Investigator barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.
OBJECTIVE
To explore investigator barriers, preferences, and attitudes towards conducting clinical trials in Finland.


METHODS
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.


METHODS
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 inhouse 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.


CONCLUSIONS
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.
Keinonen
Tuija
T
Department of Pharmacology and Toxicology, University of Kuopio, P.O. Box 1627, 70211 Kuopio, Finland. tuija.keinonen@medifiles.fi
Keränen
Tapani
T
Klaukka
Timo
T
Saano
Veijof
V
Ylitalo
Pauli
P
Enlund
Hannes
H
D001291:Attitude of Health Personnel; D002986:Clinical Trials as Topic / Q000592:standards*; D004345:Drug Industry / Q000191:economics / Q000592:standards; D015507:Drugs, Investigational / Q000191:economics / Q000592:standards; D005387:Finland; D006785:Hospitals, University; D006801:Humans; D009042:Motivation; D012108:Research Personnel / Q000191:economics / Q000523:psychology*
D015507:Drugs, Investigational