Concepedia

Protocol Amendment Design

Protocol Amendment Design is a methodological framework within clinical trial design that specifies the systematic approach for modifying an established trial protocol while maintaining scientific integrity, regulatory compliance, and participant safety.

62

Publications

5K

Citations

575

Authors

278

Institutions

Publications per year

2017–2026

26

Parents

Publications

62

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

Delayed administration of dexrazoxane provides cardioprotection for patients with advanced breast cancer treated with doxorubicin-containing therapy.

Sandra M. Swain, Fredrick S. Whaley, Mirjam C. Gerber et al. · Journal of Clinical Oncology · 1997 · 269 citations

, , +11

Everolimus versus Mycophenolate Mofetil in the Prevention of Rejection in De Novo Renal Transplant Recipients: A 3-Year Randomized, Multicenter, Phase III Study

Marc I. Lorber, Shamkant Mulgaonkar, Khalid M.H. Butt et al. · Transplantation · 2005 · 232 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

Everolimus and Reduced-Exposure Cyclosporine in de novo Renal-Transplant Recipients: A Three-Year Phase II, Randomized, Multicenter, Open-Label Study

Björn Nashan, John J. Curtis, Claudio Ponticelli et al. · Transplantation · 2004 · 192 citations

, , +17

1–5 of 62

Authors

575

  1. KG
    Kenneth Getz

    Tufts University, United States

    6 publications · 504 citations

    6

    h-index

  2. DD
    Daniel D. Mikol

    Amgen (United States), United States

    3 publications · 385 citations

    3

    h-index

  3. SC
    Sunfa Cheng

    Amgen (United States), United States

    3 publications · 385 citations

    3

    h-index

  4. UR
    Uwe Reuter

    Charité - Universitätsmedizin Berlin, Germany

    3 publications · 385 citations

    3

    h-index

  5. MA
    Messoud Ashina

    University of Copenhagen, Denmark

    3 publications · 385 citations

    3

    h-index

1–5 of 575

Institutions

278

  1. Tufts University

    Medford, United States

    7 h-index

    14 publications

    931 citations

  2. Dana-Farber Cancer Institute

    Boston, United States

    6 h-index

    17 publications

    9.9K citations

  3. Novartis (Switzerland)

    Basel, Switzerland

    5 h-index

    6 publications

    807 citations

  4. Pfizer (United States)

    New York, United States

    5 h-index

    15 publications

    1.5K citations

  5. Charité - Universitätsmedizin Berlin

    Berlin, Germany

    4 h-index

    4 publications

    527 citations

  6. Amgen (United States)

    Thousand Oaks, United States

    4 h-index

    15 publications

    1.9K citations

  7. Novartis (United States)

    New York, United States

    4 h-index

    6 publications

    1K citations

  8. Thomas Jefferson University

    Philadelphia, United States

    4 h-index

    4 publications

    434 citations

1–8 of 278

Venues

  1. Journal of Clinical Oncology

    8 publications · 1.5K citations

    8

    h-index

  2. Cephalalgia

    3 publications · 235 citations

    3

    h-index

  3. Therapeutic Innovation & Regulatory Science

    TIRS · 3 publications · 234 citations

    3

    h-index

  4. BMC Cancer

    2 publications · 79 citations

    2

    h-index

  5. BMC Medical Research Methodology

    2 publications · 93 citations

    2

    h-index

1–5