Publication Trends of Clinical Trials Performed in South Africa

BACKGROUND:Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results; whether positive or negative; in a timely manner.OBJECTIVES:To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not.METHODS:A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ); the Cochrane Library; Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central; all of which are indexed on MEDLINE via PubMed. In addition; a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. RESULTS:Of the 79 clinical trials surveyed; 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal; the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published; 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled.CONCLUSION:The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner

Views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management

Background: Sub-Saharan Africa is home to 25.8 million people living with HIV/Aids. In November 2003; the South African government approved The Operational Plan for Comprehensive Treatment and Care for HIV and Aids; which aimed to provide antiretroviral treatment to 500 000 patients by the end of 2007. The successful implementation of this operational plan requires many healthcare providers trained in aspects of HIV. This study aimed to establish and compare the views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management and to elucidate an appropriate role for pharmacists. Ethical approval was obtained from the MEDUNSA Research Ethics and Publications Committee. Methods: The study population consisted of general practitioners in the province of Gauteng and community pharmacists in Gauteng and the Western Cape. Two hundred medical practitioners were selected at random from the 7 157 registered in Gauteng. Pharmacist respondents (293 from 879 community pharmacies in Gauteng and 200 from 493 in the Western Cape respectively) were selected randomly. The respondents were contacted individually by telephone and asked to complete a pilot-tested 10-statement questionnaire on their views of aspects relating to a role for pharmacists in HIV/Aids management. Results: Mean values for positive responses were calculated and analysed (two-sided t test). The response rates for general practitioners and pharmacists were 44.5and 38.1respectively. The responses were grouped into two categories; dispensing and advice and testing and treatment. Both groups agreed about the dispensing and advice category. Of the general practitioners surveyed; 95.5agreed that pharmacists should counsel patients on the correct use of medications and 100agreed that the pharmacist should be aware of all related side effects and drug interactions of HIV medications; i.e. the general practitioners were comfortable with pharmacists providing a dispensing and advisory role. The groups differed significantly about the testing and treatment category. Conclusion: GPs were generally not in favour of pharmacists being involved in the testing and treatment of HIV/Aids. The pharmacists surveyed; on the other hand; indicated their willingness to assume an expanded role in HIV/Aids management. A potential role for pharmacists was elucidated. It complements the role of the pharmacist in HIV/Aids management described in the South African Pharmacy Council Position Paper. The differences in views identified in the survey hold serious implications as South Africa struggles to contend with the HIV/Aids epidemic

Views of General Practitioners and Pharmacists on the Role of the Pharmacist in HIV/Aids Management

Background: Sub-Saharan Africa is home to 25.8 million people living with HIV/Aids. In November 2003; the South African government approved The Operational Plan for Comprehensive Treatment and Care for HIV and Aids; which aimed to provide antiretroviral treatment to 500 000 patients by the end of 2007. The successful implementation of this operational plan requires many healthcare providers trained in aspects of HIV. This study aimed to establish and compare the views of general practitioners and pharmacists on the role of the pharmacist in HIV/Aids management and to elucidate an appropriate role for pharmacists. Ethical approval was obtained from the MEDUNSA Research Ethics and Publications Committee.Methods: The study population consisted of general practitioners in the province of Gauteng and community pharmacists in Gauteng and the Western Cape. Two hundred medical practitioners were selected at random from the 7 157 registered in Gauteng. Pharmacist respondents (293 from 879 community pharmacies in Gauteng and 200 from 493 in the Western Cape respectively) were selected randomly. The respondents were contacted individually by telephone and asked to complete a pilot-tested 10-statement questionnaire on their views of aspects relating to a role for pharmacists in HIV/Aids management.Results: Mean values for positive responses were calculated and analysed (two-sided t test). The response rates for general practitioners and pharmacists were 44.5 and 38.1 respectively. The responses were grouped into two categories; dispensing and advice and testing and treatment. Both groups agreed about the dispensing and advice category. Of the general practitioners surveyed; 95.5 agreed that pharmacists should counsel patients on the correct use of medications and 100 agreed that the pharmacist should be aware of all related side effects and drug interactions of HIV medications; i.e. the general practitioners were comfortable with pharmacists providing a dispensing and advisory role. The groups differed significantly about the testing and treatment category.Conclusion: GPs were generally not in favour of pharmacists being involved in the testing and treatment of HIV/Aids. The pharmacists surveyed; on the other hand; indicated their willingness to assume an expanded role in HIV/Aids management. A potential role for pharmacists was elucidated. It complements the role of the pharmacist in HIV/Aids management described in the South African Pharmacy Council Position Paper. The differences in views identified in the survey hold serious implications as South Africa struggles to contend with the HIV/Aids epidemic