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Table 1 Factors that may predict recruitment success[10].

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.