Jan 2011

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FDA Releases Draft Guidance on Electronic Source Documentation. Study sites will need to maintain a list of individuals, devices and instruments that are authorized to transmit data elements to electronic case report forms (eCRF) according to a draft guidance the FDA released Jan. 6.
FDA revises informed consent regulations to incorporate clinical trial registration requirements. The FDA issued a Final Rule1 amending the current informed consent regulations pursuant to the requirements of the FDA Amendments Act of 20072 (FDAAA).

As part of its ongoing transparency initiative, the FDA has issued 19 action items including a new website to help the industry save time and resources in its interaction with the agency. FDA Basics for Industry (www.fda.gov/FDABasicsforIndustry) includes information about the regulatory process, particularly that information frequently requested by industry.

An international consortium of pharmaceutical companies and academic institutions has created a massive database of clinical data that researchers hope can lead to better treatments for schizophrenia and depression. The collaborative group, called NEWMEDS (Novel Methods Leading to New Medications in Depression and Schizophrenia), has pooled data from 67 trials on 11 compounds in more than 25 countries—creating the largest single database of clinical trial data ever amassed in psychiatric research—to help devise new ways to predict which treatment is likely to work for which patient, rather than using the standard trial-and-error approach for everyone.

Knowledge of trial process can drive away volunteers. The more a potential trial volunteer learns about the clinical trial process, the less likely he or she is to agree to participate. That finding stunned Patrina Caldwell, lead author of the report “Strategies for Increasing Recruitment to Randomised Controlled Trials: Systematic Review,” published in a recent issue of PLoS Medicine.

Sponsors must consider the challenges as well as advantages when moving trials to emerging markets. As drug sponsors increasingly look to emerging markets for greater patient access and lower trial costs, they must also consider the potential disadvantages of moving operations to a developing country when choosing the best location for a clinical trial, according to new research from Cutting Edge Information.