Screenshot of WWARN's toolkit

Have you seen the updated WWARN toolkit?

23 July 2018

Have you heard of the Malaria Clinical Trials Toolkit? The ‘toolkit’ aims to improve the quality and standard of trial data by creating a step-by-step guide for researchers and clinicians on how to design, implement and analyse malaria clinical trials.

The complexity of standards used in designing and conducting clinical trials has increased over time and malaria clinicians and researchers are faced with a growing number of tools and resources to choose from. Such a wide range of resources results in heterogeneous quality and incomplete data sets, limiting the global health benefits of trial results and the opportunities to get the most scientific output from a data set.

“The WWARN toolkit has procedures that have helped our laboratory team in analysing samples. We would encourage other researchers to use this vast platform of resources” – respondent from a recent online survey.

The Malaria Clinical Trials Toolkit is easy to navigate and supports researchers to set up each phase of a clinical trial, or specialists to find specific tools for their area of work. Each step enables trial managers to collect reliable and comprehensive evidence in a standardised format.

Here are some examples of the guidelines, templates and online tools available to you at each stage of the clinical trial process:

  1. Research Question: The WWARN Explorer online tool allows you to select results by adjusting parameters from summary clinical and pharmacology trial data. The results can be used to answer your Research Questions and identify opportunities to fill research data gaps.
  2. Plan: To help investigators generate ideas for a trial, the comprehensive Clinical Trials Publication Library is available to search publication history.
  3. Execute: The CDISC Malaria Therapeutic Area User Guide (TAUG-Malaria) is an international malaria data standard to help guide data capture and enable the assessment of antimalarial drug efficacy.
  4. Analyse: The standardised Malaria Case Record Form helps you to implement the CDISC malaria standards. Statistical Analysis Plans such as the Malaria in Pregnancy Treatment Efficacy Study Group are provided to outline the approach used for individual patient IPD meta-analyses.
  5. Report: Study Data Tabulation Models for standard malaria data analyses can be found including data management tables for standard efficacy analysis which are compatible with WWARN’s Malaria Case Record Form.
  6. End of trial process: Tools and resources on how to close malaria clinical trials such as archiving essential documents and on-site monitoring.

Dr Muhammed Afolabi, Assistant Professor and Trial Coordinator at the London School of Hygiene & Tropical Medicine starting using the WWARN toolkit after ASTMH:

“Having been involved in malaria vaccine trials for nearly a decade, I have used the WWARN toolkit extensively to execute malaria clinical trials. Specifically, I have used the guidance on obtaining consent from participants with low literacy and procedure for informed consent to engage trial participants. Using these resources has led to an improved understanding of consent information by the participants, high retention rate and improved community trust and confidence in the trial; making safety follow-up much easier. I have also used the toolkit to disseminate complex trial findings in a comprehensible manner to several important stakeholders.”

Some of the tools and resources are also available in other languages to support researchers and clinicians globally. For instance, WWARN’s Parasite Clearance Estimator (PCE) and In Vitro Analysis and Reporting Tool (IVART) are available in French. We are also supporting TDR to lead the translation of the Microscopy Methods Manual into French later this year.

An online cross-sectional study conducted by Clifford Banda, EDCTP / TDR fellow at WWARN, in 2017 was conducted to determine the needs of investigators conducting malaria clinical trials. We need your feedback in order to continue to update our Malaria Clinical Trials Toolkit, please email us with your suggestions to improve our current tools and any new resources you would like us to develop: info [at] wwarn [dot] org