Newsletter | January 13, 2020

01.13.20 -- BMS-Pfizer Alliance Evaluates AFib Screening And Stroke Connection

Featured Editorial
BMS-Pfizer Alliance Evaluates AFib Screening And Stroke Connection
By Ed Miseta, chief editor, Clinical Leader

In November 2019, the BMS-Pfizer Alliance announced the initiation of a new randomized, controlled study called GUARD-AF. The trial will evaluate whether atrial fibrillation (AFib) screening can ultimately impact the rate of stroke compared to standard medical care in older individuals in a real-world setting.

An Immunologist’s Journey To Get An Ovarian Cancer T-Cell Therapy Into Clinical Trials
By Kevin Honeycutt and Erin Graham, Alliance for Cancer Gene Therapy (ACGT)

Ovarian cancer is a formidable foe, killing about 15,000 women a year in the United States alone. It’s especially hard to treat because there are no effective screening tests. That means that the disease is usually only diagnosed after it has significantly advanced, leaving women with a five-year survival rate of less than 25 percent.

Industry Insights
Returning Study Results To Research Participants
White Paper | By David Forster, JD, MA, CIP, Lindsay McNair, MD, MPH, MSB, and Brandis Pickard, WCG

Studies show that most clinical trial participants want to know what was learned from their involvement. A growing number of sponsors are implementing plans to deliver plain language summaries to trial participants. Read this white paper to learn about the current best practices for the content and preparation of plain language summaries and the current guidance for how sponsors should work with institutional review boards (IRBs), which have oversight of the clinical trials for which the summaries are provided.

Clinical Trial Disclosure Efficiency In Five Steps
Article | TransPerfect

At present, sponsors of multinational clinical trials must coordinate clinical trial disclosure according to international and national guidelines. Challenges of disclosure include collecting data from various sources, data validation, registry input, process tracking, prevention of redundancies in multiregistry postings, and maintaining timelines per each registry. Whether you opt for an automated software system or choose to input manually, the following five-step process will help minimize error and optimize efficiency.

How To Create And Maintain An Inspection-Ready Culture
Article | Veeva Systems, Inc.

Inspection readiness has a significant and measurable impact on staff, trial performance, and study execution. Unfortunately, many organizations begin preparing for an inspection only when a drug or device is filed for approval or when they receive notification of an impending inspection — causing undue stress and burden. Get the checklist for nine steps to achieve ongoing inspection readiness.

Good Pharma Scorecard: See What The Top 5 Sponsors Have In Common
Article | TrialScope

The Good Pharma Scorecard, as its acronym suggests, is the industry GPS for clinical trial transparency. See what this year's top-ranked sponsors all have in common.

Considerations For Clinical Studies In Heavy Menstrual Bleeding
White Paper | Health Decisions Inc.

Clinical trials of therapeutics for heavy menstrual bleeding (HMB) involve unique operational and methodological considerations including defining eligibility requirements, proper training, and accurate measurements to name a few. Read more about these considerations as well as key risks and mitigations in HMB studies.

The Critical Importance Of Comparator Temperature Excursion Management
Case Study | Thermo Fisher Scientific

Today, comparator procurement is one of the most expensive components of clinical trials. This cost can take on further meaning as the risk of a temperature excursion or a loss of drug due to time out of environment can result in additional charges and even delays in the trial.

Comparator Sourcing: The Challenge Of Compliantly And Cost-Effectively Navigating Global Supply Chains
E-Book | Almac Group

The challenge of compliantly and cost-effectively navigating global supply chains, often involving high-value, temperature-sensitive products, has never been greater. This eBook explores the growing significance of comparator product use, typical sourcing models, and the common pitfalls sponsors should look to avoid.

Landmark AMA To Rely On Regulatory Reliance
Podcast | DIA

In February 2019, heads of state and governments of African countries endorsed the creation of an African Medicines Agency. “The concept of reliance is becoming really, really important and many countries and many regions are recognizing that,” explains David Mukanga, senior program officer regulatory affairs, Africa systems, Bill and Melinda Gates Foundation. “Now companies see a region coming together, more simplified, more efficient processes, and it makes it attractive for industry to then file applications into these regions.”

  7th Annual Patients As Partners U.S.

March 16 and 17, 2020 | Philadelphia, PA

The Patients as Partners U.S. conference delves deep into patient involvement ideas, strategies, and implementation processes that biopharma can utilize in order to help advance patient participation for better clinical outcomes. Each session demonstrates the what, where, when, and how to co-create solutions with patients and measure the impact of those initiatives. Use the code LSL15 for a 15% discount.

Data Management Workbench
Oracle Health Sciences
A Seamless Approach To IRT Integration
Cenduit LLC
Pharmacovigilance And Risk Management Strategies Conference

January 27 to 29, 2020 | Washington, D.C.

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