1. Open Source Analytics App for Clinical Trials: Letter to the Editor—A Novel App for Insights into Laboratory Data of Clinical Trials

   • Björn Koneswarakantha
   • Timothé Ménard

   Letter to the Editor 06 August 2021 Pages: 1107 - 1108

   

2. Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans

   • Dominik Karres
   • Gregory Reaman
   • Jean Temeck

   Commentary 08 September 2021 Pages: 1109 - 1110

3. Radiologists and Clinical Trials: Part 1 The Truth About Reader Disagreements

   • Annette M. Schmid
   • David L. Raunig
   • Robert R. Ford

   Review 06 July 2021 Pages: 1111 - 1121

4. Radiologists and Clinical Trials: Part 2: Practical Statistical Methods for Understanding and Monitoring Independent Reader Performance

   • David L. Raunig
   • Annette M. Schmid
   • Robert R. Ford

   Review 09 July 2021 Pages: 1122 - 1138

   

5. Promoting Best Practices for Medical Science Liaisons Position Statement from the APPA, IFAPP, MAPS and MSLS

   • Paul Theron
   • Matthew Britland
   • Ajay Tiku

   Review Open access 08 July 2021 Pages: 1139 - 1144

6. Practical Considerations and Recommendations for Master Protocol Framework: Basket, Umbrella and Platform Trials

   • Chengxing (Cindy) Lu
   • Xiaoyun (Nicole) Li
   • Jingjing Ye

   Review 23 June 2021 Pages: 1145 - 1154

7. Implementation of a Pregnancy Prevention Programme (PPP) with a Controlled Distribution System (CDS) for the Generic Teratogenic Phthalimides Thalidomide, Lenalidomide and Pomalidomide

   • Marion Mueller
   • David J. Lewis

   Review 30 July 2021 Pages: 1155 - 1164

   

8. Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines

   • S. D. Faulkner
   • C. A. C. M. Pittens
   • M. Subramaniam

   Original Research Open access 28 June 2021 Pages: 1165 - 1179

   

9. An Innovative Health Literacy Approach Designed to Improve Patient Understanding of Medication Labeling

   • Kara L. Jacobson
   • Juliette Faughnan
   • Michael S. Wolf

   Original Research Open access 02 August 2021 Pages: 1180 - 1192

   

10. Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development

    • Debra L. Michaels
    • Yaritza Peña
    • Kenneth A. Getz

    Original Research 20 July 2021 Pages: 1193 - 1198

    

11. New Visualization Models of Designation Pathway and Group Categorization of Cell-Device and Protein-Device Combination Products in the United States

    • Nobuo Uemura
    • Hiroshi Kasanuki
    • Mitsuo Umezu

    Original Research 21 June 2021 Pages: 1199 - 1213

    

12. A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group

    • James Buchanan
    • Mengchun Li
    • Jeremy Wildfire

    Original Research Open access 19 July 2021 Pages: 1214 - 1219

    

13. elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials

    • Silke Janitza
    • Madhurima Majumder
    • Hermann Kulmann

    Original Research 01 July 2021 Pages: 1220 - 1229

    

14. Correction to: elaborator: A Novel App for Insights into Laboratory Data of Clinical Trials

    • Silke Janitza
    • Madhurima Majumder
    • Hermann Kulmann

    Correction 22 July 2021 Pages: 1230 - 1230

15. The Competency of Clinical Research Coordinators: The Importance of Education and Experience

    • Carlton A. Hornung
    • Jared Kerr
    • Carolynn Thomas Jones

    Original Research 29 June 2021 Pages: 1231 - 1238

    

16. Enhancing the Measure of Participation Burden in Protocol Design to Incorporate Logistics, Lifestyle, and Demographic Characteristics

    • Z. Smith
    • M. Wilkinson
    • K. Getz

    Original Research 30 August 2021 Pages: 1239 - 1249

    

17. Ascertaining Nonfatal Endpoints in Clinical Trials: Central Adjudication Versus Patient Insurance Claims

    • Eric L. Eisenstein
    • Meredith N. Zozus
    • Kevin J. Anstrom

    Original Research 06 July 2021 Pages: 1250 - 1257

    

18. Impact of Tumor Assessment Frequency on Statistical Power in Randomized Cancer Clinical Trials Evaluating Progression-Free Survival

    • Yuki Nakagawa
    • Takuya Yoshimoto
    • Takashi Asakawa

    Original Research 28 July 2021 Pages: 1258 - 1264

19. Historical Benchmarks for Quality Tolerance Limits Parameters in Clinical Trials

    • Marcin Makowski
    • Ruma Bhagat
    • Sabine Turri

    Original Research Open access 27 August 2021 Pages: 1265 - 1273