We are a clinical trials group conducting large-scale simple trials in primary care, as well as supporting secondary care studies into treatments for inflammatory bowel disease. Our aim is to improve the methodology of clinical trials, to ensure that large-scale studies can be conducted for important clinical issues, without the funding associated with pharmaceutical studies.
Clinical trials that measure the effect of an intervention on a clinical outcome are more influential than those that investigate intermediate surrogate measures. However, if the outcome occurs infrequently such studies need to be large, making them costly to conduct using conventional approaches. Consequently, outcomes studies tend only to be done where there is a substantial funding source, such as a pharmaceutical company, and commercial motivation, such as the development of a new class of drug. This introduces a systematic bias in the information available to prescribers. It is therefore crucial to develop new methods for conducting simple, large-scale studies to answer important clinical questions.
1. Ulcer-bleeding in aspirin users?
Aspirin use is widespread and increasing in elderly patients. The main hazard is gastrointestinal bleeding, which may be increasing because of increasing aspirin use.
We are conducting the Helicobacter Eradication Aspirin Trial (HEAT) based on evidence that peptic ulcer bleeding in aspirin users occurs predominantly in H. pylori positive people. We also run a similar trial looking into ulcer-bleeding in patients who use non-steroidal anti-inflammatory drugs (NSAIDs).
2. Crohn’s Disease and Ulcerative Colitis?
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