![]() 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. assembled and classified a comprehensive bibliography of factors limiting the quality, number and progress of RCTs. ![]() They recognised that in the recruitment stage of a randomised controlled trial (RCT), the most demanding activity is to establish and implement a range of effective management techniques which parallel those used to run a successful business. examined whether clinical trials could be considered from a business management perspective and proposed that the dimensions of running a successful trial includes 'marketing', 'sales' and 'ongoing client management'. In addition, the MRC acknowledged that the failure of some trials can be due to practical problems with trial management rather than scientific problems or problems with the trial design. The STEPS collaborators suggest that anyone undertaking trials should think about the different needs at different phases in the life of a trial and put greater emphasis on 'conduct' (the process of actually doing trials). One factor observed in trials that recruited successfully was that they had employed a dedicated trial manager (odds ratio: 3.80, 95% CI: 0.79 to 36.14 P = 0.087). Less than one third of the trials recruited their original target number of participants within the time originally specified, and around one third had to be extended in time and resources. Clinical trials all require the same coordinated processes and systems, regardless of the size, scope, costs or duration.Īn analysis of 114 multicentre trials funded by the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) and UK Medical Research Council (MRC), STEPS, showed that 45% failed to reach 80% of the prespecified sample size. The key challenge is then to establish and implement management systems and techniques that are effective and responsive to the needs of the trial and the trialist. Once the science is determined and the trial accepted through the peer review process, the challenge is quite different. It is recognised that well designed trials are the basis for addressing important clinical questions, but science alone will not be sufficient to successfully deliver a trial. Trial management is essential amongst the key competencies that are needed to deliver high-quality trials. Rarely is this essential depth of thinking applied to how the trial will actually be managed. To review the literature, develop a protocol, apply for funding and design data collection forms requires lengthy consultations and a considered approach. A randomised trial involves a huge investment of time, money and people therefore, it warrants expert management and needs to be managed from its inception like any other business. The human and financial resources for conducting a randomised trial is finite, so it is crucial that every effort is made to ensure that a trial is implemented simply and managed efficiently. Many clinical trials fail to deliver because of the lack of a structured, practical, businesslike approach to trial management. However, how to manage these important trials has had little mention in most commentaries. Over the past 50 years, eminent trialists have written persuasively and repeatedly of the need for large, randomised, controlled trials, and such trials are considered the highest level of evidence for guiding clinical practice. ![]()
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