DOKUMENTY , REGLAMENTIRUYuShchIE MEZhDUNARODNUYu PRAKTIKUPROVEDENIYa KLINIChESKIKh ISPYTANIY ASSISTIRUYuShchIKh ROBOTOV


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Abstract

This review brings to light and analyzes the list of documents which regulate the international practice of organization
of non-pharmacological clinical trials including employment of assisting robots in rehabilitation medicine and publication of
results.

References

  1. Bollapragada S.S., Norrie J.D., Norman J.E. Review of new regulations for the conduct of clinical trials of investigational medicinal products 1. oducts // BJOG. 2007. Vol. 114, No 8. P. 917-921.
  2. ClinicalTrials.gov : The Official Site / URL: http://clinicaltrials.gov/ct2/home (дата обращения: 13.04.2010).
  3. CONONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials / Moher D. et al. // J Clin Epidemiol. 2010. Vol. 63. March 2010. Published ahead of print. doi: 10.1016/j.jclinepi.2010.03.004. 37 p. PDF. URL: http://www.consort-statement.org/ consort-statement/overview0/ (дата обращения: 12.04.2010).
  4. Controlled-trials.com / The Controlled Trials Official Site. URL: : http://www.controlled-trials.com/ (дата обращения: 13.04.2010).
  5. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices // Official Journal L 169. 1993, 12 July. P. 0001 - 0043. doi 31993L0042. URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML (дата обращения: 13.04.2010).
  6. Detailed guidance on the request to the competent authorities for authorisation of a clinical trial … (CT-1). 2010/C 82/01. 2010, 30 March / EUROPEAN COMMISSION // Official J Eur Union. 2010. 19 p. PDF. URL: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:082:0001: 0019:en:PDF (дата обращения: 11.04.2010).
  7. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration / Boutron I. et al. // Ann Intern Med. 2008. Vol. 148, No 4. P. 295-309. PDF. URL: http://www.annals.org/content/148/4/295.full.pdf+html (дата обращения: 20.04.2010).
  8. Found 17 studies with search of: Lokomat // ClinicalTrials.go / US National Institutes of Health. URL: http://clinicaltrials.gov/ct2/results?term=Lokomat (дата обращения: 06.03.2010).
  9. Guideline for Good Clinical Practice / International conference on harmonisation of technical … human use. June 1996. 59 P. PDF. URL: http://www. ich.org/LOB/media/MEDIA482.pdf (дата обращения: 23.03.2010).
  10. ICMJE Initiative: Protocol Registration System // The Official Site of ClinicalTrials.gov. URL: http://prsinfo.clinicaltrials.gov/icmje.html (дата обращения: 17.04.2010).
  11. Schulz K.F., Altman D.G., Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Ann Int Med. 2010. Vol. 152. Ann Intern Med published ahead of print March 24, 2010. 11 p. PDF. URL: http://www.annals.org/content/early/2010/03/18/0003-4819- 152-11-201006010-00232.full.pdf+html?sid=d3155942-ff3c-481b-85e6-044d25fcdba9 (дата обращения: 12.04.2010).
  12. Systematic review of the empirical evidence of study publication bias and outcome reporting bias / Dwan K. et al. // PLoS ONE. 2008. Vol. 3. P. e3081. URL: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0003081 (дата обращения: 15.04.2010).
  13. The ATLET Study 15/18 // The Official Site of ClinicalTrials.gov. URL: http://clinicaltrials.gov/ct2/show/NCT00854555?term=Lokomat&rank=15 (дата обращения: 20.04.2010).

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