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Amarex Publishes White Paper on Adaptive Designs for Clinical Trials

Germantown, MD, USA (February 10, 2020) – Amarex Clinical Research, LLC has published a white paper on “Understanding Adaptive Designs for Clinical Trials”. The paper, co-authored by Hana Mekonnen, MS, Senior Vice President of Biometrics (Amarex) and Deborah Cole, MS (Amarex), was published on January 23, 2020 in NSF International’s Health Sciences Journal, Issue 46, 2020 entitled Make 2020 Your Best Year, and is the product of a new initiative proposed by the United States Congress to facilitate patient access to available treatments.

The white paper defines adaptive design, summarizes its history and current application and discusses concerns, including inexperience, fears from stakeholders and regulators and practical limitations/challenges. Challenges are also addressed and the paper recommends sponsors to:

  1. Consider the benefits of adaptive designs, which, overall, lead to enhanced utilization of resources
  2. Familiarize oneself with adaptive design methods to assuage fears preventing implementation
  3. Consider practical, trial specific limitations and challenges
  4. Consult expert biostatisticians from design through study completion to ensure challenges and complexities are appropriately addressed
  5. Explore a number of design options and discuss considerations with the appropriate FDA review division
  6. Remember that regulatory bodies, such as the US FDA, can help you through this process

Reflecting on recommendations contained in the white paper, Dr. Kazem Kazempour, President & CEO of Amarex and former Statistical Reviewer at the FDA, noted, “It is great that the US FDA updated its guidance on adaptive designs for clinical trials as a part of this initiative to bring products to market faster. Adaptive designs are immensely useful, but unfortunately it is true that fears surrounding their complexity prevent their use. Hopefully, by educating researchers, sponsors and other members of the biotechnology community, and with added support from the US FDA, we can dispel these fears and elevate adaptive designs to the status that they deserve. We have a great tool at our disposal to support the mission of our field, and it should be used.”

The white paper is available as a downloadable PDF at www.nsf.org/knowledge-library/white-paper-understanding-adaptive-designs-for-clinical-trials.

About NSF International

Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. Our mission is to protect and improve global human health. As an independent, accredited organization, our standards group facilitates the development of standards, and our service groups test and certify products and systems. We also provide auditing and risk management solutions for public health and the environment.

About Amarex Clinical Research, LLC, an NSF International company

Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexus.com.

Amarex Contact:
Patrick J. Burke
Business Development
patrickb@amarexcro.com

20201 Century Blvd., Fourth Floor
Germantown, MD 20874 USA
301 528 7000
www.amarexus.com

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