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March 3/2020

news roundup

Increased Data Sources Contributing to Trial Delays

According to a new report from eClinical Solutions and Tufts CSDD, the increasing volume and diversity of external data sources is contributing to longer database lock cycle times. Other findings from their study include that over two-thirds of sponsors are using or piloting at least four types of data in clinical trials; and only one-third of sponsors have implemented a formal data strategy.


Science 37 Introduces Mobile Support for Patient Platform

Science 37, a provider of decentralized clinical trials services, has introduced native support for iOS and Android operating systems, for patients to learn more about a study, provide consent, schedule and participate in study visits, complete assessments, and more within a single platform.


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Virtual, Decentralized, Site-less Trials… What Does it All Mean?
Thursday, March 12, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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In this edition

European COVID-19 Efforts
Gene Testing, Future Problem or Blip


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Three Key Critical Considerations Before Embarking on Decentralized Trials
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Events

11th Proactive GCP Compliance Conference
9th Annual Publication and Clinical Trial Transparency, London
DIA 2020 Global Annual Meeting
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Articles

GCP Refresher Courses for Clinical Trial Personnel

Clinical Research Malaysia (CRM), a research organization founded by the Malaysia Ministry of Health (MOH), shares the results of its GCP refresher workshops for clinicians, nurses, allied health professionals, and study coordinators who have been certified with Malaysian GCP.

The ICH E9 Estimand Framework Explained

In this article, the authors detail the ICH E9 guidance addressing statistical methods for use in clinical trials, which outlined a structured statistical framework based on the use of estimands for use in clinical trials, released in November 2019. The objective of the estimand framework is "to align the clinical study objective with the study design, endpoint, and analysis to improve study planning and the interpretation of analysis."

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AI in Action: Clinical Development AI Use Cases
Access an online resource with useful tools and practical information about advances in RBM. The site provides useful white papers, articles, webcasts, and more.
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Blog Posts

Gene Testing, Future Problem or Blip

In this opinion, Editor Lisa Henderson discusses a drop in the use of consumer gene testing kits, and what this could mean to the future uses of genetic data in clinical trials.

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Ask the editor

Lisa Henderson
Editor in Chief
LHenderson@mmhgroup.com

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Todd Baker
Group Publisher
TBaker@mmhgroup.com