Digital Clinical Trials: A Multi-Stakeholder Analysis of the Challenges and Opportunities
As one evaluates the many challenges of the US health care system, it is important to note that drug development within the pharmaceutical industry has not markedly changed in the past three decades. The lack of progress has a direct impact on patients, as medicines and vaccines that could provide improved quality of life or cures for patients, are delayed. According to the Tufts Center for Drug Development the cost to bring a drug to market is estimated to be over $2 billion dollars. The drug development process takes 12-15 years, with little efficiency improvement over time. (Terjesen 2015) As pharmaceuticals represent between 10-15% percent of the total health care cost, any efficiencies in the drug development process may offer an opportunity to accelerate treatments or cures to patients, while also lowering pharmaceutical company operating costs which can offer opportunities for lower pricing to patients, governments and health care systems. Given the intense pressure on pharmaceutical company pricing in the US, there is a business imperative to explore any opportunities to change the current research model. Employing digital technology into drug development may be an enabler to the current drug development process. This paper will explore the challenges and opportunities of digital clinical trials from the perspective of the key stakeholders, patients, regulators, pharmaceutical companies, insurers, investigators and technology companies. Currently digital clinical trials have not been fully adopted by the stakeholders. However, it is important to note the momentum that is building due to the rapid acceleration of technology that is coupled with the strong case for change. There is an opportunity for the stakeholders outlined in this paper to collaborate, learn and develop a consistent approach that can serve as a modern model for drug development designed to better meet patient and societal needs.
Recommended CitationNissen, Janice and Kaminski, MD, MBA, Mitchell, "Digital Clinical Trials: A Multi-Stakeholder Analysis of the Challenges and Opportunities" (2019). Master of Population Health Program Thesis and Capstone Presentation. Presentation 2.