Concepedia

Protocol Deviations

Protocol Deviations is a type of noncompliance with the approved clinical trial protocol that occurs during the conduct of a study and involves a departure from the established procedures, criteria, or safeguards without prior approval, thereby potentially affecting the integrity of the trial data or the rights, safety, and well-being of participants.

76

Publications

5.4K

Citations

314

Authors

178

Institutions

Publications per year

2017–2026

6

Parents

Children

Publications

76

What Experimental Protocol Influence Disparities Between Actual and Hypothetical Stated Values?

John A. List, Craig A. Gallet · Environmental and Resource Economics · 2001 · 987 citations

, , +10

A tutorial on sensitivity analyses in clinical trials: the what, why, when and how

Lehana Thabane, Lawrence Mbuagbaw, Shiyuan Zhang et al. · BMC Medical Research Methodology · 2013 · 901 citations · Full text

, , +16

Therapeutic misconception and the appreciation of risks in clinical trials

Charles W. Lidz, Paul S. Appelbaum, Thomas Grisso et al. · Social Science & Medicine · 2003 · 330 citations

, , +13

Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis

Priya Ranganathan, C.S. Pramesh, Rakesh Aggarwal · Perspectives in Clinical Research · 2016 · 313 citations · Full text

, , +11

Analysis of Longitudinal Trials with Protocol Deviation: A Framework for Relevant, Accessible Assumptions, and Inference via Multiple Imputation

James R. Carpenter, James Roger, Michael G. Kenward · Journal of Biopharmaceutical Statistics · 2013 · 293 citations

, , +14

1–5 of 76

Authors

314

  1. MG
    Michael G. Kenward

    London School of Hygiene & Tropical Medicine, United Kingdom

    5 publications · 463 citations

    5

    h-index

  2. KG
    Kenneth Getz

    Tufts University, United States

    3 publications · 155 citations

    3

    h-index

  3. JR
    James R. Carpenter

    London School of Hygiene & Tropical Medicine, United Kingdom

    3 publications · 412 citations

    3

    h-index

  4. CM
    Christos Melidis

    Radboud University Nijmegen, Netherlands

    2 publications · 257 citations

    2

    h-index

  5. SC
    Suzie Cro

    University College London, United Kingdom

    2 publications · 119 citations

    2

    h-index

1–5 of 314

Institutions

178

  1. London School of Hygiene & Tropical Medicine

    London, United Kingdom

    5 h-index

    14 publications

    1.6K citations

  2. McMaster University

    Hamilton, Canada

    4 h-index

    25 publications

    13.1K citations

  3. Tufts University

    Medford, United States

    4 h-index

    18 publications

    571 citations

  4. European Organisation for Research and Treatment of Cancer

    Brussels, Belgium

    2 h-index

    6 publications

    771 citations

  5. Protein Metrics (United States)

    San Carlos, United States

    2 h-index

    2 publications

    89 citations

  6. University of Massachusetts Chan Medical School

    Worcester, United States

    2 h-index

    4 publications

    1.1K citations

  7. Biogen (United States)

    Cambridge, United States

    2 h-index

    2 publications

    141 citations

  8. University Hospital of Geneva

    Geneva, Switzerland

    2 h-index

    3 publications

    228 citations

1–8 of 178

Venues

  1. Journal of Clinical Epidemiology

    5 publications · 309 citations

    5

    h-index

  2. PubMed

    Repository · 4 publications · 238 citations

    4

    h-index

  3. Therapeutic Innovation & Regulatory Science

    TIRS · 4 publications · 120 citations

    4

    h-index

  4. The Lancet

    3 publications · 45 citations

    3

    h-index

  5. Social Science & Medicine

    3 publications · 423 citations

    3

    h-index

1–5