Trials & Triumphs: Clinical Research Chronicles
February 2025 Newsletter
Welcome Message
Welcome to the February 2025 Edition of Trials & Triumphs: Clinical Research Chronicles!
We are excited to continue advancing clinical research in 2025. This month, our Feature Topic explores Open Trials and the need for transparency and rigour in Clinical Research.
In the Research Highlight section, we will take you through the series of interesting activities from the IVON-IS Dissemination Meeting, the LVASA Scientific and Data Analysis Meeting, and the inaugural CAPREMAN Stakeholders Meeting.
Thank you for your feedback from the other editions. There is no need to download anymore, just click the link below to access the full edition for this month on our website. We remain committed and dedicated to give you insights from the centre.
Sincerely,
The CCTRIS Team.
Feature Topic
Open-Label Trials: Balancing Transparency and Rigour in Clinical Research
Clinical trials vary in design, with open-label trials being those where both researchers and participants know the treatment being administered. Unlike blinded trials, which conceal treatment allocation to minimise bias, open-label trials prioritise transparency and practicality in specific research settings.
When Are Open-Label Trials Used?
Open-label trials are commonly employed when blinding is impractical or unnecessary, such as in:
- Comparative effectiveness studies, assessing real-world treatment outcomes.
- Long-term safety studies, monitoring prolonged effects of a drug.
- Rare or life-threatening conditions, where ethical considerations require treatment transparency.
- Dose-titration studies, allowing clinicians to adjust doses based on patient response.
- Hybrid effectiveness-implementation trials, where researchers evaluate both clinical efficacy and real-world adoption. Open-label designs in hybrid trials help assess how well an intervention works in routine practice, making them valuable for studying feasibility, patient adherence, and provider uptake.
Advantages and Challenges of Open-Label Trial Design
Open-label trials offer practical benefits, such as better patient adherence and real-world applicability. However, they also pose challenges, including bias risk and the potential for placebo effects, which can influence perceived outcomes. Researchers address these issues using robust statistical methods and hybrid trial designs.
Why Open-Label Trials Matter
Despite limitations, open-label trials remain essential in clinical research, particularly when controlled trials are not feasible. They provide valuable insights into treatment effectiveness, safety, and patient compliance, ensuring that promising therapies reach those who need them most.
Research Highlight Section
Verbal and Social Autopsy: Uncovering the Real Causes of Maternal Mortality
Understanding the true burden of maternal deaths and stillbirths requires more than just numbers—it demands an in-depth exploration of the circumstances surrounding these tragedies. The Lagos State Verbal and Social Autopsy Sample Registration System (LVASA-SRS), implemented by CCTRIS across all 20 LGAs, employs Verbal Autopsy (VA) and Social Autopsy (SA) methods to generate reliable maternal mortality estimates while identifying key social and health system factors contributing to these deaths.
How Verbal and Social Autopsy Work
- Verbal Autopsy (VA): VA is a structured interview conducted with caregivers, family members, or community respondents of a deceased individual to determine the probable medical cause of death. Standardised questionnaires are used to collect detailed accounts of symptoms, illness progression, and healthcare-seeking behaviour before death. This method is particularly useful in settings where civil registration systems are incomplete or cause-of-death certification is lacking.
- Social Autopsy (SA): While VA focuses on the medical causes, SA investigates the social, cultural, and health system barriers that may have contributed to the death. This includes delays in recognising danger signs, accessing healthcare facilities, financial constraints, and systemic gaps in maternal care.
Why VA and SA Matter for Maternal Health
By implementing VA and SA within the LVASA-SRS, CCTRIS aims to bridge the data gap on maternal deaths in Lagos State. The first phase of the project retrospectively examines maternal deaths and stillbirths from the past year, while the second phase will prospectively track such deaths over 12 months starting in 2024. The insights gained will provide evidence-based recommendations to policymakers, ensuring that maternal health interventions are responsive, targeted, and effective in reducing preventable deaths.
Events and Spotlights
LVASA-SRS Scientific Workshop on Maternal Mortality in Lagos
To effectively tackle maternal mortality in Lagos State, accurate data on maternal deaths and their causes is essential. The Lagos State Verbal and Social Autopsy Sample Registration System (LVASA-SRS) project is addressing this gap by generating reliable data to inform targeted interventions.
From 19th to 22nd February, LVASA-SRS held a 4-day scientific workshop to review findings from the past year. Supported by APHRC and LSHTM, the meeting brought together experts from LUTH, LASUTH, LSMOH, MIST, PHCB, and MPDSR to analyse maternal mortality trends and shape evidence-based policies for improved maternal health outcomes in Lagos.
IVON-IS Stakeholders' Dissemination Workshop
The IVON-IS (Implementation Research for Intravenous Iron Use in Pregnant and Postpartum Nigerian Women) project held its Stakeholders' Dissemination Workshop on Monday, 24th February 2025. The event featured presentations, panel discussions, and interactive sessions where stakeholders shared insights on improving anaemia care for pregnant and postpartum women. The study, conducted across six healthcare facilities in Lagos, demonstrated significant improvements in anaemia screening rates and IV iron administration, highlighting the effectiveness of targeted interventions.
A key outcome of the workshop was the commitment from policymakers, healthcare providers, and community leaders to implement the study's recommendations and scale up anaemia care services. The findings underscore the need for sustainable healthcare solutions to reduce anaemia-related morbidity and mortality in Nigeria. As stakeholders push for wider adoption of IV iron therapy, the study sets the stage for strengthening maternal healthcare and ensuring that all women receive timely and effective anaemia treatment.
Inaugural Stakeholder Engagement Meeting for the CAPREMAN Project
The MRH Collective, in collaboration with CCTRIS, held its inaugural stakeholder engagement meeting on 27th February in Abuja. The meeting convened key stakeholders from Lagos, Kano, Kaduna, and the Federal Ministry of Health to present findings from the IVON-IS project and introduce the Comprehensive Approach to the Prevention and Management of Maternal Anaemia in Nigeria (CAPREMAN) project. CAPREMAN aims to develop and implement a comprehensive guideline for the prevention and management of maternal anaemia.
This mixed-method study, to be conducted in Kano, Kaduna, and Lagos, goes beyond anaemia treatment—it seeks to drive evidence-based policy reforms that will shape future maternal health strategies. By addressing maternal anaemia holistically, CAPREMAN represents a critical step toward improving maternal and child health outcomes in Nigeria.
Did You Know?
Negative trials—studies that do not show a statistically significant benefit of an intervention—are just as important as positive trials in clinical research. While they may seem like setbacks, negative trials help prevent ineffective or harmful treatments from reaching patients, refine future research questions, and contribute to scientific integrity by reducing publication bias. They play a crucial role in evidence-based medicine, ensuring that only safe and effective therapies are implemented in clinical practice.