for the last mile to ensure that your communications media are available for your trial by leveraging the FedEx logistics network. There are specific healthcare and pharmaceutical sectors within our network that specialize in transferring information in a very secure manner and we have developed specialized workflows for this. You can safely say that we get the documents where they need to be and as quickly as possible. “

Before the COVID-19 pandemic, biopharmaceutical companies were pushing towards patient-centric clinical trials, particularly with DCT and hybrid studies. The pandemic has accelerated an existing trend. According to a McKinsey & Company report,3 By mid-2021, remote participant interactions are expected to triple in the coming years. The demand for communicating and reaching trial participants where they live in the most convenient and efficient way is increasing daily and having a dynamic printing solution can help to achieve this.

To learn more about how FedEx Office can help your business communicate important messages through print, visit fedex.com/businesssolutions today.


The references

  1. “Practical Approaches to Operationalize Decentralized Clinical Trials.” BioPharma diving. August 5, 2021. https://www.biopharmadive.com/spons/practical-approaches-to-operationalizing-decentralized-clinical-trials/604513/

  2. Bancroft, C. “Meeting the Requirements for Clinical Trial Data in Asian Markets.” Clinical Manager. 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. “Nothing better than being at home? Speeding 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


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