Experts describing recent advances in drug development often drift into hyperbole — but really, can you blame them? Gene therapies and drugs that weaponize the immune system against tumor cells are among recent breakthroughs that were unthinkable even a decade ago. But therapies for central nervous system disorders have been a stubborn exception. “We recognize...
Forecasting the cost of clinical drug and medical device trials has never been easy, and as trials become more complex, estimating (and re-estimating) these costs becomes even more challenging. Lack of accurate forecasts has serious schedule and cost implications. By impeding effective cash management, inaccurate projections can lead to disruptions and delays that cost sponsors...
After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went over...
The regulatory landscape for medical devices in Europe is undergoing some major changes. Published in May 2017, the new European Medical Device Regulation (MDR) (Regulation [EU] 2017/745) and In Vitro Diagnostics Regulation (IVDR) (Regulation [EU] 2017/746) is gradually replacing the Medical Devices Directive and the Implantable Medical Devices Directive in the European market. Although the...
Under the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP), sponsors have extensive responsibilities for ensuring not only the ethical and scientific quality of clinical trials, but also the protection of study participants and the integrity of clinical trial data. The recent update of...
No doubt you’ve heard much about Meltdown and Spectre, major security defects in the microprocessors that underpin nearly all of the world’s computers. Hackers, the world learned in early January, can exploit these defects to steal the entire memory contents of PCs, mobile devices, and the servers that make up cloud computing networks. That puts...
First produced in June 1996, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) is an internationally agreed standard that ensures ethical and scientific quality in designing, recording and reporting trials that involve human subjects. The objective of the standard is to ensure that...
Since the mid-1990s, researchers have struggled to enroll sufficient numbers of patients in their trials for Alzheimer’s disease (AD) therapies. As a result, few new therapies have actually come to market—which is tragic for the 47 million people currently living with the disease. Three key strategies, executed in concert, may help overcome recruitment issues in...
An effective team is critical to the success of any clinical study. And when your product is destined for a market valued at $4-16 billion—such as the AVR (transcatheter aortic valve replacement) and TMVR (transcatheter mitral valve replacement) markets—you want to ensure a particularly strong foundation for your study. You build that foundation with your...
Clinical trial sponsors and the clinical research organizations (CROs) supporting them have more clarity from the U.S. Federal Food & Drug Administration (FDA) on how to better select trial participants and design precision-based clinical trials for targeted therapies. New direction is contained in two new agency draft guidance documents recently published by the agency. They...