Access planning and resource coordination for clinical research operations

Deglise‐Hawkinson, Jivan; Kaufman, David L.; Roessler, Blake J.; Oyen, Mark P. Van

doi:10.1080/24725854.2019.1675202

Cited by 5 publications

(3 citation statements)

References 34 publications

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“…Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [17]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [18].…”

Section: Practical Aspects Of a Clinical Trial Operationsmentioning

confidence: 99%

Clinical Trials and Clinical Research: A Comprehensive Review

Kandi¹,

Vadakedath²

2023

Cureus

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Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

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Section: Practical Aspects Of a Clinical Trial Operationsmentioning

confidence: 99%

Clinical Trials and Clinical Research: A Comprehensive Review

Kandi¹,

Vadakedath²

2023

Cureus

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“…Other papers consider the fact that each patient (job) may initiate a time series of appointments over multiple days with deadlines/time windows for downstream appointments (see Gocgun and Ghate 2012, Hulshof et al 2013, Saur e et al 2012. Targeting clinical trial site operations, Deglise-Favre- Hawkinson (2015) studies capacity reservation and time windows for service, but focuses on the selection of which clinical trials to conduct subject to capacity. Turkcan et al (2012) studies an optimization approach to planning as well as scheduling for chemotherapy infusion.…”

Section: Context and Literature Surveymentioning

confidence: 99%

A Capacity Allocation Planning Model for Integrated Care and Access Management

Deglise‐Hawkinson

Helm

Huschka

et al. 2018

Production and Operations Management

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The prevailing first-come-first-served approach to outpatient appointment scheduling ignores differing urgency levels, leading to unnecessarily long waits for urgent patients. In data from a partner healthcare organization, we found in some departments that urgent patients were inadvertently waiting longer for an appointment than non-urgent patients. This paper develops a capacity allocation optimization methodology that reserves appointment slots based on urgency in a complicated, integrated care environment where multiple specialties serve multiple types of patients. This optimization reallocates network capacity to limit access delays (indirect waiting times) for initial and downstream appointments differentiated by urgency. We formulate this problem as a queueing network optimization and approximate it via deterministic linear optimization to simultaneously smooth workloads and guarantee access delay targets. In a case study of our industry partner we demonstrate the ability to (1) reduce urgent patient mean access delay by 27% with only a 7% increase in mean access delay for non-urgent patients, and (2) increase throughput by 31% with the same service levels and overtime.

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“…Errors caused by duplicate data input are reduced by storing clinical trial site data in the CDMS in the form of case record forms. Premarket approval applications verify operations from laboratory to animal to human clinical investigations for safety and efficacy [5].…”

Section: Introductionmentioning

confidence: 99%

Biostatistical Methodologies in Clinical Trials: An Overview of Recent Developments and Pitfalls

Sagar Kumar

2023

Int J Clin Biostat Biom

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Biostatistical analysis has emerged as one of the most crucial applications for clinical trial systems. The relevance of statistical analysis in clinical trials cannot be overstated in the advancement of novel pharmaceuticals and therapeutics. Data volumes, including effectiveness and safety summaries, are produced throughout the process of developing and approving novel medicines. Data standards developed by the Clinical Data Interchange Standards Consortium (CDISC) are well-established, widely accepted, and widely utilized by the pharmaceutical sector for submissions to regulatory bodies. Biostatistical programs like PRM, ODM, CDASH, SDTM, ADaM, SAS, and ARDM have come a long way in recent years, and this article highlights those developments. The present study has made an effort to report on the typical difficulties encountered when using biostatistical methods, as with every new discovery, there is always a potential pitfall. Even the main endpoint of the experiment might be improperly analysed without adequate validation of model assumptions. Biostatisticians must collaborate closely with physicians to choose the most suitable statistical methods for data assessment; otherwise, the results may be ambiguous or misleading. To guarantee that a clinical trial satisfies the requirements of regulatory agencies in drug approvals, future research should concentrate on strategies that can enhance the compliance and validation processes.

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Access planning and resource coordination for clinical research operations

Cited by 5 publications

References 34 publications

Clinical Trials and Clinical Research: A Comprehensive Review

Clinical Trials and Clinical Research: A Comprehensive Review

A Capacity Allocation Planning Model for Integrated Care and Access Management

Biostatistical Methodologies in Clinical Trials: An Overview of Recent Developments and Pitfalls

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