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June 2/2020

news roundup

What Do Patients Know About COVID-19 Clinical Trials?

CISCRP released the results of its survey conducted in April on what the public and patients perceptions about clinical research in regard to the pandemic. Overall, awareness of clinical trials remains low—as 58% had not heard of a COVID-19 clinical research study recently.


EMA Prepares for Real-World Monitoring of COVID-19 Vaccines

EMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once authorized in the European Union.


Covance Adopts Medable’s Platform for Decentralized Trials

LabCorp’s drug development business, Covance, announced it will adopt Medable’s modular software platform as its patient and site interface to allow patients to participate in decentralized clinical trials.


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COVID-19 Serology Assays: To Test or Not to Test
Tuesday, June 2, 2020 at 11am EDT
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In this edition

TCSDD, Biogen Study Keys to Increasing Diversity in Clinical Trials
Germany’s HTA Agency Seeks COVID-19 Transparency

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DIA 2020 Global Annual Meeting, Now Virtual
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Bioforum, the Forum for EmergingBio's Outsourcing Decisions
As the biopharma industry traverses unchartered waters amid the COVID-19 crisis and doubles down on its efforts to bring new therapies to market faster, cheaper and without affecting quality, the success of strategic partnerships and functional service provider models will become more critical than ever before.
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Articles

Considerations in Re-Planning Clinical Trial Enrollment

Re-planning recruitment during the COVID-19 pandemic is a challenge, but can be started now despite the complexity and uncertainties related to the pandemic. The authors suggest creating multiple scenarios, ranging from the best to worst case assumptions, to assess a reasonable window-of-time, when recruitment may re-start and end.


TCSDD, Biogen Study Keys to Increasing Diversity in Clinical Trials

The Tufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research are presented in this article and provide key insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.


Blog Posts

Challenges in Sepsis Clinical Trials

Designing and operating clinical trials for diagnosing sepsis can be a challenge, as septic blood cultures predict sepsis only 14% of the time, which makes it a very challenging baseline for generating strong predictive data to prove novel diagnostics’ efficacy. Dr. Rolland Carlson, CEO of Immunexpress, discusses how the company overcame the challenges of implementing sepsis clinical trials.

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Lisa Henderson
Editor in Chief
LHenderson@mjhlifesciences.com

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Todd Baker
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TBaker@mjhlifesciences.com