Most clinical researchers are motivated by the desire to improve patient health and drive innovation in healthcare. To optimize health system performance, Bodenheimer and Sinsky, building on the work of Donald Berwick, proposed the quadruple aim as a means to improve health system performance. The quadruple aim focuses on (1) enhancing the patient experience, (2) improving population health, (3) reducing costs, and (4) improving the work life of health care providers, including clinicians and staff. Clinical research should follow the quadruple aim to improve the design and conduct of clinical trials. To achieve these goals, first step is to engage the correct stakeholders during project development and implementation – the subjects and the sites.
Subject Engagement
The Belmont Report, in 1974, identified three basic principles that support the ethical conduct of research involving human subjects: respect of persons, beneficence, and justice. To implement these principles, clinical researchers must include subjects in study planning and ensure that studies are designed to measure outcomes that are most important to the subjects. Implementing a subject-centric approach extends well beyond study design to considering how to ease the burden on the subject during participation and how to effectively communicate with subjects throughout the project lifecycle. A 2018 report by The Economist Intelligence Unit suggests that trials that make participation as convenient as possible for subjects were 20% more likely to be launched compared to trials that did not (87% compared to 68%). Additionally, subject-centric trials took less time to recruit 100 participants (4 months), compared to other trials (7 months).
Site Engagement
Sites are also key stakeholders in the design and implementation of clinical trials. Investigative sites are busy, and most have limited resources. Taking the time, at the start of the study, to understand the site process, resources, and limitations is critical to developing support strategies for the site. One example could be asking site data entry teams if they tend to enter data for the trial on a specific day of the week. If so, setting a reminder to send the Data Entry and Query Resolution Reports on the same day will help the site staff enter data efficiently. Another example is including sites in reviewing drafts of manuals and protocol amendments. As subject matter experts, sites have extremely valuable feedback to share with Sponsors and CROs about lessons they have learned. My experience has been that they want to be included in conversations about study planning.
Summary
Adopting the quadruple aim as a framework for optimizing clinical trial operations will ultimately improve the health and lives of patients. Including subjects and sites as key stakeholders is key to effective design and implementation of clinical trials. At PROMETRIKA, we have designed a flexible process that incorporates the efficiencies we learn from our sites and subjects and keeps subject safety at the forefront. Our goal is to work collaboratively with our Sponsors to engage subjects and sites, reducing the costs and shortening the timelines of clinical trials.
References
- Berwick DM, Nolan TW, Whittington K. The Triple Aim: Care, health, and cost. Health Affairs. 2008 May/June; 27(3):759-769.
- Bodenheimer T, Sinsky C. From triple to quadruple aim: care of the patient requires care of the provider. Ann Fam Med. 2014;12(6):573-576. doi:10.1370/afm.1713
- The Economist Intelligence Unit. 2018. The innovation imperative: the future of drug development. https://druginnovation.eiu.com
