Managing Clinical trials
Prescott et al. assembled and classified a comprehensive bibliography of factors limiting the quality, number and progress of RCTs. They identified barriers to clinician participation that included, for example, time constraints, concern about the impact on doctor-patient relationships, concern for patients, lack of reward and recognition, and an insufficiently interesting question. Barriers to patient participation included issues such as additional demands of the trial, patient preferences, concern caused by uncertainty and concerns about information and consent. They recommended that to overcome barriers to participation, a trial should address an important research question and the protocol and data collection should be as straightforward as possible, with demands on clinicians and participants kept to a minimum. Dedicated research staff may be required to support clinical staff and participants. The recruitment processes of an RCT should be carefully planned and piloted regardless of size or complexity.
On the basis of experience in noncommercial academic initiated trials, Farrell and Kenyon in The Guide to Efficient Trial Management suggest that actively managing every aspect of the trial is key to success. If clinicians are to recruit participants, they should feel comfortable and trained in trial processes and procedures. This can be achieved using a variety of methods: one-to-one training, group work, distance learning methods (videos via the web and teleconferences). National and international presentations and discussions to continually highlight the importance of the trial must be organised by the trial team. Maintaining a personal interface with a collaborative group of clinicians, whether this is a group of 7 or 700, is probably the biggest challenge for a trial manager and the trial team but one that will result in a more cohesive trial.
A trial manager
The importance of a trial manager to the success of the project is recognised by the NIHR HTA programme, and they recommend that all primary research projects appoint a dedicated project/trial manager. Ideally, trial managers should be involved early on in the trial design phase, but this is rarely possible because of funding constraints. However, a good trial manager involved in the trial design and funding application will make a valuable contribution to the practicalities of conducting the trial, potentially saving money and avoiding unworkable systems. Generic job descriptions produced by the HTA and the UK Trial Managers' Network (UKTMN) identify the key responsibilities of a trial manager as follows:
• Having a leading role in planning, coordinating and completing a project
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.