Author details

Full Name

Robert Temple

Affiliation

ORCID

Career Start Year

1965

Papers

138

H Index

Expertise

CM4AI Collaborator

PMID	Paper Title	Journal Title	Published Year
34656074	Roadmap to 2030 for Drug Evaluation in Older Adults.	Clin Pharmacol Ther	2022
36239939	Participation of Older Adults in Clinical Trials for New Drug Applications and Biologics License Applications From 2010 Through 2019.	JAMA Netw Open	2022
35639381	Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.	JAMA Netw Open	2022
36318210	Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.	JAMA network open	2022
34544200	U.S. racial and ethnic participation in global clinical trials by therapeutic areas.	Journal of Clinical Pharmacy and Therapeutics	2021
34320283	An Appropriate Use of Accelerated Approval - Aducanumab for Alzheimer's Disease.	New England Journal of Medicine	2021
33111972	Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929-2020).	Clinical Pharmacology and Therapeutics	2021
31541454	Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project.	Clin Pharmacol Ther	2020
31992065	Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions.	Circulation	2020
31977211	Scientific and Regulatory Approach to Botanical Drug Development: A U.S. FDA Perspective.	Journal of Natural Products	2020
31116916	Esketamine for Treatment-Resistant Depression - First FDA-Approved Antidepressant in a New Class.	New England Journal of Medicine	2019
30445835	FDA-Catalyst-Using FDA's Sentinel Initiative for large-scale pragmatic randomized trials: Approach and lessons learned during the planning phase of the first trial.	Clin Trials	2019
30731371	Stroke prevention in atrial fibrillation: Closing the gap.	Am Heart J	2019
29495982	2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.	J Am Coll Cardiol	2018
28815894	Challenges of developing and conducting clinical trials in rare disorders.	American Journal of Medical Genetics, Part A	2018
29724348	Participation of Women in ClinicalÂ TrialsÂ Supporting FDAÂ ApprovalÂ of Cardiovascular Drugs.	Journal of the American College of Cardiology	2018
29483172	2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials.	Circulation	2018
29440007	Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank.	J Am Heart Assoc	2018
29754667	Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?	Am Heart J	2018
29473145	Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.	Clin Pharmacol Ther	2018
29581359	Remembering Dr Ray Lipicky.	Circulation	2018
29802975	Leveraging electronic health records for clinical research.	Am Heart J	2018
28493654	The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin.	Journal of Clinical Psychiatry	2017
28385403	The Devil Is Always in the Details.	JACC: Cardiovascular Interventions	2017
28455296	Streamlining cardiovascular clinical trials to improve efficiency and generalisability.	Heart	2017
27959688	Real-World Evidence - What Is It and What Can It Tell Us?	N Engl J Med	2016
26335083	Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials.	Journal of Clinical Psychiatry	2015
25708309	Building a roadmap for developing combination therapies for Alzheimer's disease.	Expert Rev Neurother	2015
25540951	Charting a path toward combination therapy for Alzheimer's disease.	Expert Rev Neurother	2015
25856596	Right job, wrong tool: a commentary on designing clinical trials for Ebola virus disease.	Am J Bioeth	2015
25562777	The US Food and Drug Administration's perspective on the new antidepressant vortioxetine.	Journal of Clinical Psychiatry	2015
26214346	Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials.	Journal of Clinical Psychiatry	2015
26459078	Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.	Circulation	2015
26541391	Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape: A Conference Report From the American Heart Association Data Summit 2015.	J Am Heart Assoc	2015
26201987	Generic lamotrigine versus brand-name Lamictal bioequivalence in patients with epilepsy: A field test of the FDA bioequivalence standard.	Epilepsia	2015
25066551	Independent data monitoring committees: preparing a path for the future.	Am Heart J	2014
25470568	Evaluating Ebola therapies--the case for RCTs.	New England Journal of Medicine	2014
24399423	Cardiac safety concerns remain for citalopram at dosages above 40 mg/day.	American Journal of Psychiatry	2014
24717376	Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration.	Journal of Clinical Psychiatry	2014
24715072	The imperative of overcoming barriers to the conduct of large, simple trials.	JAMA - Journal of the American Medical Association	2014
24552082	Commemorating the 50th anniversary of the Drug Amendments of 1962.	Food and Drug Law Journal	2013
23923991	Zolpidem and driving impairment--identifying persons at risk.	New England Journal of Medicine	2013
23475863	Q&A: Rajeshwari Sridhara, Robert Temple on trial design. Interviewed by Suzanne Rose.	Cancer Discovery	2013
23588316	Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.	Clinical Pharmacology and Therapeutics	2013
22082709	Balancing transparency and uncertainty.	Arch Intern Med	2012
22334467	Panel discussion 2.	Clin Trials	2012
22318615	The prevention and treatment of missing data in clinical trials: an FDA perspective on the importance of dealing with it.	Clinical Pharmacology and Therapeutics	2012
22761131	Removal from labeling of 60-mg citalopram dose.	Pharmacoepidemiol Drug Saf	2012
21975523	A regulator's view of comparative effectiveness research.	Clinical Trials	2012
21856478	Injectable extended-release naltrexone for opioid dependence.	Lancet, The	2011