HRA Chief Executive, Matt Westmore, and Senior Development Manager, Catherine Blewett, have contributed to a research paper on how to use a placebo in surgical clinical trials.
The ‘Further considerations for placebo controls in surgical trials’ paper, which was published in the research journal Trials, is based on an international workshop that analysed the ASPIRE guidance on how to safely design and conduct surgical clinical trials using an invasive placebo control.
An invasive placebo control is where a group of patients are given a dummy procedure which is compared to another group who are given a surgical treatment. Studies set up this way help researchers to identify whether the surgical procedure is effective when compared to established non-surgical treatments. However, there are a number of ethical considerations which need to be considered before setting up this kind of study.
The workshop provided further insights into this topic, including the purpose and design of invasive placebo controls, the use of patient information and how findings from these trials may be used to inform decision-making.
Matt, who was part of the ASPIRE group which co-authored the paper, said: ‘By carefully and thoughtfully incorporating placebo controls in surgical trials, we gain valuable insights into the genuine benefits and underlying mechanisms of surgical interventions.
‘Including placebos in surgical trials is not straight forward and so this paper contributes to the body of knowledge on how to do that. It builds on previous work the HRA has done in this area.
‘Placing patients at the heart of these trials is of utmost importance, as it guarantees their wellbeing and ensures participants can make informed choices. Ultimately, prioritising patient-centred research not only enhances the quality of care but also nurtures trust, transparency, and shared decision-making among patients, researchers, and surgical health professionals.’
Catherine, who took part in the workshop, added: ‘The inclusion of placebo controls in clinical trials to evaluate the effectiveness of surgical procedures is a challenging but important ethical question to address.
‘I was delighted to be involved in this work which aimed to better understand the ethical issues associated with such trials, and I believe that the resulting paper moves this complex issue forward in a really positive way.’
The ASPIRE guidance was published in the Lancet in 2020.
Matt Westmore‘By carefully and thoughtfully incorporating placebo controls in surgical trials, we gain valuable insights into the genuine benefits and underlying mechanisms of surgical interventions.
‘Placing patients at the heart of these trials is of utmost importance, as it guarantees their wellbeing and ensures participants can make informed choices. Ultimately, prioritising patient-centred research not only enhances the quality of care but also nurtures trust, transparency, and shared decision-making among patients, researchers, and surgical health professionals.’
Catherine Blewett‘The inclusion of placebo controls in clinical trials to evaluate the effectiveness of surgical procedures is a challenging but important ethical question to address.'