The introduction of Western healthcare, via colonialism, into Africa facilitated a confrontation of indigenous and exogenous “medical” knowledge as well as the attendant praxis. Although colonialism has been expunged from the shores of Africa, the epistemic and ideological frictions it introduced into the sphere of healthcare linger and raise different dilemmas. Against this background, this paper explores pragmatic and ethical approaches that may help engage these tensions in the context of drug development based on validated traditional phytomedicines.

Pragmatic clinical trials (PCTs) seek to show the effectiveness of treatments in routine, clinical practice (MacPherson 2004). However, a number of ethical challenges come to the fore when collater...

Many drugs used in paediatric medicine are off-label. There is a rising call for the use of adaptive clinical trial designs in responding to the need for safe and effective drugs given their potential to offer efficiency and cost-effective benefits compared with traditional clinical trials. ADs have a strong appeal in paediatric clinical trials given the small number of available participants, limited understanding of age-related variability and the desire to limit exposure to futile or unsafe interventions. Although the ethical value (...) of adaptive trials has increasingly come under scrutiny, there is a paucity of literature on the ethical dilemmas that may be associated with paediatric adaptive designs. This paper highlights some of these ethical concerns around safety, scientific/social value and caregiver/guardian comprehension of the trial design. Against this background, the paper develops a non-static conceptual lens for understanding PADs. It shows that ADs are epistemically open and reduce some of the knowledge-associated uncertainties inherent in clinical trials as well as fast-track the time to draw conclusions about the value of evaluated drugs/treatments. On this note, the authors argue that PADs are ethically justifiable given they have multiple layers of safety, exposing enrolled children to lesser potential risks, create social/scientific value generally and for paediatric populations in particular, specifically foster the flourishing of paediatric populations and can significantly improve paediatric trial efficiency when properly designed and implemented. However, because PADs are relatively new and their regulatory, ethical and logistical characteristics are yet to be clarified in some jurisdictions, the cooperation of various public and private stakeholders is required to ensure that the interests of children, their caregivers and parents/guardians are best served while exposing paediatric research subjects to the most minimal of risks when they are enrolled in paediatric trials that use ADs. Data sharing not applicable as no datasets generated and/or analysed for this study. Not applicable. (shrink)

Volume 19, Issue 7, July 2019, Page 53-55.

Funding broadly connotes the notion of an institution and/or institutions making money and other resources available to individual researchers and organizations to accomplish specific projects. Whi...

The power of the scientific enterprise presents multiple avenues for harnessing and increasingly controlling biological phenomena and instituting interventions in different areas of biomedicine (Af...

Contexts where the same clinician with an ongoing physician-patient relationship seeks to enroll his or her own patient(s) into a clinical research are ethically tricky due to the associated role c...

One of the central characteristics of public health disasters is the rapid overlapping of different needs and priorities that require making critical choices that inevitably elicit conflicti...

Volume 20, Issue 2, February 2020, Page 38-41.