Strengthening the FDA's Enforcement of ClinicalTrials.gov Reporting Requirements

JAMA. 2021 Dec 7;326(21):2131-2132. doi: 10.1001/jama.2021.19773.

Authors

Reshma Ramachandran^{1

2}, Christopher J Morten^{3

4}, Joseph S Ross^{1

5}

Affiliations

¹ National Clinician Scholars Program, Yale School of Medicine, Department of Internal Medicine, New Haven, Connecticut.
² Veterans Affairs Connecticut Healthcare System and Yale University, West Haven, Connecticut.
³ Columbia Law School, New York, New York.
⁴ Global Health Justice Partnership, Yale Law School, New Haven, Connecticut.
⁵ Section of General Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

PMID: 34766971
DOI: 10.1001/jama.2021.19773

No abstract available

MeSH terms

Activin Receptors, Type II / therapeutic use
Antineoplastic Agents / therapeutic use
Axitinib / therapeutic use
Carcinoma, Renal Cell / drug therapy
Clinical Trials as Topic / legislation & jurisprudence*
Clinical Trials as Topic / statistics & numerical data
Clinical Trials, Phase II as Topic / legislation & jurisprudence
Drug Industry / legislation & jurisprudence*
Humans
Immunoglobulin Fc Fragments / therapeutic use
Kidney Neoplasms / drug therapy
Law Enforcement*
Mandatory Reporting*
National Institutes of Health (U.S.) / legislation & jurisprudence
Recombinant Fusion Proteins / therapeutic use
Registries
United States
United States Food and Drug Administration / legislation & jurisprudence*

Substances

Antineoplastic Agents
Immunoglobulin Fc Fragments
Recombinant Fusion Proteins
Axitinib
Activin Receptors, Type II
ALK1-Fc fusion protein, human