Re: Are clinical trials units essential for a successful trial?
Of course a Clinical Trials Unit (CTU) is not essential for a successful trial, but it is increasingly difficult to run a multi-centre trial without the support of a multi-disciplinary team experienced in designing and running clinical trials. The question should not be is a CTU essential, but does involvement of a CTU increase the chance of success and is it a cost-efficient way to invest in clinical trials.
Ian Chetter lists several barriers to success of clinical trials and suggests that a CTU is unlikely to have much influence on these barriers. We disagree.
Time-constraints: We wanted to recruit patients for a trial during a routine GP consultation, but were told that we would need to add 20 minutes to a primary care consultation in order for a nurse to recruit and obtain informed consent. With the help of the CTU we discussed the design with individual practices and successfully ran a trial in which patients were recruited without substantially increasing the time of the consultation.
Doctor-patient relationship: By organising patient (and doctor) involvement in the design and management of trials we can help ascertain what the issues are and often find that the relationship is strengthened.
Lack of equipoise: Where there is lack of equipoise, a trial must be designed carefully to ensure that it addresses a relevant clinical question about which there is equipoise and does so without compromising individual clinicians who may not have equipoise. Designs in which patients are randomised to see different specialists (rather than requiring the specialist to randomise patients to different treatments), for instance, are becoming more common. CTUs can play a role in surveying clinicians and patients to find out where there is equipoise.
Patient information and consent: Most CTUs have considerable experience in working with patient representatives and running focus groups to improve consent procedures and to ensure that the patient information is clear and balanced.
A key benefit of working with a CTU is that the large team should enable an individual trial to continue smoothly should the trial manager leave suddenly.
One of the biggest challenges to clinical trials today is the increasing bureaucracy caused by ever more stringent regulation and risk-averse research offices. The number of clinical trial applications fell by 25% from 2007 to 2011 and the cost per patient recruited in NIHR funded trials has increased sharply. Maybe it is too much to ask of CTUs to reverse this worrying trend.
Competing interests: PS is the director of a CTU, BA is the operations manager of a CTU