Publications (32) View all
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Article: The case for conducting first-in-human (phase 0 and phase 1) clinical trials in low and middle income countries.
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ABSTRACT: Despite the increase in the number of clinical trials in low and middle income countries (LMICs), there has been little serious discussion of whether First in Human (FIH; phase 0 and phase 1) clinical trials should be conducted in LMICs, and if so, under what conditions. Based on our own experience, studies and consultations, this paper aims to stimulate debate on our contention that for products meant primarily for conditions most prevalent in LMICs, FIH trials should preferably be done first in those countries. There are scientific and pragmatic arguments that support conducting FIH trials in LMIC. Furthermore, the changing product-development and regulatory landscape, and the likelihood of secondary benefits such as capacity building for innovation and for research ethics support our argument. These arguments take into account the critical importance of protecting human subjects of research while developing capacity to undertake FIH trials. While FIH trials have historically not been conducted in LMICs, the situation in some of these countries has changed. Hence, we have argued that FIH should be conducted in LMICs for products meant primarily for conditions that are most prevalent in those contexts; provided the necessary protections for human subjects are sufficient.BMC Public Health 01/2011; 11:811. · 2.00 Impact Factor -
Article: Evidence-based priority setting for health care and research: tools to support policy in maternal, neonatal, and child health in Africa.
PLoS Medicine 07/2010; 7(7):e1000308. · 16.27 Impact Factor -
Article: Setting priorities for health interventions in developing countries: a review of empirical studies.
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ABSTRACT: To assess and summarize empirical studies on priority-setting in developing countries. Literature review of empirical studies on priority-setting of health interventions in developing countries in Medline and EMBASE (Ovid) databases. Eighteen studies were identified and classified according to their characteristics and methodological approaches. All studies were published after 1999, mostly between 2006 and 2008. Study objectives and methodologies varied considerably. Most studies identified sets of relevant criteria for priority-setting (17/18) and involved different stakeholders as respondents (11/18). Studies used qualitative (8/15) or quantitative (3/15) techniques, or combinations of these (4/15) to elicit preferences from respondents. In a few studies, respondents deliberated on results (3/18). A minority of studies (7/18) resulted in a rank ordering of interventions. This review has revealed an increase in the number of empirical studies on priority-setting in developing countries in the past decade. Methods for explicit priority-setting are developing, being reported and are verifiable and replicable and can potentially lead to solutions for ad hoc policy-making in health care in many developing countries.Tropical Medicine & International Health 07/2009; 14(8):930-9. · 2.80 Impact Factor -
Article: Successful priority setting in low and middle income countries: a framework for evaluation.
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ABSTRACT: Priority setting remains a big challenge for health managers and planners, yet there is paucity of literature on evaluating priority setting. The purpose of this paper is to present a framework for evaluating priority setting in low and middle income countries. We conducted a qualitative study involving a review of literature and Delphi interviews with respondents knowledgeable of priority setting in low and middle income countries. Respondents were asked to identify the measures of successful priority setting in low and middle income countries. Responses were grouped as: immediate internal or external/delayed internal or external. We also identified some pre-requisites for successful priority setting. The immediate internal measures included increased efficiency in decision making, improved quality of decisions and fairer priority setting. Immediate External measures included-improved public understanding and acceptance of decisions, increased public participation, increased trust. Delayed Internal measures included increased satisfaction, understanding, compliance, balanced budget, achievement of organization goals, and improved internal accountability. Delayed External measures include impact on policy and practice, improved population health and reduction of health inequalities, achievement of health system goals and strengthening of health care systems. Identified pre-requisites for successful priority setting included; the presence of credible priority setting institutions, incentives for participation and implementation and resources, capacity and political will to implement. These would be augmented in a conducive political, social and economic context. This framework, although not exhaustive, provides a practical basis for planning and evaluating priority setting in low and middle income countries.Health Care Analysis 04/2009; 18(2):129-47. · 1.02 Impact Factor -
Article: Health Care Rationing and Professional Autonomy: The Case of Cardiac Care in Ontario
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ABSTRACT: The purpose of this paper is to explore how rationing decisions are made by government and hospital policy makers and practitioners, at the micro, meso and macro levels of analysis, through examining the rationing of cardiac care in a Canadian hospital, and discussing how the interaction between policy makers and practitioners at each of these levels affects the process and outcomes. Data were collected through in-depth interviews with 20 key informants. We found that decision-making for rationing cardiac care is a complex process. As government and hospital policy makers seek to control costs through greater oversight of clinical decisions, practitioners resist this perceived challenge to their autonomy. Attempts by policy makers at the macro and meso levels to standardize the rationing process have had limited success as practitioners have largely retained their ability to make independent rationing judgments at the micro level. This study underscores the difficulties associated with efforts to constrain the autonomy of practitioners in making "bedside rationing" decisions and the need to move towards a more collaborative model of clinical governance.01/2009; 2:34-41.
