Industry Trend: Patient-Centered Medicine

Patient-Centered Medicine

The gradual industry-wide shift towards decentralized medicine paints an optimistic picture for the future of clinical research. Optimistic because the drivers of change are firmly grounded in the improvement of a patient’s experience in medicine. The incentives of faster patient recruitment, better retention, more diverse patient populations, and better capability to explore rare conditions are all aligned with the goal of making participation in medical research as accessible and as human an experience as possible. As it turns out, designing the experience of clinical research around that of the patients and doctors nearest to the point of care, may drive the entire system to run faster, more efficiently, and with better outcomes for the patients involved.

No matter what touchpoint of eClinical applications you examine, there is a fresh focus on device compatibility, and mobile capabilities. This push for wearable sensors and applications that can be run from mobile devices is all focused on bringing the point of care to the patient’s home. Most patients live more than 2 hours from a research site and often, those involved in trials are ill and struggle to make appointments for site visits. Focusing on reducing or eliminating the burden to patients is driving these inconveniences out with the power and assistance of newer, more networked technologies.

As we’ve experimented more with this structure of clinical care, we’ve found that some patients simply prefer not to go to clinics in person. Video conferencing tools are enabling these patients also to receive care and participate in research in new ways that are more accommodating to their lifestyles and needs. 85% of trials fail to retain enough patients. Keeping patients happy, comfortable, and cared for is one of the most critical challenges for the success of clinical research, and the industry is responding. 

Decentralized Clinical Trials

Although Decentralized Clinical Trials (DCT) may seem like a newly popular buzzword, the process of decentralization has been a steady progression in the clinical trial industry for some time now. As early as the 1980s large pharma companies were highly centralized, outsourcing some of their operations to contractors, that now, we would call CROs. Today, the decentralization trend has expanded to include a specialized industry of CROs with diverse areas of expertise and extensive experience in therapeutic domains. Their demand for tools helped create what we know today as the EDC, CTMS, eTMF, ePRO and many others. The operational layer of the clinical trial is fairly decentralized at this point and is quite effective in its operations.

The upcoming frontier in clinical research involves placing more emphasis on the clinic and the patient. A significant challenge in clinical research is the difficulty in consistently locating patients and doctors who are willing to dedicate their time to participate in such studies. This has led to a greater focus on identifying the specific tools and services that both patients and doctors require to enhance their experience in clinical research, particularly in a setting where a majority of the information is derived from devices and patients themselves.

Some Changes to Trial Conduct

• With fewer on-site visits, some trials are exploring ways to have clinical supply delivered directly to patient’s homes. 

• Virtual visits allow physicians to see many more patients that may not be able to make that 2 hour drive, and provide a good standard of care when doing so. 

• Real-time eSource data is enabling more efficient and responsive interactions with sites and patients, also enabling strategies like remote monitoring, and risk-based monitoring.

• The concept of ePRO is pushing the development of specialized, patient-facing interfaces to healthcare and clinical research.

• There is growing interest in optimizing the experience of the clinical research site through tailored interfaces. 

This is also driving us to look, with more attention, at interoperability with electronic medical records, in an attempt to bridge the gap between the hospital or the clinic, and the central (or virtual) site where clinical events and data are managed.

Decentralized Clinical Industry

The last noteworthy aspect to consider is the broadening trend of decentralization across the industry. Currently, a large percentage of clinical research is conducted within a limited geographical area. This is due, in part, to the necessity for a stable regulatory environment and access to sites and patient populations with the relevant medical condition under investigation. Many countries are investing in establishing reliable regulatory framework for clinical research; some are developing fast track programs and tax incentives, encouraging the development of clinical research. Nonetheless, there are obstacles such as offline ePRO data collection and developing multilingual applications, which technology is currently actively working on resolving. Decentralization at this level promises to make medicine more inclusive, globally. A previous blog on the Value of Diversity in Clinical Research, can be read here. Just as prioritizing the well-being and convenience of patients contributes to the advancement of the clinical research industry, enhancing the accessibility for people worldwide to discover and take part in the latest medical research will ultimately benefit society as a whole.