Del real world data a la farmacoterapia personalizada. ¿Por dónde vamos?

Eduardo López-Briz; Juan Pablo Ordovás-Baines

Del real world data a la farmacoterapia personalizada. ¿Por dónde vamos?

Eduardo López-Briz, Juan Pablo Ordovás-Baines

Resumen

Texto completo:

PDF (English) PDF

Referencias

Sackett D. How to read clinical journals: I. Why to read them and how to start reading them critically. Can Med Assoc J. 1981;1245:555-8.

Makady A, De Boer A, Hillege H, Klungel O, Goettsch W; on behalf of GetReal Work Package 1. What Is Real-World Data? A Review of Definitions Based on Literature and Stakeholder Interviews. Value Health. 2017;20(7):858-65. DOI: 10.1016/j.jval.2017.03.008

Food and Drug Administration. Real-World Evidence [webpage] [accessed 07/2021]. Available at: https://www.fda.gov/science- research/science-andresearch-special-topics/real-world-evidence

Meneu R, Márquez-Calderón S. La incertidumbre sobre la efectividad y seguridad de los fármacos. Relevancia de los estudios de utilización de medicamentos. Farm Hosp. 2005;29(4):221-4. DOI: 10.1016/S1130- 6343(05)73668-0

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, et al. Real-World Evidence. What is it and what can it tell us? New Engl J Med. 2016;375:2293-7. DOI: 10.1056/NEJMsb1609216

Quigley JM, Thompson JC, Halfpenny NJ, Scott DA. Critical Appraisal of Real World Evidence. A Review of Recommended and Commonly Used Tools. Value Health. 2015;18(7):A684. DOI: https://doi.org/10.1016/j.jval.2015.09.2525

Feinberg BA, Gajra A, Zettler ME, Phillips TD, Phillips EG, Kish JK. Use of Real-World Evidence to Support FDA Approval of Oncology Drugs. Value Health. 2020;23(10):1358-65. DOI: 10.1016/j.jval.2020.06.006

Boyle JM, Hegarty G, Frampton C, Harvey-Jones E, Dodkins J, Beyer K, et al. Realworld outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study. Eur J Cancer. 2021;155:136-44. DOI: 10.1016/j.ejca.2021.07.001: 10.1016/j.ejca.2021.07.001

Bernstein Iriart JA. Precision medicine/personalized medicine: a critical analysis of movements in the transformation of biomedicine in the early 21st century. Cad Saude Publica. 2019;35(3):e00153118. DOI: 10.1590/0102-311X00153118

Metzler I. Biomarkers and their consequences for the biomedical profession: a social science perspective. Per Med. 2010;7(4):407-20. DOI: 10.2217/pme.10.41

Duffy DJ. Problems, challenges and promises: perspectives on precision medicine. Brief Bioinform. 2016;17(3):494-504. DOI: 10.1093/bib/bbv060

Turakhia MP, Sabatine MS. How We Evaluate Biomarker Studies. JAMA Cardiol. 2017;2(5):524. DOI: 10.1001/jamacardio.2017.0291

Ioannidis JPA, Panagiotou OA. Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses. JAMA. 2011;305(21):2200-10. DOI: 10.1001/jama.2011.713

Prasad V. Perspective: The precision-oncology illusion. Nature. 2016;537(7619):S63. DOI: 10.1038/537S63a

Davis C, Naci H, Gurpinar E, Poplavska E, Pinto A, Aggarwal A, et al. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13. BMJ. 2017;359:j4530. DOI: 10.1136/bmj.j4530