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Implementation of Project Management in Clinical Research

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Abstract

Clinical research is a robust process which involves billions of dollars and several years of time to test an investigational drug or a device in the clinical trials conducted on human subjects for the determination of the product efficacy in curing the disease or for implementing a new treatment procedure respectively. The success of a process or a project depends on how well it is planned, organized, implemented and managed. This is also known as project management. The current study deals with the application of project management in executing clinical trials. Clinical trials involve huge supply of resources, energy, effort, man power and time in a way to acquire the desired results which is exceptionally not very productive. Utilization of the project management methodologies along with the conventional techniques would increase the chances of execution of clinical trials in a much cost and resource effective and time-efficient manner. In this article, different methods of project management, data collection and analysis were discussed especially to cut down the costs, efforts and time spent in executing a clinical trial successfully in this fast paced environment in an efficient way.

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... This is reflected in the possibility of certification granted by many entities around the world (e.g., Project Management Institute, International Project Management Association, APMG, etc.). There are also numerous examples of adaptations of guidelines, standards, and practices in the field of project management in clinical trial management (Goodarzynejad & Babamahmoodi, 2015;Parvathaneni, Pattarkine, & Chappidi, 2018;Shirley, 2020). ...
... A clinical trial meets all requirements of the project definition (Doganov & Yanev, 2006). There are numerous examples of adaptations of guidelines, standards, and practices in project management in clinical trial management (Goodarzynejad & Babamahmoodi, 2015;Parvathaneni et al., 2018;Shirley, 2020). The good practices used by the standard-setting organizations and accreditation bodies as well as examiners and certifiers in the field of project management are clear and rational. ...
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Aim/purpose – The purpose of this paper is to clarify the certification process of the Good Clinical Practice (GCP) competencies based on a comparison with the project management (PM) certification process. This aim was accomplished by model development. Design/methodology/approach – The study was divided into three main phases: 1st phase – the identification of key characteristics of PM and GCP certification processes, 2nd phase – the development of certification models for PM and GCP, 3rd phase – the conclusions from in-depth interviews. Findings – As a result of the research, key characteristics of PM and GCP certification processes were identified, certification models for PM and GCP were developed. In addition, based on conclusions from in-depth interviews, solutions for organizing the way of confirming knowledge of GCP guidelines were proposed. Research implications/limitations – The proposed rules may be too complex and may exceed the needs and expectations of the clinical trial environment. The models focus on stakeholder relations, without the rules of certification granting procedures, to enable broader contextualization of the issues discussed in the paper. The analysis might be fragmented as it regards the sole certification process. The research refers to Poland only, hence it will be valuable to identify whether foreign authorities have the same attitude to the GCP competency certification model. It is recommended to increase the number of respondents’ interviews to obtain results of higher validity and reliability. Originality/value/contribution – The paper raises research topics at the crossroads of project management, clinical trials, and GCP, topics that have been underdeveloped so far. The results might be significant for all organizations involved in conducting clinical research projects. The findings contribute to the quality of clinical trials and provide public assurance that the rights, safety, and well-being of trial subjects are protected and the clinical trial data are credible.
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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.
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Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.
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presented,in meeting abstracts: “Research results should be easily accessible to people
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Cite this article as: Madhukiran Parvathaneni, Mrunalini Pattarkine, Deepthi Y Chappidi. Implementation of Project Management in Clinical Research. Inventi Rapid: Clinical Research, 2018(1):1-6, 2017.