Survey shows need for greater consistency in “real world” observational research


Results from the 9th Annual Survey on Observational Research conducted by Continuum Clinical suggest that the pharmaceutical, biotech, and medical device industries are aware of the benefits of observational research in better understanding the real world value of their products. However, they also show that there is continued need to improve the design and implementation of the studies.

While more traditional controlled clinical trials are the conventional pathway for regulatory approval of drugs, observational studies are increasingly viewed as essential for companies interested in understanding how their products perform under actual medical conditions.

“Controlled clinical research remains the gold-standard for regulatory approval,” said Jeff Trotter, president of Continuum Clinical, and author of the survey. “But other stakeholders including payers, physicians, and patients need to understand a product’s clinical, economic and humanistic value once it is approved and being prescribed and utilised in the ‘real world.’ As a result, drug and device companies must generate these data through studies that are designed and implemented under post-approval conditions.”

The survey reveals ten key findings about prospective observational studies, and identifies opportunities for drug and device companies to improve the implementation of real world research. Among the key findings were:

  • 70% of respondents see their organisations becoming increasingly involved with observational studies, and 75% see their company “comfort level” improving;
  • Less than half of respondents indicated that their organisations had standard operating procedures specific to observational studies;
  • 83% of respondents felt constrained in utilising vendors (for observational research) that do not understand observational research;
  • A vastly underutilised source for enrolling patients into observational studies was “patients interested in but not qualifying for pre-approval clinical trials”.

Trotter added, “What we are seeing is that there is a strong consensus that observational research is critical, but a lot of confusion regarding how to efficiently and effectively implement the studies.”

Over its nine iterations, approximately 2,000 respondents worldwide have participated in the survey, representing a cross-section of the pharmaceutical industry and job functions.