scholarly journals Development of Novel, Value-Based, Digital Endpoints for Clinical Trials: A Structured Approach Toward Fit-for-Purpose Validation

2020 ◽  
Vol 72 (4) ◽  
pp. 899-909 ◽  
Author(s):  
M. D. Kruizinga ◽  
F. E. Stuurman ◽  
V. Exadaktylos ◽  
R. J. Doll ◽  
D. T. Stephenson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Fit For Purpose ◽  
Structured Approach

scholarly journals Achieving effective patient and public involvement in international clinical trials in neurology

2019 ◽  
Vol 10 (3) ◽  
pp. 265-272 ◽  
Author(s):  
Emma C. Tallantyre ◽  
Nikos Evangelou ◽  
Clare Bale ◽  
Burhan Z. Chaudhry ◽  
Emma H. Gray ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Research Team ◽  
Public Involvement ◽  
Patient And Public Involvement ◽  
Controlled Trials ◽  
Framework Analysis ◽  
Randomized Controlled ◽  
Structured Approach

There is a growing need for patient and public involvement (PPI) to inform the way that research is developed and performed. International randomized controlled trials are particularly likely to benefit from PPI, but guidance is lacking on how or when it should be incorporated. In this article, we describe the PPI process that occurred during the design and initiation of an international treatment clinical trial in MS. PPI was incorporated using a structured approach, aiming to minimize bias and achieve equivalence in study design, implementation, and interpretation. Methods included PPI representation within the study research team, and the use of focus groups, analyzed using thematic framework analysis. We report the outcomes of PPI and make recommendations on its use in other neurology clinical trials. By sharing our model for PPI, we aim to maximize effectiveness of future public involvement and to allow its effect to be better evaluated.

Impact of Fit-for-Purpose Monitoring on EOR Planning

2021 ◽  
Author(s):  
Jaime Eduardo Moreno ◽  
Yunlong Liu ◽  
Oluwale Talabi ◽  
Omer Gurpinar ◽  
Morten Kristensen ◽  
...  
Keyword(s):  
Control Strategies ◽  
Time Lapse ◽  
Monitoring Strategy ◽  
Reservoir Performance ◽  
Fit For Purpose ◽  
Reduce Risk ◽  
Pilot Design ◽  
Monitoring Technologies ◽  
Performance Heterogeneity ◽  
Structured Approach

Abstract Challenges in the design of efficient EOR field pilots have been discussed and documented in the industry, particularly when it comes to optimization of monitoring plans for technical and economical perspectives. This paper explores the benefits of pilot planning where the monitoring/control strategies are included in the early stages of the design to reduce risk of measurements ambiguity and ensure good quality pilot results evaluation. It addresses the use of new and existing technology in monitoring by highlighting the advantages and challenges of each alternative including potential pairing of complementary options to achieve the pilot objectives including illustration of the use of continuous and sporadic measurements on the evaluation. The proposed approach starts with a review of reservoir performance, heterogeneity and pilot objectives to ascertain the plausible monitoring technologies/strategies to aid during the pilot de-risking, followed by the identification of adequate novel and mature monitoring options, which are specific to EOR type and measurement nature (permanent, time lapse, etc.). Advantages of incorporating the monitoring strategy as integral part of the pilot design, as well as evaluation of the effectiveness/viability in the presence of uncertainty of the selected monitoring alternatives are discussed providing a reference of suitable/plausible EOR specific technologies. The paper illustrates the importance of selecting monitoring alternatives that feed off each other and the importance of using fit-for-purpose evaluation algorithms and a digitally enabled, structured approach to analyze and democratize pilot results and enable actionable decisions in operations.

scholarly journals Clinical trials in the pandemic age: What is fit for purpose?

2020 ◽  
Vol 4 ◽  
pp. 58 ◽  
Author(s):  
Dan Hartman ◽  
Penny Heaton ◽  
Nick Cammack ◽  
Ian Hudson ◽  
Shawn Dolley ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Clinical Study ◽  
Clinical Research ◽  
Vulnerable Groups ◽  
Equitable Access ◽  
Fit For Purpose ◽  
Gates Foundation ◽  
And Migration ◽  
Scientific Questions

It is critical to ensure that COVID-19 studies provide clear and timely answers to the scientific questions that will guide us to scalable solutions for all global regions. Significant challenges in operationalizing trials include public policies for managing the pandemic, public health and clinical capacity, travel and migration, and availability of tests and infrastructure. These factors lead to spikes and troughs in patient count by location, disrupting the ability to predict when or if a trial will reach recruitment goals. The focus must also be on understanding how to provide equitable access to these interventions ensuring that interventions reach those who need them the most, be it patients in low resource settings or vulnerable groups.  We introduce a website to be used by The Bill & Melinda Gates Foundation, Wellcome Trust, and other funders of the COVID Therapeutics Accelerator that accept proposals for future clinical research. The portal enables evaluations of clinical study applications that focus on study qualities most likely to lead to informative outcomes and completed studies.

scholarly journals The Clinical Trials Transformation Initiative: Methodology supporting the mission

2018 ◽  
Vol 15 (1_suppl) ◽  
pp. 13-18 ◽  
Author(s):  
Amy Corneli ◽  
Zachary Hallinan ◽  
Gerrit Hamre ◽  
Brian Perry ◽  
Jennifer C Goldsack ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Public Private Partnership ◽  
Private Partnership ◽  
Key Stakeholders ◽  
Duke University ◽  
Fit For Purpose ◽  
Evidence Gathering ◽  
The U.S

The mission of the Clinical Trials Transformation Initiative, a public–private partnership co-founded by the U.S. Food and Drug Administration and Duke University, is to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. The Clinical Trials Transformation Initiative works collaboratively with key stakeholders, implements “fit-for-purpose” evidence-gathering projects, and develops actionable recommendations and tools to address the challenges faced by the clinical trials enterprise. In pursuit of its mission, The Clinical Trials Transformation Initiative follows an innovative and collaborative, five-step methodology: (1) state the problem and identify impediments to research, (2) gather evidence to identify gaps and barriers, (3) explore results by analyzing and interpreting findings, (4) finalize solutions by developing recommendations and tools, and (5) drive adoption through disseminating and implementing recommendations and tools. This article describes each step of the Clinical Trials Transformation Initiative's methodology, with a specific focus on describing the evidence-gathering activities.

An operational and scientific monitoring program (OSMP) for the Prelude and Ichthys fields: a case study from the Browse Basin

2014 ◽  
Vol 54 (2) ◽  
pp. 480
Author(s):  
David Souter ◽  
Steve Rogers ◽  
Jamie Oliver
Keyword(s):  
Oil Spill ◽  
Monitoring Program ◽  
Baseline Data ◽  
Australian Institute ◽  
Monitoring Programs ◽  
Oil Spill Response ◽  
Fit For Purpose ◽  
Gas Fields ◽  
Structured Approach

An OSMP is the principle tool for determining the extent, severity, and persistence of environmental impacts from an oil spill. The OSMP developed for the Shell Prelude and Inpex Ichthys gas fields has 13 operational monitoring programs (OMPs) and 12 scientific monitoring programs (SMPs) reflecting the complexity of the environment in which the developments are located. A partnership of organisations led by the Australian Institute of Marine Science (AIMS) will provide specialist expertise to help implement the OSMP. This unique multi-disciplinary partnership, comprising AIMS, CSIRO, University of Western Australia, Curtin University, WA ChemCentre, and Monash University, guarantees capability and capacity, reducing the level of risk incurred by individual organisations within the partnership. Fundamental to the success of any OSMP is the existence of adequate, fit-for-purpose baseline data against which post spill observations can be compared to determine the extent and severity of the spill and assess effectiveness of oil spill response. In addition, we believe adequate baselines with sufficient temporal resolution are essential for OSMP credibility and maintenance of the scientific reputations of partners. In committing capability to the OSMP implementation, AIMS and its partners have adopted a risk-based approach to assessing the adequacy of existing baseline data, to identify knowledge gaps, and assess the significance of those gaps and the feasibility of filling them. This extended abstract describes the structured approach taken to analyse the various risks and to develop a balanced suite of environmental baseline studies to address these risks.

scholarly journals A structured approach to choosing estimands and estimators in longitudinal clinical trials

2012 ◽  
Vol 11 (6) ◽  
pp. 456-461 ◽  
Author(s):  
C. H. Mallinckrodt ◽  
Q. Lin ◽  
I. Lipkovich ◽  
G. Molenberghs
Keyword(s):  
Clinical Trials ◽  
Structured Approach
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