What is a pivot study?
The Prostate Cancer Intervention Versus Observation Trial (PIVOT): a randomized trial comparing radical prostatectomy with expectant management for the treatment of clinically localized prostate cancer.
Is medial pivot total knee arthroplasty suitable for patients with valgus knee osteoarthritis?
Conclusion: The use of MP-TKA featuring ball-in-socket medial tibiofemoral articulation in patients with valgus knee OA showed equally favorable clinical outcomes more than 2 years after surgery, compared to patients with varus knees who received MP-TKA.
What is the difference between pilot and pivotal study?
In the first step, a pilot BE trial is conducted to evaluate the acceptability of the test drug product as a candidate for further evaluation in a subsequent pivotal BE trial. In the second step, a full-scale pivotal BE trial is conducted to formally establish bioequivalence.
What are pivotal clinical trials?
A pivotal clinical trial is a clinical study seeking to demonstrate the efficacy of a new drug in order to obtain its marketing approval by regulatory authorities (e.g. FDA in the United States and EMA in Europe).
What is a medial pivot knee?
The medial pivot knee design involves a CR femoral component and a highly congruent polyethylene liner. The medial compartment acts as ball and socket and pivot center, while the lateral compartment is less concave to allow the lateral femoral condyle to roll posteriorly during flexion.
What is a Phase 2 pivotal study?
Definite dose range finding study in patients with efficacy as. primary endpoint. Exceptionally, Phase II studies can be used as pivotal trials, if the. drug is intended to treat life-threatening or severely-debilitating. illnesses as in oncology indications.
Why is it called a pivotal trial?
However, in the figurative sense phase III trials are often colloquially termed “pivotal” in the sense that they are the most important, critical trials to determining whether a potential new treatment is safe and effective enough to receive FDA approval.
What is a Phase 3 pivotal study?
A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects.
What phase is a pivotal study?