Articles

1. Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?

   • Hans-Peter Podhaisky

   Commentary 24 April 2024

   

2. Factors Associated with Inclusion of Japan in Phase I Multiregional Clinical Trials in Oncology

   • Akio Maki
   • Mamoru Narukawa

   Original Research 23 April 2024

   

3. Unlocking the Potential: A Systematic Review of Master Protocol in Pediatrics

   • Yimei Li
   • Robert Nelson
   • Jingjing Ye

   Review Open access 23 April 2024

   

4. A Survey to Assess the Current Status of Structured Benefit-Risk Assessment in the Global Drug and Medical Device Industry

   • Martin Gebel
   • Cheryl Renz
   • Michael Colopy

   Original Research 22 April 2024

   

5. Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET^®) in Japan

   • Masatoshi Tanigawa
   • Mei Kohama
   • Hideto Yokoi

   Original Research 21 April 2024

   

6. Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials

   • Hadir Aljohani
   • Fares S. Alrubaish
   • Fawaz Al-Harbi

   Review 18 April 2024

   

7. Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) Amyloidosis

   • James Signorovitch
   • Jialu Zhang
   • Isabelle Lousada

   Analytical Report Open access 17 April 2024

   

8. Correction: Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union

   • Mohammed Alnuhait
   • Abdullah Alshammari
   • Abdullah M. Alrajhi

   Correction 16 April 2024

   

9. The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History

   • Jonathan H. Sussman
   • Ahmed Albayar
   • William C. Welch

   Review Open access 15 April 2024

   

10. Improvement of Midpoint Imputation for Estimation of Median Survival Time for Interval-Censored Time-to-Event Data

    • Yuki Nakagawa
    • Takashi Sozu

    Original Research 10 April 2024

    

11. Reflections on the Saudi FDA Regulatory Experience with Smart GxP Inspections

    • Ali M. Alhomaidan
    • Nawaf G. Al-Murikhi
    • Mohammed A. Dahhas

    Original Research 10 April 2024

    

12. Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies

    • Masayasu Hidaka
    • Hideki Hanaoka
    • Yoshiaki Uyama

    Original Research 04 April 2024

    

13. Benchmarking Site Activation and Patient Enrollment

    • Mary Jo Lamberti
    • Abigail Dirks
    • Kenneth Getz

    Original Research 03 April 2024

14. Diversity Plans and Postmarketing Studies: First Impressions of Anticipated Diversity Requirements in the United States

    • Blake Schouest
    • Krithi Rao Bindal

    Original Research 03 April 2024

    

15. An Open-Source R Package for Detection of Adverse Events Under-Reporting in Clinical Trials: Implementation and Validation by the IMPALA (Inter coMPany quALity Analytics) Consortium

    • Björn Koneswarakantha
    • Ronojit Adyanthaya
    • On behalf of the IMPALA (Inter coMPany quALity Analytics) Consortium

    Analytical Report Open access 02 April 2024

    

16. How Aggregate Safety Assessment Planning Supports Investigational New Drug Safety Reporting Decisions

    • Barbara A. Hendrickson
    • Cynthia McShea
    • Susan Talbot

    Analytical Report 30 March 2024

    

17. Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports

    • Malak Almutairi
    • Aljoharah Algabbani
    • Amani S. Alqahtani

    Original Research 28 March 2024

    

18. Adoption of Decentralization: Are Our Perceptions Holding Us Back?

    • Lindsay Kehoe
    • Sara Bristol Calvert
    • Morgan Hanger

    Commentary Open access 28 March 2024

19. Comparative Assessment of Drug Lag for Approved Oncology Targeted Therapies Between Saudi Arabia, the United States, and the European Union

    • Mohammed Alnuhait
    • Abdullah Alshammari
    • Abdullah M. Alrajhi

    Original Research 27 March 2024

    

20. International Comparison of Qualification Process for Medical Product Development Tools

    • Daichi Uchijima
    • Shingo Kano

    Original Research Open access 27 March 2024

21. The Elusiveness of the Win Ratio Parameter in the Presence of Missing Data

    • Heng Li
    • Wei-Chen Chen
    • Yu Zhao

    Letter to the Editor 26 March 2024 Pages: 431 - 432

22. Recent Status of Phase I Clinical Trials for Brain Tumors: A Regulatory Science Study of Exploratory Efficacy Endpoints

    • Shinya Watanabe
    • Takahiro Nonaka
    • Eiichi Ishikawa

    Original Research Open access 26 March 2024

    

23. New Benchmarks on Protocol Amendment Experience in Oncology Clinical Trials

    • Emily Botto
    • Zachary Smith
    • Kenneth Getz

    Original Research 26 March 2024

24. The Evolving Regulatory Paradigm of AI in MedTech: A Review of Perspectives and Where We Are Today

    • Karen Zhou
    • Ginny Gattinger

    Review Open access 25 March 2024 Pages: 456 - 464

25. The Next Horizon of Drug Development: External Control Arms and Innovative Tools to Enrich Clinical Trial Data

    • Kelly H. Zou
    • Chelsea Vigna
    • Jim Z. Li

    Review Open access 25 March 2024 Pages: 443 - 455

    

26. Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry

    • Nicholette Conway
    • Orin Chisholm

    Original Research Open access 15 March 2024 Pages: 567 - 577

    

27. Industry Perceptions and Experiences with the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations

    • Gaia Geraci
    • Robert Smith
    • Tse Siang Kang

    Original Research Open access 08 March 2024 Pages: 557 - 566

    

28. A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy

    • Fernanda Lacerda da Silva Machado
    • Martín Cañás
    • Luciane Cruz Lopes

    Original Research 04 March 2024 Pages: 549 - 556

    

29. New Benchmarks on Protocol Amendment Practices, Trends and their Impact on Clinical Trial Performance

    • Kenneth Getz
    • Zachary Smith
    • Arnaud Dauchy

    Original Research 04 March 2024 Pages: 539 - 548

30. Access to Innovative Medicines: Regulation Change and Factors Associated with Drug Approval Lag in Malaysia

    • Wan Lee Chow
    • Nur Afiqah Mohd Salleh
    • Tse Siang Kang

    Original Research 20 February 2024 Pages: 528 - 538

    

31. Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability

    • Anders Vinther
    • Emma Ramnarine
    • David Fryrear

    Review Open access 18 February 2024 Pages: 433 - 442

    

32. Comprehensive Assessment of Risk-Based Quality Management Adoption in Clinical Trials

    • Abigail Dirks
    • Maria Florez
    • Kenneth Getz

    Original Research Open access 16 February 2024 Pages: 520 - 527

33. Correction: Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

    • Sai Dharmarajan
    • Zhong Yuan
    • Ram Tiwari

    Correction 12 February 2024 Pages: 519 - 519

34. Real-World Evidence to Support the Registration of a New Osteoporosis Medicinal Product in Europe

    • Colleen Davenport
    • Patricia Gravel
    • Bruce Mitlak

    Original Research Open access 10 February 2024 Pages: 505 - 518

    

35. Does Central Statistical Monitoring Improve Data Quality? An Analysis of 1,111 Sites in 159 Clinical Trials

    • Sylviane de Viron
    • Laura Trotta
    • Marc Buyse

    Original Research Open access 09 February 2024 Pages: 483 - 494

    

36. Translating a Culture of Quality to Clinical Research Conduct: Expanding the Clinical Development Quality Framework

    • Michael Torok
    • Leslie Sam
    • Jennifer Hebert

    Analytical Report Open access 07 February 2024 Pages: 404 - 414

    

37. A Modified Delphi Study to Establish Essential Clinical Pharmacology Competencies

    • Bernadette Johnson-Williams
    • Kellie Reynolds
    • Albert Rundio

    Original Research Open access 06 February 2024 Pages: 473 - 482

    

38. Quality Tolerance Limits: A General Guidance for Parameter Selection and Threshold Setting

    • Annett Keller
    • Nathalie van Borrendam
    • Jun Liu

    Analytical Report 06 February 2024 Pages: 423 - 430

    

39. Decentralized Clinical Trials: Scientific Considerations Through the Lens of the Estimand Framework

    • Rima Izem
    • Emmanuel Zuber
    • Robert Hemmings

    Original Research 05 February 2024 Pages: 495 - 504

    

40. The Finkelstein–Schoenfeld Test: A Note on Some Overlooked Issues Concerning Power

    • Rong Tang
    • Wei-Chen Chen
    • Yu Zhao

    Original Research Open access 05 February 2024 Pages: 465 - 472

    

41. Decentralized Clinical Trials in the Development of Drugs and Biological Products

    • Ryan Robinson
    • Leonard Sacks

    Commentary Open access 02 February 2024

42. Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa

    • Armel Zemsi
    • Lorraine Jinette Guedem Nekame
    • Umberto D’Alessandro

    Analytical Report Open access 29 January 2024 Pages: 395 - 403

43. Incorporating Prior Data in Quantitative Benefit–Risk Assessments: Case Study of a Bayesian Method

    • Sai Dharmarajan
    • Zhong Yuan
    • Ram Tiwari

    Analytical Report 24 January 2024 Pages: 415 - 422

    

44. Correction: An Overview of Current Statistical Methods for Implementing Quality Tolerance Limits

    • Rakhi Kilaru
    • Sonia Amodio
    • Susan Talbot

    Correction Open access 20 January 2024 Pages: 285 - 285

45. Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia

    • Jayanthi Boobalan
    • Kyu-Been Sohn
    • Ornamphai Shinawatra

    Analytical Report 09 January 2024 Pages: 223 - 233

    

46. Aggregate IND Safety Reporting for Smaller Companies and Programs

    • Greg Ball
    • Mengchun Li
    • Jay Herson

    Original Research 08 January 2024 Pages: 368 - 379

47. Quantifying Site Burden to Optimize Protocol Performance

    • Maria Florez
    • Zachary Smith
    • Kenneth Getz

    Original Research 08 January 2024 Pages: 347 - 356

48. US FDA’s Dose Optimization Postmarketing Requirements and Commitments of Oncology Approvals and the Impact on Product Labels from 2010 to 2022: An Emerging Landscape from Traditional to Novel Therapies

    • Joseph M. Gendy
    • Naomi Nomura
    • Gideon Blumenthal

    Original Research Open access 05 January 2024 Pages: 380 - 386

    

49. Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval

    • Yoshihiro Oda
    • Mamoru Narukawa

    Original Research 04 January 2024 Pages: 387 - 394

    

50. Pediatric Market Access: A Qualitative Study

    • Lieke Maas
    • Angelika Joos
    • Mickael Hiligsmann

    Original Research Open access 03 January 2024 Pages: 336 - 346