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Therapeutic Innovation & Regulatory Science|May 2, 2018
Development of Prescription Drug Information Leaflets: Impact of Cognitive Effort and Patient Involvement on Prescription Medication Information ProcessingHarshali K Patel, Shweta S Bapat, Archita H Bhansali, et al.Therapeutic Innovation & Regulatory Science|July 27, 2018
Evaluating the Completeness of ClinicalTrials.govStella Stergiopoulos, Kenneth A Getz, Christine BlazynskiTherapeutic Innovation & Regulatory Science|August 10, 2018
Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot ProgramWendy Selig, Ian Banks, Anjelica Davis, et al.Therapeutic Innovation & Regulatory Science|August 10, 2018
Possible Causes of Failing to Meet Primary Endpoints: A Systematic Review of Randomized Controlled Phase 3 Clinical Trials in Patients With Non-Small Cell Lung CancerMitsugu Ikeda, Tatsuya Ochibe, Masahiro TohkinTherapeutic Innovation & Regulatory Science|June 19, 2018
Minimizing Patient Burden Through the Use of Historical Subject-Level Data in Innovative Confirmatory Clinical Trials: Review of Methods and OpportunitiesJessica Lim, Rosalind Walley, Jiacheng Yuan, et al.Therapeutic Innovation & Regulatory Science|July 31, 2018
Perceived Burden of Completion of Patient-Reported Outcome Measures in Clinical Trials:: Results of a Preliminary StudySerge Bodart, Bill Byrom, Mabel Crescioni, et al.Therapeutic Innovation & Regulatory Science|May 30, 2017
Overview of FDA's Expanded Access Program for Investigational DrugsJonathan P Jarow, Peter Lurie, Sarah Crowley Ikenberry, et al.Therapeutic Innovation & Regulatory Science|May 30, 2017
Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA's Role in Ensuring Patient SafetyJonathan P Jarow, Steven Lemery, Kevin Bugin, et al.Therapeutic Innovation & Regulatory Science|May 16, 2018
Reported Adverse Drug Reactions During the Use of Corticosteroids in a Tertiary Care HospitalSarika ParadkarTherapeutic Innovation & Regulatory Science|May 16, 2018
From the Valley of Death to the Crossroads of Opportunity: A Discussion of Evolving Benefit/Risk Evaluation StandardsPeter J Pitts, Patrick BradyPageof 165