Clinical trials - the personal perspective of the research physician?

  • Authors: Egorova M.Y.1, Shuvalova I.A.1, Zvonareva O.I.2, Pimenov I.D.3, Kobyakova O.S.1, Deev I.A.1, Kulikov E.S.1
  • Affiliations:
    1. Siberian State Medical University
    2. Integrative Approaches to Public Health and Healthcare Siberian State Medical University Department of Health, Ethics and Society, Maastricht University
    3. Integrative Approaches to Public Health and Healthcare Siberian State Medical University
  • URL: https://vestnikramn.spr-journal.ru/jour/article/view/1356
  • DOI: https://doi.org/10.15690/vramn1356
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Abstract

Abstract


The organization of clinical trials (CTs) requires the participation and coordination of healthcare providers, patients, public and private parties. Obstacles to the participation of any of these groups pose a risk of lowering the potential for the implementation of CTs. Researchers are a key human resource in conducting of CT. Their motivation for participation can have a significant impact on the recruitment and retention of patients, on the quality of the data collected, which determines the overall outcome of the study.

Aims: to assess the factors affecting the inclusion of Russian physicians - researchers in CT, and to determine their role in relations with patients - participants.

Methods: The study was organized as a part of the Russian multicenter face-to-face study. A survey was conducted of researchers from 10 cities of Russia (2017-2018). The participation in the survey for doctors was anonymous and voluntary.

Results: The study involved 78 respondents. Most research doctors highly value the importance of research for science (4,84±0,39), society (4,67±0,46) and slightly lower for participating patients (4,44±0,61). The expectations of medical researchers are related to improving their financial situation and attaining   new experience (n=14;18,18%). However, the opportunity to work with new technologies of treatment and diagnosis (n=41; 52,56%) acted as a motivating factor. According to the questionnaire, the vast majority of research doctors (n=29; 37,18%) believe that the main reason for patients to participate in CT is to receive quality and free medical care. The most significant obstacle to the inclusion of participants in CT was the side effects of the study drug (n=38; 48,71%).

Conclusions:  Russian medical researchers emphasize the importance of ongoing CTsfor science and society. The potential of clinical researchers in Russia is very high. The patient-participant acts for the research doctor as the subject of the study, and not the object, so the well-being of the patient is not indifferent to the doctor. However, the features of the functioning of our health care system form the motivation of doctors-researchers (additional earnings, professional self-development) and the way they perceive the motivation of patients (CT as an opportunity to receive quality medical care).


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About the authors

Maria Yrevna Egorova

Siberian State Medical University

Author for correspondence.
Email: egorova.m.u.egorova@ya.ru
ORCID iD: 0000-0003-3603-4774
SPIN-code: 4937-1342

Russian Federation, 2 Moskovsky tract, 634050, Tomsk, Russia

Irina Alekseevna Shuvalova

Siberian State Medical University

Email: 0-i-r-i-n-a-0@mail.ru
ORCID iD: 0000-0001-6079-172X
SPIN-code: 1334-6411
2 Moskovsky tract, 634050, Tomsk, Russia

Olga Igorevna Zvonareva

Integrative Approaches to Public Health and Healthcare Siberian State Medical University
Department of Health, Ethics and Society, Maastricht University

Email: o.zvonareva@maastrichtuniversity.nl
ORCID iD: 0000-0001-5548-7491
SPIN-code: 9145-4513
2 Moskovsky tract, 634050, Tomsk, Russia; Postbus 616, Maastricht Limburg 6200 MD, Netherlands

research fellow at StrAU Integrative Approaches to Public Health and Healthcare Siberian State Medical University and assistant professor at Department of Health, Ethics and Society, Maastricht University, PhD

Igor Dmitrievich Pimenov

Integrative Approaches to Public Health and Healthcare Siberian State Medical University

Email: igor.d.pimenov@gmail.com
ORCID iD: 0000-0003-3866-100X
SPIN-code: 3757-0769
2 Moskovsky tract, 634050, Tomsk, Russia

research fellow at StrAU Integrative Approaches to Public Health and Healthcare, Siberian State Medical University

Olga Sergeevna Kobyakova

Siberian State Medical University

Email: rector@ssmu.ru
ORCID iD: 0000-0003-0098-1403
SPIN-code: 1373-0903

Russian Federation, 2 Moskovsky tract, 634050, Tomsk, Russia

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

Ivan Anatolevich Deev

Siberian State Medical University

Email: ivandeyev@yandex.ru
ORCID iD: 0000-0002-4449-4810
SPIN-code: 2730-0004
2 Moskovsky tract, 634050, Tomsk, Russia

DM, Professor of Division of Faculty Pediatrics, Siberian State Medical University, Tomsk, Russian, DMedSc

Evgeny Sergeevich Kulikov

Siberian State Medical University

Email: evgeny.s.kulikov@gmail.com
ORCID iD: 0000-0002-0088-9204
SPIN-code: 9934-1476

Russian Federation, 2 Moskovsky tract, 634050, Tomsk, Russia

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

References

  • Yanagawa H., Kishuku M., Akaike M. et al. View of physicians on and barriers to patient enrollment in a multicenter clinical trial: experience in a Japanese rural area. Int Arch Med. 2010; 3:7. doi: 10.1186/1755-7682-3-7.
  • Messner D.A., Moloney R., Warriner A.H. et al. Understanding practice-based research participation: The differing motivations of engaged vs. non-engaged clinicians in pragmatic clinical trials. Contemporary clinical trials communications vol. 2016; 4 136-140. doi: 10.1016/j.conctc.2016.08.003.
  • Butryn T., Cornejo K., Wojda T.R., et al. Keys to success in clinical trials: a practical review. Int J Acad Med. 2016; 2:203–16. doi: 10.4103/2455-5568.196881.
  • Chalachew Alemayehu, Geoffrey Mitchell & Jane Nikles et al. For conducting clinical trials in developing countries- a systematic review. International journal for equity in health, 2018; 17(1), 37. doi: 10.1186/s12939-018-0748-6.
  • Solyom, A. Ethical Challenges to the Integrity of Physicans: Financial Conflicts of Interest in Clinical Research. Accountability in Research, 11(2). 2004; 119–139. doi: 10.1080/03050620490512313.
  • Dickinson CJ. Clinical research in the NHS today. J R Coll Physicians Lond. 1994; 28(5):460-463. PMID:7807437
  • Taylor K.M., Margolese R.G., Soskolne. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer.1984; N Engl J Med, 310(21):1363-7.
  • Rahman, S., Majumder, M. A., Shaban, S. F. et al. Physician participation in clinical research and trials: issues and approaches. Advances in medical education and practice. 2011; 2, 85–93. doi: 10.2147/AMEP.S14103.
  • Звонарева О. И., Куликов Е. С., Деев И. А., Кобякова О. С., Федорова О. С., Кириллова Н. А., Старовойтова Е. А., Жукова Н. Г., Жукова И. А., Есип В. В., Счастный Е. Д., Хурхурова Н. В., Никитина Л. Ю., Голосова Т. Г., Пименов И. Д., Нетаева М. А., Федосенко С. В. Роль информированного согласия в принятии решения об участии в исследовании: данные многоцентрового исследования в России «Лицом к лицу» — Бюллетень сибирской медицины 2016; №4; 40-51. doi: 10.20538/1682-0363-2016-4-40–51.
  • [Zvonareva O.I., Kulikov E.S., Deev I.A., Kobyakova O.S., Fedorova O.S., Kirillova N. А., Starovoytova E.А., Zhukova N.G., Zhukova I.А., Esip V.V., Schastnyy E.D., Khurkhurova N.V.,
  • Nikitina L.Yu., Golosova T.S., Pimenov I.D., Netaeva M.А., Fedosenko S.V. Role of Informed Consent in a Decision-making on Participation in The Clinical Trial: Multicenter study in Russia “Face to Face” — Bulletin of Siberian Medicine. 2016; №4; 40-51. doi: 10.20538/1682-0363-2016-4-40–51].
  • Maslin-Prothero SE. Factors affecting recruitment to breast cancer clinical trials : an examination of the British Association of Surgical Oncology II trial and the International Breast Cancer Intervention Study. ETH:342600.
  • Ito-Ihara, T., Hong, J. H., Kim O. J. et al. An international survey of physicians regarding clinical trials: a comparison between Kyoto University Hospital and Seoul National University Hospital. BMC medical research methodology. 2013; 13, 130. doi: 10.1186/1471-2288-13-130.
  • Апарцин К.А. «Азарт» исследователя. Организационные аспекты проведения клинических исследований — М.: ООО Группа «Ремедиум», 2017; 48-49.
  • [Apartsin K.A "Excitement" of the researcher. Organizational aspects of clinical trials. —M .: Remedium Group LLC, 2017; 49-50. ]
  • Raftery J., Kerr C., Hawker S. et al. Paying clinicians to join clinical trials: a review of guidelines and interview study of trialists. Trials. 2009;10:15. doi: 10.1186/1745-6215-10-15.
  • A. Conradie, R. Duys, P. Forget et al. Barriers to clinical research in Africa: a quantitative and qualitative survey of clinical researchers in 27 African countries. British Journal of Anaesthesia. 2018; 121 (4): 813-821. doi: 10.1016/j.bja.2018.06.013.
  • Laura P. Forsythe, Lori B. Frank, Thomas A Workman et al . Patient, caregiver and clinician views on engagement in comparative effectiveness research, Journal of Comparative Effectiveness Research, 2017; 6 (3), 231-244. doi: 10.2217/cer-2016-0062.
  • Mahmud A., Zalay O., Springer A. et al. Barriers to participation in clinical trials: a physician survey : Curr Oncol. 2018; 25(2): 119–125.
  • Hollis, A.C.; Davis, E.T. Understanding the factors that influence patient participation in Orthopaedic Clinical Trials. International orthopaedics. t.42 (8), 2018; 1769-1774. doi: 10.1007/s00264-018-3890-2.
  • Kessel, Kerstin & M.E. Vogel et al. Cancer Clinical Trials - survey evaluating patient participation and acceptance in a university-based Comprehensive Cancer Center. Clinical and Translational Radiation Oncology. 2018.doi: 13. 10.1016/j.ctro.2018.10.001.

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