Drugs developed using patient-centric clinical trials are more likely to reach the market and more quickly adopted by payers, a new study reveals
Developing innovative medicines is becoming more difficult and more expensive, according to industry experts, with R&D costs estimated to have doubled between 2003 and 2016. It can take 12 years to bring a new drug to market, at a cost of around $2.6 billion – and rising.
A new report by the Economist Intelligence Unit (EIU) on the future of drug development set out to identify game-changing ways to rethink the current system. Entitled The Innovation Imperative and commissioned by Parexel, a life sciences consulting firm and biopharmaceutical services provider, it delved into how medicines are invented, tested, regulated and paid for, in search of a more sustainable path forward.
‘We cannot carry on doing the same thing and expecting different results,’ says Rosamund Round, Director of Parexel’s Patient Innovation Center. ‘We must think about how we can do things differently and ensure that these innovations are adopted.’
The report’s findings on patient-centric trials are startling. Looking at potential medicines in phase II and III clinical studies, researchers found that trials designed with patients were more likely to be launched. In fact, on average there was a 19 percentage-point difference in the chances of making it to market for patient-focused studies.
Better still, these trials had higher enrolment levels (533 vs 271) and shorter recruitment times (4 months vs 7 months for the first 100 participants). This allowed more time to be spent on treatment and wiped months off late-stage trials, which can be lengthy and costly.
For products approved by regulators, the road to reimbursement was also shorter, as drugs developed through patient-centric trials were adopted more quickly by payers.
Patient-centric trials were most common in oncology in the US, EU, China and Japan (41%), whereas neurology (CNS) was the leading therapy area for patient-centric trials elsewhere (27%).
The findings have understandably triggered significant interest from patient groups and research organisations, as well as from pharma industry business leaders. For those who embraced patient-centred clinical trials several years ago, the EIU report will help to make the business case for patient engagement.
Parexel’s Rosamund Round has been presenting the data at conferences since its publication, including the Patients as Partners event in the US in March. ‘The response has been incredible,’ she says. ‘There is a sense that this marks a major step forward in patient-centricity. We always knew it was the right thing to do from an ethical perspective, and now we have the data to show that it’s good for business too.’
The impact of improving the trial design by listening to patient voices varies depending on the number of sites and the size of the study. However, there are several ways in which it can deliver efficiency and reduces costs. ‘Shorter recruitment times and shorter studies reduce overall costs,’ explains Rosamund. ‘And that’s before calculating the benefit to patients and companies of getting a drug to market faster.’
For researchers and companies just tuning into the potential of patient engagement, the immediate questions are how to do it and how much it will cost. Rosamund believes companies will find it much easier than they imagine. As far as costs are concerned, the initial outlay is often lower than expected – and the return on investment is now indisputable.
‘There are so many ways to get patients involved and the costs are low compared to the investment involved in drug development,’ she says. ‘One is to have strong relationships with advocacy groups. Another is to access online patient communities interested in helping to make a trial design better.’
Patient insights research can provide invaluable information that helps avoid missteps that could set a trial back by months. This can cost as little as €10,000 which, considering the monthly costs of running a multicentre trial, is remarkably low. ‘It’s always worth it,’ says Rosamund. ‘We’ve never once done a piece of patient insight work and come back without an unexpected way that we can improve what we’re doing.’
Parexel has also taken simple practical steps to help its teams think about their work from a patient perspective, including inviting patients and clinicians into their office to meet the staff at ‘town hall’ meetings.
It’s not at all as daunting as people sometimes imagine, and the benefits are too great to ignore, says Rosamund who believes the EIU data could be a tipping point in the history of patient engagement.
‘This data is changing the conversation, helping to get late-adopters over the line,’ she says. ‘The fact that a patient-centric approach can deliver quicker recruitment and a faster journey to market is helping people understand that it’s a business and world health imperative.’