When the COVID-19 pandemic threatened to entirely disrupt clinical trials, decentralized clinical trials (DCT) and direct-to-patient (DTP) models were quickly adopted as a solution. DTP models present opportunities to increase patient convenience and engagement and to simplify recruitment and retention, particularly for rare diseases affecting small, geographically dispersed populations.
Successful execution of DCTs require telemedicine, mobile/local healthcare providers, and other processes and technologies that differ from the traditional clinical trial model, as well as the DTP provision of clinical trials materials — including the IMP, comparator drugs, and ancillary supplies.
In this webinar, Yourway discusses the growth of DCT/DTP trials and the lessons learned through their early implementation — before and during the pandemic. Particular emphasis is placed on the complexity of the logistics underlying DTP trials.
One significant hurdle is the complexity of the logistics necessary to provide DTP services, a challenge only exacerbated by the temperature-control requirements for the storage and DTP transport of biologic drugs, vaccines, and cell therapies, as well as the direct-from-patient (DFP) transport of patient samples and other biological materials. Layered on top of that complex clinical supply chain for individual clinical trials materials is the need for comprehensive choreography of a variety of supplies to ensure that everything arrives at the patient’s home in the correct sequence. DTP trials additionally require unique approaches to elements of clinical trials practice like study blinding.
The presenter will discuss all of the above considerations and more, as well as solutions that have been developed to overcome these challenges, culminating in a set of recommendations and best practices for developing overall clinical strategies and designing efficient, effective, and patient-centric DTP clinical trials.
This will include insights pertinent to pharmaceutical sponsor companies, clinical service organizations, regulators, and patients. DCTs present a paradigm shift and an inversion of the conventions that have historically governed clinical trials. As such, sponsor companies planning to begin pursuing DTP trials, as well as those who are currently running DTP trials but are seeking ways to maximize their efficiency and success, will find a lot to learn in this presentation from experts who are deeply experienced in the nuances of these approaches.
Register to learn more about the benefits, challenges, solutions, and strategies for running effective DCTs using DTP/DFP operations.
Key Learning Objectives
- Understand the range of benefits of DCTs
- Gain an appreciation for the logistical complexities of DTP operations
- Learn best practices for optimizing DTP
- Understand how to design your own studies to make the best use of DTP
Target Audience
- C-Suite Level
- Directors (Supply Chain, Procurement, Product, Operations, Business Development, CRO)
- Managers (Procurement, Clinical Trial Management)
- Regulatory/Quality Assurance Specialist
