Newsletter | October 21, 2019

10.21.19 -- DPHARM 2019: Emerging Technologies Set To Disrupt Clinical Trials

Featured Editorial
DPHARM 2019: Emerging Technologies Set To Disrupt Clinical Trials
By Ed Miseta, chief editor, Clinical Leader

DPHARM: Disruptive Innovations is an annual conference that focuses on the innovators shaping the future of trials. Its goal is to bring together disruptive thinkers and change makers to discuss and share ideas on how to transform drug development. In this Q&A, Tammy Guld, global team lead in Janssen Clinical Innovation and co-chair at this year’s conference, shares her key takeaways from the 2019 event.

5 Narrative Elements That Will Reveal The Masterpiece In Your TMF
By Thomas Cocciardi, LMK Clinical Research Consulting

In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.

Industry Insights
Risk Evaluation And Mitigation Strategies: FDA Guidances For Assessing Effectiveness
Article | By Samantha Hoopes, Ph.D., RAC, Rho

In January 2019, the Food and Drug Administration (FDA) released two draft guidance documents regarding assessment of risk evaluation and mitigation strategies (REMS). These documents are meant to provide industry with additional information to more accurately assess the effectiveness of their REMS. This article gives an overview of each of these documents and what they could mean for you.

The Politics Of Investigator-Initiated Trials
Article | By Jennifer Dennis-Wall, Ph.D., Biorasi

Investigator-initiated trials (IITs) present a way for post-marketing, real-world data to be added to a drug or device’s portfolio without the sponsor initiating the research. Everyone can agree on the fact that more research, and especially real-world evidence, is helpful for advancing the field of medicine, but not everyone is always in favor of IITs. Following are problems and benefits of IITs.

To Mitigate Placebo Response, Test, Train, And Control Expectations
Article | By Dr. Nathaniel Katz, WCG

The placebo effect. It’s the curse of clinical trials across indications, but it’s a particularly thorny issue for pain researchers. In fact, along with the inability of many patients to accurately report symptoms, it may be the main challenge facing analgesic trials. Left unaddressed, these issues have contributed to the failure of many clinical trials.

Best Practices For Clinical Trial Labeling Success
Article | By Joanne Staszczyszyn and Kay Kim, Bellwyck Pharma Services

If you are also responsible for the labeling of your trial drug, you know that this is sometimes an afterthought or considered the final phase in the process. However, it is the key to the overall success of the trial. Read how a focus on preplanning and following labeling best practices will not only help you get your trial drug ready faster but will ensure all regulatory requirements have been met and prevent any delays in study start-up.

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?

Six Issues To Consider For Rare Disease Pre-IND Meetings
Article | Premier Research

Careful planning is important for all early drug development programs, but it is particularly critical in rare diseases where study populations are limited and precedents for drug development are lacking. By proactively preparing for this meeting sponsors can set themselves up for productive discussions that may help in identifying areas of regulatory flexibility.

New Developments In The Clinical Development Landscape For Ophthalmology
Q&A | Medpace

Ophthalmology is a growing therapeutic area in clinical research with new and exciting developments occurring in the field, particularly in stem cell and gene cell therapies. Marco Tangelder, M.D., senior medical director, medical department at Medpace, highlights some of the advancements in ophthalmology research and where the field is headed.

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