Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts a drive to ‘push’ patients into trials, industry disagrees.
Data from a recently published Industry Standard Research (ISR) whitepaper has found 72% of patients currently in clinical trials were ‘pulled’ into them by way of their physician who happens to be a principal investigator for such a study.
However, the paper suggests over the next two years there will be an increase in the number of patients encouraged to find a particular investigator or site, and thus ‘pushed’ into trials, with sponsors and CROs proactively encouraging such a transition due to the cost-savings associated with expediting recruitment.
“Patient recruitment is the major bottleneck in the clinical development process,” Andrew Schafer, President of ISR, told Outsourcing-Pharma.com. “People can talk about EDC build times or query resolution turnaround, but patient recruitment is the single largest lever that impacts trial timelines.”
Therefore, he continued, “any company, technology, or process that can be shown to reduce this time will get the attention of sponsors and CROs,” and CROs are looking at the pull-push patient recruitment dynamics “as to whether they partner, or buy, or build competencies in this area.”
Push to service firms
Using standalone patient recruitment and patient networks service companies can identify patients and attempt to push them towards clinical trials, the report said, but such use by CROs is relatively low.
However, it is expected to increase as sponsors look to expedite recruitment times, and Schafer told us consolidation between such services and CROs is a possibility. “Companies like Quintiles have decided to take this on themselves – [forming a unit comprised of a number of on-line sources ] - and have been quite successful.”
In the last year Acurian – who was cited in the ISR paper as the industry leader in standalone patient recruitment with roughly 40% of survey respondents (comprising of sponsors and CROs) having used them – was purchased by contract research firm PPD .
Gentle nudge rather than push?
We therefore spoke to Rick Malcolm, Executive Vice President & General Manager of Acurian. He agreed with Shafer patient recruitment was a complex problem for sponsors, and whilst last year’s acquisition created “a strategic advantage for PPD in helping biopharmaceutical clients accelerate their research programs,” he was unable to comment on how others in the industry addressed the problems of patient recruitment.
However, he disagreed that firms such as Acurian were looking to ‘push’ patients towards trials but were rather creating “awareness in a suitable population through IRB [Institutional Review board] and ethics committee-approved communications.”
Whilst a firm like Acurian has a singular mission, CROs are also turning to patient network groups to help push enrolment on top of other services.
However, Paul Wicks, VP of Innovation at PatientsLikeMe - who partnered with Genentech last week in a five-year collaboration – also rejected the notion of ‘pushing’ patients towards trials.
“Ultimately whether or not a patient chooses to participate will be based on their understanding of the trial's protocols, what is expected of them, and what kind of support they can get in return,” he told this publication. “I see our role as making patients as aware of as many trial opportunities as possible.”
Schafer rebutted such views, saying these actions by service firms demonstrate the shift towards the 'pushing' of patients into trials. "If patient recruitment timelines are going to be improved over time, then CROs and sponsors will need to use sources - whether it be outside patient recruitment companies or building their own databases/ capabilities - in order to drive patients to clinical sites."
"Companies will increasingly need to look beyond the patients contained at their investigational sites," he continued. "Therefore, using any tools/ techniques/ media platforms to increase this pool of potential patients will be necessary to cut recruitment timelines."