Subjects: Clinical Trials as Topic - Digital Collections - National Library of Medicine Search Results

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41. Multiple endpoints in clinical trials: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Biostatistics
Clinical Trials as Topic
Endpoint Determination
Government Regulation
United States
United States. Food and Drug Administration

42. E14 and S7B clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential: questions and answers

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2022
Subject(s):: Arrhythmias, Cardiac
Clinical Trials as Topic
Electrocardiography
Government Regulation
United States

43. Excluding older, sicker patients from clinical trials: issues, concerns, and solutions

Publication:: Washington, D.C. : AARP Public Policy Institute, c2011
Subject(s):: Clinical Trials as Topic
Patient Selection
Randomized Controlled Trials as Topic
Aged
Aged, 80 and over
Chronic Disease
Cost-Benefit Analysis
Frail Elderly
Sample Size
Selection Bias
Humans
United States

44. Pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an endpoint to support accelerated approval

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Breast Neoplasms
Clinical Trials as Topic
Neoadjuvant Therapy
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

45. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:: Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

46. Cancer clinical trial eligibility criteria: brain metastases

Publication:: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

47. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

48. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

49. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:: Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):: Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

50. Statistical considerations for clinical trials during the COVID-19 public health emergency

Publication:: [Silver Spring, MD] : Center for Drug Evaluation and Research, June 2020
Subject(s):: Clinical Trials as Topic
Statistics as Topic
COVID-19
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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