November 2004
Involvement of doctors and patients
Crucial to a successful clinical trial is the participation and co-operation of both patients and doctors.
Healthy volunteers for phase I trials can usually be found and retained without too much difficulty.
However, patient participation rates in phase II and phase III trials are currently low, for example in all cancer trials participation by patients after phase 1 is only 5-10%. Of industry funded research, while 70% of agreed recruitment targets are met, 30% of UK sites fail to recruit a single patient [Go to note 4].
However, in 2002/03 the UK participants in international studies were recruited within the allotted timeline three quarters of the time [Go to note 5]. Of UK studies, less than half were able to finish recruitment on time. The inclusion of international studies is important to note as they make up over 80% of studies undertaken in the UK.
The issue of low participation rates must be addressed, and the higher success of international studies must be examined. Increasing accrual rates to trials would lead to critical questions being answered sooner, more rapid advances in disease treatments, and lower trial costs. Slow recruitment may result in changes in practice and conditions, such as the development of skills in applying treatment, which may negatively influence results [Go to note 6]. Various issues have been identified as being linked to low participation rates of both doctors and patients.
Use the links below to access a summary of these issues, which if addressed by trial researchers, may overcome the current inertia in participation.