08.16.21 - A Proactive Approach To Preparing For The Release Of ICH E6

By Laurie Halloran and Michelle Pratt

Managing up, regardless of title, can be a challenging skill to master from the onset. Laurie Halloran and Michelle Pratt of Halloran Consulting share their six key lessons that they’ve learned in their careers in clinical development. This article will help you manage your relationships with your colleagues in a more senior role, while also positioning yourself for success.

By Ed Miseta, chief editor, Clinical Leader

Approximately 25 years ago, work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and sponsor companies need to be prepared for it.

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By Alicia C. Staley, Medidata, a Dassault Systèmes company

Without an engaged patient, a clinical trial cannot do its essential work. It is also important that we remember that clinical trial participants are people; they aren’t just the data we collect. We put the patient experience at the center of clinical trial design.

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By Melva T. Covington, MPH, MBA, Ph.D.,
Ciox Life Sciences

The projected costs of healthcare in the United States due to COVID-19 are eye-opening. One critical question is the extent to which digital technologies can be useful in informing our understanding of what works in healthcare delivery and what does not. Access to more complete data is crucial to empower a diverse range of stakeholders with the knowledge and ammunition needed to make informed choices about expenditures and the use of scarce healthcare resources.

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By Yves Massicotte,
Ropack Pharma Solutions

Blister packaging, not long ago considered a less-significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. The pharmaceutical manufacturing industry has witnessed a significant increase in the number of drug approvals by the FDA over the past few years, leading to several packaging innovations. Here are the factors that are driving blister to the forefront of pharmaceutical packaging, and at an even faster rate than its current growth.

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By Samantha Roberts, Dylan Bechtle, Katherine Williams, and Rasika Kalamegham,
DIA

The U.S. FDA’s 2020 Drug Trials Snapshots Summary Report found that clinical trials supporting the 53 new molecular entities approved by FDA’s Center for Drug Evaluation and Research (CDER) in 2020 included, on average, only 11% Hispanics and 8% African Americans. This lack of diversity in clinical trials can have a direct impact on health outcomes. Read below to see how the events of the past year have brought a renewed sense of urgency to ensure that underserved and understudied patient populations are not left behind in our age of personalized healthcare.

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By Tyler Bye and Patrick McNamara,
WCG

A proactive approach to site augmentation helps enroll over 30,000 vaccine study participants in just over three months.

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By Irene Figari,
Premier Research

Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life. Read how that’s changed with the recent publication of a new draft guidance from the U.S. FDA’s Oncology Center of Excellence (OCE), Core Patient-Reported Outcomes in Cancer Clinical Trials.

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By Krista Bradley,
IQVIA Research & Development Solutions

When we talk about decentralized clinical trials (DCTs), the conversation usually centers on the technology; however, DCTs require more than technology. There is an equally important human component driven by specialized study teams, including mobile research nurses and phlebotomists, who engage patients where they live. This blog explores how mobile research teams have become the unsung heroes of the tech-enabled clinical trials movement.

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Thermo Fisher Scientific

With increasing costs of clinical trials and the advantages of being first-to-market, it’s time to take a closer look at your supply chain to ensure it delivers with speed, efficiency, quality, and within your budget. This article is a guide through numerous considerations to decide whether to build your capability, outsource it, or create a hybrid insource/outsource model.

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Medrio

Electronic patient-reported outcome (ePRO) solutions are helping bridge the gap between patient-centric workflows that engage patients while generating higher quality, more reliable data that successful studies need. This blog explores the role ePRO plays in patient engagement and how to harness it moving forward.

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KPS Life LLC

Sponsors and CROs employ clinical research associates (CRAs) to monitor clinical study sites. Because most site monitoring is done in the field, it is challenging for study managers to know and understand if CRAs/monitors are conducting their duties effectively and efficiently. Many study sponsors therefore employ co-monitoring/oversight visits to directly evaluate CRA performance and facilitate training. The following process can help to achieve successful co-monitoring/oversight visits.

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ISR Reports

ISR was engaged by the global marketing director at a Top 20 CDMO with the above question. The client had years of experience in marketing their brand to prospective customers but had recently begun to question the efficiency of their marketing spend. The client wanted to demonstrate to their company stakeholders that their marketing efforts were not only hitting the right targets, but that the language used in those efforts reflected their customers’ needs. Knowing this information would allow the client’s marketing department to move away from broad, product-based messaging focused on how good their services are, to messaging focused on how their services address their customers’ concerns.

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IQVIA Technologies

Two of America’s greatest assets are its diverse demographics and its relentless pursuit of new medicines and treatments to improve patients’ lives worldwide. Unfortunately, it is a widely known (but little discussed) challenge that the two do not go hand in hand. Minority participation in clinical trials is staggeringly deficient.

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PCI Clinical Services

Rich Nelson, senior manager, global logistics, recently discussed the different aspects to importing clinical supplies into China including the unique import requirements that China has, the benefits of running clinical trials in China, and moving clinical supply between Hong Kong and China.

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Greenphire

When the catalyst of the COVID-19 pandemic wanes, we risk losing the progress our industry has made unless we collectively refuse to go back to the way things were before and instead dedicate ourselves to implementing even more advancements and innovations that we’ve previously only dreamed of.