Monthly Features

FDA Fast Track designations reach 20th year

Sunday, October 1, 2017

Twenty years after its inception, the FDA’s Fast Track designation program is going strong, with many signs that it has achieved its goal of bringing novel drugs to the market faster. Now, even with a new FDA Commissioner at the helm, the Fast Track program is unlikely to change substantially, although it may adjust to more explicitly address current areas of high-unmet medical need such as antibiotic resistance and cardiovascular disease.

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Tracking adoption of risk assessment and RBM

Sunday, October 1, 2017

For all the talk about how risk-based monitoring (RBM) can improve efficiencies in clinical trial processes, the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodology and some organizations have not yet pursued alternatives to traditional monitoring strategies.

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Is eConsent adoption poised to grow?

Friday, September 1, 2017

Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

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Site selection a continuing conundrum

Friday, September 1, 2017

For many companies, searching for clinical trial sites begins with a look at paper-based and spreadsheet tools that document where they had held earlier trials. Returning to familiar sites allows clinical trial teams to work with principal investigators with whom they have built relationships over time.

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Fastest drug developers and their practices

Tuesday, August 1, 2017

Drug development is a long and costly process, and companies struggle with efforts to compress cycle times and reduce costs. A new CenterWatch analysis of new molecular entities (NMEs) approved by the FDA from 2014 through 2016 shows no signs of dramatic, industry-wide improvement. Sponsors interviewed by CenterWatch cited multiple factors that influence the speed of their development programs. In particular, the selection of investigative sites and vendors (including CROs), and the relationships forged with them, were an important focus of companies seeking to improve the speed and efficiency of clinical trials.

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Preparing sites for post-acquisition integration

Tuesday, August 1, 2017

The seemingly endless number of tasks required to sell a clinical research site often means there isn’t enough attention focused on what happens after the deal closes. Successful post-acquisition integration can be one of the most challenging, yet important, parts of an M&A process.

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Preparing sites for acquisition

Saturday, July 1, 2017

The unprecedented level of M&A activity in the clinical research site sector during the past 24 months has spurred many investigative site owners to consider selling their businesses.

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Revisiting patient diversity in clinical trials… again

Saturday, July 1, 2017

Minority groups have historically been excluded from clinical research, an inequity that has led to well-documented public health problems in which therapies tested primarily in Caucasian patients do not work as well in other ethnic and racial groups. This problem is famously exemplified by Sanofi’s blood thinner Plavix, which was approved in 1997 but slapped with a boxed warning in 2010 after researchers realized up to half of Asian and Pacific Islander populations cannot process the drug.

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Assessing the strategic impact of supply chain management

Thursday, June 15, 2017

The globalization of clinical trials and more complex protocols, which include adaptive designs and those for targeted therapies, have driven the need for new practices and strategies to reduce waste and inefficiencies in the clinical supply logistics area.

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