The recent Outsourcing Southeast conference in RTP, NC highlighted one of the hot topics currently buzzing in the pharmaceutical industry, i.e., the need to define and implement a more patient-centric model of clinical trials.
The concept of patient-centricity in the drug development world consists of several basic struts:
- Engage subjects/advocacy groups as partners in the process
- Develop protocols, processes, and systems that are maximally user-friendly (i.e., long on feasibility, convenience, and common sense)
- Put patient interests and point of view on equal footing with corporate research objectives
It is generally accepted that the new model can lead to improved subject recruitment, subject retention, and overall compliance with study goals. It is also expected that study results will better reflect Real World Evidence (RWE) related to the disease of interest and its treatments.
This new perspective being embraced by Sponsors raises many questions of implementation, including those relating to vendors. Specifically, how will the concept of patient-centricity apply to certain suppliers – for instance, an Interactive Response Technology (IRT/IWR/IVR) provider?
Presenter Greg Hottell, Director, Supply Chain Group Lead at GSK, suggests that encouraging patient-centricity should logically include:
- Selecting vendors who are patient-centric in their approach so that your trial design is effectively implemented
- Harnessing new technologies to maximize the relationship between investigator and patient to improve reporting and reduce dropout rates
Hottell sees the most near-term promise in the following cultural changes:
- Patient Advisory Panels
- Patient Group input to protocols, consent, and feasibility
- Direct-to-Patient clinical supplies & home nursing support
- Patient wearable devices
- Smart Phone Apps
All but the first constitute potential pathways of change for classic IRT paradigms:
- ‘Feasibility’ suggests finding new ways to enhance the user-friendliness and intuitive operation of IRT systems as they relate to diaries or other electronic Patient Reported Outcome (ePRO) mechanics – and to do so in concert with user advisors rather than presuming what the user might want or need
- IRT developers should consider ways to expand support for direct-to-patient shipping and scheduled/unscheduled resupply paradigms, adding new levels of sophistication to current offerings, including no-clinic-visit scenarios
- IRT systems should expand utilization of patient compliance data in real time, including complex alerts that help reveal or abort potential problems with patient IP usage for at-home subjects, from study start through to study end
- IRTs should provide expanded integration options, addressing a broad range of devices and wearable applications, including but not limited to smart phones
Some visionaries see more dramatic modifications: for example, coordination between patient-centricity and the growing desire in the industry for more real-world-evidence of drug performance. Such coordination could cast the classic model of randomized clinical trials in a whole new light, even, conceivably, having it take a back seat to enhanced open label investigations. This is an exciting time for clinical trials!
Share this Post