1. Medical Information Practices Across the Pharma Industry: What Can We Learn from Benchmarking Surveys?

   • Ina Shah
   • Izzat Janajreh
   • Stacey M. Fung

   Editorial 12 November 2020 Pages: 1259 - 1262

2. phactMI Benchmarking Survey on Content Development and Inquiry Management

   • Jacqueline Byun
   • Jin Ah Jong
   • Ina Shah

   Original Research 04 March 2020 Pages: 1263 - 1268

   

3. Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Results of Organizational Structure and Resourcing of Medical Information Services in Support of Building Departmental Strategies

   • Kirstie Marasigan
   • Sara Doshi
   • Stacey Fung

   Original Research 14 March 2020 Pages: 1269 - 1274

   

4. Pharma Collaboration for Transparent Medical Information (phactMI™) Benchmark Study: Trends, Drivers, and Value of Product Support Activities, Key Performance Indicators, and Other Medical Information Services: Insights from a Survey of 27 US Pharmaceutical Medical Information Departments

   • Meera Patel
   • Leena Jindia
   • Kirstie Marasigan

   Original Research 23 May 2020 Pages: 1275 - 1281

   

5. Where are We Now in Providing Medical Information in the Digital Space? A Benchmark Survey of PhactMI™ Member Companies

   • Priya Patel
   • Rania Gaspo
   • on behalf of the PhactMI™ Benchmarking Committee

   Original Research 25 September 2020 Pages: 1282 - 1290

   

6. phactMI™ Benchmarking Survey: Analysis of 27 Medical Information Departments Responses to Inquiries from Health Care Decision Makers

   • AnnaMaria D’Ascoli
   • Andrew Gazo
   • Shemanta Akanda

   Original Research 08 April 2020 Pages: 1291 - 1295

   

7. Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes

   • Mary E. Ritchey
   • Cynthia J. Girman

   Original Research 07 May 2020 Pages: 1296 - 1302

   

8. Proposed Best Practice Guidelines for Scientific Response Documents: A Consensus Statement from phactMI

   • Evelyn R. Hermes-DeSantis
   • Renee M. Johnson
   • Patrick Reilly

   Review 20 April 2020 Pages: 1303 - 1311

9. Advancing Therapeutic Development for Pulmonary Morbidities Associated with Preterm Birth

   • Sarah Sheehan
   • Gerri Baer
   • Susan McCune

   Analytical Report 27 April 2020 Pages: 1312 - 1318

10. Evaluating the Success of ZaZiBoNa, the Southern African Development Community Collaborative Medicines Registration Initiative

    • Tariro Sithole
    • Gugu Mahlangu
    • Stuart Walker

    Review Open access 29 April 2020 Pages: 1319 - 1329

    

11. Assessing the Scope and Predictors of Intentional Dose Non-adherence in Clinical Trials

    • Kenneth Getz
    • Zachary Smith
    • Adam Hanina

    Original Research 04 May 2020 Pages: 1330 - 1338

12. A Systematic Review of the Efficacy and Safety of Aspirin When Delivered at Different Medication Times for the Primary and Secondary Prevention of Cardiovascular and Cerebrovascular Diseases

    • Boya Zhou
    • Qiaoyu Wang
    • Xin Feng

    Review Article 07 May 2020 Pages: 1339 - 1348

    

13. Benchmarking the Vendor Qualification Process

    • Kenneth Getz
    • Michael Wilkinson
    • Deborah Profit

    Original Research 06 May 2020 Pages: 1349 - 1358

    

14. Coronavirus Disease 2019 (COVID-19) Spread and Pharmacovigilance Implications: Expert Opinion

    • Peter Yamoah
    • Thelma Mpoku Alalbila
    • Frasia Oosthuizen

    Commentary 01 May 2020 Pages: 1359 - 1362

15. Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation

    • Daphne Guinn
    • Rajanikanth Madabushi
    • Kimberly Maxfield

    Original Research 16 May 2020 Pages: 1363 - 1371

    

16. Factors that have an Impact on Abbreviated New Drug Application (ANDA) Submissions

    • Saranrat Wittayanukorn
    • Matthew Rosenberg
    • Liang Zhao

    Original Research 03 June 2020 Pages: 1372 - 1381

    

17. Healthcare Professionals’ Perceptions of Infographics Within Medical Information Response Letters

    • Zil Patel
    • Chandni Patel
    • Autri Sajedeen

    Original Research 28 July 2020 Pages: 1382 - 1387

    

18. Opinions and Trends of Healthcare Providers Concerning Scientific/Standard Response Documents

    • James Young
    • Roma Bhavsar
    • Evelyn Hermes-DeSantis

    Original Research 26 May 2020 Pages: 1388 - 1397

    

19. eSubmission of Promotional Labeling and Advertising Materials via the eCTD FDA Gateway

    • Joanne Hathaway
    • Kevin Hom
    • Albert D’Alonzo

    Review 27 May 2020 Pages: 1398 - 1403

20. Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation

    • Magdalena Bujar
    • Neil McAuslane
    • Stuart R. Walker

    Original Research Open access 29 May 2020 Pages: 1404 - 1415

    

21. An Empirical Comparison of Statistical Methods for Missing Data in Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trials for Chronic Pain and Lipid-Lowering Products

    • Jeanine Gnang
    • Yoonhee Kim
    • Yongman Kim

    Original Research 04 June 2020 Pages: 1416 - 1427

    

22. A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016

    • Prisha Patel
    • Daniela Marreco Cerqueira
    • Neil McAuslane

    Original Research Open access 09 June 2020 Pages: 1428 - 1435

    

23. Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review

    • Yodit Seifu
    • Margaret Gamalo-Siebers
    • Rosalind Walley

    Review 08 June 2020 Pages: 1436 - 1443

    

24. Likelihood Ratio Test Method for Multiple Medical Devices Comparison Using Multiple-Site Data with Continuous Outcomes

    • Tingting Hu
    • Jianjin Xu
    • Ram Tiwari

    Original Research 11 June 2020 Pages: 1444 - 1452

25. The Financial Benefits of Faster Development Times: Integrated Formulation Development, Real-Time Manufacturing, and Clinical Testing

    • Joseph A. DiMasi
    • Michael Wilkinson

    Original Research 04 June 2020 Pages: 1453 - 1460

    

26. The Current Status of European and National Financial Sources for Clinical Research and Their Impact on Paediatric Non-commercial Clinical Trials: A Case Study of the Czech Republic

    • L. Horavova
    • K. Nebeska
    • P. Babula

    Original Research Open access 05 June 2020 Pages: 1461 - 1472

    

27. Methodological and Regulatory Considerations for Updated Guidance on the Pressor Effects of Drugs

    • Nicholas R. Harrison
    • Philip T. Sager
    • William B. White

    Analytical Report 04 June 2020 Pages: 1473 - 1476

28. Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting

    • Trevor A. Lentz
    • Lesley H. Curtis
    • Susan S. Ellenberg

    Original Research 08 June 2020 Pages: 1477 - 1488

    

29. Amplifying the Voice of the Patient in Clinical Research: Development of Toolkits for Use in Designing and Conducting Patient-Centered Clinical Studies

    • TransCelerate Biopharma Toolkits Core Team
    • Mary Elmer
    • Stephen Yates

    Analytical Report Open access 02 July 2020 Pages: 1489 - 1500

    

30. Characteristics of Drug Intervention Clinical Trials and Scientific Impact of the Trial Outcome: A Bibliometric Analysis Using the Relative Citation Ratio in Non-small Cell Lung Cancer from 2007 to 2016

    • Yutaka Noguchi
    • Masayuki Kaneko
    • Mamoru Narukawa

    Original Research 11 June 2020 Pages: 1501 - 1511

    

31. AdEPro: Animation of Adverse Event Profiles—Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data

    • Nicole Mentenich
    • Christoph Tasto
    • Bastian Becker

    Analytical Report 11 June 2020 Pages: 1512 - 1521

    

32. Evaluation of the Content Validity and Cross-Cultural Validity of the Study Participant Feedback Questionnaire (SPFQ)

    • Alison Greene
    • Mary Elmer
    • Adam Gater

    Original Research Open access 20 July 2020 Pages: 1522 - 1533

    

33. Characteristics on Drug Safety Measures in Japan Stratified by System Organ Classes and Therapeutic Categories in Relation to the Approval Date

    • Ayaka Hiramatsu
    • Hideki Hanaoka
    • Yoshiaki Uyama

    Original Research 10 June 2020 Pages: 1534 - 1540

    

34. Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017

    • Kenneth A. Getz
    • Zachary P. Smith
    • Yaritza Peña

    Original Research 18 June 2020 Pages: 1541 - 1550

35. Statistical Evaluation of Clinical Trials Under COVID-19 Pandemic

    • Shein-Chung Chow
    • Wei Zhang

    Original Research 24 June 2020 Pages: 1551 - 1556

36. Bayesian Meta-analysis of Safety Outcomes Using Blinded Clinical Trial Data

    • Emily Goren
    • Li-An Lin
    • Greg Ball

    Original Research 23 June 2020 Pages: 1557 - 1565

    

37. Use of Patient-Reported Outcomes to Understand & Measure the Patient Experience of Novel Cell and Gene Therapies

    • Laura Lasiter
    • Alicyn Campbell
    • Jeff Allen

    Commentary 22 June 2020 Pages: 1566 - 1575