The evolving healthcare landscape and what it means for the future of clinical trials
By: Jeanne Hecht, MBA, PMP | January 12, 2016
Clinical trial participation can be a strongly positive influence on patient care, as highlighted by a recent white paper. According to the paper, in addition to improving health, excellent patient experiences of clinical research can improve population health, develop patient advocates for research, and boost trial effectiveness, efficiency and cost management.
These benefits are much needed in today’s changing healthcare landscape. By 2020, for example, an estimated 80% of U.S. physicians will be employed by healthcare systems. There is increasingly active engagement of consumers in their healthcare, through population health management and Accountable Care Organizations (ACOs) that shift risk to providers, along with high-deductible health plans and Health Savings Accounts shifting risk to patients. Also, in January 2015, several of the nation's largest health systems and insurers set up the Health Care Transformation Task Force with the goal of shifting 75% of their business to contracts with incentives for quality and lower-cost healthcare by January 2020. Value-based delivery and payment systems must be designed to deliver the ‘triple aim’ of improving the patient experience of care, improving population health and reducing the per-capita cost of healthcare, according to the group’s website.
Despite the clear benefits of clinical research, the growth in the number of unique principal investigators is starting to slow down: the most recent four-year annual growth rate was 3.3% compared with the prior four-year period of 4.1% and an average of 5.6% over the last 15 years, according to 2015 findings from the Tufts Center for the Study of Drug Development. Furthermore, the average clinical trial site start-up costs an estimated $25,000, pointing to an urgent need to reduce the financial burden for investigators and sites.
Technology is playing a vital role toward providing cost-effective alternatives when conducting clinical research. More than 50% of office-based physicians are currently using an Electronic Health Record (EHR) system, up from some 35% in 2007. Increasingly, sponsors and CROs are increasingly looking to move their clinical trials into settings that have the infrastructure and support of EHRs, with their promise of enabling sharing of data, demonstrating value in evidence-based medicine, improving outcomes and reducing costs. Some 89% of healthcare executives expect telemedicine to transform the United States’ healthcare system over the next decade. Added to this, 20% of clinicians use two or more social media sites for personal and professional use.
Against this backdrop, delegates at the Site Vision Forum (Charlotte, NC; October 29-30), including representatives from Quintiles and its Partner and Prime Sites, identified four key themes for the future of clinical research participation:
Clinical Research Participation as a Care Option: Driving Patient Experience and Satisfaction: Clinical research participation offers an innovative care option, which engages patients in their own healthcare, benefiting all stakeholders. This approach can support the goals of the “triple aim” to improve both the patient experience of care and population health, while reducing the per-capita cost of healthcare. Looking ahead, clinical research should take a well-deserved place on the value agenda in the U.S. healthcare system.
EHRs in Clinical Research: Present achievements, future promise: Electronic Health Records (EHRs) are central to performance improvement initiatives, with potential to unlock insights from patient data, demonstrate value in evidence-based medicine, improve outcomes and reduce costs. There continue to be challenges, including flexibility and interoperability, to adapt EHRs to clinical trial needs. In promising steps forward, EHR data has been used successfully to pre-identify pediatric autism and ovarian cancer patients for inclusion in clinical trials, and to link evidence-based medicine with improved outcomes in heart failure patients.
Leveraging Telemedicine to Modernize Clinical Drug Development: A ‘digital tsunami’ has modernized banking, financing and entertainment, allowing entry of unexpected and non-traditional competitors. And the same mobile technologies that transformed these industries are beginning to transform the delivery of clinical care. Telemedicine, for example, is improving patient access to clinical care while bending the cost curve. With the ubiquity of mobile devices (i.e., approximately 2 billion smart phones globally) and new software platforms, there is an opportunity to innovate clinical drug development. Mobile technologies such as a telemedicine allow for greater reach into new patient populations and can greatly decrease the burden of subjects and their families associated with trial participation.
As we have seen in other industries, mobile technologies and platforms are disruptive, forcing reinvention of business models. Clinical research teams should aim to “think like a software company” to optimize site capabilities.
Social Media: The Evolving Impact on Clinical Trials: Social media may have negative as well as positive impacts on clinical research. Although helpful in recruitment and retention, awareness and education of clinical trial patients and online sharing of participants’ experiences – including clinical data and side effects – is causing concern due to risks to patient safety and safety reporting, and because of potential for unblinding and bias. Decisions on how to protect against such impacts will need to be made on a case-by-case basis.