Last Updated: 25/07/2025

EDCTP-TDR TMA 2015 – KAKOLWA

Objectives

This research grant outlines a career trajectory in malaria clinical trials, highlighting roles in study coordination and safety assessments. The applicant plans to undergo a 12-month training at GlaxoSmithKline to enhance skills in study design, clinical development, and regulatory science, followed by a six-month reintegration period focused on participating in trial activities and training at their home organization.

Principal Institution

Ifakara Health Institute (IHI), Tanzania
GlaxoSmithKline (GSK), United Kingdom

Principal Investigators / Focal Persons

Mwaka Kakolwa

Rationale and Abstract

Mwaka Kakolwa started her research career at Ifakara Health Institute (IHI) as a study coordinator for a clinical trial on malaria in pregnancy. The trial, conducted from 2010 to 2013, evaluated the efficacy and safety of mefloquine compared to sulfadoxine-pyrimethamine (SP) for the prevention of malaria in pregnant women. In the same year, following the completion of the malaria in pregnancy (MiP) study, she joined a second clinical trial that assessed the clinical safety of Dihydroartemisinin/Piperaquine (Eurartesim) in the general population from 2013 to 2014.

In both trials, she held similar responsibilities, including coordinating clinical activities, attending to trial participants, managing randomization processes, ensuring accountability of investigational products, and overseeing quality control of data, including case report forms (CRFs) and source documents. She was also responsible for ensuring that laboratory procedures and sample collection adhered to Good Clinical Practice (GCP) guidelines, maintaining and updating essential documents, submitting weekly reports to the sponsor, assessing and reporting serious adverse events (SAEs), and participating in investigators’ meetings.

In 2014, before pursuing her MSc studies, she was involved in the Therapeutic Efficacy Studies (TES) of antimalarial drugs as a sub-principal investigator at the IHI sites. In 2016, a few months before beginning her fellowship, she joined the Focal Screening and Treatment (FSAT) group within the Entomology Department as a supervisor of the clinical team. This study aimed to reduce malaria transmission in the coastal region of Tanzania.

As part of her fellowship, she undertook 12 months of training at GlaxoSmithKline (GSK) in the United Kingdom, with the following objectives:

To gain an understanding of GSK’s operations.
To learn about study design, protocol development, and the creation of case report forms.
To understand the processes involved in study implementation.
To participate in or observe Safety Review Team (SRT) meetings for ongoing clinical studies.
To familiarize herself with the Clinical Development Plan (CDP), including lifecycle management and post-marketing activities.
To learn how to prepare CDPs (particularly focusing on Phase I) for new molecules in transition.
To evaluate pre-clinical data (pharmacology, ADME, toxicology, quality) relating to small molecules and biological investigational medicinal products (IMPs), and to identify any gaps.
To identify potential risks in the pre-clinical packages of new molecules or biological IMPs and develop appropriate risk mitigation strategies for protocol development and trial design, including the selection of suitable facilities.
To gain knowledge of drug interactions, metabolism, and pharmacokinetics, with a focus on special populations such as children and pregnant women.
To acquire practical experience in Phase 1 and 2 trial activities, particularly relevant to the work conducted at IHI’s Bagamoyo site.
To understand regulatory science and the pathways involved in drug registration from discovery to post-market approval.
To develop data management skills, including database selection, database locking, and quality control processes.
To enhance statistical competencies, including sample size estimation, data analysis, and involvement in systematic reviews.
To strengthen her skills in grant writing and proposal development.
To improve scientific writing capabilities.
To gain experience in financial management, administration, and documentation.
To develop effective communication skills for engaging with local teams and sponsors.
To gain a clear understanding of the sponsor’s role and their interactions with study sites and co-development partners.
To acquire knowledge of consortium agreements.