Dr. Pirker on New Clinical Trial Designs in Lung Cancer

Robert Pirker, MD
Published: Friday, Sep 30, 2016



Robert Pirker, MD, Department of Medicine I, Medical University of Vienna, discusses novel clinical trial designs that researchers should use going forward in lung cancer.

Clinical trials have traditionally been in the order of phase I, II, III, and then FDA approval, with additional analyses and follow-up studies coming later on, Pirker explains. However, with how rapid research has progressed over the last few years, he says that the pipeline sequence should change.

If results are positive, the FDA should grant accelerated approval to agents following phase II trials, he adds. After a promising phase III trial, and post-marketing studies, the agency could grant a full approval based on confirmatory findings. This would allow patients to receive novel, effective therapies quicker.


Robert Pirker, MD, Department of Medicine I, Medical University of Vienna, discusses novel clinical trial designs that researchers should use going forward in lung cancer.

Clinical trials have traditionally been in the order of phase I, II, III, and then FDA approval, with additional analyses and follow-up studies coming later on, Pirker explains. However, with how rapid research has progressed over the last few years, he says that the pipeline sequence should change.

If results are positive, the FDA should grant accelerated approval to agents following phase II trials, he adds. After a promising phase III trial, and post-marketing studies, the agency could grant a full approval based on confirmatory findings. This would allow patients to receive novel, effective therapies quicker.

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