Clinical Trials at Swiss TPH

CLINICAL TRIAL EXPERTISE IN GLOBAL HEALTH Bringing Science to Patients

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At a Glance Key Figures Services at Swiss TPH Clinical Trials and Studies Our Expertise

Concept and edits: Danielle Powell Contributions: Elisabeth Reus Pictures: Christian Heuss, Danielle Powell, DK Lee, DNDi, Joachim Pelikan, Justin Makangara / Fairpicture, Olivier Brandenburg

Swiss Tropical and Public Health Institute Kreuzstrasse 2 4123 Allschwil Switzerland +41 (0)61 284 81 11 www.swisstph.ch

Design: Neeser & Müller GmbH Printing: Gremper AG Copyright: Swiss TPH 2022

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Improving Health Systems Worldwide The Swiss Tropical and Public Health Institute (Swiss TPH) is a world-leading institute in global health with a particular focus on low- and middleincome countries. Associated with the University of Basel, Swiss TPH combines research, education and services at the local, national and international level. 900 people from 80 nations work at Swiss TPH focusing on infectious and non-communicable diseases, environment, society and health as well as health systems and interventions.

Introduction

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At a Glance Swiss TPH translates research into action and helps strengthen health systems and policy shaping to generate measurable outputs and create lasting impact for individuals and communities worldwide.

Research, education and services By uniquely combining research, education and services, we aim to improve the health and well-being of people through a better understanding of disease and health systems and by acting on this knowledge.

Taking science to impact Our translational approach, from innovation and validation to application, enables us to bring novel diagnostics, drugs and vaccines directly to people, communities, policy and decision makers. Throughout, we pursue a spirit of partnership and strive for sustainable impact in over 100 countries.

Broad expertise 900 employees and students work at Swiss TPH, focusing on infectious and non-communicable diseases environment, society and health as well as health systems and interventions. Our expertise spans from the bench to the field, from basic to operational, from molecular to spatial, and from genes to health systems.

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At a Glance

Selected funding partners and clients → Doctors Without Borders (MSF)

→ Novartis

→ Drug for Neglected Diseases Initiative ( DNDi )

→ UNITAID

→ The European and Developing Countries Clinical Trials Partnership (EDCTP) → European Union

→ The University Hospital of Basel For the full list, please visit: www.swisstph.ch/partners

→ Innosuisse → Merck

At a Glance

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Key Figures

907 Employees at Swiss TPH

209 Employees based abroad

620 Postgraduate students

≥ 10 projects ≥ 5 projects ≥ 1 project

Swiss TPH offices

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Key Figures

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Nations represented at Swiss TPH

698 Employees based in Basel

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Countries in which we work

Swiss TPH is committed to the achievement of the Sustainable Development Goals (SDGs), placing an emphasis on SDG 3 “Ensure healthy lives and promote well-being for all at all ages”.

Key Figures

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Services at Swiss TPH Swiss TPH offers a diversity of services in global health, from clinical trials and diagnostic services to project implementation and medical consultations.

Diagnostic services

Clinical trials and studies Swiss TPH conducts clinical trials for new drugs, diagnostics and vaccines to improve access, quality and cost-effectiveness of healthcare globally.

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Services at Swiss TPH

Our diagnostic centre is specialised in diagnosing infectious tropical diseases. The laboratory has an internationally recognised expertise in parasitic infections and was nominated as the Swiss National Reference Centre for Imported Parasitic Diseases.

Vaccinations and medical consultations 15,000 pre-travel medical consultations, 1,500 post-travel consultations and 30,000 phone calls annually - our travel clinic is a national centre of competence for travel and tropical medicine.

Consultancy and project implementation Swiss TPH offers state-of-the-art consultancy and project implementation services in the area of global health.

Clinical Trials and Studies With over 20 years of clinical research and operational experience, Swiss TPH has a unique expertise in clinical trials. We are dedicated to the design, implementation, management and monitoring of Phase I to Phase IV clinical trials with a focus on poverty related diseases. As both a sponsor and service provider, we understand the barriers to delivering clinical trials in difficult settings and offer strategic, customized solutions with the aim to deliver high quality data, putting the patient at the center of our efforts.

Clinical Trials and Studies

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Our expertise lies in the development and evaluation of drugs, diagnostics and vaccines and finding novel solutions for non-communicable and neglected tropical diseases. We do this through:

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Local know-how of regional context

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Understanding of patient pathway

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Academic and scientific innovation

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Global network of partners and collaborators

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Clinical Trials and Studies

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Clinical expertise and management

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Our Expertise Through our multidisciplinary teams, large network of collaborators and local and global experts, Swiss TPH supports a diversity of clients. Our longstanding expertise allows us to continuously adapt and develop knowledge from both investigatorinitiated studies as well as regulatory trials.

Our services include: Trial Management of Multinational Studies Study Design and Adaptability Feasibility and Study Site Evaluation Strengthening Capacity Building Planning and Conducting of Studies Phase I– IV Research Governance and Good Clinical Practice

Our Expertise

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Trial Management of Multinational Studies Our global, multidisciplinary clinical research professionals are dedicated to advancing clinical trials.

Through our combined clinical, research and local expertise with long-standing partners in an extensive global network of regional collaborators, we support the management, conduct and monitoring of multi-center studies to deliver high-quality, consumerfocused clinical trial results.

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Our Expertise

Project Highlights → ANTICOV

→ Pediatric Praziquantel Consortium

In 2019, African countries and a international network of research institutions, including Swiss TPH, joined forces to launch the largest COVID-19 clinical trial in Africa. The ANTICOV clinical trial aims to respond to the urgent need to identify treatments that can be used to treat mild and moderate cases of COVID-19 early and prevent spikes in hospitalisation that could overwhelm fragile, overburdened health systems in Africa. Swiss TPH is responsible for the active monitoring of the sites in the Democratic Republic of Congo, providing Good Clinical Practice trainings for individuals in 13 countries. Funding is provided by the German Federal Ministry of Education and Research (BMBF).

In 2021, the Pediatric Praziquantel Consortium completed its pivotal clinical Phase III trial of arpraziquantel – a potential new treatment option for the estimated 50 million preschool-aged children with schistosomiasis. As a member of the Consortium, Swiss TPH led the implementation of the clinical trials in Côte d’Ivoire and Kenya.

The trial, co-funded by the Global Health Innovative Technology Fund and the European & Developing Countries Clinical Trials Partnership (EDCTP), is a major step towards the treatment of schistosomiasis, one of the most damaging parasitic diseases that affects the lives of over 200 million people.

→ TB-PRACTECAL TB-PRACTECAL, a clinical trial led by Médecins Sans Frontières with partners including Swiss TPH, found that a new all-oral treatment regimen for rifampicin-resistant tuberculosis (RR-TB) is safer and more effective than the current accepted standard of care. These results signal the start of a new chapter for patients who often endure grueling treatment regimens that have a catastrophic effect on physical and mental health. The trial enrolled 552 patients and took place in seven sites across Belarus, South Africa and Uzbekistan. Swiss TPH was responsible for monitoring the multinational trial.

Our Expertise

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Study Design and Adaptability Good clinical trial design is key to optimizing study conduct. Performing clinical trials based on a sound understanding of clinical practice facilitates the implementation of evidence-based practice and adaptability. Through a multifaceted approach and diverse expertise from clinical staff, pharmacists, biologists, epidemiologists, data managers and statisticians, we aim to optimize clinical trials robustness and success.

→ The MSP1 Study Malaria remains a heavy burden in tropical and subtropical regions. The MSP1 study is a Phase Ib trial to assess safety, reactogenicity, immunogenicity and parasite growth rates of a candidate bloodstage malaria vaccine. In a collaboration between Sumaya Biotech GmbH, Ifakara Health Institute and Swiss TPH, the aim of the trial is to evaluate SumayaVac and assess its efficacy in ensuring sufficient and long-lasting protection against malaria.

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Our Expertise

Feasibility and Study Site Evaluation It’s estimated that more than 90% of clinical trials fail due to poor patient recruitment, inefficient clinical investigator selection, poor understanding of ethical and local regulatory aspects of the selected site for conducting the study, cost incurred due to delays and more. Swiss TPH has been successfully facilitating the feasibility, set-up, project management and monitoring of epidemiological studies and clinical trials (Phase I-IV) in low-income settings and emerging economies for 20 years.

→ The CALINA study CALINA is a multicenter, open-label, single-arm study to evaluate the safety and efficacy of a new artemether-lumefantrine dispersible tablet to treat infants and neonates weighing less than 5kg with acute malaria. The project is led by Novartis in collaboration with the PAMAfrica consortium and Medicines for Malaria Venture (MMV). Swiss TPH has the role of trial site set-up, management and monitoring in the Democratic Republic of Congo.

Our Expertise

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Strengthening Capacity Building Through our combined clinical, research and local expertise and an extensive global network of regional collaborators, Swiss TPH embeds capacity building throughout all our projects as part of our commitment to sustainable development. In addition, we provide mentorship and training support for people at the European Centre for Clinical Research, the University of Basel and we are an active member of the WHO Special Programme for Research and Training in Tropical Diseases.

→ Capacity Building in Lesotho Over the last decade, enormous progress has been made in Lesotho, Africa in generating evidence for practice, national guidelines and policies. This increase in clinical research required strengthening and building a monitoring capability and infrastructure in-country. In collaboration with SolidarMed and the University of Basel, Swiss TPH has been actively involved in establishing a clinical research monitoring team.

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Our Expertise

Planning and Conducting Phase I-IV Studies Swiss TPH combines translational and clinical research to advance laboratory discovery and apply the findings within communities. By working across medical parasitology to infection biology, our researchers collaborate with international partners to bridge the gap between bench and bedside, ensuring that safe, effective and innovative treatments reach patients as quickly as possible.

→ Helminth Elimination Platform (HELP) HELP is a consortium of research institutes, universities, not-for-profit organisations and pharmaceutical companies formed to develop new drugs for infections caused by parasitic worms (helminths), a debilitating group of diseases that includes river blindness, lymphatic filariasis, as well as infection with hookworm and whipworm. Together, these diseases affect close to a billion people.

Our Expertise

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Research Governance and Good Clinical Practice Promoting evidence-based medicine and conducting clinical research requires customized solutions.

We constantly enhance our quality processes and adherence to Good Clinical Practice (GCP). Continuous improvement of our processes is supported by the use of our validated clinical trial management system.

Through collaboration with our partners, we offer a wide range of quality services as well as provide Swissethics validated GCP training.

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Our Expertise

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Kreuzstrasse 2 4123 Allschwil +41 (0)61 284 81 11 www.swisstph.ch