The Institute of Cancer Research (ICR) has announced new guidelines for clinical trials to improve and support future research and development in oncology and non-oncology settings.
The two new guidance documents, which focus on early-phase dose-finding clinical trials, will ensure clinical trial protocols and reports are complete, high-quality and transparent.
The variation in which trial findings are reported can affect the impact they have on other researchers, potentially obstructing medical progress. Low standards of reporting, as well as poorly designed protocols within trials, can put patient safety at risk and waste already-limited resources.
Researchers from the ICR’s Clinical Trials and Statistics Unit (ICR-CTSU), in partnership with international experts, led the DEFINE (DosE-FIndiNg Extensions) to tailor guidance in early-phase dose-finding trials by creating new checklists for research teams.
After carrying out a two-round modified technique known as Delphi, which uses a systematic and interactive approach, 36 candidate items for SPIRIT-DEFINE and 44 for CONSORT-DEFINE were selected.
The first stage involved 206 participants from 24 countries, while 151 participants participated in the second stage.
Subsequently, 34 specialists from seven countries participated in a consensus meeting to determine the most important candidate items.
The final stage consisted of pilot testing and draft checklists, where 17 new and 15 modified items for SPIRIT-DEFINE and 21 new and 19 modified items for CONSORT-DEFINE were confirmed.
The DEFINE guidelines were structured in a similar format to the CONsolidated Standards Of Reporting Trials (CONSORT) 2010 and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statements for researchers to use in all clinical settings.
Dr Olga Solovyeva from the ICR’s division of clinical studies, said: “Improving transparency in clinical trial reporting is critical for scientific progress and public welfare. Transparent reporting improves trial design, builds public trust, uncovers conflicts of interest and promotes academic growth. It also encourages accountability and ethical research practices.
“We believe that we are filling a critical gap in the guidance.”
The team also ran several masterclasses to show attendees how to use the guidelines to maximise the impact of their work.
A follow-up survey revealed that 80% of researchers were “very interested” or “extremely interested” in using the DEFINE guidelines.
The DEFINE team intends to initiate further masterclasses and two extension and elaboration papers as a learning exercise in response.