Global Health seminar: 20+ years of global trials with a focus on children: some reflections

Event details

Abstract:

In this talk I will reflect on the infectious disease global trials which I have led or co-led, which have been mainly late stage trials undertaken with collaborators in East and Southern Africa, but also in Europe and South Asia. I will start by discussing the need for paediatric trials and discuss when, in general, trials are needed in children to generate evidence in a timely manner, and issues around including older children and adolescents in adult trials. I will discuss some of the design, implementation, nested substudies (eg pharmacokinetics), results and subsequent impact of trials I have been involved in with a particular focus on HIV infection. I will discuss the roles of generic companies in the EDCTP-funded CHAPAS trials and why appropriate formulations and nested pharmacokinetic substudies for children are so important. Childhood tuberculosis was long been neglected in the trials arena and I will talk about the African/Indian SHINE trial of treatment shortening for non-severe tuberculosis in children, updating what has happened since the trial was published and WHO guidelines changed in 2022. I will also discuss the important role of health economics and including cost effectiveness data in the primary trial paper. With respect to implementation, I will discuss examples of changes in guidelines, policy and practice as a result of trial results and pose the question ‘why are results of some trials but not others implemented rapidly’, including the ‘whys and hows’ in the pathway from evidence generation to changes in policy and practice.

I will finish with some reflections on my experience of running trials and looking forward to our new methods agenda for making trials more efficient and to ensuring inclusion of vulnerable populations, such as pregnant women and children.

If you are interested in attending a seminar, please contact akseer.hussain@york.ac.uk so that you can be added to the mailing list.

Speaker: Diana Gibb, Scientific Programme Leader, MRC Clinical Trials Unit at UCL

Diana's web page