Dr Corinne Merle MD MSc
- Room 104
- Keppel Street
- WC1E 7HT
- T: 0044 20 7927 2826
- F: 0044 20 7636 8739
Since the beginning of my clinical specialisation in Public Health and Epidemiology in 1994, I have been actively involved in clinical research. My contributions have been made in a variety of roles, including lead investigator, trial monitor, provision of methodological advice related to the design of studies, implementing studies, responsibility for statistical analyses, and disseminating study results. Given the broad nature of my qualifications and my clinical research career so far, and the variety of my collaborators, I have worked in multicultural environment, on multiple diseases and multiple aspects of public health (prevention, determination of disease risk factors, treatments, costs and cost-effectiveness, health system organisation).
For the last ten years, I have focused my interest on tuberculosis (TB) and TB/HIV research, with a full-time involvement ,as the clinical study coordinator, in a Phase III multicentre randomised controlled TB clinical trial since 2003 (OFLOTUB project). This trial is close to completion (more details are given below).
I am also the project coordinator for a randomised trial research project (RAFA project), which is conducted in three West African countries (Benin, Senegal and Guinea Conakry) aiming to assess, in ARV-naïve TB/HIV patients the efficacy of 3 treatment strategies. More details concerning this project can be found at the adresse: http://www.rafatbnet.com
I am involved in the Distance Learning MSc in Clinical Trials. I wrote teaching teaching materials for the core module "Clinical Trial in practice" and coordinated the writing of the advanced module on GCP, Ethics and regulatory affairs in Clinical Trials for which I am currently the module Organiser.
I am also lecturing or leading practicals for various in-house study units, mainly in the module "Design and Analysis of Epidemiological Studies" (DANES) and the module "Epidemiology and Control of Communicable Diseases" (ECCD).
OFLOTUB is a pivotal phase III, randomised, open-label, parallel group, multi-centre trial included in the registration portfolio for a gatifloxacin-containing TB regimen. The objective of the trial is to evaluate the efficacy and safety of a gatifloxacin-containing four-month regimen (test regimen) in the treatment of pulmonary TB in comparison with the standard WHO-recommended six-month regimen (reference regimen). Subjects are randomised to receive either the test or standard regimen. Each patient is followed for 24 months after the end of treatment. Patients are recruited in five sites in Africa Benin (Cotonou, National TB program), Guinea (Conakry, National TB program), Kenya (Nairobi, KEMRI), Senegal (Dakar, National TB program) and South Africa(Durban, MRC).
The RAFA project is a 3 parallel arm, multi-centre, open-label randomised controlled trial with a nested pharmacokinetic (PK) study aiming to assess in ARV-naïve TB/HIV patients with a CD4 count of <350 cells/mm3 the efficacy in terms of mortality, 12 months after starting TB treatment, of 3 treatment strategies:
- Early ARV initiation (at 2 weeks after starting TB treatment ) combined with standard TB treatment;
- Delayed ARV treatment (at 2 months after starting TB treatment) combined with standard TB treatment; and
- Delayed ARV treatment (at 2 months after starting TB treatment) with a high dose rifampicin regimen during the intensive phase of TB treatment (15mg/Kg instead of 10 mg/Kg) followed by a standard continuation phase.
The collaborators for this project are: the Tropical Institute of Antwerp, the Hopitaux de Paris, University College London, the TB National Program of Benin, Senegal and Guinea, the HIV National Program of Benin, Senegal and Guinea, the University of Cape Town. The LSHTM is the sponsor of this study which is also aiming to create a West African platform able to conduct, in compliance with the GCP-ICH standards, further international multicentre TB and TB/HIV clinical trials. It started in January 2011 and will end in September 2013.
- Clinical trials
- Public health
Disease and Health Conditions
- Infectious disease
- Tropical diseases
- East Asia & Pacific (developing only)
- Middle East & North Africa (all income levels)
- Sub-Saharan Africa (developing only)
- South Africa
- Monitoring And Evaluation
- capacity building