Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Sprenger, Ken; Nickerson, David F.; Meeker-O’Connell, Ann; Morrison, Briggs W.

doi:10.1177/0092861512458909

Cited by 13 publications

(7 citation statements)

References 8 publications

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“…Previous studies about clinical drug trial quality usually focused on specific aspects, such as trial design, 5 subject recruitment, 6,7 rights protection, [8][9][10][11][12][13][14] role of nurses, [15][16][17][18] control of side effects 16,19 and trial data 20,21 from a micro-perspective. Further, Moher et al, 2 Verhagen et al, 22 Maher et al 23 and Liu et al 24 undertook comprehensive studies that analysed the components, determinants and evaluation instruments with respect to quality of clinical trials: such efforts emphasize the design or implementation of trials at the micro-level.…”

Section: What Is K Nown and Objec Tivementioning

confidence: 99%

Quality of phase I clinical drug trials: Influence of organizational management factors

2020

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What is known and Objective Focusing on the tolerance and pharmacokinetics of new drugs, phase I clinical drug trials are characterized by high risk, poor compliance and management difficulties. High‐quality clinical drug trials ensure subjects' safety while extending new drug research and development. Many studies have examined micro‐level concerns of trial design and implementation rather than macro‐level factors. Accordingly, we evaluated the quality of phase I clinical drug trials (trial quality) and analysed the influence of organizational management factors from a macro‐level perspective. Methods We surveyed staff at clinical trial institutions engaged in phase I clinical drug trials in China using convenience sampling. We employed a five‐point Likert‐scale questionnaire, comprising five items on phase I clinical drug trial quality and items on organizational management factors. Data from 604 questionnaires were analysed. We utilized a logistic regression model to estimate the influence of organizational management factors on trial quality, using individual demographic factors as controlling variables. Results and discussion The trial quality score was 3.81, which indicates that substantial improvement is required. Government regulation, industry management and medical institution management had a positive effect on trial quality: β = 0.842, 0.691 and 0.579, respectively; P < .01. Contract research organization management had a negative effect on trial quality: β = −0.476; P = .013. Research team management had no effect on trial quality: β = 0.325; P = .141. What is new and Conclusion This study is the first to model the influence of organizational management factors on the quality of phase I drug trials involving different organizations from a macro‐perspective. Efforts are needed to help research teams take responsibility for trial quality and to correct the negative impact of contract research organizations on trial quality.

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Section: What Is K Nown and Objec Tivementioning

confidence: 99%

Quality of phase I clinical drug trials: Influence of organizational management factors

2020

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“…12 Other methods to prevent deviations may include qualityby-design approaches, including describing select details in study guidelines, manuals, and plans rather than the protocol; leaving certain criteria up to the ''discretion of the investigator''; and not classifying missing data due to subjects being withdrawn from the study as protocol deviations. [13][14][15]…”

Section: Protocol Complexity and Objectivesmentioning

confidence: 99%

The Life Cycle and Management of Protocol Deviations

Mehra

Kurpanek²,

Petrizzo³

et al. 2014

Ther Innov Regul Sci

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Clinical trials are designed to evaluate the efficacy, safety, or other characteristics associated with medical products. Trials are usually complex and require a large group of professionals to follow a clinical trial protocol, standard operating procedures, and study-specific manuals, guidelines, and plans. Clinical trial protocols prospectively describe the background and rationale for conducting the trial, the objectives of the trial, the trial design, the equipment to be used, the procedures to be performed, and the statistical methods on how the trial data are to be analyzed. Deviations from the protocol can result in harm to subjects, biased or inaccurate results, and possible rejection of all or part of the trial data by the sponsor or regulatory authorities. Despite preventive efforts, protocol deviations are likely to occur in most trials. This position paper proposes a common definition of protocol deviations and recommends best practices for their detection, classification, and management as part of their life cycle, with a goal of reducing their impact on subject safety and data integrity. The information contained herein is drawn globally from industry experts within the DIA Good Clinical Practice and Quality Assurance community, an industry-wide survey, and presentations with discussions at various industry meetings.

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“…During the past decade, protocol deviations have received increased attention as part of a broader effort to improve protocol design and executional quality [ 5 , 6 ]. Consortia and collaborative groups have developed consensus definitions of protocol deviation types as well as frameworks to prevent and manage them.…”

Section: Introductionmentioning

confidence: 99%

Benchmarking Protocol Deviations and Their Variation by Major Disease Categories

Getz

Smith

Jain

et al. 2022

Ther Innov Regul Sci

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Background Little to no data exist quantifying and benchmarking the magnitude of protocol deviation experience. Methods Nearly two-dozen companies provided the Tufts Center for the Study of Drug Development (Tufts CSDD) with data on the design and the performance of 187 protocols. Results The results of this working group study show that phase II and III protocols have a mean total of 75 and 119 protocol deviations, respectively, involving nearly one-third of all patients enrolled in each clinical trial. Oncology clinical trials have the highest relative mean number of protocol deviations affecting more than 40% of patients enrolled in each trial. The number of endpoints, the number of procedures per visit, and the number of countries were modestly positively associated with and predictive of, the incidence of deviations per protocol. A strong positive relationship was shown between the number of investigative sites and the number of protocol deviations. Conclusion The results of this initial study provide useful measures that sponsor companies can use to benchmark their own protocol deviation experience, identify factors most associated with protocol deviations, and determine whether remediation is warranted.

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Quality by Design in Clinical Trials: A Collaborative Pilot With FDA

Cited by 13 publications

References 8 publications

Quality of phase I clinical drug trials: Influence of organizational management factors

Quality of phase I clinical drug trials: Influence of organizational management factors

The Life Cycle and Management of Protocol Deviations

Benchmarking Protocol Deviations and Their Variation by Major Disease Categories

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