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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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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