Study Conduct

Medidata, SHYFT Analytics partner

Wednesday, September 7, 2016

Medidata and SHYFT Analytics have announced a strategic commercial partnership to increase access to healthcare data analytics in clinical trials. The partnership will enable life sciences companies to add real world evidence (RWE) data from electronic medical records (EMRs) and health claims to information traditionally collected in clinical trials, providing a more comprehensive view of patient health.

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Advancing patient protection through proposed Common Rule changes for informed consent

Thursday, September 1, 2016

Research practitioners eagerly anticipate finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule, which is scheduled to be released in September 2016. Many experts speculate that the revised policy may not be published as expected, yet there appears to be consensus that change in the rules governing human subjects is inevitable; the question remains as to what will be the final rulemaking and the impact on research practice. More than five years have passed since the impending change was announced in an Advance Notice of Proposed Rulemaking (ANPRM) on July 26, 2011 [FR 2011; 76(143): 44512-44531]. After consideration of substantive public debate, the U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies published a Notice of Proposed Rulemaking (NPRM) with prospective revisions to the Common Rule on September 8, 2015 [FR 2015; 80(173): 53933-54060]. Stakeholders have carefully reviewed the proposed revision, provided essential feedback during an extended open comment period, and continued to consider the implications of potential new requirements as they await publication of a final rulemaking.1,2

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Benefits for international multicenter clinical trials in Russia

Thursday, September 1, 2016

In the last 20 years, Russia has seen an increasing growth of the clinical trials industry. Among the factors contributing to that are top-grade research facilities, vast and easy-to-access populations and low participation costs. Over the past two years, significant changes have occurred in this market that are likely to have a global impact. All recent legislative efforts were aimed at harmonizing the local regulatory requirements with international standards and pharmacovigilance procedures. Clinical trials in Russia undergo regular FDA inspections and are among one of the world’s best in terms of quality, exceeding Western countries.

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Leapcure, Scientist.com partner to accelerate patient recruitment

Wednesday, August 31, 2016

Leapcure, a provider of patient engagement solutions for clinical trials and pharmaceutical research, has teamed up with Scientist.com, a marketplace for pharmaceutical services, to provide patient recruitment services for users of Scientist.com’s network of 10 pharmaceutical research marketplaces. The partnership will provide white-label, global clinical recruitment services using Leapcure’s smart patient engagement platform.

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DCRI, Pfizer, Premier partner on vaccination rates

Tuesday, August 30, 2016

A new quality improvement initiative that aims to create effective solutions in optimizing adult vaccination rates has been announced. The program, the Adult Immunization Project, is a collaboration among the Duke Clinical Research Institute (DCRI), Duke Primary Care, Pfizer and Premier. Researchers will jointly work to develop evidence-based interventions to support indicated adult vaccination practices among providers in the Duke Health system.

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GSK deal with Italian Medicines Agency highlights performance-based curative model

Monday, August 29, 2016

GlaxoSmithKline (GSK) has signed a pay-for-performance deal with the Italian Medicines Agency (AIFA) to boost usage of Strimvelis, the pharmaceutical company’s gene therapy treatment developed for ADA-SCID, a rare genetic disorder in children. The key to the contract, however, is that the drug must work. If treatment doesn’t provide a cure, GSK must return a portion of the funds paid by AIFA based on the terms of the agreement.

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The importance of multifaceted virtual investigator meetings

Monday, August 15, 2016

Meetings for all personnel involved serve as initial training for clini­cal trials. The level of effort and cost, along with the wait for most sites to be ready for a meeting, makes virtual in­vestigator meetings attractive in con­trast to traditional face-to-face events.

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