Monthly Archives: July 2018

In May 2012, the leaders of 30 medicine regulatory bodies from around the world gathered at the 65th World Health Assembly in Geneva, collectively puzzling over how to improve cooperation among them. Their answer came later that year: form the International Coalition of Medicines Regulatory Authorities (ICMRA), a voluntary group of Heads of Agency (HoA)Read more

DURHAM, N.C., JULY 30, 2018 — Premier Research, a global provider of clinical development services to biopharmaceutical product innovators, has acquired Regulatory Professionals, Inc. (RPI), a California-based company that provides regulatory expertise and solutions to biotechnology, pharmaceutical, and medical device companies. This partnership will form a new Regulatory Services Division of Premier Research, and DonnaRead more

 The placebo effect’s impact on drug development is widely known, but you may be surprised to learn that the word “placebo” has had multiple meanings — all of them pejorative — going back hundreds of years. Scott Millard, Premier Research’s Executive Director for Strategic Development and Analgesia, explores the role of placebos in theRead more

The primary purpose of early-stage clinical trials is to determine the recommended dose and toxicity profile of an investigational drug or multi-drug combination therapy. Since molecularly targeted agents (MTAs) and immunotherapies have toxicities that are distinct from cytotoxic chemotherapies, traditional dose escalation methods using toxicity-based endpoints may not be suitable for phase I studies ofRead more

 Patient registries and natural history studies are vital tools for orphan drug researchers, who often struggle with limited understanding of diseases and sparse data due to small patient numbers. In the second installment of the Premier Voices podcast with Angi Robinson, Vice President, Clinical Development Services, Rare Disease & Pediatrics, and Juliet Moritz, ExecutiveRead more

Traditionally, phase I oncology trials have relied on a standard 3+3 dose escalation design to achieve the objective of defining a recommended phase II dose (RP2D). However, statistical simulations have shown that as few as one in three trials using the 3+3 design succeed in identifying the maximum tolerated dose.[1] Concerns have also been raisedRead more

In a clinical trial landscape where global, multi-center studies have become increasingly common, trial monitoring has become more complex. Regulations require that sponsors of medical device studies perform site monitoring to ensure that investigators are compliant with federal regulations, sponsor agreements, the investigational plan and the requirements set forth in the Investigational Review Board (IRB)Read more

While clinical trials for medical devices have many similarities to those for pharmaceuticals, the regulatory evaluation of devices is distinct from that of drugs – and there are critical differences in the way the device trials are designed and executed. Here are a few of the key differences: Requirement for a clinical trial When studyingRead more

The inaugural edition of Premier Voices focuses on rare oncology drug development and takes a looks at: * Using adaptive design to limit patient exposure to ineffective treatments and increase the overall likelihood of success * Making the most of small and geographically dispersed patient populations * Dealing with limitations such as a lack of definedRead more

DURHAM, N.C., July 2, 2018 — Premier Research’s head of patient engagement will talk about the role of natural history studies in clinical research at the International Children’s Advisory Network’s Research & Advocacy Summit on July 12 in Edinburgh, U.K. Juliet Moritz, the CRO’s Executive Director, Program Strategy, Rare Disease and Pediatrics/Patient Engagement, will discussRead more

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