Setting the stage for randomized controlled trials in Cameroon: a workshop report
Lawrence Mbuagbaw1,2,3,&, Lehana Thabane1,2,4,5,6, Pierre Ongolo-Zogo3,7
1Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada, 2Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare - Hamilton, ON, Canada, 3Centre for Development of Best Practices in Health, Yaounde Central Hospital, Yaounde, Cameroon, 4Departments of Paediatrics and Anaesthesia, McMaster University, Hamilton, ON, Canada, 5Centre for Evaluation of Medicine, St Joseph’s Healthcare - Hamilton, ON, Canada, 6Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada, 7Faculty of Medicine and Biomedical Sciences, University of Yaounde 1, Yaoundé, Cameroon
Lawrence Mbuagbaw, Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada
In order to improve the generation and use of high quality health research evidence among Cameroonian researchers, the Centre for Development of Best Practices in Health (CDBPH) located in the Yaounde Central Hospital organised a three day workshop on clinical trials from the 29th April to the 1st May 2013. Sixteen participants form the Faculty of Medicine and Biomedical Science of the University of Yaounde 1 and the Ministry of Health attended this workshop. This report includes the material covered in the workshop, the readings and supplementary resources for clinical trials. The workshop was well received by the participants and resulted in significant gains in knowledge on clinical trials.
Randomized controlled trials (RCTs) are often regarded as the most rigorous method available for hypothesis testing about the effects of therapies, interventions or treatments in epidemiology and medicine . In its simplest form, participants are randomly allocated to one of two interventions and followed up for a predefined duration over which to measure specific outcomes . Since randomized controlled trials are experimental studies involving human subjects, specific design, ethical, administrative and organisational issues must be understood by health researchers. The Centre for Development of Best Practices in Health (CDBPH; www.cdbph.org) is a knowledge translation institution located in the Yaounde Central Hospital, Yaounde, Cameroon, that supports decision-makers, members of civil society organisations, journalist and health researchers in the collection, use and generation of health research evidence.
In December 2010, the CDBPH organised a workshop on systematic
reviews which involved appraising RCTs [2
]. Systematic reviews
of RCTs (and other studies) inform evidence-based health care and are used to
develop health care practice and policies. During this workshop, we noted significant
limitations in understanding the concepts related to RCTs. For this reason, we
organised another workshop introducing Cameroonian medical research scientists
to clinical trials. The number of clinical trials conducted in Cameroon is relatively
low, with only 34
registered trials on the www.clinicaltrials.gov website (search conducted 22nd
June 2013), compared to other countries like Ghana (81 trials) or Malawi (99
with similar population sizes [3
]. This workshop responds
to the urgent needs for health research capacity building in developing countries
to promote evidence based health care [4
This lack of research capacity is often seen in the considerably small number
of African-led trials within the continent [6
The purpose of this report is to provide a detailed account of the activities and the material covered during the workshop, such that it can be replicated and adapted to suit other trainers’ needs.
The CDBPH arranged and supported the workshop, which took place from the 29th April to the 1st May 2013, at the Laurence Vergne Room of the Yaounde Central Hospital, Yaounde, Cameroon.
The aims of this workshop were to build clinical trials skills in Cameroon by enabling participants to 1) distinguish clinical trials from other forms of clinical research, 2) describe the different phases of clinical trials, 3) list the steps involved in conducting a clinical trial, 4) understand key concepts in design, analysis and reporting of clinical trials, 5) understand the limitations of clinical trials and 6) describe variants in clinical trial design. These concepts were introduced at a basic level and followed-up in-depth according to participant interest.
The CDBPH invited lecturers from the Faculty of Medicine and Biomedical Sciences, of the University of Yaounde 1 and staff from the Division of Health Operations Research of the Ministry of Health.
The facilitators where chosen based on their methods expertise and experience with clinical trials in resource limited settings: a Canadian professor of biostatistics and epidemiology, originally from Lesotho, with extensive experience conducting international trials; a Cameroonian professor of radiology and epidemiology, with vast experience in evidence-based policy development and a Cameroonian doctor and epidemiologist with a strong background and experience in heath research methodology and clinical trials.
Prior to the workshop, participants were expected to 1) complete one introductory reading on clinical trials [7
], 2) prepare one research question for which a randomized clinical trial would be appropariate and 3) find one randomized clinical trial in their respective fields for appraisal.
Over three days participants were introduced to the role of clinical trials in clinical research and how to set-up and run a clinical trial in Cameroon, using practical examples. Their clinical trial topics were discussed and revised according to standard recommendations for question formulation[8
]. Table 1
is a list of trial topics proposed by the participants. The sessions were interactive, with engaging discussions between the staff from the Ministry of Health and individual researchers. Participants were also expected to take a pre- and post-workshop multiple choice questionnaire to evaluate their clinical trial knowledge. The questionnaire was tailored to assess if the objectives of the workshop were met.
During the workshop, participants described the challenges they faced in conducting clinical research in Cameroon. As a compliment to the new material provided to participants during the workshop, discussions were held upon the difficulties they encountered in their own clinical research and solutions were proposed. For example, issues related to high drop-out rates were addressed during the session on attrition. The following challenges were identified:
- Lengthy and complex consent forms
- Lengthy ethics approval procedures
- Difficulties in securing funding
- Poor access to high quality medical archives
- High drop-out rates
- Stigma preventing participants from taking part in research
- Difficulties in obtaining adequate comparators (placebos)
- Limited statistical competency
- Limited access to information regarding the regulation of research in Cameroon
Course material and readings
The participants were provided with reading material relevant to each topic addressed. Table 2
is a summary of the topics covered in the workshop, the readings and other electronic resources. We sought to make the training relevant to the country by using some local readings and examples as often as possible.
The results of the questionnaire were evaluated and compared. The questionnaire covered all topics discussed during the workshop. A total of 35 points could be obtained for responding correctly to 13 questions. The mean score (standard deviation) before the workshop was 16.5 (6.93) compared to 25.5 (5.05) after the workshop. This difference (+9) was statistically significant (t(30) =-4.2; p<0.001), showing a marked improvement in knowledge on clinical trials. Participants were also asked to rank the workshop in the following domains: quality of the lectures, quality of the practical exercises, quality of the reading material, pace of the course and the amount of subject material covered. Overall, the workshop was well received (Figure 1
Participants appreciated the interactive nature of the workshop; the practical exercises and the quality and timeliness of the presentations. They also noted some points for improvement such as: the need to develop a concrete trial proposal as part of the workshop, to reduce the amount of material covered and to allocate more time for practical sessions. In addition, they recommended a follow-up workshop with more French material.
The workshop was well received and resulted in significant knowledge gains amongst participants. The next steps will involve continuous support to all participants who wish to conduct RCTs and accrued efforts to deliver locally relevant material in terms of context and language.
This workshop was supported by the Effective Health Care Research Consortium which is funded by UKaid from the Department for International Development. It was organised by the Centre for Development for Best Practices in Health/Yaounde Central Hospital. We also wish to thank Professor Thabane from McMaster University for his availability during the workshop.
1: Topics proposed by participants of clinical trials workshop
2: Workshop outline
Figure 1: Overall
assessment of clinical trials workshop by participants (n=12)
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