Transcript Slide 1
SIGNAL ABOVE THE NOISE EARLY DETECTION OF ADVERSE DRUG REACTIONS IN THE LITERATURE Marie Anne Slaney Therapeutic Goods Administration 18/07/2015 The role of the TGA • ensure timely access to therapeutic goods that are of high quality, and are safe and effective for their purpose • ensure the risks associated with medicines & devices are minimised and manageable How the TGA regulates • relies on the scientific and medical expertise of its highly skilled workforce • TGA evaluation is based on a risk-benefit analysis – no product is completely free of risk but the benefit should be greater than the possible side-effects • Expert Advisory Committees – provide independent advice About myself •biomedical information retrieval specialist at TGA for 16 years • lead a team of five professional librarians •have significant role in systematic literature searching for TGA Marie Anne Slaney TGA 18/07/2015 4 Background story Many years ago............. Marie Anne Slaney TGA 18/07/2015 5 Current trend •Increasing speed and penetration of reporting to regulatory agencies but •still some reliance on publishing to capture anecdotal reporting Marie Anne Slaney TGA 18/07/2015 6 Early signals: what are we looking for? Association; not necessarily causality Remember that symptoms: •describe effect, not cause •may be confounded in the individual patient •may be loosely reported •range in severity Marie Anne Slaney TGA 18/07/2015 7 Two key search concepts •Physiological system: •broad e.g cardiovascular, CNS •narrow e.g. ocular, renal •Class of medicine: •e.g. Cox-2 inhibitors, Glitazones Marie Anne Slaney TGA 18/07/2015 8 Three more to consider •Pharmacokinetics •Non-clinical results •Language Marie Anne Slaney TGA 18/07/2015 9 Formatted databases •Allow slicing and dicing different ways to control searching •Allow recording of complex search history •Allow discrimination in results Marie Anne Slaney TGA 18/07/2015 10 •(Insert picture of pond ripples) Marie Anne Slaney TGA 18/07/2015 11 Questions? Marie Anne Slaney TGA 18/07/2015 12 Contact details Marie Anne Slaney Therapeutic Goods Administration [email protected] www.tga.gov.au Marie Anne Slaney TGA 18/07/2015 13