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Investigator barriers and preferences to conduct clinical drug trials in Finland: a qualitative study

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Abstract

Objective: To explore investigator barriers, preferences, and attitudes towards conducting clinical trials in Finland. Method: In‐depth, semi‐structured interviews with 20 clinicians working in the field of cardiovascular medicine were performed. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Twenty clinicians from all (five) university hospitals in Finland and from three subgroups: 1) with long experience, 2) with limited experience and 3) reluctant to carry out clinical trials, were sampled purposefully. Main outcome measures: Barriers and (de)motivating factors in carrying out clinical trials and need for training in Good Clinical Practice (GCP).Results: Overall, the investigators had a positive attitude towards conducting clinical trials. The major barriers seemed to occur at the beginning of the trial: bureaucracy, lack of time and laboriousness. The informants hoped for more specific in‐house rules and flexibility in hospitals. The greatest investigator barriers were insufficient financial incentives, trial‐related reasons and administrative affairs/bureaucracy. The smallest barriers were reported in subject recruitment, clinical work, documentation, investigational product logistics and communication with ethics committees. Financial incentives, a possibility to incorporate a personal sub‐study or other benefits for personal research and scientific and clinical interest in the trial were reported as the most motivating factors. Carrying out studies in practice and an opportunity to participate in a trial during one's postgraduate specialist education were considered beneficial. Training in GCP, mainly in the course of postgraduate education, and a certificate or equivalent were generally considered necessary, although a voluntary system was preferred.Conclusion: The interviews of clinicians provide valuable information about the barriers and preferences related to the practical implementation of clinical trials. If the trial is scientifically/clinically interesting and involves a small administrative burden and sufficient financial compensation, investigators are motivated to participate. The barriers and preferences should be considered in decision‐making, to meet the various needs of all parties involved and to produce high‐quality GCP‐compliant clinical drug research. This would ensure the availability of sufficient conditions to carry out clinical trials also in the future.

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Authors and Affiliations

  1. Department of Pharmacology and Toxicology, University of Kuopio, P.O. Box 1627, 70211, Kuopio

    T. Keinonen

  2. Finland and MedFiles Ltd, P.O. Box 1450, 70501, Kuopio, Finland E‐mail

    T. Keinonen

  3. Department of Pharmacological Sciences, University of Tampere, Tampere, 33014, Finland

    T. Keränen

  4. Department of Neurology, Turku University Hospital, P.O.Box 52, 20521, Turku, Finland

    T. Keränen

  5. Social Insurance Institution, P.O. Box 450, 00101, Helsinki, Finland

    T. Klaukka

  6. National Agency for Medicines, P.O. Box 55, 00301, Helsinki, Finland

    V. Saano

  7. Tampere University Hospital, P.O. Box 2000, 33521, Tampere, Finland

    P. Ylitalo

  8. Department of Pharmacy Practice, Kuwait University, P.O. Box 24923, Safat, 13110, Kuwait

    H. Enlund

  9. Department of Social Pharmacy, University of Kuopio, P.O. Box 1627, 70211, Finland

    H. Enlund

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Keinonen, T., Keränen, T., Klaukka, T. et al. Investigator barriers and preferences to conduct clinical drug trials in Finland: a qualitative study. Pharm World Sci 25, 251–259 (2003). https://doi.org/10.1023/B:PHAR.0000006517.36241.a5

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