The CenterWatch Monthly December 2010

Monday, November 29, 2010 12:30 PM

Pessimism and instability defining the clinical research workforce

Work environments have become more unstable across the clinical research industry as a high percentage of employees worry about job security, consider switching jobs within the next year, and don’t see much opportunity for advancement within their organizations. More than half of clinical research professionals who participated in the survey, which CenterWatch conducted in collaboration with Applied Clinical Trials, regard their current operating environment as bleak and don’t expect it to improve during the next year. Importantly, the survey findings suggest the emergence of a more transient workforce as employees feel they must change jobs in order to earn higher salaries and advance their careers. This trend creates significant challenges for the industry.

By Karyn Korieth 

Ideas to improve informed consent hit barriers

An array of tactics have been offered up to improve the typically overwhelming informed consent process in clinical trials. Yet despite a wide variety of improvement solutions available, few, if any, have been adopted. Clinical trial and oversight complexity appear to be at the heart of the problem. As the number of visits, eligibility criteria and procedures per protocol have increased, the length of informed consent forms has grown. Protocol complexity has made it harder to convince patients to participate in trials—and has left sponsors, CROs and ethical committees grappling with how to find effective ways to clearly communicate risks and side effects and still retain participation through trial completion. A complex system of human subject protection and regulatory compliance has scared away more progressive approaches to obtaining volunteer consent.

By Ronald Rosenberg

Eye On Genentech 

Genentech, a global biotechnology company, over the past three decades has used human genetic information to discover, develop, manufacture and market medications for  the treatment of serious or potentially fatal diseases. In March 2009, it merged with the Roche Group but maintained its Genentech Research and Early Development as an independent center within Roche. Current technologies pursued by Genentech’s more than 1,100 researchers include molecular biology, protein chemistry, bioinformatics and small molecule drug discovery, as applied to the therapeutic fields of Oncology, Immunology, Disorders of Tissue Growth and Repair, Neuroscience and Infectious Disease. 

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CWWeekly

May 21

Parexel consultant testifies on FDA biosimilars guidance

Global Telecom Testing checks ex-U.S. toll-free phone lines for multinational clinical trials

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CWWeekly

May

Newer sites most optimistic about the future
Investigative sites of all sizes, from part-time physician-run sites to large dedicated research centers, report a rebound in operating conditions, according to a new CenterWatch analysis, yet sites from each subgroup indicate they have concerns…

Risk-based monitoring slow to catch on with industry
It's estimated that the cost of physically sending monitors to all investigative sites at regular intervals, a model the industry itself developed and has adhered to for about a decade, eats up one-third to one-half of…

Eye On Millennium
Millennium, The Takeda Oncology Company, discovers and develops novel treatments applying world-class recombinant technology to a wide variety of oncology disease targets…

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