Clinical Trials: What, Where, When?

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Abstract

Currently randomized clinical trials (RCTs) are a key stage in the development of new drugs. Despite the huge scale of the CT market, general awareness of the issue remains low and the society has formed a number of stereotypes and misconceptions about CTs. The presented review of Russian and foreign studies provides the information on the level of general awareness of clinical research in different countries, as well as among patients and practitioners. The conducted literature analysis demonstrates that awareness of clinical trials remains low both in society at large and among patients or in the professional community of practitioners. According to foreign studies, only 20–30% of respondents have heard anything about medical research while a relatively small percentage of respondents have more complete knowledge of RCTs. Among practitioners, only one in five is sufficiently informed about CTs while, according to different data, only about half fully realize what evidence-based medicine is and understand the importance of CTs as a source of reliable knowledge in everyday practice.

About the authors

Olga S. Kobyakova

Siberian State Medical University

Email: olga_kobyakova@rambler.ru
ORCID iD: 0000-0003-0098-1403

Head of Division of General medical practice of Siberian State Medical University, DMedSc, professor.

2, Moscovsky trakt, 634050 Tomsk.

SPIN-код: 1373-0903

Russian Federation

Ivan A. Deev

Siberian State Medical University

Email: ivandeyev@yandex.ru
ORCID iD: 0000-0002-4449-4810

Professor of  Division of  Faculty pediatrics, DMedSc.

SPIN-код: 2730-0004

Russian Federation

Evgeny S. Kulikov

Siberian State Medical University

Email: evgeny.s.kulikov@gmail.com
ORCID iD: 0000-0002-0088-9204

Professor of Division of General medical practice of Siberian State Medical University, DMedSc.

SPIN-код: 9934-1476

Roman I. Shtykh

Siberian State Medical University

Email: shtykh.roman@gmail.com
ORCID iD: 0000-0001-9060-7428

Student.

SPIN-код: 3988-4881

Russian Federation

Igor D. Pimenov

Siberian State Medical University

Author for correspondence.
Email: igor.d.pimenov@gmail.com
ORCID iD: 0000-0003-3866-100X

Resident.

SPIN-код: 3757-0769

Russian Federation

Olga I. Zvonareva

Siberian State Medical University

Email: zvonoks@gmail.com
ORCID iD: 0000-0001-5548-7491

Researcher at the Central Research Laboratory.

SPIN-код: 9145-4513

Russian Federation

Igor V. Mareev

Goldberg Research Institute of Pharmacology and Regenerative Medicine, Tomsk National Research Medical Сеntеr of the Russian Academy of Sciences

Email: igor.mareev@pharmso.ru
ORCID iD: 0000-0003-0700-121X

Clinical pharmacologist at Goldberg Research Institute of Pharmacology and Regenerative Medicine.

SPIN-код: 9629-3810

Russian Federation

References

  1. Moorcraft SY, Marriott C, Peckitt C, et al. Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17. doi: 10.1186/s13063-015-1105-3.
  2. synergycro.ru [Internet]. SRG Orange Papers. Orange paper: clinical trials in Russia 1’st quarter 2017; 2007–2017 [cited 2017 Aug 20]. Available from: http://synergycro.ru/analytics/orange-paper.html.
  3. Viergever RF, Li K. Trends in global clinical trial registration: an analysis of numbers of registered clinical trials in different parts of the world from 2004 to 2013. BMJ Open. 2015;5(9):e008932. doi: 10.1136/bmjopen-2015-008932.
  4. lillypad.lilly.com [Internet]. Patient participation in clinical trials infographic; c1994-2017 [updated 2016 Jan 25; cited 2017 Aug 15]. Available from: https://lillypad.lilly.com/.
  5. Куликов Е.С., Деев И.А., Кобякова О.С., и др. Клиническое исследование глазами пациента: мотивация, ожидания, восприятие // Клиническая медицина. — 2017. — Т.95. — №8 — С. 751–757.
  6. Parsons S, Starling B, Mullan-Jensen C, et al. What the public knows and wants to know about medicines research and development: a survey of the general public in six European countries. BMJ Open. 2015;5(4):e006420. doi: 10.1136/bmjopen-2014-006420.
  7. Joshi VD, Oka GA, Kulkarni AA, Bivalkar VV. Public awareness and perception of clinical trials: quantitative study in pune. Perspect Clin Res. 2013;4(3):169–174. doi: 10.4103/2229-3485.115378.
  8. Chu SH, Kim EJ, Jeong SH, Park GL. Factors associated with willingness to participate in clinical trials: a nationwide survey study. BMC Public Health. 2015;15:10. doi: 10.1186/s12889-014-1339-0.
  9. Choi YJ, Beck SH, Kang WY, et al. Knowledge and perception about clinical research shapes behavior: face to face survey in Korean General Public. J Korean Med Sci. 2016;31(5):674–681. doi: 10.3346/jkms.2016.31.5.674.
  10. Mackenzie IS, Wei L, Rutherford D, et al. Promoting public awareness of randomized clinical trials using the media: the ‘Get Randomised’ campaign. Br J Clin Pharmacol. 2010;69(2):128–135. doi: 10.1111/j.1365-2125.2009.03561.x.
  11. Brown M, Moyer A. Predictors of awareness of clinical trials and feelings about the use of medical information for research in a nationally representative US sample. Ethn Health. 2010;15(3):223–236. doi: 10.1080/13557851003624281.
  12. Lee SJ, Park LC, Lee J, et al. Unique perception of clinical trials by Korean cancer patients. BMC Cancer. 2012; 12:594. doi: 10.1186/1471-2407-12-594.
  13. Lim Y, Lim JM, Jeong WJ, et al. Korean cancer patients’ awareness of clinical trials, perceptions on the benefit and willingness to participate. Cancer Res Treat. 2017;49(4):1033–1043. doi: 10.4143/crt.2016.413.
  14. Mc Grath-Lone L, Day S, Schoenborn C, Ward H. Exploring research participation among cancer patients: analysis of a national survey and an in-depth interview study. BMC Cancer. 2015;15:618. doi: 10.1186/s12885-015-1628-8.
  15. Teschke K, Marino S, Chu R, et al. Public opinions about participating in health research. Can J Public Health. 2010;101(2):159–164.
  16. Jones CW, Braz VA, McBride SM, et al. Cross-sectional assessment of patient attitudes towards participation in clinical trials: does making results publicly available matter? BMJ Open. 2016;6(11):e013649. doi: 10.1136/bmjopen-2016-013649.
  17. Al-Dakhil LO, Alanazy R, Al-Hamed RE, et al. Attitudes of patients in developing countries toward participating in clinical trials: a survey of Saudi patients attending primary health care services. Oman Med J. 2016;31(4):284–289. doi: 10.5001/omj.2016.55.
  18. Al-Tannir MA, El-Bakri N, Abu-Shaheen AK. Knowledge, attitudes and perceptions of Saudis towards participating in clinical trials. PLoS One. 2016;11(2):e0143893. doi: 10.1371/journal.pone.0143893.
  19. Jenkins V, Farewell D, Batt L, et al. The attitudes of 1066 patients with cancer towards participation in randomised clinical trials. Br J Cancer. 2010;103(12):1801–1807. doi: 10.1038/sj.bjc.6606004.
  20. Звонарева О.И., Куликов Е.С., Деев И.А., и др. Роль информированного согласия в принятии решения об участии в исследовании: данные многоцентрового исследования в России «Лицом к лицу» // Бюллетень сибирской медицины. — 2016. — Т.15. — №4 — С. 40–51. doi: 10.20538/1682-0363-2016-4-40-51.
  21. Jacobs SR, Weiner BJ, Reeve BB, et al. Organizational and physician factors associated with patient enrollment in cancer clinical trials. Clinincal Trials. 2014;11(5):565–575. doi: 10.1177/1740774514536000.
  22. Kaplan CP, Nápoles AM, Dohan D, et al. Clinical trial discussion, referral, and recruitment: physician, patient, and system factors. Cancer Causes Control. 2013;24(5):979–988. doi: 10.1007/s10552-013-0173-5.
  23. Zhang J, Zhang H, Yu C, et al. The attitudes of oncology physicians and nurses toward phase I, II, and III cancer clinical trials. Contemp Clin Trials. 2011;32(5):649–653. doi: 10.1016/j.cct.2011.04.015.
  24. Ulvenes LV, Aasland O, Nylenna M, Kristiansen IS. Norwegian physicians’ knowledge of and opinions about evidence-based medicine: cross-sectional study. PLoS One. 2009;4(11):e7828. doi: 10.1371/journal.pone.0007828.
  25. Heselmans A, Donceel P, Aertgeerts B, et al. The attitude of Belgian social insurance physicians towards evidence-based practice and clinical practice guidelines. BMC Fam Pract. 2009;10:64. doi: 10.1186/1471-2296-10-64.
  26. De Vito C, Nobile CG, Furnari G, et al. Physicians’ knowledge, attitudes and professional use of RCTs and meta-analyses: a cross-sectional survey. Eur J Public Health. 2009;19(3):297–302. doi: 10.1093/eurpub/ckn134.
  27. Oliveri RS, Gluud C, Wille-Jørgensen PA. Hospital doctors’ self-rated skills in and use of evidence-based medicine — a questionnaire survey. J Eval Clin Pract. 2004;10(2):219–226. doi: 10.1111/j.1365-2753.2003.00477.x.
  28. Al Omari M, Khader Y, Jadallah K, et al. Evidence-based medicine among hospital doctors in Jordan: awareness, attitude and practice. J Eval Clin Pract. 2009;15(6):1137–1141. doi: 10.1111/j.1365-2753.2009.01260.x.
  29. Ahmadi-Abhari S, Soltani A, Hosseinpanah F. Knowledge and attitudes of trainee physicians regarding evidence-based medicine: a questionnaire survey in Tehran, Iran. J Eval Clin Pract. 2008;14(5):775–779. doi: 10.1111/j.1365-2753.2008.01073.x.
  30. Al-Ansary LA, Khoja TA. The place of evidence-based medicine among primary health care physicians in Riyadh region, Saudi Arabia. Fam Pract. 2002;19(5):537–542. doi: 10.1093/fampra/19.5.537.
  31. Аджиенко В.Л. Отношение врачей к практике клинических исследований // Вестник ВолГМУ. — 2005. — Т.4. — №16. — С. 32–34.

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