Project: EDCTP-TDR TMA 2015 - Kakolwa

Acronym MWWA (Reference Number: TMA2015-1172)
Duration 01/05/2017 - 30/10/2018
Project Topic My career in research started few years ago, when I joined Ifakara Health Institute(IHI) as a study coordinator of the malaria in pregnancy clinical trial. This trial evaluated the efficacy and safety of the mefloquine against SP in preventing malaria in pregnant women from 2010 to 2013. In the same year after the MiP study I joined the second trial which assessed the clinical safety of the Dihydroartemisin/Piperaquine(Euratersim) in the general population from 2013 to 2014. In both trials, I had similar roles of coordinating clinical activities and other roles such as; attending trial participants, randomization, accountability of the investigational products, quality control of data including CRFs and source documents, making sure that lab procedures and sample collection follows the GCP, keeping and updating essential documents, sending weekly reports to the sponsor, SAE assessment and reporting and attending investigators meeting. In 2014, I was involved in the Therapeutic and Efficacy studies(TES) of anti-malaria as a sub-PI of the IHI sites before going for Msc Course. In 2016 few months before this fellowship I joined the Focal Screening and Treatment (FSAT) group which is part of the Entomology as a supervisor of the clinical team. This study aimed at reducing malaria transmission in the Coastal region of Tanzania. I will be pursuing 12 months training at Glaskosmithkline(GSK) United Kindgom with the objectives of: 1. Understanding GSK activities. 2. Study designs, concepts, protocols development and case report forms design. 3. Study implementations. 4. Participate or observe in safety review team (SRT) meetings for the on-going clinical studies. 5. Understanding of the Clinical development plan (CPD) including life cycle management activities such as post marketing activities. 6. Preparation of the CDP (phases i-iv, with the focus on phase I) can be undertaken for new molecules as and when they are transitioning 7. Evaluation of pre-clinical information (pharmacology, ADME, toxicology, quality) relating to small molecule and biological IMPs, identifying the need for additional information. 8. Identifying risks in the preclinical package of new small molecules or biological IMPs and devising a risk mitigation plan, its application in the protocol development, trial design and procedures and choosing suitable facilities to carry out such studies with minimal risks. 9. Drug interactions, metabolism and pharmacokinetics; aim is to gain knowledge on the clinical pharmacology as well as the understanding of the pharmacokinetics in special groups like children and pregnant women who need protection. 10. Experience of phase 1 and 2 trial activities; aim is to learn and gain experience on the early phases trial activities since Ifakara health institute Bagamoyo site is engaged to undertake early phase trials. 11. Regulatory Science; Understanding of pathways of drug registrations; aim is to understanding the steps taken from the discovery to post market registrations. 12. Data management; including the choice of the data bases and data base locks and quality controls. 13. Statistical skills; Sample size estimations, data analysis and systematic reviews involvement 14. Grant application skills 15. Writing skills 16. Financial management, administration and documentation. 17. Good communication skills; communication with local team and sponsor 18. Understand clearly roles of the sponsor and interactions with sites and co-development partners 19. Knowledge on consortium agreements Reintegration activities that will be implemented at the home organisation over 6 months: 1. To participate in phase 1and phase 2 trial activities/studies 2. To attend/serve safety monthly meetings 3. Training of GCP/SOPs 4. To facilitate journal clubs 5. To participate in systematic review writing 6. Proposal/concept notes/Grants writings
Project Results
(after finalisation)
• Capacity development (Human resources): completion of placement at host institution GSK UK, involving trainings on topics such as malaria drug development, statistics, tafenoquine implementation protocol workshop, GCP, informed consent, and investigational medicinal product management • Capacity development (Human resources, Systems and Infrastructure): Implementation of transferable skills at Ifakara Health Institute., Tanzania: oWorked on the malaria vaccine candidates trials: ChAd63 RH5 and MVA RH5, for adults, young children oAttended the IHI Institutional Review Board (IRB) meetings, sharing investigator’s expertise in clinical research oFacilitated Cochrane systematic review course for PhD students and supported one Mater’s student in thesis development. oSelected to be a member of the data safety team of the study ‘Single low-dose primaquine efficacy and safety for treatment of uncomplicated Plasmodium falciparum malaria based on cytochrome P450 2D6 activity in Bagamoyo district, Tanzania’ Following the placement the fellow is now leading a randomized cluster trial as a Co-PI.
Network EDCTP2
Call EDCTP-TDR Clinical Research and Development Fellowships 2015

Project partner

Number Name Role Country
1 Ifakara Health Institute Trust Coordinator Tanzania