Trials & Triumphs: Clinical Research Chronicles
March 2025 Edition
Welcome Message
Dear Readers,
Welcome to the March edition of Trials and Triumph: Clinical Research Chronicles. This month, we feature an article on Patient Registries: Unlocking Long-Term Insights in Clinical Research, highlighting their role in providing valuable data that drives better clinical outcomes and personalized treatments.
In our Research Highlight, we celebrate our recent publication in PLOS Global Public Health on "Unravelling the Conundrums of Social Autopsy for Maternal Mortality in Low- and Middle-Income Countries". This study sheds light on the complexities of social autopsy in understanding maternal deaths, offering important insights to inform policies and improve maternal health in resource-limited settings.
Deputy Director, Clinical Trials – CCTRIS
College of Medicine, University of Lagos
Feature Article
Patient Registries: Unlocking Long-Term Insights in Clinical Research
Patient registries are powerful tools in long-term clinical research, providing a structured system for systematically collecting and analysing patient data over extended periods. These registries track disease progression, treatment outcomes, and long-term safety profiles, offering invaluable real-world evidence that shapes clinical practice and healthcare policies.
Types of Patient Registries
Patient registries can be broadly categorised into different types based on their purpose and scope:
- Disease or Condition-Specific Registries: Focus on patients with a particular disease, such as cancer, diabetes, or rare genetic disorders, to study long-term outcomes, treatment efficacy, and disease patterns.
- Product or Drug Registries: Designed for post-market surveillance, these registries monitor the safety and effectiveness of new drugs, vaccines, or medical devices over time.
- Health Services Registries: Evaluate the performance of healthcare systems, tracking metrics such as hospital readmission rates, surgical outcomes, and quality of care.
- Population-Based Registries: Capture health data across a defined population, providing insights into public health trends, risk factors, and disease burden at a community or national level.
Patient Registries and Real-World Evidence
Patient registries are a critical source of real-world evidence (RWE), which refers to data collected outside controlled clinical trials to reflect how treatments perform in everyday healthcare settings. The integration of registries with electronic health records (EHRs), wearable health technologies, and administrative health data enhances their ability to generate high-quality RWE. This is particularly valuable for assessing long-term safety, effectiveness, and healthcare utilisation patterns in diverse patient populations.
With advancements in big data analytics and artificial intelligence, patient registries are evolving into dynamic research platforms that not only support evidence-based medicine but also drive precision healthcare and policy development. Their role in bridging clinical research and real-world practice ensures that medical advancements translate into meaningful improvements in patient care.
Research Highlight
Unravelling the conundrums of social autopsy for maternal mortality in low- and middle-income countries
Understanding the underlying causes of maternal mortality in low- and middle-income countries (LMICs) requires more than clinical diagnoses—it necessitates exploring the social, cultural, and systemic factors contributing to these deaths. Social autopsy has emerged as a valuable tool in this regard, offering insights beyond traditional verbal autopsies by examining the broader social determinants of maternal mortality. However, as highlighted in a recent publication from the LVASA-SRS project, the implementation of social autopsies is fraught with methodological and ethical challenges that demand careful consideration.
Key Findings
Three key conundrums were identified in conducting social autopsies:
- Defining the scope and participants of social autopsies remains contentious, with some approaches involving large community dialogues that may inadvertently foster blame and stigma.
- The methodological debate on whether social autopsies should be predominantly qualitative or quantitative raises concerns about the efficiency and effectiveness of existing tools.
- The appropriate scale of implementation remains unclear, as social factors influencing maternal deaths vary by context, yet overly localized reporting may compromise anonymity.
Recommendations
To address these challenges, there is a need for:
- A standardized, globally recognized framework for social autopsy, akin to the WHO's guidance on verbal autopsies
- Prioritizing qualitative methods for deeper insights
- Ensuring psychosocial support for participants
- Balancing the need for detailed community-level analysis with safeguarding anonymity
Ultimately, while social autopsies hold immense potential for shaping maternal health policies and interventions, ethical and methodological refinements are crucial to maximizing their impact while preserving the dignity of the deceased and their families.
Read the full paper here: https://doi.org/10.1371/journal.pgph.0004295
Did You Know?
Trillions of bacteria in your gut play a critical role in how your body processes medications. Recent research has shown that gut microbes can activate, inactivate, or even modify drugs, leading to significant variations in treatment responses between individuals. For instance, certain bacterial species can break down medications before they reach their intended target, reducing drug effectiveness. In contrast, some microbes can enhance drug absorption or convert inactive compounds into their active forms. This explains why two people taking the same medication at the same dose may experience different effects or side effects. Scientists are now exploring ways to personalize drug therapy by analyzing a patient's microbiome, paving the way for more precise and effective treatments in the future.