Concepedia

Protocol Amendment Planning

Protocol Amendment Planning is a methodological framework within study planning that systematically addresses the identification, documentation, and implementation of modifications to a research protocol after its initial approval, ensuring scientific integrity, regulatory compliance, and minimal disruption to study objectives.

16

Publications

1.7K

Citations

128

Authors

62

Institutions

Publications per year

2017–2026

6

Parents

Publications

16

Randomized, Controlled Trial of Irinotecan Plus Infusional, Bolus, or Oral Fluoropyrimidines in First-Line Treatment of Metastatic Colorectal Cancer: Results From the BICC-C Study

Charles S. Fuchs, John L. Marshall, Edith P. Mitchell et al. · Journal of Clinical Oncology · 2007 · 857 citations

, , +17

Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy

Perry Elliott, Brian Drachman, Stephen S. Gottlieb et al. · Circulation Heart Failure · 2021 · 193 citations · Full text

, , +13

Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome

Yu‐Tze Ng, Joan A. Conry, Rebecca Drummond et al. · Neurology · 2011 · 191 citations · Full text

, , +10

Secukinumab shows sustained efficacy and low structural progression in ankylosing spondylitis: 4-year results from the MEASURE 1 study

Jürgen Braun, Xenofon Baraliakos, Atul Deodhar et al. · Lara D. Veeken · 2018 · 142 citations · Full text

, , +16

The statistical analysis of a clinical trial when a protocol amendment changed the inclusion criteria

Christian Lösch, Markus Neuhäuser · BMC Medical Research Methodology · 2008 · 36 citations · Full text

, , +11

1–5 of 16

Authors

128

  1. JS
    J. Stolle

    UConn Health, United States

    1 publications · 191 citations

    1

    h-index

  2. AV
    Andres Virchis

    University College London, United Kingdom

    1 publications · 15 citations

    1

    h-index

  3. MA
    Martha A. Maurer

    University of Wisconsin–Madison, United States

    1 publications · 15 citations

    1

    h-index

  4. CS
    Charles S. Fuchs

    Dana-Farber Cancer Institute, United States

    1 publications · 857 citations

    1

    h-index

  5. KS
    Koji Sasaki

    The University of Texas MD Anderson Cancer Center, United States

    1 publications · 22 citations

    1

    h-index

1–5 of 128

Institutions

62

  1. Leeds Teaching Hospitals NHS Trust

    Leeds, United Kingdom

    2 h-index

    2 publications

    155 citations

  2. University College London

    London, United Kingdom

    2 h-index

    13 publications

    373 citations

  3. University of Leeds

    Leeds, United Kingdom

    2 h-index

    2 publications

    157 citations

  4. St James's University Hospital

    Leeds, United Kingdom

    1 h-index

    1 publications

    15 citations

  5. MRC Clinical Trials Unit at UCL

    London, United Kingdom

    1 h-index

    1 publications

    13 citations

  6. Institute of Cancer Research

    London, United Kingdom

    1 h-index

    3 publications

    39 citations

  7. Northwestern University

    Evanston, United States

    1 h-index

    1 publications

    193 citations

  8. Barts Health NHS Trust

    London, United Kingdom

    1 h-index

    3 publications

    45 citations

1–8 of 62

Venues

  1. Journal of Clinical Oncology

    3 publications · 914 citations

    3

    h-index

  2. Journal of International Economic Law

    1 publications · 17 citations

    1

    h-index

  3. Therapeutic Innovation & Regulatory Science

    TIRS · 1 publications · 14 citations

    1

    h-index

  4. Circulation Heart Failure

    1 publications · 193 citations

    1

    h-index

  5. Lara D. Veeken

    1 publications · 142 citations

    1

    h-index

1–5