PharmaNet Development Group, Inc. a leading provider of drug development services to the pharmaceutical, biotechnology, generic drug and medical device industries, today announced the availability of the results from its fourth semi-annual industry survey on pharmaceutical observational research. The results reveal evolving trends in the design and implementation of post-approval research and identify best practices and continuing challenges in observational studies and patient registries. The survey is designed to enhance the understanding of observational research among sponsors, regulators, policymakers, physicians and patients.
“Observational research is an important vehicle for compiling post-approval data on real world clinical performance, economic value, patient quality of life and product safety,” commented Jeff Trotter, Executive Vice President, Phase IV Development, and principal author of the survey.
Mr. Trotter continued, “Observational studies are different from pre-approval clinical trials. The survey results reinforce our experience assisting clients in understanding, planning, designing and executing these increasingly critical studies in a cost-efficient manner.”
To date, nearly 1000 industry professionals from over twenty-five countries have participated in the four surveys. A report on the survey is available with sections on organizational responsibility, terminology, strategic rationale, methodology, operational processes and future considerations.
