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Clinical pharmacy and clinical trials (including case series)
Investigator perception of trial presentation to the clinical research ethics committee
  1. N. Vilardell,
  2. S. Redondo,
  3. N. Giménez,
  4. L. Soriano,
  5. R. Pla,
  6. S. Quintana
  1. 1Hospital Universitari Mútua Terrassa Pharmacy Department. Clinical Research Ethics Committee, Terrassa, Spain
  2. 2Hospital Universitari Mútua Terrassa, Clinical Research Ethics Committee, Terrassa, Spain
  3. 3Hospital Universitari Mútua Terrassa, Pharmacy Department, Terrassa, Spain

Abstract

Background There has been a Clinical Research Ethics Committee (CREC) in the hospital since 1993. A characteristic of the committee is that the main investigators (MIs) are called to present the project at the CREC evaluation meeting.

Purpose To analyse the MIs' perceptions about face-to-face project presentation and the CREC's handling of administrative and advisory matters.

Materials and methods Descriptive study performed over nine months (January to September 2011) through a voluntary questionnaire given to MIs who attended the CREC meetings. Each MI was only give on questionnaire regardless of the number of projects presented during the study period.

The questionnaire contained a numeric range (1-10) with which to evaluate presenting the study and the satisfaction with the CREC considering bureaucratic, ethical, scientific-methodological aspects, its legal recommendations and overall functioning.

Results The questionnaire was answered by 36 MIs (94.7%). Projects presented to the CREC meetings comprised 55.3% observational studies and the rest (44.7%) clinical trials. 77.8% of the MIs polled did not have previous experience in presenting studies to other CRECs. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9) and the subjective benefit of balancing time spent and result obtained was rated 8.4 (SD 1.3). Average scores for selected administrative points such as meeting organisation, document formalities and contract procedures were 8.3 (SD 1.2), 8.7 (SD 1.0) and 8.1 (SD 1.3) respectively. The average scores obtained for CREC recommendations relating to ethical aspects of the trial treatment, the patient information sheet and informed consent were 8.0 (SD 1.2) and 8.3 (SD 1.2). An average of 7.9 (SD 1.4) was recorded for the proposed changes related to scientific/methodological aspects and 8.4 (SD 1.2) for other suggestions made by CREC members. Evaluations of legal issues such as the insurance policy and procedures with various agencies and institutions were 7.4 (SD 1.9) and 6.8 (SD 2.2) respectively. Overall average evaluation of CREC tasks was 8.6 (SD 1.0). The main comments made by 61% of the MIs were positive about presenting the project because they were closely involved in the subject presented. 8.3% emphasised the difficulty of juggling clinical services and the CREC meeting timetable. 22.2% did not have any comments.

Conclusions The study showed a high opinion of defending projects face-to-face and expressed the effort made by MIs to contribute for the smooth running of CREC meetings. MIs evaluated the administrative and advisory performance of the CREC as very satisfactory.

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