Newton workshop promotes clinical research excellence in poverty-related diseases

The workshop, co-sponsored by the British Council’s Newton Researcher Links Programme, TDR (the Special Programme for Research and Training in Tropical Diseases) and WWARN, aimed to help early- to mid-career investigators, data managers and statisticians to produce high-quality clinical data capable of maximising the impact of initial findings. Running from 23 to 26 January, the workshop brought together specialists in data generation, data curation and meta-analyses to share their experiences and learn from each other’s challenges and experiences.

A partnership between research institutions in Kenya, South Africa and the UK, the workshop brought together 26 professionals from these countries, plus an additional 17 attendees from elsewhere. Facilitators from WWARN and other organisations provided an overview of key concepts, including how data are obtained, recorded, curated and analysed; participants then engaged in a series of exercises on standardising data, building a database and performing statistical analyses.

“It was an outstanding group that was both geographically and professionally diverse, and committed to acquiring the skills needed to do more with clinical data,” said Lesley Workman, Scientific Coordinator of WWARN’s Clinical Pharmacology Group based at the University of Cape Town, who led the effort to secure the Newton funding and plan the workshop contents. “We were highly impressed.”

“Working across different disciplines and levels of experience, attendees discussed the importance of data management and statistical best practices applied to a wide range of tropical neglected diseases,” said Prof Guérin, Director of WWARN, who joined with Prof Karen Barnes, Head of WWARN's Pharmacology Group and Prof. at University of Cape Town and Prof Bernhards Ogutu, WWARN Board member and researcher at Strathmore University in Nairobi, to coordinate the workshop.

Prof Ogutu, whose Strathmore University served as the official host, agreed that future workshops could meet a significant need. In one workshop lecture, he spoke of the shortage of statistical analysis capacity in Africa.

“With a sharp increase in the number of clinical trials conducted in Africa in recent years, there is clearly much more work to be done to collect, curate, store and analyse this information,” Prof Ogutu told WWARN. “We hope workshops like this will be a catalyst for action.”

The three coordinators spoke of their own experiences working with data.

“You can’t invest enough in the quality of your data, and networks such as WWARN provide an ideal platform for sharing much-needed data management skills and tools as demonstrated in this landmark workshop,” Prof Barnes told attendees when describing her journey from policy-making to clinical research, and from conducting individual studies to also sharing her data with others. She highlighted some of the benefits of data sharing, including secure long-term storage, and the ability of pooled individual patient data to increase the statistical power of studies and test new hypotheses - even many years after original studies have been conducted.

Participants also heard from data managers, including Lesley Workman, Michael Otieno of the Drugs for Neglected Diseases initiative (DNDi) and Kalynn Kennon, who guided attendees through the use of Clinical Data Interchange Standards Consortium (CDISC) protocols and REDCap, a database-building software.

Otieno spoke on data management best practices, including the development, design and completion of case report forms (CRFs) - a critical tool used by clinical trial sponsors to record information from each participating patient.

“Maintaining a clear, concise and consistent approach with regard to the CRF will save time and boost your chances of success later,” said Otieno, who is also a WWARN collaborator and helped secure some workshop funding from TDR.

The final day of the workshop focused on statistics, with presentations from WWARN’s Head of Statistics, Dr Kasia Stepniewska, and Dr Raymond Omollo, a statistician and head of DNDi’s Data Centre.

Participants said they were grateful for the opportunity to develop their skills and network. Dr Chester Kalinda, a post-doctoral researcher in Public Health at the University of KwaZulu-Natal in Durban, South Africa, said he was struck by the discussion of data re-use beyond primary analysis and why it matters, as well as the hands-on demonstration of REDCap, which he described as valuable.

“Such workshops are not just important but extremely important,” said Kalinda, who credited the session with fostering communications between researchers that could reduce duplication and encourage new lines of inquiry. He said subsequent workshops, particularly across Africa’s regions, would have a great impact. “Resources permitting, it would be wonderful to triangulate such workshops to be regional so that more participants are invited.”

Carole Khairallah, a data manager at the Liverpool School of Tropical Medicine, also praised the skills she acquired – as well as the smaller setting which enabled her to take them on board.

“I learned new skills, and new tools which I will certainly use in the future,” said Khairallah, highlighting CDISC and REDCap in particular. “Personally, this was the added value of the workshop: we could question the ‘experts’ who were very available.”

Prof Rashad Abdul-Ghani, who researches medical and molecular parasitology at Sana’a University in Yemen, said future workshops could provide a critical service. “I think there is an utmost need for conducting similar workshops to serve the public and global health through data sharing,” Prof Abdul-Ghani said.

Workshop coordinators said plans for similar workshops will depend on funding. Meanwhile, WWARN will continue to hold shorter sessions on data standardisation at major conferences, including one planned for the Multilateral Initiative on Malaria (MIM) meeting in April 2018.