Premier Perspectives Blog

Insider Insights in Clinical Development

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

Premier Research recently contributed to the STARR 911 initiative, a project of the STARR Coalition to provide actionable guidance for clinical researchers after identifying volunteers with suicidal leanings. This post provides more information on the process itself, which was presented earlier this year at the 2018 ASCP Annual Meeting in Miami. Background The primary goalRead more

Having a chronic condition increases the odds of suicide by 363%, and patients with mental illness are particularly at risk.[1] For individuals contacting sites about possible enrollment in a clinical trial, the call may be their first attempt to reach out for help – yet many do not receive the education and support that couldRead more

While clinical investigations of medical devices and investigational drugs have their differences, what they do have in common is the goal of safeguarding the rights and welfare of study participants while bringing safe and effective products to market as quickly and efficiently as possible. Not all medical devices require a clinical trial, depending on theirRead more

It’s been 46 years since researchers Theodore Friedmann and Richard Roblin published a landmark paper in the journal Science that posed a provocative question: “Gene therapy for human genetic disease?” And while clinical trials for gene therapy drugs have become much more common in the past 20 years — more than 2,400 had been conductedRead more

You get one chance to initiate a clinical trial. Botch the start-up and you’ll expend great effort correcting course and playing catch-up. The waste of money and time — commodities that are chronically scarce among the biotech and specialty pharma companies that comprise most of our customer base — can be devastating. That’s why weRead more

Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantables such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. To ensure the safety and efficacy of these devices, regulators expectRead more

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