| The general objective of the APRIORI program is to establish the Kilimanjaro Clinical Research Centre to conduct vaccine trials and drug trials and to develop at the same time a community-focused integral approach for prevention and treatment. A team of researchers and assisting personnel will be recruited and trained with a career perspective within KCRC. Furthermore, physical structures and facilities need to be in place. APRIORI will adopt the following guiding principles: - Capacity building through learning by doing. - Basic and operational research with focus on malaria, tuberculosis and TB/HIV. - Streamlining of activities on these three diseases to obtain internal cohesion, collaboration and cross-fertilisation. - Application of existing knowledge and innovative research (new tools and strategies). - Collaborative research so that African and European researchers work hand in hand with supervision of African and European seniors. - Research will strengthen patient care as well as the training of medical students/specialists. - The Clinical Research Centre has its roots in a university and is owned by that university. - Multidisciplinary approach involving biomedical and behavioural sciences. - Equal partnership, open communication, and long-term collaboration. The principles for the establishment of a Clinical Research Centre are the following: - Attract, train and adhere resident researchers and to provide conditions for local careers. - Stabilisation and improvement of local infrastructure. - Upgrading of clinical research at level of international excellence. - Improvement of local teaching capacity. - Reinforcement position of the institute within relevant networks. - Good governance, Tanzania-owned. The strong links between centres of excellence from Africa and Europe which merges into research and capacity building in KCRC is an innovative concept in Africa. The Malian and Ethiopia institutes will play a significant role in this grant by sharing their expertise in clinical trials capacity building to international standards (adherence with WHO, FDA, ICH standards). The aim is to focus on "training by doing" in field and laboratories: - GLP: short course and laboratory practices during ongoing trials. - GCP: short course and clinical practices on volunteers during a specific trial. - Ethical training of investigators and nurses preparing IRB documents and performing the process of informed consent on volunteers. - Practical training of a target Tanzanian on regulatory affaires. - Laboratory workshop and field based workshops on writing SOPs and CRF. - Data management and preparing report for Monitors and SMCs or DSMBs and data auditing. - Reporting of adverse events and serious adverse events. - Vaccines/drugs storage system and monitoring. - Keeping the blinding and randomisation procedures. - Medical skills. From the existing MPH training programme of KCM College, students will be selected to conduct field work within the APRIORI public health projects. These students will be supervised by a local investigator and a APRIORI postdoc. In addition, the Mali and Ethiopian institutes have an important role in the training programmes. MRTC Mali offers an MSc degree in Clinical Trials in which Tanzanian students will participate. These trained students will bring the expertise back to KCMC which will aid the gradual transition of the curriculum to KCMC with help from Mali colleagues. So after some years, KCM College will offer also a MSc degree in Clinical Trails. Furthermore, scientific training is provided by all partners in the program. This training, for MSc, MPH and PhD students at MSc and PhD level comprises the following elements: - Research methodology; - Data management; - Epidemiology; - Statistics; - Questionnaire design; - Scientific writing; - Oral presentation skills. Finally, all APRIORI senior members are convinced that true capacity building towards sustainability can only be achieved by training a substantial number of talented Africans at PhD level. To achieve this, high-quality and continuous supervision and instruction should be provided in Africa. Therefore, also Dutch experts (postdocs) will be stationed at KCRC to guide this process and postdocs (not necessarily the same person for the whole period) will be available at KCRC for the entire APRIORI project period (2006-2010). |
