The need for pharma to generate evidence – describing real world outcomes for their therapeutics – developed as a result of 3 main reasons in medicine:
Part 1 – The development of evidence-based medicine
Part 2 – Safety concerns of drugs in real world populations
Part 3 – Cost-cutting measures by healthcare payers and providers
All of these factors have created a perfect storm and have lead to pharma directing vast resources into generating real world data and compelling this information into value propositions for their already approved therapies.
Part 1 – The discipline of evidence-based medicine developed from clinical epidemiology, a subject which was promoted from the creation of the Journal of Clinical Epidemiology in 1989 which had previously been published as the Journal of Chronic Diseases. The journal in question was successfully established by Alvan Feinstein and Walter O Spitzer, and set out to advance the application of the following innovative methods:
Â· Conducting and presenting primary research;
Â· Synthesizing research results;
Â· Disseminating results; and
Â· Translating results into optimal clinical practice;
Â· With special attention to the training of new generations of scientists and clinical practice leaders
Thus clinical epidemiology was attempt to link clinical practice and public health using population health sciences to inform clinical practice. Essentially this built the methodology for Evidence-based medicine and has driven a transformation of clinical practice in medicine. Certainly many health service decision-makers in this decade incorporate these scientific methods in strategic planning for health provision for patients and greater public health.
In 1996, David Lawrence Sackett (a Canadian medical doctor, pioneer in evidence-based medicine and founder of the first department of clinical epidemiology in Canada at McMaster University & the Oxford Center for Evidence-Based Medicine) described evidence-based medicine as âthe conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients'. This definition has since been adopted by major organizations, including the Cochrane Collaboration and the Centre for Evidence Based Medicine.
Does Evidence interest you? Read about our Evidence exhibition this October in Boston.