Last week I got a comment on one of my blog posts asking what my PhD project is about – I scrolled back through my blog and couldn’t find a post dedicated to explaining it (I’ve clearly been too busy banging on about women in STEM, public engagement, and clinical trials in general terms…), so here’s a blog post focussing on my PhD project to remedy the situation.
Making clinical trials more efficient: consolidating, communicating and improving knowledge of participant recruitment interventions
Where and when?
The University of Aberdeen’s Health Services Research Unit (HSRU), based with Trial Forge.
Study phases and objectives:
Phase 1: To consolidate existing information on participant recruitment into clinical trials.
This will involve completion of a systematic review of non-randomised evaluations of strategies to improve participant recruitment to RCTs (protocol is published here), involvement in updating the existing Cochrane review on randomised evaluations of strategies to improve participant recruitment to RCTs (the 2010 version is published here, and the update is coming!), and involvement with a new Cochrane review led by NUI Galway which will look at the factors that impact participants’ decisions regarding trial participation using a qualitative evidence synthesis (protocol is published here).
Phase 2: To investigate how best to present and distribute this information for the consumption of clinical trial teams. This phase will comprise of a semi-structured interview study with trial ‘recruiters’ (i.e. people who are actively involved in the process of identifying, approaching and recruiting participants to trials), and ‘designers’ (i.e. the people who are in a position to make decisions regarding the methods that a trial uses to recruit – e.g. the person who decides that using a Twitter post, newspaper article, or radio advert would be a good idea to attract participants to the trial), generation of multiple methods of presenting recruitment evidence, and user-testing of these methods using a think-aloud protocol.
Phase 3: To improve the current knowledge base through facilitation of work designed to fill gaps in evidence. To do this I will be producing protocols for a number of SWATs (studies within trials) specifically designed to fill gaps in knowledge found in the reviews that make up Phase 1 of the project. These protocols will be published on the SWAT repository, encouraging trial teams around the world to fill these gaps in our recruitment knowledge.
Why is the project important?
Clinical trials are at the core of evidence-based healthcare; because they randomise participants to each arm of the trial, they guard against selection bias and therefore offer the fairest way of evaluating healthcare interventions. In more basic terms, randomising participants to Group A and Group B, then you can make sure that you don’t end up with all of one type of participant (e.g. older people, younger people, more ill people, only one gender etc) in Group A, and none in Group B.
The recruitment of participants into clinical trials is difficult – lots of trials have problems with recruitment, and many require extensions to both time and budget as a result of these recruitment issues. In the worst cases, trials can be abandoned entirely because they can’t recruit enough participants; this causes huge waste. What is surprising then, is that the process of recruitment has very little evidence behind it. Largely, we’re relying on gut instinct, experience, and hope.. none of which seem to be working all that well.
My project aims to begin to tackle the problem of trial inefficiency by getting to grips with how participants are recruited into trials, ultimately aiming to improve recruitment methods in order to alleviate recruitment problems in trials on a global scale.
Why this project?
As part of my undergraduate degree, I did an industrial placement year – I swapped student life for a year working in recruitment. I worked for a recruitment agency that supported clinical research companies in industry to recruit staff (Principal Investigators, Research Nurses, Project Managers etc). Essentially, I spent a lot of time on LinkedIn, a lot of time on the ‘phone, and a lot of time annoying people by calling them after seeing their CV on job sites.. Anyway, as part of that role I set up a bank of Research Nurses for an international clinical research organisation. I hired 15 nurses who would do ad hoc shifts when the trial sites needed some extra pairs of hands. I really enjoyed that part of the job, it was nice to get someone from application through to being hired, and to go on that person’s journey alongside them. What wasn’t so nice though, was when those Research Nurses that I had hired started to get turned away from work. This was because the trials that they were working on didn’t have enough participants – no participants, means no data collection, and therefore no need for my Research Nurses.
When I went back to Uni to finish my degree, I was still searching for ways to recruit participants effectively – I didn’t find much, other than an advertisement for a PhD. I applied, interviewed, and was offered the post the same day. I started a month after graduating from my Undergrad, and I’m still working out how on Earth to recruit participants to trials.. it looks like it might be a career-length question, which is totally fine by me 🙂