Monthly Features

Sites wrestle with protocol design complexity

Wednesday, March 1, 2017

The growing complexity of protocols is resulting in longer cycle times, rising costs and increased pressures on staff and patients throughout the clinical trial process. Tufts Center for the Study of Drug Development (CSDD) studies have found that the number of endpoints, procedures and eligibility criteria of typical phase III protocols increased significantly during 2002-2012, and have continued to grow. These factors combine to increase costs and burdens on research teams.

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Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

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The need for—and barriers to—adopting eSource

Wednesday, February 15, 2017

Electronic data collection responsibility borne by investigative sites to support each clinical trial is onerous, with little to no relief in sight. In many instances, these responsibilities are being managed at the same time that paper data collection processes are prevalent.

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Reassessing site engagement activities

Wednesday, February 1, 2017

Drug development sponsors and CROs increasingly recognize the importance of investigative sites having a stronger, more respected voice in the clinical research community and have begun adopting initiatives designed to incorporate site viewpoints into improving clinical development processes.

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Personalized medicine impacting study conduct

Sunday, January 1, 2017

As the analysis of genetic data is fast becoming a significant part of clinical research programs, both to enroll study participants and understand how drugs work, investigative sites are increasingly asked to collect genetic samples and conduct genetic screenings for clinical trials.

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Big Data in clinical trials: Promise and pitfalls

Monday, August 15, 2016

Privacy versus medical progress. Proprietary ownership versus public information. Cost-effectiveness versus unnecessary burdens. Welcome to the swirl of opinions and emotions around Big Data and its potential—or not—in the clinical trials industry.

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Mixed experience with the Sunshine Act

Monday, August 1, 2016

Pharmaceutical companies have finished submitting the third batch of data detailing their financial relationships with physicians and teaching hospitals under the Open Payments program, also referred to as the Physician Payment Sunshine Act. Investigators now face the prospect of implementing sophisticated new processes and systems that can track and verify clinical research grant payment information.

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Three resonating patient-centric initiatives

Friday, July 1, 2016

Sponsor companies are piloting patient-centric initiatives at a furious pace. Although few initiatives designed to engage patients as clinical research partners have achieved widespread adoption, several are making substantial inroads. In this issue, CenterWatch profiles three major patient-centric initiatives that appear to be resonating across the clinical research enterprise.

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