Project Management of Randomized Clinical Trials: A Narrative Review

Abstract

Context:A well-structured protocol for a clinical trial may be able to answer clinical questions, but it cannot be deemed enough to ensure success in the face of incompetent management of time as well as human and economic resources. To address this problem, in this article, we present our literature review on evidence as to how a good knowledge of proper management among researchers can enhance the likelihood of the success of clinical trial projects.Evidence Acquisition:Using multiple search strategies, we conducted a literature review on published studies in the English language from 2002 to 2012 by searching the Cochrane Database of Systematic Reviews, MEDLINE, Google Scholar, and EMBASE.Results:Our review suggests that a successful trial requires a work plan or work scope as well as a timeline. The trial manager should subsequently manage the study in accordance with the plan and the timeline. Many research units have called for a clinical project manager with scientific background and regulatory skills to effect coordination among various aspects of a clinical trial.Conclusions:Project management may benefit both the managerial and scientific aspects of medical projects and reduce fund waste. However, little has been written to date on project management in the context of clinical research. The suggestions represent the views of the individual authors. To provide a high level of evidence in this regard, we recommend that a randomized controlled trial be performed to compare trial projects progressed with and without the use of project management.

Learning from OCTET – exploring the acceptability of clinical trials management methods

“…Research evidence has suggested that despite the importance of having a well-constructed protocol, success is enhanced by efficient management of research tasks, timelines and staff [ 10 ]. It is generally considered that approximately 50% of the total time spent on a study relates to its conduct, including recruitment of participants and collection and monitoring of data [ 11 ].…”

“…Trial managers have to project confidence amongst other team members, be highly organised, communicate and coordinate effectively, have the ability to multi-task, think laterally and strategically and be motivational [ 4 ]. If the trial manager is performing successfully, enhancing communications and negotiations with significant contributors via an appropriate infrastructure [ 15 ], trial outcomes can be optimised [ 10 ].…”

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“…Several studies have suggested solutions to administrative/managerial barriers to research recruitment by adopting methodologies from business world and marketing, including elements such as building brand value, explicit marketing plan, signaling worthiness, making the sale and others (7). Future studies may need to test benefits of these methodologies for recruitment of practices especially from larger organizations.…”

“…While several studies identified some barriers to primary care physicians' recruitment and research participation (4,5), to date, evidence is limited to inform provider recruitment planning for primary care research projects (4). While many studies focus on the patient and provider recruitment in clinical trials (6,7), recruitment needs in primary care, however, go far beyond the scope of randomized clinical trials.…”

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“…Furthermore, proper facilities, location, equipment, laboratory, product storage, and archive must be provided prior to study initiation [22,23].…”