Today, Thursday 20 May, we are marking Clinical Trials Day 2021.
We asked members of our Policy and Communications Group to nominate clinical trials that have been ground-breaking or have driven lasting change.
I have chosen the SENSCIS® clinical trial (NCT02597933) as this trial has demonstrated the benefits of patient involvement and engagement for the trial and beyond. This was a phase III clinical trial in scleroderma-associated interstitial lung disease which integrated patient insights derived from a community advisory board which was a collaboration between the scleroderma patient community and the sponsor, Boehringer Ingelheim. The insights improved the implementation and conduct of the trial with practical changes to the study design which increased patient safety and comfort as well as ensuring more accurate data. The collaboration also ensured that the results of the trial were understandable to lay audiences and patients. In parallel the collaboration co-developed tools for opening blister packs and bottles to make this easier for patients as scleroderma affects patients’ hands.
This trial is an example of how a flawed negative study can influence the clinical practice over decades. In fact, the use of hormone replacement therapy (HRT) is still considered controversial nowadays. HRT has been used without evidence of benefits over risks from the 1960s with increasing use in the 1990s. This popularity favoured the Women’s Health Initiative (WHI) study with 161809 postmenopausal women enrolled in the age range of 50 to 79 years for 5 years (1993-1998). After the publication of the WHI study results, numerous studies have been conducted and published, which confirmed benefit of taking HRT. The WHI study remains ones of the cited studies in the history of clinical trials.
This ground-breaking umbrella type trial was run by CRUK and investigated a number of treatments for lung cancer. It demonstrated a really good way to investigate a number of different treatments simultaneously and efficiently.