Transformation of the clinical trial enterprise : lessons learned from the COVID-19 pandemic : final report / Ariel Dora Stern, Mark Trusheim.

Format:

Book

Author/Creator:

Stern, Ariel Dora, author.

Contributor:

Trusheim, Mark, contributor.

Language:

English

Subjects (All):

COVID-19 (Disease).

Physical Description:

1 online resource (82 pages) : illustrations

Other Title:

Transformation of the clinical trial enterprise

Place of Publication:

[Massachusetts] : Co-Bio Consulting, 2024.

Summary:

In 2023, ASPE launched a research project to understand the impacts of COVID-19 on the clinical trial enterprise and identify key lessons learned. This project included an environmental scan of the peer-reviewed and gray literature from 2020 to 2023 as well as a series of interviews with experts in clinical trial design, clinical trial operations, decentralized clinical trials, digital health technologies, clinical trial diversity, and regulatory oversight and evaluation. The methods and results from this project are described in detail in the report.

Contents:

ACKNOWLEDGMENTS

1. Report summary

2. Methods

3. Disruptions to clinical trials due to COVID-19

Types of interruptions

4. Decentralized clinical trials and digital health technologies

DCT and DHT Implementation during COVID-19

Lessons Learned for decentralized clinical trials and digital health technologies

5. Platforms and statistical innovation in clinical trial design

Utilization of platforms and statistical innovation in clinical trial design during COVID-19

Lessons Learned for platforms and statistical innovation in clinical trial design

6. Participant diversity drivers and infrastructure

Impact of COVID-19 trial disruptions and innovations on participant diversity

Lessons Learned for increasing participant diversity in clinical trials

7. Real-world evidence and the gap between clinical research and practice

Applications of RWE during the covid-19 pandemic

Lessons Learned for RWE and the gap between clinical research and practice

8. Regulatory trial oversight and evaluation

Description of COVID-19 Impacts

Lessons Learned for regulatory trial oversight and evaluation

9. General operational considerations for clinical trials

Lessons Learned for general operational considerations

10. Testing the lessons learned: areas for future analysis

11. Conclusions

Key Lessons Learned

12. Appendix A: Definitions

13. Appendix B: Acronyms

14. Appendix C: Search terms for environmental scan

15. Appendix D: FDA COVID-19 related guidance documents directly regarding clinical trials

16. APPENDIX E: Testing the lessons learned: feasibility demonstrations

17. Bibliography.

Notes:

Description based on publisher supplied metadata and other sources.