Observational studies

Observational research encompasses several study designs in which groups of patients are observed within routine clinical practices. In the biopharmaceutical and device industries, observational studies can provide valuable insights into the causal association between a treatment (e.g. a drug product, device, or procedure) and a particular event or outcome (e.g. long-term effectiveness and safety). These non-interventional studies have become critical tools in health care research because they offer a broader range of approaches to answering important, "real world" clinical research and product usage questions. They can also be challenging to implement, however, due to differing interpretations of standards of conduct and regulatory oversight, particularly on a global level.

Several study designs fall within this category of epidemiology research including:

• Cohort studies, including prospective patient registries
• Case-control studies, including retrospective chart reviews; and
• Database studies using electronic health records (EHR) or 3rd party databases

Video: Neal Mantick, Sr Director Global Observational Research. Interviewed during the Annual DIA Meeting 2011

At PAREXEL, we have a global team of pharmacoepidemiologists, pharmacovigilance, regulatory, and research operations experts who can:

• help you define the needs of your target audience(s) and to develop the best study design to meet your research objectives;
• define the optimal regulatory authority and ethics committee submission strategies in each country or region; and
• implement a study management and resourcing model trained to collect the required data in the most efficient manner and to agreed-upon standards of quality

For more information contact us