From: Studying a disease with no home - lessons in trial recruitment from the PATCH II study
Relevant factors | PATCH II |
---|---|
Quality of Study team/multi-disciplinary team | Experienced multi-disciplinary team including dermatologists, trialists, statistician and health economist. Independent Chair of Steering Committee and independent Data Monitoring Committee. |
Involvement of a Clinical Trials Unit | Yes - Nottingham Clinical Trials Unit (CTU) |
Trial Manager | Yes - based at co-ordinating centre |
Local recruitment co-ordinators | No - this was a major weakness for PATCH II. Local research nurses, with dedicated time to work on the study could have made a real difference to recruitment. |
Feasibility work | Twelve-month feasibility study conducted prior to starting trial. |
Peer reviewed study protocol | Protocol peer reviewed by UK DCTN and Nottingham CTU |
Simple study design | Simple parallel group study (but complicated by recruitment into a similar study that was being run in parallel). |
Service user input | Focus group discussions as part of feasibility study & through discussion with the Lymphoedema Support Network |
Important research question with support of the clinical community | Identified as a priority trial by the UK Dermatology Clinical Trials Network |
Drug trial/intervention only available in study | Yes. Some may have felt that prophylactic antibiotics were only available to them within the trial, although this depended very much on local practice of the treating physician. |
Appropriately funded | Limited funding available due to charity as the source of funding. |