Trial development project
Although there is a need to test new treatments in bullous pemphigoid, it is uncertain whether there are enough people in England that could take part in these clinical trials. In a three-year period, we estimated that about 10,800 people would be diagnosed with bullous pemphigoid for the first time.
Based on a review of their pre-existing health conditions, we believe about 5,300 might be able to take part in a trial and a further 5,100 might be able to take part as long as their pre-existing illnesses were monitored and treated appropriately. Only a small subset of about 400 people are likely to have pre-existing health conditions that makes participation in a trial unlikely.
Using electronic health records to inform trial trial feasibility
Key facts
Why do the research?
Treatment options for bullous pemphigoid are limited and trials of new treatments are necessary to find safe and effective alternatives. However, it is uncertain if there are enough people in England to take part in these trials. In particular, because bullous pemphigoid predominately affects older people, we needed to find out how many have serious pre-existing illnesses that might stop them from taking part in such trials.
How was the research conducted?
Using electronic health records from general practices and hospital stays, we identified people that had been diagnosed with bullous pemphigoid. We then looked at their medical records to see how many had pre-existing illnesses that might make them unsuitable for a trial. We applied these estimates to the whole population of England in 2015-2017 to determine the total number of people available.
What were the results of the study?
We estimated that about 10,800 people are diagnosed with bullous pemphigoid for the first time in England over a three-year period. The majority have pre-existing illnesses, although we believe that 5,100 may still be able to take part in a trial. A further 5,300 might also be able to take part, but have pre-existing illnesses that would need to be monitored during the trial. Less than 400 have pre-existing illnesses that make them unsuitable for trials. Finally, we believe that about 11-17% of people have pre-existing dementia
What do the results mean for patients?
We believe there are substantial numbers of patients with bullous pemphigoid that might be eligible to take part in future trials in England. We hope that researchers will be able to use the results from our study to plan new trials, thereby improving the treatment options for people with bullous pemphigoid.
Who funded the study?
NIHR Research for Patient Benefit