Newsletter | September 11, 2019

09.11.19 -- What I Learned At AbbVie's Development Design Center

  CTMS Market Dynamics And Service Provider Benchmarking (2nd Edition)

ISR surveyed 110 qualified CTMS decision makers for insights on CTMS selection drivers, outsourcing trends, use, and perceptions of providers. Respondents shared improvements they’d like to see in the next generation of CTMS software and conveyed provider-specific advantages and improvement suggestions for their preferred system. Furthermore, recent users of 25 CTMS softwares rated how they compared against expectations on 26 attributes across four categories (capabilities, data/documentation features, user-friendliness, and scalability). More.

Featured Editorial
What I Learned At AbbVie’s Development Design Center
By Ed Miseta, chief editor, Clinical Leader

In July 2019 I had the opportunity to visit the AbbVie campus in North Chicago. My purpose for being there was to tour the company’s Development Design Center (DDC), which provided a detailed look into what AbbVie sees as the future of clinical trials.

Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs
By Dominika Rudnicka-Noulin, Ph.D., Decision Resources Group

Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.

Industry Insights
5 Reasons To Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy
Article | By Esha Senchaudhuri, Cytel

An important trend in clinical development involves integrating strategic pharmacometric analysis with program-level decision making to make the most use of available data. This article highlights five reasons why you should consider utilizing model-based meta-analyses (MBMAs) for your program or portfolio development.

Master Protocols And The New FDA Guidance
Article | By Kevin Barber, Ph.D., Rho

In September of 2018, the FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges?

Spotlight: 510(k) — What FDA Changes Could Mean For Medical Device Research And Beyond
Article | By Nick O’Brien, Medrio

The medical device industry is undergoing seismic regulatory shifts. These shifts have major implications for clinical trials and eClinical technology, and are largely aimed toward modernizing some of the industry’s biggest institutions — namely, the 510(k) program. At Medrio, we’ve been keeping close watch on how the story develops.

The Importance Of Advocating For Female Participation In Clinical Trials
Article | By Kristen Snipes, Health Decisions Inc.

For decades, drugs were approved without being tested on women or factoring in whether women would have different reactions or require different dosages than men. Attitudes around involving women in clinical trials have evolved significantly in the past 25 years; however, despite new expectations from regulators pushing for women to be involved in studies, parity has yet to be achieved.

Differentiating Oncology Research Pipeline In Today’s Competitive Era
White Paper | By Paul Roma, Florian Quarre, and Julie Krommenhoek, Ciox Health - Life Sciences

With novel therapies being launched there is a shift in data and evidence requirements as well. How can you be sure you are keeping up with the real-world evidence demands?

Investigational New Drug Applications: Four Common Mistakes
Article | Premier Research

Before starting Phase 1 trials, an Investigational New Drug (IND) application must be approved by the FDA. This critical early step in clinical trial development grants an exemption to laws prohibiting the transportation of drugs across state lines prior to market approval. Here are the most common errors we’ve seen made with IND submissions.

Solving The Challenge Of Comparator Drug Procurement
Case Study | Thermo Fisher Scientific

A leading pharmaceutical company needed assistance in obtaining comparator study medication for a global Phase 3 program. The global trial was focused on an infectious disease and involved 130 sites.

Tailored Ultra-Low Temperature Labeling Environment Enables Trial Success
Case Study | Almac Group

Clinical labeling is a function that has the potential to make or break a study, depending upon design and execution. Incredibly specific and complex handling requirements associated with new medicines and biologics amplify the challenges of compliantly packaging and labeling clinical supply. In our latest case study, we look at the complexities involved in the labeling and kit assembly of an IP with very rigid, ultra-low storage and stability conditions.

Clinical Statistics For Nonstatisticians
Continuing Education Course
October 14, 2019, 8:00 AM EDT | Philadelphia, PA
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