Operational Differences between Product Development Partnership, Pharmaceutical Industry, and Investigator Initiated Clinical Trials.

Medicine development is a lengthy endeavour. Increasing regulatory stringency and trial complexity might lead to reduced efficiency, dwindled output, and elevated costs. However, alternative models are possible. We compared the operational differences between pharmaceutical industry sponsored trials, product development partnership trials, and investigator-initiated trials to identify key drivers of inefficiency in clinical research. We conducted an exploratory mixed-methods study with stakeholders, including clinical trial sponsors, contract research organisations, and investigators. The qualitative component included 40 semi-structured interviews, document reviews of 12 studies and observations through work shadowing in research institutions in Burkina Faso, Mali, and Switzerland. The findings were triangulated with an online survey polling clinical research professionals. The operational differences were grouped under five categories: (i) trial start-up differences including governance and management structure; (ii) study complexity; (iii) site structural and organisational differences; (iv) study conduct, quality approaches, and standard operating procedures; and (v) site capacity strengthening and collaboration. Early involvement of sites in the planning and tailored quality approaches were considered critical for clinical operations performance. Differences between the types of trials reviewed pertained to planning, operational complexities, quality approaches, and support to the sites. Integration of quality-by-design components has the potential to alleviate unnecessary process burden.

Opportunities and challenges for decentralised clinical trials in sub-Saharan Africa: a qualitative study.

INTRODUCTION: Digital health has gained traction in research and development, and clinical decision support systems. The COVID-19 pandemic accelerated the adoption of decentralised clinical trials (DCTs) as a mitigation and efficiency improvement strategy. We assessed the opportunities and challenges of a digital transformation in clinical research in sub-Saharan Africa from different stakeholders' perspectives. METHODS: A qualitative study, including 40 in-depth semi structured interviews, was conducted with investigators of three leading research institutions in sub-Saharan Africa and Switzerland, contract research organisations and sponsors managing clinical trials in sub-Saharan Africa. A thematic approach was used for the analysis. RESULTS: Interviewees perceived DCTs as an opportunity for trial efficiency improvement, quality improvement and reducing the burden of people participating in clinical trials. However, to gain and maintain an optimal quality of clinical trials, a transition period is necessary to tackle contextual challenges before DCTs are being implemented. The main challenges are categorised into four themes: (1) usability and practicability of the technology; (2) paradigm shift and trial data quality; (3) ethical and regulatory hurdles and (4) contextual factors (site-specific research environment and sociocultural aspects). CONCLUSION: The transformation from a site to a patient-centric model with an increased responsibility of participants should be context adapted. The transformation requires substantial investment, training of the various stakeholders and an efficient communication. Additionally, commitment of sponsors, investigators, ethics and regulatory authorities and the buy-in of the communities are essential for this change.

Trends and risk factors for childhood diarrhea in sub-Saharan countries (1990-2013): assessing the neighborhood inequalities.

BACKGROUND: Diarrheal diseases are a major cause of child mortality and one of the main causes of medical consultation for children in sub-Saharan countries. This paper attempts to determine the risk factors and neighborhood inequalities of diarrheal morbidity among under-5 children in selected countries in sub-Saharan Africa over the period 1990-2013. DESIGN: Data used come from the Demographic and Health Survey (DHS) waves conducted in Burkina Faso (1992-93, 1998-99, 2003, and 2010), Mali (1995, 2001, 2016, and 2012), Nigeria (1990, 1999, 2003, 2008, and 2013), and Niger (1992, 1998, 2006, and 2012). Bivariate analysis was performed to assess the association between the dependent variable and each of the independent variables. Multilevel logistic regression modelling was used to determine the fixed and random effects of the risk factors associated with diarrheal morbidity. RESULTS: The findings showed that the proportion of diarrheal morbidity among under-5 children varied considerably across the cohorts of birth from 10 to 35%. There were large variations in the proportion of diarrheal morbidity across countries. The proportions of diarrheal morbidity were higher in Niger compared with Burkina Faso, Mali, and Nigeria. The risk factors of diarrheal morbidity varied from one country to another, but the main factors included the child's age, size of the child at birth, the quality of the main floor material, mother's education and her occupation, type of toilet, and place of residence. The analysis shows an increasing trend of diarrheal inequalities according to DHS rounds. In Burkina Faso, the value of the intraclass correlation coefficient (ICC) was 0.04 for 1993 DHS and 0.09 in 2010 DHS; in Mali, the ICC increased from 0.04 in 1995 to 0.16 in 2012; in Nigeria, the ICC increased from 0.13 in 1990 to 0.19 in 2013; and in Niger, the ICC increased from 0.07 in 1992 to 0.11 in 2012. CONCLUSIONS: This suggests the need to fight against diarrheal diseases on both the local and community levels across villages.