Do feasibility studies contribute to, or avoid, waste in research?

Abstract

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to ‘fail’. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway.

Value of surgical pilot and feasibility study protocols

“…Working collaboratively to design and perform pretrial work can deliver surgical PFS in a cost-effective and timely manner, and can advance the development of definitive studies 46 . High-quality PFS may also be resource-and cost-effective, preventing waste by averting futile main trials, or providing information to improve the design and conduct of the main trial 47 . The findings from this study indicate, however, that PFS in surgery are not currently used to their full potential.…”

A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials

“…standalone randomised pilot studies) or ‘external pilots’ funded by the NIHR Research for Patient Benefit (RfPB) programme progressed to main studies. In a cohort of 89 trials which had closed by May 2016, 20 (30%) were judged ‘not feasible’, of which 6 (7%) were intending to apply for funding for the main trial [8]. However, in the current review all but one internal pilot, which was still under review at the time of analysis, continued to the main trial, even when progression criteria had not been met.…”

Feasibility Study of a Facility to Produce Injection Molded Parts for Automotive Industry

“…A preliminary feasibility assessment has been widely conducted as the first, foremost step before starting a business or developing projects (Hwang et al, 2019, Halil et al, 2016, Ma et al, 2019, Eksangsri and Jaiwang, 2014, Chingua et al, 2019. The main objective of a feasibility assessment is to 'de-risk' potential full trial funding (Morgan, 2018). Considering some assessments in the feasibility study performed by mentioned researchers, this research activity can mainly provide reassurance and potentially avoid waste and to obtain an answer to the project in question of the company, which in this case is especially applied in the automotive sector.…”