Drug development innovations not widely adopted, despite benefits: Report

The Economist Intelligence Unit (EIU) recently released the report ​– commissioned by Parexel – which evaluated four areas of innovation: Adaptive, patient-centric, precision, and real-world data clinical trials.

Per the report, the use of innovative trial types reduced patient recruitment time by at least 37% across the therapeutic areas studied, including neurology, oncology, and rare diseases.

Yet the use of innovation is low in Phase II and III trials, ranging from less than 1% for adaptive designs and real-world data trials, to 5% for patient-centric and 14% for precision medicine trials, according to the report.

“Most notably, the likelihood of launch increased for drugs developed using the innovations by 10-21% compared to drugs that did not use these innovations,”​ David Humphreys, head of health policy practice, EIU said.

“However, what is most striking is that, despite the positive impact of these innovations on important measures of drug development and market access, adoption rates remain surprisingly low,” ​he told Outsourcing-Pharma.com.

Alberto Grignolo, PhD, corporate vice president, Parexel, said the culmination of the research is a call to action for industry stakeholders, and others, to foster an environment in which the benefits of these innovations can be realized.

“As drug development continues to grow in complexity and expense, raising questions about the sustainability of the industry, the research findings provide hard evidence that these innovations can improve productivity in drug development, increase likelihood of launch and improve patient access to medicines,”​ Grignolo told us.

However, the existence of vast amounts of patient data residing in separate, disparate, and unconnected systems that do not communicate is a significant challenge standing in the way of creating an environment ripe for change, he explained.

“This lack of system interoperability is a brake on innovation and on a better understanding of disease, how to treat it and how to improve patient access to and compliance with medications,” ​Grignolo added. “Connecting these silos is now imperative.”​

Additionally, Grignolo noted that there aren’t enough professionals trained in health data sciences, a field in which the need for talent will increase exponentially with the advent of big data, and hopefully, health data system interoperability.

“Industry and academia can partner to educate and train this fundamental workforce of tomorrow,”​ he added, “because tomorrow is here today.”​

Eroom’s Law ​

The failure rate of drug development is as high as 90% and the average time to market – which has not decreased in the last three decades – is around 12 years. This, as costs continue to increase.

Eroom’s Law personifies this trend and is the observation that the cost of drug discovery and development doubles every nine years, explained Humphreys, who said it is critical that the industry adopt new, innovative approaches.

“That said, responsibility lies with all stakeholders, both inside and outside the industry, to overcome the barriers that have prevented leveraging these innovations, including the staggering amount of new and fragmented data available today, an inadequately trained workforce, negative perceptions of pharma’s approach to innovation among payers and patients, and cultural barriers surrounding drug development and innovation,”​ he added.

“The ecosystem will not change without a sense of urgency and collective action from the industry and relevant stakeholders such as regulators, payers, patients, and academia.”​