LAUSR

Aim: Clinical trials are vital to inform decision making and improve patient access to novel technologies; however, research budgets are limited, and therefore, resources should be allocated to trials that maximise return on investment. We aimed to prospectively assess the return on investment of a randomised controlled trial in prostate cancer. Methods: Existing evidence about the effectiveness and cost‐effectiveness of a cognitive behavioural intervention in highly distressed cancer patients was used to estimate the expected Value of Research of a randomised controlled trial of a nurse‐led multimodal psychosocial intervention compared with usual care in men with advanced prostate cancer. Value of Research comprised (1) the expected monetary benefit of reducing decision uncertainty (i.e. benefit of avoiding wrong decisions) and (2) the expected monetary benefit of improved implementation (i.e. benefit of changing practice). Value of Research was scaled up to the population expected to benefit from the intervention over 5 years after the completion of the trial, assuming uptake rates from 10% in year 1 up to 50% in year 5. Value of Research was compared with the trial cost to calculate the expected return on investment. Results: Simulating the expected benefit from the proposed clinical trial of 250 participants, the expected value of reducing uncertainty would be $215 per patient and $650 per patient from improved implementation. The expected Value of Research would be $865 per patient and $27.7 million at the population level over 5 years. With a total trial cost of $1.1 million, the expected net monetary gain of the proposed clinical trial would be around $26.6 million, which is a return on investment of approximately 2400% (i.e. $26.6 million/$1.1 million). Conclusions: Prospectively assessing the Value of Research of oncology clinical trials is feasible and useful to ensure that trials with the maximum expected return on investment are prioritised for funding.