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List of works by Robert J. Temple

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

scientific article published in February 2018

2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

scientific article published in March 2018

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

scientific article

Adverse Effects of Newly Marketed Drugs ⬇️

scientific article published on 01 May 1979

Anticoagulant Options — Why the FDA Approved a Higher but Not a Lower Dose of Dabigatran ⬇️

scientific article published on April 13, 2011

Antithrombotic drug development for atrial fibrillation: proceedings, Washington, DC, July 25-27, 2005.

scientific article published on May 2008

Bleeding Academic Research Consortium consensus report: the Food and Drug Administration perspective

scientific article published on 01 June 2011

Blood pressure as an example of a biomarker that functions as a surrogate

scientific article

Building a roadmap for developing combination therapies for Alzheimer's disease

scientific article

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified release products: workshop summary report

scientific article published on 4 May 2010

Challenges and opportunities in establishing scientific and regulatory standards for assuring therapeutic equivalence of modified-release products: workshop summary report

scientific article published on 27 March 2010

Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report ⬇️

scientific article published on September 1, 2010

Charting a path toward combination therapy for Alzheimer's disease

scientific article published on 26 December 2014

Clinical and research issues regarding chronic advanced coronary artery disease part II: Trial design, outcomes, and regulatory issues

scientific article published on 31 January 2008

Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials

scientific article

Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.

scientific article published on 23 February 2018

Contributors

Endpoints in Heart Failure Drug Development: History and Future

scientific article published on 06 April 2020

Enrichment designs: efficiency in development of cancer treatments

scientific article published on 27 June 2005

Erythropoiesis-stimulating agents--time for a reevaluation

scientific article published on 06 January 2010

Evaluating Ebola therapies--the case for RCTs

scientific article published on 3 December 2014

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

scientific article published on 16 November 2018

Farewell to our Wonderful Friend and Colleague, J. Richard (Dick) Crout (1929-2020)

scientific article published on 28 October 2020

Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus: Lessons Learned and Future Directions

scientific article published on 29 January 2020

Impact of cardiovascular outcomes on the development and approval of medications for the treatment of diabetes mellitus

scientific article published on March 2010

Implications of effects in placebo groups

scientific article published in January 2003

Independent data monitoring committees: preparing a path for the future

scientific article

Is there a role for pharmacokinetic/pharmacodynamic-guided dosing for novel oral anticoagulants?

scientific article published on 10 October 2017

Issues in regulatory guidelines for data monitoring committees

scientific article published in January 2004

Leveraging electronic health records for clinical research

article

New FDA Regulation to Improve Safety Reporting in Clinical Trials ⬇️

scientific article published on 08 June 2011

Panel discussion 2 ⬇️

scientific article published on 01 February 2012

Participation of Women in Clinical Trials Supporting FDA Approval of Cardiovascular Drugs

scientific article published on 01 May 2018

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective

scientific article published on October 2015

Preventing tomorrow's sudden cardiac death today: part II: Translating sudden cardiac death risk assessment strategies into practice and policy

scientific article published in June 2007

Real-World Evidence - What Is It and What Can It Tell Us?

scientific article

Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank

scientific article published on 10 February 2018

Regulatory and scientific issues in studies to evaluate sexual dysfunction in antidepressant drug trials

scientific article published on 7 July 2015

Remembering Dr Ray Lipicky

scientific article published on 01 March 2018

Right job, wrong tool: a commentary on designing clinical trials for Ebola virus disease

scientific article

Rosiglitazone and the FDA.

scientific article published on 29 August 2007

Safety of newly approved drugs: implications for prescribing

scientific article published on 01 May 2002

Sensible guidelines for the conduct of large randomized trials

scientific article published on 01 January 2008

Specific barriers to the conduct of randomized trials.

scientific article published in January 2008

Streamlining cardiovascular clinical trials to improve efficiency and generalisability

scientific article published on 28 April 2017

Stroke prevention in atrial fibrillation: Closing the gap

scientific article published on 25 October 2018

Summary of findings from the FDA regulatory science forum on measuring sexual dysfunction in depression trials

scientific article published on August 2015

Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation

scientific article published on 21 October 2019

The Devil Is Always in the Details

scientific article published on 01 April 2017

The FDA's assessment of follow-on protein products: a historical perspective

scientific article published on 01 June 2007

The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin

scientific article published on 09 May 2017

The US Food and Drug Administration's perspective on the new antidepressant vortioxetine

scientific article published on January 2015

The imperative of overcoming barriers to the conduct of large, simple trials

scientific article published in April 2014

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

scientific article

Zolpidem and driving impairment--identifying persons at risk

scientific article

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