Top issues facing ClinOps executives

Never before have operating conditions for clinical studies been more difficult. Clinical operations groups face growing pressure to get drugs to market faster while improving efficiencies and study quality. Development costs continue to rise. At the same time, the logistics of conducting a clinical trial have become more complex in the increasingly competitive and regulated environment. As the operating environment has become more challenging, The CenterWatch Monthly asked four experienced, high-level clinical operations executives about the issues that keep them up at night. Some of the concerns were surprisingly mundane, while others got to the core of why they choose to work in the clinical research enterprise.

Renewed attention for investigator-initiated trials

After a five- to eight-year decline, investigator-initiated trials (IITs) are gaining renewed interest as more biopharmaceutical companies are using them as a creative and cost-effective way to innovate and further improve patient safety. Unlike industry-sponsored trials focused on regulatory approval of new medications, IITs are developed and executed under the direction of third-party clinical investigators who are physician researchers, often within an academic institution. The investigator or affiliated study sponsor, working in an academic medical center, is responsible for study conception, design, operational execution, data handling, and data analysis and interpretation, along with subsequent publication.

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