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. 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 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. 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.

Pharmaceutical industry's barriers and preferences to conduct clinical drug trials in Finland: a qualitative study.

The objectives of our study were to explore the barriers, preferences and attitudes of the pharmaceutical industry towards conducting clinical trials in Finland. In-depth semi-structured interviews were conducted with 18 representatives of the pharmaceutical industry with different amounts of experience of clinical trials. The interviews were audiotaped, transcribed verbatim and analysed qualitatively. Overall, the respondents had a positive attitude towards conducting clinical trials in Finland. The major barriers seemed to occur at the beginning of the trial and mostly consisted of bureaucratic obstacles. The informants hoped for a more positive attitude of the public sector, more flexibility in hospitals and professionalism in practical implementation, e.g. having special research centres or site management services. The most dismotivating factors were the high costs and the constraints imposed by bureaucracy. The variety in practices of local ethics committees was considered problematic, and the need for common standard operating procedures was pointed out. The smallest barriers were encountered in subject recruitment by the investigators and their clinical work, documentation, investigational product logistics and communication with the regulatory authorities. The quality, know-how and reliability of the study personnel, the tightening of time lines in general, an investigator register/pool and collaboration with media in disseminating information about clinical trials to the general public were reported as the most appealing factors. Training in GCP, mainly incorporated in the medical education programme, and a certificate or equivalent were generally considered necessary, though a voluntary system was preferred. The barriers and preferences pointed out suggest various improvements and ways to produce high-quality, GCP-compliant clinical drug research and to ensure the availability of sufficient conditions to carry out clinical trials also in the future.

The quality and characteristics of clinical drug study notifications reviewed by the regulatory agency in Finland.

The aim of our study was to investigate the validity of clinical drug study notifications reviewed by the regulatory agency in Finland during the 1990s. (In practice, the notification is equivalent to tacit authorization, which the agency has full powers to revoke before it takes effect.) All clinical drug studies reviewed by the agency during the years 1992, 1994, 1996, and 1998 were studied retrospectively. The main measurements used were the number of studies with no objection to start; the number and type of questions raised; the profile, phase, and type of study; and the study design. Additionally, the studies approved by two ethics committees of university hospitals during the same years were cross-checked to see whether the agency was notified of them in accordance with the national regulations. In total, 1174 study notifications were reviewed. Most studies were international (52%), phase III (46%), placebo-controlled with/without active control (35%) investigations of new chemical entities (38%) and were carried out in university hospitals (63%). The regulatory agency had no objections or questions regarding 55% of the notifications; 37% of the studies were permitted to begin after a clarification; 5% had to be clarified a second time; and 3% were rejected. Most questions dealt with subject information. Out of the 1140 permitted studies, 8% were later canceled or prematurely terminated as reported by the applicant. Altogether 71% of the studies that had been reviewed and approved by the ethics committees were reported to the authorities before commencement. Study completions were rarely reported. Most of the clinical drug studies planned in Finland are large international studies to investigate new chemical entities. More than half of the notifications are valid according to the regulatory authorities. Not all studies, nor the majority of study completions, are reported to the authority, though according to the regulations they should be so reported. The results show that better compliance with regulatory requirements is needed, and the contents of submitted documents should be improved to gain better Good Clinical Practice compliance. The regulatory agencies and committees that review clinical study documents should improve their current practices by a more specific division of responsibilities.