“The first thing you feel when a trial fails is a sense of shame,” says physician Siddhartha Mukherjee. Then comes the “exhilarating — and dangerous” instinct to slice and dice the data to resurrect the drug’s potential.
Here Siddartha discusses the lure to make more of the science than is perhaps there, when stakes are high and we are desperate to find hope for patients who are out of treatment options. Continue reading “When a clinical drug study fails…the importance of proper interpretation and dissemination of negative trial results”
Report from the DIA Pharmacovigilance and Risk Management Strategies Conference, January 23-25, 2017, Washington, DC.
Written by Suzanne Berresford, Product Manager, Pharmacovigilance, Springer Nature
The nature of medicinal products is in a rapidly shifting world, with therapeutic innovation becoming a major global trend that is here to stay. The precision medicine approach and use of targeted therapies such as biologicals, gene therapy and stem cell therapy is weaving its way into standard practice but questions still remain about monitoring the long-term safety and efficacy of such advanced therapies. The DIA Pharmacovigilance and Risk Management Strategies Conference set out to discuss some of the challenges and to provide an opportunity for pharmacovigilance professionals to share their experiences in these areas. Continue reading “A brave new world: what does the future hold for pharmacovigilance?”