Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities
Abstract
Real-world evidence (RWE) has gained significant attention as a valuable source of evidence in healthcare decision-making. This article provides a comprehensive analysis of the regulatory development, adoption, and perseverance of RWE with global health authorities, as well as a synopsis of the major trends and practices among global health authorities. The aim is to shed light on the current landscape, and prospects of utilizing RWE in regulatory processes. Globally, many health authorities are drafting guidelines for RWE and implementing various regulations. Implementation is in the initial stages because RWE has certain limitations. This article examines the experiences of selected global health authorities in the development and implementation of RWE strategies. It also examines regulatory guidelines, pilot programmes, and collaborations designed to establish a solid foundation for the use of RWE. However, despite all challenges and limitations, RWE is widely being used in drug approval and commercial sense.
Keywords:
Real-world evidence (RWE), Clinical Trials, randomized controlled trials (RCTs), FDA, CBER, PMDA, TMDA, ICH, Covid-19, Health Canada
Downloads
Download data is not yet available.
References
1. Anagnostopoulos C, Champagne D, Devereson A, Huijskens T, and Macak M. Generating real-world evidence at scale using advanced analytics [Internet]. McKinsey; 2022 Mar 15 [cited 2024 Apr 02]. Available from:
https://www.mckinsey.com/industries/life-sciences/our-insights/generating-real-world-evidence-at-scale-using-advanced-analytics
2. Yang H, Yu B, editors. Real-world evidence in drug development and evaluation. CRC Press; 2021 Jan 11.
3. Varnai P, Davé A, Farla K, Nooijen A, Petrosova L. The Evidence REVEAL study: exploring the use of real‐world evidence and complex clinical trial design by the European pharmaceutical industry. Clinical Pharmacology & Therapeutics. 2021 Nov;110(5):1180-9.
4. Hampson G, Towse A, Dreitlein WB, Henshall C, Pearson SD. Real-world evidence for coverage decisions: opportunities and challenges. Journal of comparative effectiveness research. 2018 Dec;7(12):1133-43.
5. Burns L, Le Roux N, Kalesnik-Orszulak R, Christian J, Hukkelhoven M, Rockhold F, O'Donnell J. Real-world evidence for regulatory decision-making: guidance from around the world. Clinical Therapeutics. 2022 Mar 1;44(3):420-37.
6. Paris V, Slawomirski L, Colbert A, Delaunay N, Oderkirk J. New health technologies managing access, value and sustainability. New Heal Technol. 2017:19-44.
7. Gandhi S, Saxena K, Kartikeyan C, Tiwari A, Jain S, Jain V, Pal P. Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities. Int J Drug Reg Affairs [Internet]. 2024Sep.19 [cited 2024 Jul. 15];12(3):38-6. Available from:
https://www.ijdra.com/index.php/journal/article/view/692
8. 9-ways-real-world-evidence-is-changing health care [Internet]. arbormetrix; 2024 [cited 2024 Apr 04]. Available from:
https://www.arbormetrix.com/?s=9-ways-real-world-evidence-is-changing+health+care
9. Mullard A. 2020 FDA drug approvals. Nature Reviews Drug Discovery. 2021 Feb 1;20(2):85-91.
10. Real-World Evidence [Internet]. USFDA; 2024 Apr [cited 2024 Apr 04]. Available from:
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
11. World Health Organization. The pursuit of responsible use of medicines: sharing and learning from country experiences. World Health Organization; 2012.
12. Liu F, Panagiotakos D. Real-world data: a brief review of the methods, applications, challenges and opportunities. BMC Medical Research Methodology. 2022 Nov 5;22(1):287.
13. Jandhyala R. A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch. current medical research and opinion. 2021;37(9):1645–1655.
https://doi.org/10.1080/03007995.2021.1947218
14. Davies SE, Kamradt-Scott A, Rushton S. Disease diplomacy: International norms and global health security. JHU Press; 2015 Mar 15.
15. Mues KE, Liede A, Liu J, Wetmore JB, Zaha R, Bradbury BD, Collins AJ, Gilbertson DT. Use of the Medicare database in epidemiologic and health services research: a valuable source of real-world evidence on the older and disabled populations in the US. Clinical epidemiology. 2017 May 9:267-77.
16. Lau C, Jamali F, Loebenberg R. Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information: Real-World Evidence used by Health Canada in Regulatory Decision Making. Journal of Pharmacy & Pharmaceutical Sciences. 2022 Jun 23;25:227-36.
17. Bubela T, McCabe C, Archibald P, Atkins H, Bradshaw SE, Kefalas P, Mujoomdar M, Packer C, Piret J, Raxworthy M, Soares M. Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regenerative medicine. 2015 Oct;10(7):897-911.
18. Menon D, Stafinski T. Health technology assessment in Canada: 20 years strong?. Value in Health. 2009 Jun;12:S14-9.
19. Allen Jr B, Seltzer SE, Langlotz CP, Dreyer KP, Summers RM, Petrick N, Marinac-Dabic D, Cruz M, Alkasab TK, Hanisch RJ, Nilsen WJ. A road map for translational research on artificial intelligence in medical imaging: from the 2018 National Institutes of Health/RSNA/ACR/The Academy Workshop. Journal of the American College of Radiology. 2019 Sep 1;16(9):1179-89.
20. Yang H, Yu B, editors. Real-world evidence in drug development and evaluation. CRC Press; 2021 Jan 11.
21. Wise J, Möller A, Christie D, Kalra D, Brodsky E, Georgieva E, Jones G, Smith I, Greiffenberg L, McCarthy M, Arend M. The positive impacts of real-world data on the challenges facing the evolution of biopharma. Drug discovery today. 2018 Apr 1;23(4):788-801.
22. Cragg L, Williams S, van der Molen T, Thomas M, Correia de Sousa J, Chavannes NH. Fostering the exchange of real world data across different countries to answer primary care research questions: an UNLOCK study from the IPCRG. npj Primary Care Respiratory Medicine. 2018 Mar 8;28(1):8.
23. Song P, Gao J, Inagaki Y, Kokudo N, Tang W. Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives. Intractable & rare diseases research. 2012 Feb 29;1(1):3-9.
24. Lee SW, Park SH, Song I, Noh Y, Park H, Ha D, Shin JY. Notable differences in drug lag between Korea and Japan of new drugs between 2009 and 2017. Therapeutic Innovation & Regulatory Science. 2020 Mar;54(2):418-23.
25. Qiu T, Hanna E, Dabbous M, Borislav B, Toumi M. Regenerative medicine regulatory policies: a systematic review and international comparison. Health Policy. 2020 Jul 1;124(7):701-13.
26. Park S, Ha SL. Characteristics of New Drugs Approved in Korea in 2007~ 2018. Research in Brief. 2020 Jun; 26(59):1-8.
27. Lee S, Kang W. Precision Regulation Approach: A COVID-19 Triggered Regulatory Drive in South Korea. Frontiers in Public Health. 2021 Feb 1;9:628073.
28. Kim DS, Bae S. Impact and challenges of enactment for advanced regenerative medicine in South Korea. Frontiers in Bioengineering and Biotechnology. 2022 Oct 12;10:972865.
29. Chaplenko A, Gildeeva G, Vlassov V. The entry lag of innovative drugs in Russia, 2010–2019. International Journal of Environmental Research and Public Health. 2021 May 11;18(10):5052.
30. TMMDA Brochure. Turkish Medicines and Medical Devices Agency [Internet]. Republic of Turkey, Ministry of Health [cited 2024 Apr 05]. Available from:
https://www.titck.gov.tr/Dosyalar/Erisim/TMMDABrochure.pdf
31. Ministry of Health of Ukraine [Internet]. Ministry of Health of Ukraine [cited 2024 Apr 05]. Available from:
https://healthresearchwebafrica.org.za/en/ukraine/institution_373
32. Regulation of the scientific ethics. Pontificia Universidad Católica de Chile [Internet]. Chile: Pontificia Universidad Católica; 2016 [cited 2024 Apr 06]. Available from:
https://eticayseguridad.uc.cl/images/DR._143-2020._Regulation_of_the_scientific_ethics...
33. Ministry of Health ANMAT. Internet]. Ministry of Health ANMAT; 2024 [cited 2024 Apr 03]. Available from:
https://www.argentina.gob.ar/anmat/anmat-en/
34. Lou J, Sarin KC, Toh KY, Dabak S, Adler A, Ahn J, Bayani DB, Chan K, Choiphel D, Chua B, Genuino AJ. Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward. International journal of technology assessment in health care. 2020 Oct;36(5):474-80.
35. Breckenridge AM, Breckenridge RA, Peck CC. Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation. British Journal of Clinical Pharmacology. 2019 Sep;85(9):1874-7.
36. Malone DC, Brown M, Hurwitz JT, Peters L, Graff JS. Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies? Value in Health. 2018 Mar 1;21(3):326-33.
37. Pulini AA, Caetano GM, Clautiaux H, Vergeron L, Pitts PJ, Katz G. Impact of real-world data on market authorization, reimbursement decision & price negotiation. Therapeutic Innovation & Regulatory Science. 2021 Jan;55:228-38.
38. Berger ML, Sox H, Willke RJ, Brixner DL, Eichler HG, Goettsch W, Madigan D, Makady A, Schneeweiss S, Tarricone R, Wang SV. Good practices for real‐world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making. Value in Health. 2017 Sep 1;20(8):1003-8.
39. Franklin JM, Lin KJ, Gatto NM, Rassen JA, Glynn RJ, Schneeweiss S. Real‐world evidence for assessing pharmaceutical treatments in the context of COVID‐19. Clinical Pharmacology & Therapeutics. 2021 Apr;109(4):816-28.
40. Wegner M. New approaches to regulatory innovation emerging during the crucible of COVID-19: in responding to a global health crisis, industry is discovering new, efficient ways of meeting objectives. Therapeutic Innovation & Regulatory Science. 2021 Mar;55:463-6.
41. Bok K, Sitar S, Graham BS, Mascola JR. Accelerated COVID-19 vaccine development: milestones, lessons, and prospects. Immunity. 2021 Aug 10;54(8):1636-51.
42. Martini N, Trifirò G, Capuano A, Corrao G, Pierini A, Racagni G, Pani L. Expert opinion on Real-World Evidence (RWE) in drug development and usage. Pharmadvances. 2020 Jul;2(2):41-50.
43. Mahase E. Covid-19: AstraZeneca vaccine is not linked to increased risk of blood clots, finds European Medicine Agency BMJ. 2021; 372:n774. doi:10.1136/bmj.n774.
44. Willmon R, George O, Selvarajah S, Adams J, Soyao G, Hart M, Gardner DD, Winders T. PCR103 A Digitally Enabled Care and Real World Evidence (RWE) Research Program Among Individuals with Asthma and COPD during the COVID-19 Pandemic. Value in Health. 2022 Jul 1;25(7):S560.
45. Mycka J, Dellamano R, Lobb W, Dalal N, Dellamano L, Pereira E. P31 Impact of COVID-19 on HTA/PRMA of Medicinal Products in Europe: A Payer Perspective. Value in Health. 2022 Jan 1;25(1):S7.
46. Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz‐Rosiak K, Baek I, Ghil J. Switching from reference adalimumab to SB5 (Adalimumab Biosimilar) in patients with rheumatoid arthritis: Fifty‐Two–Week Phase III randomized study results. Arthritis & Rheumatology. 2018 Jun;70(6):832-40.
47. Cohen SB, Alonso-Ruiz A, Klimiuk PA, Lee EC, Peter N, Sonderegger I, Assudani D. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Annals of the Rheumatic Diseases. 2018 Jun 1;77(6):914-21.
48. Sidky H, Young JC, Girvin AT, Lee E, Shao YR, Hotaling N, Michael S, Wilkins KJ, Setoguchi S, Funk MJ. Data quality considerations for evaluating COVID-19 treatments using real world data: learnings from the National COVID Cohort Collaborative (N3C). BMC medical research methodology. 2023 Dec;23(1):1-21.
49. Chuenkitmongkol S, Solante R, Burhan E, Chariyalertsak S, Chiu NC, Do-Van D, Husin M, Hwang KP, Kiertiburanakul S, Kulkarni PS, Lee PI. Expert review on global real-world vaccine effectiveness against SARS-CoV-2. Expert Review of Vaccines. 2022 Sep 2;21(9):1255-68.
50. Clements M, Stem K. The Modernization of Clinical Trials: COVID-19's Lasting Impact. Clinical Researcher. 2021:52.
51. Li JX, Rees RC. From Small Data to Big Data, From RCT to RWE, the Impact of Statistics: Selected Articles From the 2019 RISW. Statistics in Biopharmaceutical Research. 2021 Jul 3;13(3):259-.
52. Zou, KH, Salem LA, & Ray A. (Eds.). Real-World Evidence in a Patient-Centric Digital Era (1st ed.). New York: Chapman and Hall /CRC; 2022.p.208.
https://doi.org/10.1201/9781003017523.
53. Ribeiro A, Walker A, Walsh K. P30 Potential Impacts of the New MHRA Policy for Biosimilar Approval for the Industry and Patients. Value in Health. 2022 Jan 1;25(1):S7.
54. Brixner D, Couto J, Worley K, Small A, Panchal R, Dharbhamalla V, Eichenbrenner P. Advancing a managed care pharmacy research agenda: Generating real-world evidence to support US Food and Drug Administration Accelerated Approvals and improving benefit design to address health inequities. Journal of Managed Care & Specialty Pharmacy. 2022 Aug;28(8):911-7.
55. Jaksa A, Wu J, Jónsson P, Eichler HG, Vititoe S, Gatto NM. Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance. Journal of Comparative Effectiveness Research. 2021 Jun;10(9):711-31.
https://www.mckinsey.com/industries/life-sciences/our-insights/generating-real-world-evidence-at-scale-using-advanced-analytics
2. Yang H, Yu B, editors. Real-world evidence in drug development and evaluation. CRC Press; 2021 Jan 11.
3. Varnai P, Davé A, Farla K, Nooijen A, Petrosova L. The Evidence REVEAL study: exploring the use of real‐world evidence and complex clinical trial design by the European pharmaceutical industry. Clinical Pharmacology & Therapeutics. 2021 Nov;110(5):1180-9.
4. Hampson G, Towse A, Dreitlein WB, Henshall C, Pearson SD. Real-world evidence for coverage decisions: opportunities and challenges. Journal of comparative effectiveness research. 2018 Dec;7(12):1133-43.
5. Burns L, Le Roux N, Kalesnik-Orszulak R, Christian J, Hukkelhoven M, Rockhold F, O'Donnell J. Real-world evidence for regulatory decision-making: guidance from around the world. Clinical Therapeutics. 2022 Mar 1;44(3):420-37.
6. Paris V, Slawomirski L, Colbert A, Delaunay N, Oderkirk J. New health technologies managing access, value and sustainability. New Heal Technol. 2017:19-44.
7. Gandhi S, Saxena K, Kartikeyan C, Tiwari A, Jain S, Jain V, Pal P. Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities. Int J Drug Reg Affairs [Internet]. 2024Sep.19 [cited 2024 Jul. 15];12(3):38-6. Available from:
https://www.ijdra.com/index.php/journal/article/view/692
8. 9-ways-real-world-evidence-is-changing health care [Internet]. arbormetrix; 2024 [cited 2024 Apr 04]. Available from:
https://www.arbormetrix.com/?s=9-ways-real-world-evidence-is-changing+health+care
9. Mullard A. 2020 FDA drug approvals. Nature Reviews Drug Discovery. 2021 Feb 1;20(2):85-91.
10. Real-World Evidence [Internet]. USFDA; 2024 Apr [cited 2024 Apr 04]. Available from:
https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
11. World Health Organization. The pursuit of responsible use of medicines: sharing and learning from country experiences. World Health Organization; 2012.
12. Liu F, Panagiotakos D. Real-world data: a brief review of the methods, applications, challenges and opportunities. BMC Medical Research Methodology. 2022 Nov 5;22(1):287.
13. Jandhyala R. A medicine adoption model for assessing the expected effects of additional real-world evidence (RWE) at product launch. current medical research and opinion. 2021;37(9):1645–1655.
https://doi.org/10.1080/03007995.2021.1947218
14. Davies SE, Kamradt-Scott A, Rushton S. Disease diplomacy: International norms and global health security. JHU Press; 2015 Mar 15.
15. Mues KE, Liede A, Liu J, Wetmore JB, Zaha R, Bradbury BD, Collins AJ, Gilbertson DT. Use of the Medicare database in epidemiologic and health services research: a valuable source of real-world evidence on the older and disabled populations in the US. Clinical epidemiology. 2017 May 9:267-77.
16. Lau C, Jamali F, Loebenberg R. Health Canada Usage of Real World Evidence (RWE) in Regulatory Decision Making compared with FDA/EMA usage based on publicly available information: Real-World Evidence used by Health Canada in Regulatory Decision Making. Journal of Pharmacy & Pharmaceutical Sciences. 2022 Jun 23;25:227-36.
17. Bubela T, McCabe C, Archibald P, Atkins H, Bradshaw SE, Kefalas P, Mujoomdar M, Packer C, Piret J, Raxworthy M, Soares M. Bringing regenerative medicines to the clinic: the future for regulation and reimbursement. Regenerative medicine. 2015 Oct;10(7):897-911.
18. Menon D, Stafinski T. Health technology assessment in Canada: 20 years strong?. Value in Health. 2009 Jun;12:S14-9.
19. Allen Jr B, Seltzer SE, Langlotz CP, Dreyer KP, Summers RM, Petrick N, Marinac-Dabic D, Cruz M, Alkasab TK, Hanisch RJ, Nilsen WJ. A road map for translational research on artificial intelligence in medical imaging: from the 2018 National Institutes of Health/RSNA/ACR/The Academy Workshop. Journal of the American College of Radiology. 2019 Sep 1;16(9):1179-89.
20. Yang H, Yu B, editors. Real-world evidence in drug development and evaluation. CRC Press; 2021 Jan 11.
21. Wise J, Möller A, Christie D, Kalra D, Brodsky E, Georgieva E, Jones G, Smith I, Greiffenberg L, McCarthy M, Arend M. The positive impacts of real-world data on the challenges facing the evolution of biopharma. Drug discovery today. 2018 Apr 1;23(4):788-801.
22. Cragg L, Williams S, van der Molen T, Thomas M, Correia de Sousa J, Chavannes NH. Fostering the exchange of real world data across different countries to answer primary care research questions: an UNLOCK study from the IPCRG. npj Primary Care Respiratory Medicine. 2018 Mar 8;28(1):8.
23. Song P, Gao J, Inagaki Y, Kokudo N, Tang W. Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives. Intractable & rare diseases research. 2012 Feb 29;1(1):3-9.
24. Lee SW, Park SH, Song I, Noh Y, Park H, Ha D, Shin JY. Notable differences in drug lag between Korea and Japan of new drugs between 2009 and 2017. Therapeutic Innovation & Regulatory Science. 2020 Mar;54(2):418-23.
25. Qiu T, Hanna E, Dabbous M, Borislav B, Toumi M. Regenerative medicine regulatory policies: a systematic review and international comparison. Health Policy. 2020 Jul 1;124(7):701-13.
26. Park S, Ha SL. Characteristics of New Drugs Approved in Korea in 2007~ 2018. Research in Brief. 2020 Jun; 26(59):1-8.
27. Lee S, Kang W. Precision Regulation Approach: A COVID-19 Triggered Regulatory Drive in South Korea. Frontiers in Public Health. 2021 Feb 1;9:628073.
28. Kim DS, Bae S. Impact and challenges of enactment for advanced regenerative medicine in South Korea. Frontiers in Bioengineering and Biotechnology. 2022 Oct 12;10:972865.
29. Chaplenko A, Gildeeva G, Vlassov V. The entry lag of innovative drugs in Russia, 2010–2019. International Journal of Environmental Research and Public Health. 2021 May 11;18(10):5052.
30. TMMDA Brochure. Turkish Medicines and Medical Devices Agency [Internet]. Republic of Turkey, Ministry of Health [cited 2024 Apr 05]. Available from:
https://www.titck.gov.tr/Dosyalar/Erisim/TMMDABrochure.pdf
31. Ministry of Health of Ukraine [Internet]. Ministry of Health of Ukraine [cited 2024 Apr 05]. Available from:
https://healthresearchwebafrica.org.za/en/ukraine/institution_373
32. Regulation of the scientific ethics. Pontificia Universidad Católica de Chile [Internet]. Chile: Pontificia Universidad Católica; 2016 [cited 2024 Apr 06]. Available from:
https://eticayseguridad.uc.cl/images/DR._143-2020._Regulation_of_the_scientific_ethics...
33. Ministry of Health ANMAT. Internet]. Ministry of Health ANMAT; 2024 [cited 2024 Apr 03]. Available from:
https://www.argentina.gob.ar/anmat/anmat-en/
34. Lou J, Sarin KC, Toh KY, Dabak S, Adler A, Ahn J, Bayani DB, Chan K, Choiphel D, Chua B, Genuino AJ. Real-world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward. International journal of technology assessment in health care. 2020 Oct;36(5):474-80.
35. Breckenridge AM, Breckenridge RA, Peck CC. Report on the current status of the use of real‐world data (RWD) and real‐world evidence (RWE) in drug development and regulation. British Journal of Clinical Pharmacology. 2019 Sep;85(9):1874-7.
36. Malone DC, Brown M, Hurwitz JT, Peters L, Graff JS. Real-world evidence: useful in the real world of US payer decision making? How? When? And what studies? Value in Health. 2018 Mar 1;21(3):326-33.
37. Pulini AA, Caetano GM, Clautiaux H, Vergeron L, Pitts PJ, Katz G. Impact of real-world data on market authorization, reimbursement decision & price negotiation. Therapeutic Innovation & Regulatory Science. 2021 Jan;55:228-38.
38. Berger ML, Sox H, Willke RJ, Brixner DL, Eichler HG, Goettsch W, Madigan D, Makady A, Schneeweiss S, Tarricone R, Wang SV. Good practices for real‐world data studies of treatment and/or comparative effectiveness: recommendations from the joint ISPOR‐ISPE Special Task Force on real‐world evidence in health care decision making. Value in Health. 2017 Sep 1;20(8):1003-8.
39. Franklin JM, Lin KJ, Gatto NM, Rassen JA, Glynn RJ, Schneeweiss S. Real‐world evidence for assessing pharmaceutical treatments in the context of COVID‐19. Clinical Pharmacology & Therapeutics. 2021 Apr;109(4):816-28.
40. Wegner M. New approaches to regulatory innovation emerging during the crucible of COVID-19: in responding to a global health crisis, industry is discovering new, efficient ways of meeting objectives. Therapeutic Innovation & Regulatory Science. 2021 Mar;55:463-6.
41. Bok K, Sitar S, Graham BS, Mascola JR. Accelerated COVID-19 vaccine development: milestones, lessons, and prospects. Immunity. 2021 Aug 10;54(8):1636-51.
42. Martini N, Trifirò G, Capuano A, Corrao G, Pierini A, Racagni G, Pani L. Expert opinion on Real-World Evidence (RWE) in drug development and usage. Pharmadvances. 2020 Jul;2(2):41-50.
43. Mahase E. Covid-19: AstraZeneca vaccine is not linked to increased risk of blood clots, finds European Medicine Agency BMJ. 2021; 372:n774. doi:10.1136/bmj.n774.
44. Willmon R, George O, Selvarajah S, Adams J, Soyao G, Hart M, Gardner DD, Winders T. PCR103 A Digitally Enabled Care and Real World Evidence (RWE) Research Program Among Individuals with Asthma and COPD during the COVID-19 Pandemic. Value in Health. 2022 Jul 1;25(7):S560.
45. Mycka J, Dellamano R, Lobb W, Dalal N, Dellamano L, Pereira E. P31 Impact of COVID-19 on HTA/PRMA of Medicinal Products in Europe: A Payer Perspective. Value in Health. 2022 Jan 1;25(1):S7.
46. Weinblatt ME, Baranauskaite A, Dokoupilova E, Zielinska A, Jaworski J, Racewicz A, Pileckyte M, Jedrychowicz‐Rosiak K, Baek I, Ghil J. Switching from reference adalimumab to SB5 (Adalimumab Biosimilar) in patients with rheumatoid arthritis: Fifty‐Two–Week Phase III randomized study results. Arthritis & Rheumatology. 2018 Jun;70(6):832-40.
47. Cohen SB, Alonso-Ruiz A, Klimiuk PA, Lee EC, Peter N, Sonderegger I, Assudani D. Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study. Annals of the Rheumatic Diseases. 2018 Jun 1;77(6):914-21.
48. Sidky H, Young JC, Girvin AT, Lee E, Shao YR, Hotaling N, Michael S, Wilkins KJ, Setoguchi S, Funk MJ. Data quality considerations for evaluating COVID-19 treatments using real world data: learnings from the National COVID Cohort Collaborative (N3C). BMC medical research methodology. 2023 Dec;23(1):1-21.
49. Chuenkitmongkol S, Solante R, Burhan E, Chariyalertsak S, Chiu NC, Do-Van D, Husin M, Hwang KP, Kiertiburanakul S, Kulkarni PS, Lee PI. Expert review on global real-world vaccine effectiveness against SARS-CoV-2. Expert Review of Vaccines. 2022 Sep 2;21(9):1255-68.
50. Clements M, Stem K. The Modernization of Clinical Trials: COVID-19's Lasting Impact. Clinical Researcher. 2021:52.
51. Li JX, Rees RC. From Small Data to Big Data, From RCT to RWE, the Impact of Statistics: Selected Articles From the 2019 RISW. Statistics in Biopharmaceutical Research. 2021 Jul 3;13(3):259-.
52. Zou, KH, Salem LA, & Ray A. (Eds.). Real-World Evidence in a Patient-Centric Digital Era (1st ed.). New York: Chapman and Hall /CRC; 2022.p.208.
https://doi.org/10.1201/9781003017523.
53. Ribeiro A, Walker A, Walsh K. P30 Potential Impacts of the New MHRA Policy for Biosimilar Approval for the Industry and Patients. Value in Health. 2022 Jan 1;25(1):S7.
54. Brixner D, Couto J, Worley K, Small A, Panchal R, Dharbhamalla V, Eichenbrenner P. Advancing a managed care pharmacy research agenda: Generating real-world evidence to support US Food and Drug Administration Accelerated Approvals and improving benefit design to address health inequities. Journal of Managed Care & Specialty Pharmacy. 2022 Aug;28(8):911-7.
55. Jaksa A, Wu J, Jónsson P, Eichler HG, Vititoe S, Gatto NM. Organized structure of real-world evidence best practices: moving from fragmented recommendations to comprehensive guidance. Journal of Comparative Effectiveness Research. 2021 Jun;10(9):711-31.
Statistics
90 Views | 78 Downloads
How to Cite
1.
Gandhi S, Saxena K, Kartikeyan C, Tiwari A, Jain S, Jain V, Pal P. Regulatory Development, Adoption, and Perseverance of Real-world Evidence with global health authorities. Int J Drug Reg Affairs [Internet]. 2024Sep.15 [cited 2025Mar.20];12(3):38-6. Available from: https://www.ijdra.com/index.php/journal/article/view/692
Section
Review
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
The International Journal of Drug Regulatory affairs require a formal written transfer of copyright from the author(s) for each article published. We therefore ask you to complete and return this form, retaining a copy for your records. Your cooperation is essential and appreciated. Any delay will result in a delay in publication.
I/we have read and agree with the terms and conditions stated Page 2 of this agreement and I/we hereby confirm the transfer of all copyrights in and relating to the above-named manuscript, in all forms and media, now or hereafter known, to the International Journal of Drug Regulatory affairs, effective from the date stated below. I/we acknowledge that the IJDRA is relying on this agreement in publishing the above-named manuscript. However, this agreement will be null and void if the manuscript is not published in the IJDRA.
Download link for COPYRIGHT FORM
