Participant recruitment has been commonly identified as a major barrier to clinical trials success, with anecdotal evidence indicating only about 60 per cent of trials in Australia recruit all the patients they are seeking and only 20 per cent meet their recruitment timeline.

With the support of the NSW Office of Health and Medical Research, SHP is collaborating with Northern Sydney Local Health District (NSLHD) to test a centralised recruitment service for clinical trials which will assess different recruitment strategies across three musculoskeletal clinical trials.

The chief investigator for two of the clinical trials involved in the pilot project, NSLHD clinician and University of Sydney Professor David Hunter, says researchers often overestimate their ability to recruit.

“Recruitment for trials often runs over time and, as a result, trials run out of funding,” he said. “As a consequence of recruitment difficulties, we are sometimes not able to complete the clinical trial we initially envisaged.”

A 2020 gap analysis undertaken by Sydney Health Partners identified a number of clinician, patient, and operational issues which can impact on recruitment success.  In consultation with its Partners, SHP proposed piloting a centralised recruitment officer, shared between three trials, who would develop and test recruitment strategies, and analyse the results.

The pilot project recruitment coordinator Lara Fitzgerald says most researchers may find it difficult to give recruitment the time and energy it needs because of all the competing demands in running a clinical trial.

“A clinical trial can succeed or fail because of recruitment,” she says.

“I think researchers may not spend enough time – right at the beginning when the trial protocol is written - to think really carefully about where they are going to find their patients and how best to approach them about participating in a trial.

“But my experience is that if you don’t consider recruitment methods right at the outset, you can be chasing your tail throughout the trial.”

Ms. Fitzgerald says it’s also very important to measure the effectiveness of different recruitment channels, such as social media advertising, newspaper advertising, radio and flyers in hospital clinics.

“There is a tendency to try everything to recruit patients without all the tools in place to measure the effectiveness of the individual recruitment strategy, other than the basic measure of was someone actually randomized into a trial?”

“But that doesn’t look at the screen failures, time spent, and the costs involved per participant for each strategy.”

Professor Hunter points out that while the cost of clinical trials recruitment can be substantial, the cost of failure can be even greater.

“The cost of recruitment is a big deal and we usually underestimate that,” he said.

“You can pour seven or eight years of effort into developing and running a clinical trial and, because of a small sample size, you aren’t able to answer the research question with sufficient statistical power. That’s frustrating.”

The Kolling Institute’s University of Sydney Professor Manuela Ferreira is using the pilot project to recruit for Australia’s first ever placebo trial of spinal surgery.

“Recruiting participants into complex trials, such as placebo trials of surgery, can be even more challenging, so this pilot project offers a unique opportunity to identify and implement the best strategies to improve recruitment and stakeholder engagement in such trials,” she said.

“It is also a great opportunity to assist researchers overcome the additional recruitment barriers imposed by COVID-19. The outcomes of this pilot will definitely inform how we design and conduct clinical trials in a broad range of disciplines.”

Professor Hunter says what is learnt in the pilot project might be used across a whole range of clinical trials involving other disciplines.

“I’m hoping that having a centralised recruitment resource will increase efficiency, hone skills but also give us greater knowledge around what is truly most efficacious in that space.”