How Can You Leverage the Different Aspects of Observational Research?
While randomized clinical trials are still the gold standard in clinical research, Phase IV studies and registries have evolved into one of the most critical aspects of the drug development life cycle, as regulatory authorities and payers request more and more real-world data. Biopharmaceutical and medical device companies must consistently strive to gather data to evaluate clinical effectiveness against competing products, manage the evidence that supports product claims and expands into further indications and gain insights into physician practice patterns or measure acceptance and satisfaction among large groups of patients. Over the last year or so, life sciences companies are placing more emphasis in this area as I start to see such titles in the industry as global payer evidence director, head of clinical effectiveness and senior director of evidence-based medicine (to name a few), in addition to the more typical roles and responsibilities in such areas as medical affairs or health economics and outcomes. Additionally, insurance companies and payers are now actively participating in late-phase industry events by discussing their needs for collecting health-based information directly from the patient and not only from their doctor. This important change demonstrates the need to design observational studies and registries with a focus towards getting high quality data in a real-world setting. This goal can be quite challenging depending on the therapeutic area, the nature of the patient population, the countries involved in the study and the level of interaction desired with the patient. While it is important to understand the differences in protocol design and operational requirements with randomized clinical trials, it is imperative to use friendly technology to gain process efficiencies and achieve real-time data access and integration between relevant applications, as well as for reporting and effective communication between all stakeholders, including sponsors, physicians and patients. This evolution has already started and will accelerate over the next few years. So, it is vital to consider new paths to allocate resources in order to interact with payers, to manage effectiveness programs and to lead newly created evidence-based medicine studies. More about Patrick Chassaigne