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. Author manuscript; available in PMC: 2024 Oct 28.
Published in final edited form as: Osteoarthritis Cartilage. 2018 Nov 19;27(4):571–579. doi: 10.1016/j.joca.2018.11.002

Fig. 2. Scenario 2 – separate PMA study.

Fig. 2.

Study design scenario 2 represents a PMA study that might be conducted as a separate study from the phase 3 trial. The PMA study population contains some or none of the original phase 3 trial subjects as a nested cohort. All patients may be on active (high vs low dose) treatment in the PMA study and followed for rates of OA progression. As for scenario 1, clinically relevant endpoints might be the time-to-event of joint replacement surgeries or clinically relevant symptomatic worsening or whichever is first.