Jump to content

User:Mtallan1013/sandbox

From Wikipedia, the free encyclopedia

Patients in clinical trials as subjects

[edit]

[1]Patient participation can include a broad spectrum of activities for human subjects during clinical trials and has become associated with several other words such as “patient engagement” or “decision making.”[2]

In the US, trends in patient participation have been influenced by a variety of sources and previous political movements. One such source for patient participation in clinical research was the AIDS epidemic in the 1980s and 1990s. During the epidemic, the AIDS activists argued not only for new clinical trial models, but for the importance of additional social service groups to support a wider range of potential human subjects.[3] Since then, the FDA has taken several steps to include patients earlier in the drug development process. The authorization of Prescription Drug User Fee Act (PDUFA) V in 2012 included the Patient-Focused Drug Development (PFDD) initiative to provide the FDA with a way of hearing the patients’ perspectives and concerns.[4] Similarly, the European Medicine Agency (EMA) has been attempting to incorporate patient perspectives during the evaluation of medicinal products by the EMA scientific committees.[5]

There has been an increased interest among healthcare providers, such as nurses, in cultivating patient participation.[6] Due to this increased interest, studies have been done to assess the benefits and risks of patient participation and engagement in research. For benefits, patient engagement improves patient outcomes as well as clinical trial enrollment and retention.[7] For risks, it has been proposed that the inclusion of patient participation may lead to extended research times and increased funding for clinical trials.[7]

A few of the tools used to cultivate patient participation in clinical research have been the growth of patient organizations along with the development of databases and patient registries.[8] These tools allow for the mass collection and dissemination of data. Registries, specifically, do not only allow patients to access personal information, but registries also allow physicians to review the outcomes and experiences of several patients who received treatment with medicinal products .[9][10] Furthermore, registries and patient participation have been particularly important to the development of rare-disease medicines. In the US, the Rare Diseases Clinical Research Network (RDCRN) was created in 2003 which includes a registry for patients afflicted with a rare-disease.[11][12] This registry provides information to the patients and allows physicians to contact potential patients for enrollment in clinical trials.[12]

Notes

[edit]
  1. ^ R., Furrow, Barry (2013). Health law : cases, materials, and problems. Greaney, Thomas L., 1948-, Johnson, Sandra H.,, Jost, Timothy S.,, Schwartz, Robert L., 1948- (Seventh ed.). St. Paul, MN. ISBN 9780314265098. OCLC 852459288.{{cite book}}: CS1 maint: location missing publisher (link) CS1 maint: multiple names: authors list (link)
  2. ^ Vahdat, Shaghayegh; Hamzehgardeshi, Leila; Hessam, Somayeh; Hamzehgardeshi, Zeinab (January 2014). "Patient Involvement in Health Care Decision Making: A Review". Iranian Red Crescent Medical Journal. 16 (1): e12454. doi:10.5812/ircmj.12454. ISSN 2074-1804. PMC 3964421. PMID 24719703.
  3. ^ Council, National Research (1969-12-31). The Social Impact of AIDS in the United States. doi:10.17226/1881. ISBN 9780309046282. PMID 25121219.
  4. ^ Research, Center for Drug Evaluation and. "Prescription Drug User Fee Act (PDUFA) - Externally-led Patient-Focused Drug Development Meetings". www.fda.gov. Retrieved 2017-09-17.
  5. ^ "European Medicines Agency" (PDF). www.ema.europa.eu. 23 October 2014. Retrieved September 16, 2017.
  6. ^ Barello, Serena; Graffigna, Guendalina; Vegni, Elena (2012). "Patient Engagement as an Emerging Challenge for Healthcare Services: Mapping the Literature". Nursing Research and Practice. 2012: 905934. doi:10.1155/2012/905934. ISSN 2090-1429. PMC 3504449. PMID 23213497.
  7. ^ a b Domecq, Juan Pablo; Prutsky, Gabriela; Elraiyah, Tarig; Wang, Zhen; Nabhan, Mohammed; Shippee, Nathan; Brito, Juan Pablo; Boehmer, Kasey; Hasan, Rim (2014-02-26). "Patient engagement in research: a systematic review". BMC Health Services Research. 14: 89. doi:10.1186/1472-6963-14-89. ISSN 1472-6963. PMC 3938901. PMID 24568690.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  8. ^ Smith, Sophia K.; Selig, Wendy; Harker, Matthew; Roberts, Jamie N.; Hesterlee, Sharon; Leventhal, David; Klein, Richard; Patrick-Lake, Bray; Abernethy, Amy P. (2015-10-14). "Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey". PLOS ONE. 10 (10): e0140232. doi:10.1371/journal.pone.0140232. ISSN 1932-6203. PMC 4605726. PMID 26465328.
  9. ^ Wiljer, David; Urowitz, Sara; Apatu, Emma; DeLenardo, Claudette; Eysenbach, Gunther; Harth, Tamara; Pai, Howard; Leonard, Kevin J (2008-10-31). "Patient Accessible Electronic Health Records: Exploring Recommendations for Successful Implementation Strategies". Journal of Medical Internet Research. 10 (4): e34. doi:10.2196/jmir.1061. ISSN 1438-8871. PMC 2629367. PMID 18974036.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  10. ^ Trotter, Jeffrey P. (2002). "Patient Registries: A New Gold Standard for "Real World" Research". The Ochsner Journal. 4 (4): 211–214. ISSN 1524-5012. PMC 3400525. PMID 22826660.
  11. ^ "Rare Diseases Clinical Research Network (RDCRN)". www.rarediseasesnetwork.org. Retrieved 2017-09-17.
  12. ^ a b Elizabeth., Hernberg-Ståhl (2013). Orphan drugs : understanding the rare disease market and its dynamics. Reljanović, Miroslav. Oxford: WP, Woodhead Publishing. ISBN 9781908818393. OCLC 867555228.