Frontiers | International oncology drug approvals for multiregional or single-country clinical trials: A systematic review
Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained
Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial - The Lancet
![Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram](https://www.researchgate.net/publication/350164644/figure/fig1/AS:1021236666703872@1620493203303/Design-of-the-pivotal-Study-311-19-and-Study-312-13-20-phase-3-clinical-trials.png "Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram")
Design of the pivotal Study 311 [19] and Study 312 [13, 20] phase 3... | Download Scientific Diagram
The role of pilot studies in medical device clinical trials
Clinical Trial Design Principles and Outcomes Definitions for Device-Based Therapies for Hypertension: A Consensus Document From the Hypertension Academic Research Consortium | Circulation
Clinical Research Services | Pivotal
TRILUMINATE pivotal: A landmark randomized clinical trial of transcatheter tricuspid valve edge-to-edge repair for tricuspid regurgitation
Overview of Drug Development
Review the Efficacy and Safety of LYBALVI® (olanzapine and samidorphan) from ENLIGHTEN-1 | Official Website for Healthcare Professionals
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA | Trials | Full Text
Pivotal is providing its specialized clinical research services for the conduct of a clinical trial in patients with COVID-19 - Pivotal
Review the Efficacy and Safety of LYBALVI® (olanzapine and samidorphan) from ENLIGHTEN-2 | Official Website for Healthcare Professionals
Ongoing and Upcoming Studies
Pivotal Trial Designs | VUMERITY® (diroximel fumarate)
A PIVOTAL Visual Abstract — NephJC
Step 3: Clinical Research | FDA
Sample construction for pivotal trials using surrogate markers with... | Download Scientific Diagram
Early phase clinical trial played a critical role in the Food and Drug Administration–approved indications for targeted anticancer drugs: a cross-sectional study from 2012 to 2021 - ScienceDirect
FDA Pivotal Clinical Trial Design and Beyond | tctmd.com
Pivotal Trial | Ofatumumab Safety Site
FARAPULSE - ADVENT Trial - Boston Scientific
