Clinical trials or literature reviews? Get real or face stricter rules
This article was originally published in Clinica
Executive Summary
One of the EU's most powerful regulatory authorities, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) believes there are too few clinical trials being undertaken with medical devices. Instead companies tend to favour the less costly literature review route. But is this sufficient to minimise as far as possible the risks associated with device use? Or will there be a backlash with regulators pressing in the near future for stricter clinical trials rules? Consultant Trevor Lewis suggests that companies should take a more objective look at their clinical trial decision-making.