ABPI publish Real World Data guidance today

The Association of the British Pharmaceutical Industry (ABPI) have today published guidance on the use of Real World data to help industry demonstrate value and provide important medicine response information on under-represented groups of patients.  Amongst other things, the guide shows how to generate robust real world data; discusses what the internal considerations for undertaking…

NEJM endorsement of Real World studies

  This week, James Ware, Professor of Biostatistics at the Harvard School of Public Health in Boston and Mary Beth Hamel, writing in the New England Journal of Medicine (NEJM) further endorse the need for good quality pragmatic trials. They say that although randomised clinical trials provide essential, high quality evidence about the benefits and harms…

BMJ editor – call for more Real World Data

Fiona Godlee, editor of the British Medical Journal (BMJ) has this week highlighted the relative lack of information on the cost effectiveness of traetments in a real clinical setting. She points out that most cost effectiveness data comes from randomised controlled studies of idealised populations of patients and the true cost to the NHS needs…