versão On-line ISSN 2078-5135
versão impressa ISSN 0256-9574
SAMJ, S. Afr. med. j. vol.99 no.6 Cape Town Jun. 2009
Are investigators satisfied with contract clinical research in South Africa?
Newtown Clinical Research, Johannesburg, firstname.lastname@example.org
To the Editor: In October 2008, I surveyed 75 principal investigators in South Africa with whom I had worked since 2004. I emailed to each a covering letter, a survey sheet with tick boxes for answers to 13 questions, and a comment sheet. I received completed surveys from 35 investigators. I could find no similar surveys in the literature.
The respondents are experienced investigators, of whom 66% had more than 5 years' experience in clinical trials, and a further 24% 2 - 5 years' experience; 37% had taken part in more than 5 trials in the previous 12 months, and a further 49% had taken part in 2 - 5 trials in the same period.
Investigator meetings were rated as 'good' by 51% of the investigators, and as 'average' by 43%; the supply of study materials to the site was rated as 'good' by 37% and 'average' by 57%. Most respondents felt that the general conduct of the study was 'good' (71%), with nobody rating the conduct as 'bad'. The conduct of monitors was rated as 'good' by 63% of investigators, with nobody rating them as 'bad'.
Only 14% of investigators rated recruitment at their site as 'bad', while 6% described the sponsor's expectations of their site as 'bad'. The process of closing a study at the site was rated as 'good' by 74%.
A preference for electronic case report forms was stated by 59%, the rest preferring paper forms. Investigator fees were described as 'good' by 26% of investigators, and 'average' by 57%.
Only 3% of investigators felt that the time to Medicines Control Council (MCC) approval was 'good', with 80% rating the time as 'bad'.
Contract clinical research in South Africa has grown steadily in the last 5 years. This is the only survey that has been conducted to determine investigator satisfaction with the clinical trial industry. Investigators are generally satisfied with the process of conducting clinical research in South Africa, and are willing to utilise enhanced technology to stay abreast of the rest of the developing world in clinical trials. The time to MCC approval remains a concern but, with steps that are under way, I am certain that the dissatisfaction will change in the near future.