Trial design The biggest
challenge to patient engagement is convincing sponsors that it’s a worthwhile investment.
feedback from study volunteers. In one case example, working with patient groups saved the organisation millions of dollars that otherwise would have been spent on patient recruitment and retention. Overall, patient input into protocol design resulted in between three and 17 changes to study requirements, including the number of required visits and procedures. “We’ve been trying to gather hard evidence that would give companies a chance to see measurable return on their patient engagement investment, but that too is difficult, as it takes time to get the data,” Getz says. “If you’re looking at a large global trial with many sites around the world, sometimes what you’re measuring in one country is not being done systematically elsewhere. Nonetheless, I’m confident that over time we will get even more quantitative data that we can integrate into the narrative of the story.”
patients to understand what it’s really like to live with a particular disease, and carrying out participation burden assessments. “If the participation burden score exceeds a certain level, it signals to the protocol author that they need to go back and revise the design of the study,” Getz explains. “We want to make clinical trials easier for patients to integrate into their lives and lifestyles. It’s really about bringing the trial to the patient rather than attracting the patient to the trial, and acknowledging that we should be designing studies in a way that gives the patient the opportunity to participate in whatever way is easiest for them.”
Demonstrate the ROI of patient engagement
87%
Clinical trials with significant patient- centred elements run between 2012 and 2017 that had positive results.
68% Economist Intelligence Unit 16
One of the big hurdles to greater adoption of patient engagement initiatives is to convince sponsors that the immediate investment of time and resources is worthwhile in the long term. “Some approaches add time, which companies are racing against,” Getz acknowledges. “It already takes so long to write a protocol to now have to accommodate input from patients. Not every company has the persistence and appetite to deal with some of the short-term challenges that come with learning how to really use and integrate some of these approaches.”
Traditional trials with no significant patient- centred elements run between 2012 and 2017 that had positive results.
That said, research CSDD has carried out with the Drug Information Association (DIA) shows that even the simplest changes can have a significant positive impact. After analysing 121 case studies by sponsor companies, they found that the patient engagement initiatives that offered the highest return on investment were patient advisory boards, professional panels, social media engagement and patient education programmes. Impacts included faster study planning, improvements in recruitment and retention rates, fewer disruptions and delays, and more positive
A new type of expertise For Brooke, it’s clearly better to engage patients at the earliest possible stage of drug development – the later they are engaged, the more likely it is that some decisions will not be totally aligned with patient expectations or needs. The challenge with early engagement, however, is to maintain a continuous relationship with the patient while the molecule moves from department to department.
“The process, tools and skills to do that have simply never been discussed, but the companies that are making the best strategic choices are shifting from shorter relationships where they say, ‘We want to work with your patient organisation for this specific phase for 12 months’ to a long-term approach aligned better with the life-cycle time frame,” he says. Takeda’s approach, which was cited in a recent Economist Intelligence Unit report on patient centricity, has been to build patient engagement into job requirements. In 2018, the company changed its employee key performance indicators to require every R&D employee to engage in three patient- themed activities of their choice. In 2019, the company went a step further by requiring all the R&D global programme study teams in every therapy area to conduct a direct patient engagement activity that informed drug development. By the end of 2020, all global programme teams were required to have a patient engagement plan that would map out how they are partnering with patients and the patient community in the development of new medicines. “It’s a new type of expertise for pharma companies
– it’s not about expertise in the science or the development process, its expertise in driving the relationship and aligning on a shared purpose,” Brooke says. “The reality of patient engagement is that, compared to the rest of the science in drug development, it is not rocket science.” ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
SpicyTruffel/
Shutterstock.com
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