Africa Clinical Trial Solutions (ACTS)

In a major revision issued last week, the Declaration of Helsinki issued by the World Medical Association now emphasizes that researchers must make their study results publicly accessible, regardless of outcome and follow ethical reporting guidelines. Publications should disclose funding sources, affiliations, and conflicts of interest, and research involving human participants must be registered in a publicly accessible database (Sections 35-36). Informed consent is also mandated for secondary research on identifiable or potentially re-identifiable data or biospecimens (Section 32).   https://lnkd.in/eGdWNhbS

The Opening Ceremony of the 75th General Assembly of World Medical Association - WMA was colourful and the chief guest was the President of the Republic of Finland, Alexander Stubb! He indeed referred to the Declaration of Helsinki which is 60 years this year. It is a statement outlining the ethical principles for medical research. It provides a foundation for scientific efforts worldwide, protecting those who participate in medical research for their own benefit as well as the benefit of other people with similar medical conditions. The outgoing WMA President Lujain Alqodmani gave farewell speech and the amazing highlights of her year as she welcomed the new WMA President Ashok Philip who was sworn in. Kenya Medical Association was at hand! We are here with yours truly standing for elections for President Elect of World Medical Association. Simon Kigondu Dr. Linda Kemunto Diana Marion Elizabeth Maina Dr Joy Mwenda-Mugambi Lukoye Atwoli, M.B.S., MBChB, MMed Psych, PhD, IFAPA WomenLift Health

Q4 has officially landed, and let’s just say mine started with a serious bang 💥! Kicked off by sitting down with some of the sharpest, design-driven and technology innovators in the Kenyan space during the "𝗘𝘃𝗼𝗹𝘃𝗶𝗻𝗴 𝗗𝗲𝘀𝗶𝗴𝗻 𝗳𝗼𝗿 𝗖𝗼𝗹𝗹𝗲𝗰𝘁𝗶𝘃𝗲 𝗚𝗼𝗼𝗱" roundtable event held on October 11th, 2024.✈️ A big thank you to Munyala Mwalo and Kanana Pauline for the invite and the seat at the table 🙏. I’m super excited to keep driving the health agenda forward and can’t wait for more chances to collaborate, innovate, and design impactful solutions — and yes, I’ll be bringing along some health sector colleagues to make sure the impact is real and lasting! Kanana Pauline, your concept of "The Collective of Action" hit home for me — it aligns perfectly with my desire to co-create, co-sustain, and collaborate for meaningful change. Let’s keep building! Ambassador Philip Thigo, MBS, you nailed it: we’re living in an era of diminished trust, my reflection especially in health, where myths and misinformation around drugs and vaccines are at an all-time high. I’m eager to dive deeper into the data on this! Some of the key takeaways that have me buzzing: 1️⃣ Design with behavior change in mind – How do we steer clinical research to achieve better health outcomes across Kenya and Africa? This is a huge question in my mind right now. 2️⃣ Continuous monitoring for continuous learning – Beyond hard data, how do we qualitatively measure success for patients? How do we use this to inform better studies and health solutions? 3️⃣ Person > Process – For me, this boils down to patient advocacy. It’s not just a box to check; it’s the heart of the matter. The person (patient/participant) must be central to innovation. 4️⃣ R&D vs. Capitalism – How do we balance bottom lines with real impact? The answer: genuine stakeholder collaboration, so we can understand pain points and deliver solutions that actually matter. As always, I took way too many pictures of the slides, and now I’m busy unpacking all the insights! 📸 It was also a pleasure meeting Roy M. Githaiga, M.Arch, Rita Oyier, Lysanne van der Voort, Ephy Yunan, Lynnet Kamau, and Zablon Wanyama Wekesa. Can’t wait to continue our conversations and make moves! Institute of Design and Innovation Thunderbird School of Global Management #Q4Goals #HealthInnovation #BehaviorChange #PatientAdvocacy #CollaborationIsKey #KenyaHealth #ClinicalResearch

Following up on last week’s post, we're delving deeper into World Health Organization 2024 guidance on 'Best Practices for Clinical Trials' to unpack the path toward health equity in LMICs, especially here in Africa. What insights and recommendations are poised to tackle persistent barriers and create a more inclusive, effective clinical trial landscape for our continent? ‼ Breaking Down the Key Challenges ‼ The guidance focuses on cutting through bureaucratic red tape, refining trial designs, and ensuring that studies are contextually appropriate. These obstacles are particularly pronounced in LMICs, where limited resources and infrastructure gaps often impede progress. The call for streamlined approval processes and targeted funding is essential to drive trials that truly address local health needs. What This Means for Africa? 🔍 Enhancing Inclusivity: The urgent need to include underrepresented groups like children and pregnant women in clinical trials is clear. The WHO's recommendations emphasize tailored strategies that align with Africa’s specific health priorities and disease trends. 🔍 Strengthening Local Capacity: By investing in infrastructure and building partnerships between local researchers, governments, and international funders, African countries can lead high-quality trials on their own terms. This shift reduces reliance on high-income country-led studies and ensures locally relevant data. 🔍 Bridging Funding Gaps: Sustainable investment is crucial. The guidance urges nations to allocate at least 2% of health budgets to R&D, an essential step toward addressing diseases that disproportionately affect LMICs, such as malaria, tuberculosis, and non-communicable diseases. The Big Questions: ✅ How can the global health community support Africa in establishing a strong clinical trial ecosystem? ✅ What actions are needed to ensure that health interventions tested in Africa are accessible and affordable for local populations? The divide in clinical trials between Africa and high-income countries goes beyond statistics—it’s a matter of equity, capacity-building, and transforming health outcomes for generations to come. Photo Credit: National Cancer Institute on Unsplash #ClinicalTrials #LMICs #HealthEquity #GlobalHealth #Africa

The World Health Organization (WHO) just dropped pivotal guidance to transform the way clinical trials are designed, conducted, and overseen in countries across all income levels. This move is set to boost country-led R&D, making safe and effective health interventions more accessible and affordable worldwide. What’s the impact?🔍 The guidance tackles key challenges like poor trial design and lack of diversity in participants, ensuring we move away from a one-size-fits-all approach. With only 5% of trials including pregnant women and 13% including children, it’s clear we need more inclusivity to improve health outcomes. But the big question is: Will this guidance finally close the gap between high-income and low- and middle-income countries in clinical trials? Let's talk about it: ✅ How can we ensure that underrepresented groups are prioritized in future trials? What has been done and worked? ❗Global divides between high-income countries (HICs) and low- and middle-income countries (LMICs) are leading to serious inequities in clinical trials. In 2022, there were 27,133 trials taking place in the world’s 86 HICs compared to 24 791 in 131 LMICs. At times, LMICs have been targeted for inclusion in clinical trials due to their disease burdens, only for the resulting data to be used in getting health interventions authorized in HICs, but not in the LMICs. #ClinicalTrials #GlobalHealth #EquitableRepresentation

Launch webinar for WHO guidance for best practices for clinical trials In May 2022, the World Health Assembly adopted Resolution 75.8, "Strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination". This resolution emphasizes the urgent need to enhance both global and national clinical trial ecosystems. The goal is to advance equitable clinical trial capacity, improve health outcomes related to endemic diseases at the national and regional levels, and ensure that trial systems can swiftly adapt during health crises. In response to this mandate, the World Health Organization (WHO) is pleased to announce the launch of its new guidance on best practices for clinical trials. This comprehensive document is designed to reinforce global standards in the organization, design, conduct, analysis, and reporting of clinical trials. The guidance is a pivotal tool for strengthening the global clinical trials ecosystem, enhancing the efficiency and credibility of clinical research, and promoting public trust in the outcomes of research and in the evidence base for health interventions. Date & Time: Sep 25, 2024 12:00 PM UTC+1 Register: https://lnkd.in/gQQ3J4Bq For more information, visit: https://lnkd.in/e6EN4p3W  #globalhealth #clinicaltrials #healthresearch

World Health Organization prequalified the first vaccine against #mpox, the MVA-BN vaccine: https://bit.ly/3TrwK71 This is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future. We now need urgent scale up in production, procurement, donations and rollout to ensure equitable access to vaccines where they are needed most.

Congratulations, Faustine Ndugulile, on your election to serve as the next WHO Africa Regional Director — it is a great privilege, and a very great responsibility. I and the entire World Health Organization family in Africa and around the world will support you every step of the way. #RC74AFRO

🔊🔊🔊🔊Breaking News!🔊🔊🔊🔊 Swiss Pharma Nigeria Limited (Swipha) has become the first Nigerian manufacturer to obtain World Health Organization prequalification for the production of a key #malaria prevention drug (sulfadoxine-pyrimethamine), used for preventing #malaria in those most at-risk – children and pregnant women. This remarkable milestone is part of ongoing efforts to strengthen regional manufacturing capacity to widen the availability of quality-assured medications to combat #malaria across Africa, where most #malaria deaths occur. Find out more: https://bit.ly/472QRxN #localmanufacturing #EndMalaria 📽️Video courtesy of Medicines for Malaria Venture, Unitaid, and Swiss Pharma Nigeria Limited

The WHO and Africa CDC have declared an urgent call to address the Mpox outbreak, particularly in Africa. The rapid rise in infections among youth under 18 has become a major cause for concern. According to Africa CDC’s Head, Kaseya, approximately 60% of the cases in the Democratic Republic of Congo (DRC) are in children under 15, rising to over 70% when considering those under 18. This alarming increase demands prompt action and public awareness. Transmission of Mpox Mpox is primarily transmitted through close contact with an infected person’s lesions, bodily fluids, respiratory droplets, or contaminated materials. It can also spread through respiratory secretions or physical contact during prolonged face-to-face interactions. In addition to human-to-human transmission, animals such as rodents and non-human primates can also spread the virus. Key prevention measures include: - Avoiding close physical contact with those infected or showing symptoms. - Regular handwashing and sanitization. - Use of personal protective equipment (PPE) for healthcare workers and individuals in close contact with suspected cases. Vaccine Availability and Shortage Vaccines can significantly help curb the spread of Mpox. However, Africa faces a shortage, with only 200,000 doses available while an estimated 10 million are needed to control the spread, according to Africa CDC. Currently, two vaccines have been recommended for use against Mpox by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE). These vaccines are recommended for at-risk populations, such as close contacts of Mpox cases and those at high risk of exposure. While vaccines are a vital tool, the WHO does not recommend mass vaccination at this stage. The process for full vaccine licensure is ongoing, but in the meantime, an Emergency Use Listing (EUL) is being pursued to expedite the availability of these vaccines. Both currently available vaccines for Mpox work by stimulating the immune system to recognize and fight the virus effectively. This is crucial in preventing severe disease outcomes, especially in vulnerable populations. There is an urgent need for global collaboration and stakeholder support to ensure vaccine availability across Africa. Together, we can make a difference by acting swiftly and ensuring that no one, especially our youth, is left behind in this battle. Sources: Gavi, the Vaccine Alliance https://lnkd.in/dRyvYFxy World Health Organization https://lnkd.in/dC2jApns BioNTech SE multivalent mRNA monkeypox virus vaccine (BNT166) https://lnkd.in/dtmadfMA