On 27 October 2022, the third call of the Belgian-Dutch cooperative programme BeNeFIT has opened, intended for clinical trials comparing existing health care interventions on their effectiveness. For example, you can think of comparisons between two different drugs for a specific condition, or a pharmaceutical intervention versus surgery. What will be the focus of BeNeFITs Scientific Evaluation Committee? Sarah Puddicombe gives new applicants some advice.
‘The BeNeFIT programme aims to fund multicentre trials comparing the effectiveness of health care interventions that are already in use in a given indication. The research should be pragmatic and practice-oriented. We are looking for randomized control designs that try to inform healthcare decision-making by providing the evidence on effectiveness, including cost effectiveness. What are the benefits and harms of different treatment options? What intervention would give the best outcomes for patients?’
‘We expect to see patient involvement all the way through into the delivery of the trial.’ Sarah Puddicombe, Scientific Evaluation Committee BeNeFIT
‘The types of interventions can be quite broad ranging. It could be a treatment, a procedure, a device, or a diagnostic test. It could even be secondary prevention, for example an intervention on preventing relapse. And it can cover things like dietary, psychological or behavioural interventions as well.’
‘We really want to see patient-centred outcomes. So I would expect to see patient involvement from the design of the study all the way through into its delivery. Another main focus is on feasibility. Is the recruitment going to be feasible? Are there a sufficient number of sites with appropriate patients involved? Have these sites considered the challenges of working together on an international study?’
‘We have a committee of expert clinicians, scientific experts and patient representatives. We have observers from the healthcare payers and reimbursement agencies as well. Apart form the criteria I just mentioned, we will be looking at the relevance and scientific quality of the study. It’s a two-step procedure. We will score outline proposals first and discuss them thoroughly in order to make a shortlist of applicants who will be invited to submit a full proposal. The next step will include external peer review and a feasibility assessment. Eventually we will advise the Call Steering Committee on those proposals that are of the highest quality and relevance.’
‘I think there's obviously an important need to think about your PICO. So who's in the patient population? What's the intervention? What are the comparators and the outcomes? This will provide you with a clear flow chart to consider the eligibility of your proposal. And do speak to colleagues who are already performing a BeNeFIT trial. They already had to overcome some of the challenges to achieve the sort of robust trial design this program is looking for.’