Project 16: Safety

Link to Phase 2 online survey

Project Title

Strategies for optimizing the accurate elicitation of patient-reported data relating to drug safety

Project Location(s)

Cape Town, South Africa and Muheza, Tanzania

Lead Principal Investigator

Professor Karen Barnes MBChB MMed

Division of Clinical Pharmacology, Department of Medicine, University of Cape Town

Tel: +27 21 4066758 Email: Karen.barnes@uct.ac.za

http://www.uct.ac.za/

Other Principal Investigators

Lead Investigator:

Elizabeth Allen BSc(Hons) MPH

Co-investigators/collaborators:

Dr Lasse Vestergaard, Centre for International Health and Development, University of Copenhagen, Denmark
Dr Martha Lemnge, National Institute for Medical Research, Tanga, Tanzania
Dr Sarah Staedke, London School of Hygiene and Tropical Medicine, UK
Dr Clare Chandler, London School of Hygiene and Tropical Medicine, UK
Dr Ushma Mehta, Pharmacovigilance Consultant, Johannesburg
Dr Ola Persson, Centre for International Health and Development, University of Copenhagen, Denmark
Dr N Nyagonde, InterACT, Clinician, Muheza, Tanzania
Ms Cheryl Pace, Liverpool School of Tropical Medicine, UK

Research Aim(s)

Safety

Project Background and Rationale

It is important to optimize the accuracy of adverse event (AE), medical history or concomitant medicine reports by malaria clinical trial participants as these are the starting points underpinning a complex process in assessing the safety of drugs. While there is no gold standard for how such safety-related data should be elicited there is evidence that more detailed elicitation methods increase sensitivity of detecting AEs and concomitant medications. Any subjectivity involved, however, is not evaluated when analyzing or presenting safety data and the influence of socio-cultural and individual idiosyncratic factors on their reporting are largely unknown. We propose to review the available literature on research that describes and compares clinical trial data elicitation methods. In addition we will nest a mixed method (qualitative and quantitative) study within selected ACT Consortium clinical trials to explore whether, and if so why, commonly-used techniques for eliciting patient-reported AEs, medical histories and concomitant medications fail to detect some data. Should this first phase of work demonstrate barriers to the accurate elicitation of data, we will commence a second phase likely to be the development and testing of an intervention aimed at overcoming such barriers.

Current Status of Project

Project 16 started in November 2009 nested within the SEACAT 2.4.2 (ACT Project 13) and InterACT clinical trials (ACT Project 10). In-depth interviews and focus group discussions have been conducted with participants who reported safety data differently between a general enquiry and checklists, to explore barriers to accurate reporting. An abstract of preliminary results from South Africa was presented at the International Conference on Pharmacoepidemiology and Risk Management, Brighton, UK in August 2010 while an oral presentation of preliminary data from both countries was presented at the MRC HTMR "Clinical Trial Methodology Conference", Bristol, Oct 2011.

A second phase of this work begins with a survey of methods used in malaria clinical drug trials to question participants about their health and treatment use. Phase 1 results have been published in the Trials Journal. In addition, a systematic review "Elicitation of safety data from clinical trial participants" has been accepted as a registered title by the Cochrane Collaboration's Methodology Review Group and is currently ongoing.