How to set up a successful multicentre randomised controlled trial in the field of neovascular age – related macular degeneration treatment? Lessons from the MATE pilot study.

Abstract

Purpose : One of the main challenges for research teams across the globe is to recruit to time and target. Poor recruitment is the most common cause for discontinuation of randomised controlled trials. There is a gap in literature about recruitment processes and challenges faced in clinical trials in ophthalmology and neovascular age – related macular degeneration (AMD) in particular. We studied the set up and recruitment phase in the MATE study which is a pilot, multicentre, randomised controlled trial comparing two treatment regimes in patients receiving aflibercept for neovascular AMD.

Methods : 40 patients in six UK Ophthalmology departments were randomised to receive aflibercept for neovascular age related macular degeneration as per either standard care or a treat and extend regimen. The study adopts a mixed methodology approach: Qualitative for the primary outcome (reported here) and quantitative for the secondary efficacy data (not reported here). Recruitment rates per site and per month and recruitment window were calculated. Face to face, in-depth interviews of key trial staff like principal investigators and trial manager were conducted at the end of recruitment. These interviews were transcribed and analysed using thematic analysis.

Results : The original recruitment window of 6 months was extended to 13 months to meet the recruitment target with last 4 months being competitive. Recruitment rate/ site is 6.67 and per month is 3.07.
Key candidate themes as below:
a) Challenges e.g. Regulatory change, site withdrawal, resource limitation (financial and personnel), competing studies and building teams
b) Positive recruitment factors e.g. Pragmatic study design, entry criteria better than NICE, dedicated members of research team recruiting patients and investigators perception of patient benefit
c) Human factors e.g. Good communication between sponsor and sites, investigator experience and dedicated research teams

Conclusions : Minimising set up delays, optimising recruitment strategy and human factors are key factors in the set up and recruitment phase of a multicentre, randomised controlled trial in this context.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

Figure 1: A thematic map of factors affecting recruitment

 

Figure 2: A plot of the recruitment timeline