The inclusion of an audio-visual DVD presentation among study invitation materials does not improve recruitment to clinical trials, a study published in BMC Medical Research Methodology has revealed.
Scottish gout patients who were benchmarked as potential participants for the Febuxostat versus Allopurinol Streamlined Trial (FAST) were randomly allocated either a standard invitation pack or an invitation pack containing a DVD.
FAST aims to assess the safety of febuxostat compared with allopurinol, two drugs commonly used to treat gout and other conditions involving uric acid deposition. The patients were all aged 60 or over, and taking allopurinol for chronic gout, with additional cardiovascular comorbidities which could have impacted the suitability of the drug in treating their chronic condition.
The standard invitation pack contained a letter and information leaflet about FAST. The DVD pack contained the letter and leaflet, plus a DVD of an audio-visual presentation about the background and operation of FAST. The additional cost of sending a DVD invitation pack in place of a standard invitation was £31.48, or £138.32 per randomised participant.
DVDs actually had a negative impact on clinical trial recruitment
A total of 1050 potential participants were identified and invited to take part in FAST. 509 individuals received the DVD presentation and 541 a standard invitation only. Of all 1050 patients contacted, 56% responded, with 31% of recipients willing to attend a screening appointment to take part in FAST.
There was a marginal statistically significant difference in positive response rate of 6% between the two groups, with DVD recipients being less likely to respond positively. While 34% of the no-DVD group responded positively, 28% of the DVD group responded positively.
Researchers have suggested that the overall negative impact of the DVD could be attributed to lack of readily available DVD viewing equipment in participant’s homes. They also hypothesised that the professionally produced film contained on the DVD may have made the study appear commercial in nature and thus less appealing to prospective participants.
Poor recruitment to clinical trials is an ongoing problem facing the life sciences industry.