Improving clinical trials: A virtual solution to a challenging reality | Deloitte UK has been saved
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Pharmaceutical companies face a very real and immediate challenge to achieve sustainable Research and Development (R&D) models and produce affordable treatments. The rising cost of drug development, highlighted in Deloitte’s return on pharmaceutical innovation research, is a key part of this challenge which could be addressed through transforming the way clinical trials are conducted.
Clinical trials are the most expensive and time consuming part of drug development, indeed Phase III trials alone are estimated to account for over 90 per cent of total development cost. The current approach involves patients traveling considerable distances to study sites for treatment and ongoing monitoring activities.
This approach to clinical trials, established over 65 years ago to develop a drug for tuberculosis, has remained largely the same. As a result there has been limited response to recent developments in science, technology and the rising expectations of patients, payers and regulators. The aforementioned developments are either drivers of increasing cost, for example the extra effort needed to demonstrate drug value to payers on top of clinical-effectiveness, or opportunities to become more cost effective. A ‘virtual clinical trial’ methodology represents one of these opportunities.
The concept of a virtual clinical trial uses electronic health records and mobile health technology (apps, monitoring devices etc) to conduct each stage of a clinical trial, from patient identification and recruitment, through to measuring clinical endpoints and adverse reactions, from the comfort of a patient’s own home. Key benefits include:
While there has been interest from pharmaceutical companies to adopt a 100 per cent virtual trial methodology, in reality there has been limited progress. Largely because it involves: radical changes in procedures; a reliance on unfamiliar technology; and a flexible regulatory environment. A more realistic expectation is the gradual decentralisation of trial activities in which a single study centre is responsible for oversight, receiving and storing data and distribution of drugs to patients. The centre would then collaborate with multiple trusted health services and health care practitioners local to the trial’s subjects to administer treatment and monitor progress. Telehealth could also provide a direct link to the trial subjects when necessary. Decentralisation however, has its own significant challenges:
A high risk, high reward approach would be to apply a decentralised methodology to the most costly development phase of clinical trials – Phase III. However, this may also be the most difficult phase to implement due to large patient populations and complex trial design. A lower risk, lower reward approach would be to apply a decentralised methodology when expanding indications for existing products, where safety profiles are well understood or in Phase II trials, which contain fewer subjects and are less complex than Phase III. This would speed up the go/ no-go decision and therefore, the critical path of the drug development process.
Whichever approach is chosen pharmaceutical companies, and third party contractors involved in running clinical trials, need to gain experience with virtual methodologies to help tackle the complexities and cost of drug development.
Karen is the Research Director of the Centre for Health Solutions. She supports the Healthcare and Life Sciences practice by driving independent and objective business research and analysis into key industry challenges and associated solutions; generating evidence based insights and points of view on issues from pharmaceuticals and technology innovation to healthcare management and reform. Karen also produces a weekly blog on topical issues facing the healthcare and life science industries.