Concepedia

Clinical Protocol Design

Clinical Protocol Design is a systematic framework that specifies the scientific and methodological structure for conducting clinical trials within the context of Investigational New Drug Applications, distinguishing itself by detailing the objectives, methodology, statistical considerations, and ethical safeguards required to evaluate the safety and efficacy of investigational pharmaceuticals in human subjects.

1K

Publications

75.7K

Citations

5.3K

Authors

1.7K

Institutions

Publications per year

2017–2026

287

Parents

Publications

1K

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

An‐Wen Chan, Jennifer Tetzlaff, Douglas G. Altman et al. · Annals of Internal Medicine · 2013 · 8K citations · Full text

, , +14

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

A.-W. Chan, Jennifer Tetzlaff, Peter C Gøtzsche et al. · BMJ · 2013 · 7.1K citations · Full text

, , +12

The Design and Analysis of Clinical Experiments.

Michael Hills, Joseph L. Fleiss · Journal of the Royal Statistical Society Series A (General) · 1987 · 3.3K citations

, , +11

Research design in clinical psychology

Journal of Clinical Psychology · 1952 · 2.2K citations

, , +13

Foundations of clinical research application to practice

Lg. Portney · Medical Entomology and Zoology · 1993 · 1.1K citations

, , +11

1–5 of 1K

Authors

5.3K

  1. KA
    Kathleen A. Marinelli

    University of Connecticut, United States

    16 publications · 762 citations

    15

    h-index

  2. CR
    Casey Rosen‐Carole

    University of Rochester, United States

    12 publications · 738 citations

    12

    h-index

  3. SR
    Sarah Reece-Stremtan

    Children's National, United States

    12 publications · 567 citations

    12

    h-index

  4. DM
    David Moher

    Ottawa Hospital, Canada

    13 publications · 16.5K citations

    12

    h-index

  5. TS
    Tomoko Seo

    University of Wisconsin–Madison, United States

    11 publications · 578 citations

    11

    h-index

1–5 of 5.3K

Institutions

1.7K

  1. Harvard University

    Cambridge, United States

    21 h-index

    53 publications

    3.9K citations

  2. University of Oxford

    Oxford, United Kingdom

    20 h-index

    70 publications

    23.7K citations

  3. University of Toronto

    Toronto, Canada

    19 h-index

    29 publications

    18.1K citations

  4. University of Washington

    Seattle, United States

    18 h-index

    44 publications

    4K citations

  5. University College London

    London, United Kingdom

    16 h-index

    52 publications

    2.7K citations

  6. Stanford University

    Stanford, United States

    15 h-index

    96 publications

    11.3K citations

  7. University of North Carolina at Chapel Hill

    Chapel Hill, United States

    15 h-index

    21 publications

    2.8K citations

  8. Johns Hopkins University

    Baltimore, United States

    15 h-index

    47 publications

    153.2K citations

1–8 of 1.7K

Venues

  1. PubMed

    Repository · 86 publications · 4.7K citations

    36

    h-index

  2. Breastfeeding Medicine

    54 publications · 3K citations

    34

    h-index

  3. Trials

    16 publications · 672 citations

    14

    h-index

  4. Annals of Internal Medicine

    13 publications · 9.2K citations

    12

    h-index

  5. Clinical Trials

    12 publications · 594 citations

    12

    h-index

1–5