Innovations in drug development positively impact clinical trials and market launches

New innovations in drug development have a positive impact on clinical trial timelines, likelihood of market launch and inclusion on payer formularies, according to a new report released by the Economist Intelligence Unit (EIU) and commissioned by PAREXEL.

“Drug development has become increasingly complex and more expensive over time. In an industry where failure rate can be as high as 90% and the average time to market for a drug has hovered around 12 years for the past three decades, the need to innovate is paramount,” revealed David Humphreys, head of Health Policy for the EIU and lead author on the research report. “With this research, we aimed to quantify, for the first time, how the industry can use innovations in drug development and market access to improve efficiency, rekindle productivity and restore sustainability.”

The Innovation Imperative: The Future of Drug Development has resulted from research conducted by the EIU into identifying the most effective innovations in drug development as well as market access. Additionally, they analysed the impact these innovations had on the market against key industry success criteria using clinical trial data and other sources in the United States, the European Union, China and Japan.

Based on their research, it was found that a market launch was 13% higher for drugs developed using adaptive trials, 19% higher for patient centric trials, 10% higher for precision medicine trials and 21% higher for trials using real-world data. Furthermore, the research showed that drugs in key therapeutic areas — neurology, oncology and rare diseases — developed with these innovations, were more likely to reach market launch, with chances increasing by 16% on average. This impact was found to be largest in oncology where innovation drugs had 33% higher likelihood of launch.

Improvements in trial efficiency were also seen when innovations were adopted, with patient recruitment time reduced by at least 37% for the therapeutic areas studied. Eight major payer formularies were also evaluated by the EIU, which found that drugs approved in 2015–2017 and developed using one or more of the selected innovations were more likely to have achieved formulary inclusion by 2018.

However, the research also pointed to low use of these innovations as a result of systemic and cultural hurdles. So, despite the positive impact these innovations have use in Phase II and III trials were low, ranging from less than one percent for adaptive designs and real-world data trials to five percent for patient-centric and 14% for precision medicine trials.

“The most striking finding was that the adoption rates for these four innovations — all of which can have a measurable impact on trial efficiency, likelihood of launch and inclusion in formularies — were surprisingly low,” commented Alberto Grignolo, PhD, corporate vice president, PAREXEL. “The research demonstrated various barriers to adoption, including silos that have traditionally divided competitors, payers, patients and regulators. This is a call to action for the industry and other stakeholders to collaborate now and find creative ways to adapt our organisations, behaviours and systems to foster a more fertile environment for innovation.”