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A mother and her child are recruited on to the PVC trial at Basse Hospital. Credit: LSHTM

Trials Network

An interdisciplinary network of trial managers, clinical research associates, data managers, epidemiologists, statisticians and practitioners with an interest and expertise in randomised controlled trials methods and delivery.

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About us

The Trials Network aims to share expertise and experience and strengthen capacity in the design and delivery of randomised controlled trials by LSHTM and its partners.

Our trials

We design and deliver randomised controlled trials that generate high quality evidence to address a wide range of questions of public health importance. We are involved in 300 trials in over 70 countries across the spectrum of early- through to late-stage trials of clinical and non-clinical interventions. 

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About Trials Network
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Aim

The Trials Network's objective is to raise internal and external awareness of the excellent quality, health and equity impacts of randomised controlled trials conducted by LSHTM and its partners. The network aims to strengthen capacity in the design and delivery of trials through:

  • generating and sharing expertise and innovation
  • channelling available tools and resources to support colleagues working on trials
  • strengthening equitable partnerships within the UK and globally
  • promoting trial efficiency and sustainability.

Who we work with

The network connects with specialists across LSHTM.  These groups provide expert support for randomised controlled trials in a range of areas:

For LSHTM staff and research partners seeking help in any aspect of planning, design, implementation or analysis of a trial, please contact us at trialsnetwork@lshtm.ac.uk and we will connect you with an appropriate expert.

Trials Network steering committee

Our trials
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PopART team in the field
Infectious diseases

LSHTM has a strong track record of conducting large-scale trials on the control of infectious diseases especially in low- and middle-income settings in collaboration with long-standing partners in West, East and Southern Africa. Many of these trials have resulted in major changes to national, regional and international policy. Tuberculosis (TB), malaria, HIV, vaccine preventable diseases and neglected tropical diseases (NTDs) have been particular areas of focus. See selected highlights from a subset of this substantial body of work.

HIV

Our work in the field of HIV has spanned all aspects of the care cascade from primary prevention through to management of complications of advanced HIV. LSHTM led the ground-breaking PopART study on community-wide implementation of HIV testing and anti-retroviral therapy in Zambia and South Africa. This trial provided crucial evidence underpinning the adoption of the universal testing and treatment strategy which now plays a key role in achieving the WHO 95-95-95 targets for HIV control. Investigators at LSHTM also co-ordinated the AMBITION study, the world’s largest trial of treatment for cryptococcal meningitis, paving the way for new therapies to be adopted worldwide for the treatment of this important HIV-associated complication. 

Tuberculosis

LSHTM's TB studies are wide-ranging, in particular in the context of HIV, including on preventative therapy, contact tracing, treatment and diagnostic strategies. The STAMP trial conducted in Malawi and South Africa was the first trial to demonstrate reduction in mortality from HIV-associated TB due to application of a diagnostic test and has had a major impact on the adoption of urine-based screening tests for TB. 

Neglected Tropical Diseases

LSHTM has run key trials on the control and elimination of NTDs. Amongst the most pivotal were a series of trials evaluating novel treatments for the elimination of trachoma, the commonest infectious cause of blindness worldwide. Much of this work was conducted in collaboration with the MRC Unit The Gambia, the Kilimanjaro Centre for Community Ophthalmology and the Ethiopian Federal Ministry of Health. These studies now underpin the SAFE WHO strategy for trachoma elimination. Currently LSHTM is leading a large study, Stronger-SAFE, which is aiming to strengthen current control efforts in order to help achieve elimination of trachoma by 2030.  

Malaria

LSHTM has played a significant role in trials of a range of strategies to control malaria. These studies have provided much of the global evidence underpinning key tools such as bed-nets, chemoprevention, vaccines and combination strategies. Recent LSHTM led studies demonstrated that combining malaria vaccines with chemoprophylaxis is a particularly effective tool for reducing mortality related to malaria.   

Vaccines

LSHTM has helped deliver critical studies on a wide range of vaccines and demonstrated the effectiveness of a new generation of conjugate vaccines. This work has underpinned their adoption by WHO. For example, LSHTM has played a leading role in research on the pneumoccocal vaccine in East and West Africa for almost two decades. Similarly, studies run by LSHTM have provided critical evidence on the effectiveness and optimal dosing schedule for controlling human papillomavirus (HPV) which is the commonest cause of cervical cancer.  

Non-communicable diseases

LSHTM has a strong portfolio of trials in non-communicable diseases (NCDs).

Cardiovascular disease

The Clinical Trials Unit cardiovascular team specialises in the design, conduct and analysis of multicentre clinical trials.

Alcohol reduction

LSHTM's work is centred around testing low-intensity and contextually relevant interventions aimed at improving access to care for individuals with alcohol use disorders. By focusing on interventions that are adapted to the specific context, the research aims to address the challenge of poor access to care for individuals dealing with alcohol-related issues. This approach aligns with the broader goal of making psychological treatments more widely available, particularly in routine health-care settings. The emphasis on context-specific interventions is a recognition of the importance of tailoring strategies to the unique circumstances and needs of the population. The work contributes to the ongoing efforts to bridge the treatment gap for alcohol use disorders, ultimately seeking to enhance the overall accessibility and effectiveness of interventions for individuals with harmful drinking behaviours.

Eye health

The International Centre for Eye Health has been involved with a diverse set of clinical trials for eye health. These have included: 

  • mHealth solutions to identify adults and schoolchildren with eye problems and to connect them to services in Kenya
  • surgical interventions such as strengthening training of eye doctors to carry out cataract surgery
  • laser therapy for glaucoma in Nigeria and Tanzania
  • trials for the diagnosis of diabetic eye disease in Tanzania using artificial intelligence.
     
Educational, social and behavioural interventions

Trials can be used to assess not only pharmacological or other bio-medical interventions but also educational, social and behavioural interventions. There is a long history of evaluating such interventions using randomised trials, for example in the fields of education and social work. 

Complex interventions 

Complex interventions involve multiple activities that interact not only with each other but also with the context in which they are delivered. Complex interventions may be used in public health to prevent diseases or promote positive health or wellbeing. They may also be used in health services or social care to educate or change the social practices or behaviours of patients, clients, carers or clinical professionals.  

For example, the Learning Together intervention to prevent bullying involved the students and staff of English secondary schools working together to plan and deliver various activities to prevent or respond to bullying. The way in which the intervention was implemented and the precise mechanisms through which this prevented bullying varied between different sorts of school, illustrating an interaction with context.

The complexity in the Learning Together intervention is probably true of many public health, health services and social care interventions involving social interactions. Even where interventions involve administering a medicine or undertaking a clinical procedure, they will tend to involve social interactions and so in this sense are complex. If interventions are complex, it is important that trials do more than just evaluate overall effectiveness.

Trials of complex interventions often include process evaluations to examine intervention delivery and mechanisms of action, and how these vary between different sites and populations. Because complex interventions are rooted in social interactions, it is likely that qualitative research (interviews or observations) will be a necessary part of process evaluations to understand these interactions. It is important that trials evaluate educational, social and behavioural interventions both to ensure effective interventions are scaled up appropriately and that harmful interventions are stopped.

Disabilities

The Programme for Evidence to Inform Disability Action (PENDA) incorporates much of LSHTM’s research on disability, including through the conduct of impact evaluations of interventions, primarily using randomised controlled trials (RCTs).

PENDA is a consortium led by the  International Centre for Evidence in Disability and funded by the UK Foreign, Commonwealth and Development Office (FCDO). Part of the PENDA project is conducting impact evaluations (primarily RCTs) of interventions designed to improve the well-being of people with disabilities in low- and middle-income countries. The interventions assessed include programmes focused on livelihood development, access to health and addressing violence and discrimination.

PENDA trials include:  

  • A non-randomised control trial of a “Cash-Plus” programme in the Xiengkhouang Province of Laos. The programme involves a regular cash transfer, family support delivered to caregivers to improve their skills and understanding of disability and provision of assistive devices for children with disabilities. The evaluation will assess the impact of the programme on child and caregiver well-being and household poverty. The follow-up period is two years.  
  • A cluster RCT of the Paediatric Development Clinic/Baby Ubuntu programme implemented by Partners in Health in Rwanda. The Paediatric Development Clinic provides early care for young children at risk of developmental disability and monitors development and growth, whilst providing support to caregivers. Baby Ubuntu is a structured programme for children with a developmental disability and their caregivers, provided over 11 sessions by a health professional and trained caregiver. The study will adopt a cluster randomised controlled design across three districts of Rwanda, with a 12-month follow-up period. Key outcomes include the participation of children in family and community life, caregiver knowledge and family quality of life. 
  • A cluster RCT of an inclusive sexual and reproductive health programme that was developed to increase access to modern contraceptive methods and reduce unmet need for family planning for women of reproductive age with disabilities in Kaduna city, Nigeria. The trial has a 12-month follow-up and the primary outcome measure is access to family planning.  
Nutrition

The Nutrition Group has expertise in designing and conducting clinical trials to generate evidence for improved nutrition outcomes. Topics span fundamental nutrition metabolism, severe malnutrition treatment programme design, and the design and evaluation of complex multisectoral interventions. The group works primarily in resource-poor contexts, with a range of partners including universities, government departments, NGOs and multilateral organisations.

Micronutrient supplementation and metabolism 

Several trials in the Nutrition Group have focused on micronutrient supplementation and health outcomes. The Nutrition & Planetary Health team based at the MRC Unit The Gambia conducts micronutrient trials in mothers and babies with a major focus on preventing iron deficiency and anaemia. The ENID and INDiGO trials test the individual and additive effects of multiple micronutrient supplementation in pregnancy and infancy. The Vitality trial has tested whether supplementation with vitamin D and calcium optimises musculoskeletal health among peripubertal children with HIV in Zimbabwe and Zambia. Comprehensive Anaemia Programme and Personalised Therapies (CAPPT) was a cluster-randomised controlled trial testing home visiting, iron supplementation, participatory learning and action groups, plus routine antenatal care on haemoglobin among pregnant women in southern Nepal. 

Treatment of severe malnutrition 

Members of the Nutrition Group are lead investigators on trials which aim to improve the management of severe malnutrition in infants and children. For example, the team is working with Jimma University Ethiopia, Goal Ethiopia and the Emergency Nutrition Network on a large cluster- randomised trial exploring a new care pathway to improve the management of small and nutritionally at-risk infants aged under 6 months.

Food and agriculture interventions 

The Nutrition Group has run several trials to generate evidence on food and agriculture-led interventions to improve nutrition and health. The Action Against Stunting Hub is conducting two trials on the impacts of an egg intervention on pregnancy outcomes in Indonesia and on infant growth, development and micronutrient status in India. The cluster-randomised Upscaling Participation and Videos for Agriculture and Nutrition (UPAVAN) trial demonstrated that a set of nutrition-sensitive agriculture interventions was effective at improving child and maternal diet diversity in rural India. The Addressing Hidden Hunger with Agronomy (AHHA) trial demonstrated that consumption of maize flour, biofortified with selenium fertiliser, was effective at correcting selenium deficiency among women and children in a rural community setting in Malawi.  

Maternal, newborn and child health

LSHTM is involved in a wide range of trials in maternal, newborn and child health (MNCH), often involving multi-disciplinary teams and contributing to complex interventions.

Maternal health

The WOMAN trial showed that early administration of tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. Advocacy on the importance of tranexamic acid for treatment of postpartum haemorrhage and further research through WOMAN-2 continue to promote the role of tranexamic acid in addressing global maternal mortality.

Newborn health

Neonatal trials include the Operationalising Kangaroo Mother Care Before Stabilisation Amongst Low Birth Weight Neonates in Africa (OMWaNA) trial of early kangaroo mother care for hospitalised neonates weighing less than 2000 g in The Gambia; and the Pre-delivery Administration of Azithromycin to Prevent Neonatal Sepsis & Death (PregANZI-2) trial of azithromycin during labour to reduce neonatal deaths in Burkina Faso and The Gambia. 

Child health

LSHTM has extensive experience in researching new treatments for childhood infections including neglected tropical diseases such as schistosomiasis. This includes the ‘Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance’ (MORDOR) trial of mass administration of azithromycin to young children in Malawi and the Praziquantel in Preschool Children (PIP) trial, a randomised controlled trial aiming to find the right dose of the only available drug to treat schistosomiasis in preschool children in Uganda and the Philippines. Results of the PIP trial will inform WHO policies on schistosomiasis control.

LSHTM has led the development and evaluation of tools for preventing major childhood infections including vaccines, insecticide-treated nets and drugs for prophylaxis. The Vaccine Centre and the Malaria Centre at LSHTM act as the focal areas for research on vaccines and malaria.

Examples include large trials of new generation pyrethroid-piperonyl butoxide nets to prevent malaria in Tanzania, South Africa and Uganda; vaccine trials such as the Pneumovac trials in The Gambia; and cluster randomised controlled trials of seasonal malaria chemoprophylaxis in West Africa.

The Child Health Intervention for Developmental Outcomes (CHIDO) trial in Zimbabwe explored early childhood development, parenting, economic resilience, retention in HIV care, and care outcomes among HIV-exposed and infected infants aged 0-2 years.

LSHTM has numerous projects in the area of early child development. The Sustainable Program Incorporating Nutrition and Games (SPRING) trial is a recently completed seven-year research programme funded by the Wellcome Trust that brought together researchers from the UK, India and Pakistan. Every Newborn – Simplified Measurement Integrating Longitudinal Neurodevelopment & Growth (EN–SMILING) extends other EN–BIRTH research to include metrics for child development and promotes early identification of adverse developmental outcomes. Building on this, Every Newborn – Reach up Early Education intervention for All Children (EN–REACH) is a randomised trial of 150 clusters in three countries evaluating a preschool readiness package.

Sexual and reproductive health

Sexual and reproductive health (SRH) is a long-standing focus area for LSHTM with trials of multi-faceted approaches and covering different areas of SRH and in different settings, including health facilities, schools and other community-based settings in the UK and internationally.  

A major area is sexual health promotion: Examples include a whole-school social marketing intervention to promote sexual health among secondary school students (the Positive Choices Trial) and the use of mhealth technologies such as text messages to promote safer sex, provide support and information to prevent unplanned pregnancies in the UK (safetxt), and a trial to promote uptake and continuation of contraception use among women in Bangladesh. Seminal trials are focusing on menstrual health, a hugely neglected issue.  The MENISCUS trial is evaluating the impact of a multi-component menstrual health intervention in Ugandan secondary schools on girls’ education, health and wellbeing.  

HIV prevention 

LSHTM has a well-established track-record of highly impactful work on HIV prevention with trials of biomedical, social and structural interventions. Examples of ongoing trials include: 

  • A trial evaluating demand for HIV pre-exposure prophylaxis (PREP) in Uganda and South Africa and an HIV prophylactic vaccine trial in Uganda 
  • A trial of differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers as part of the AMETHIST consortium in Zimbabwe. 

Sexually transmitted infections 

LSHTM is a world-leader in research on sexually transmitted infections (STIs) and is a WHO collaborating Centre for STIs. The STI Research Interest Group at LSHTM promotes and disseminates research, facilitates cross-disciplinary and cross-faculty research work on STIs and HIV and facilitates internal and external collaborations.  LSHTM has been involved in policy-changing studies of the human papillomavirus (HPV) vaccine. 

Major trials include: 

  • a cluster randomised controlled trial investigating the impact of point-of-care testing and treatment of STIs in antenatal care on birth outcomes in Papua New Guinea 
  • the IMPROVE trial focusing on preventive therapy for malaria combined with azithromycin for prevention of STIs 
  • a trial in Zambia is investigating self-sampling for schistosomiasis as well as other genital tract infections 
  • the STICH trial investigating the impact of community-based screening for STIs among youth on population-level prevalence. The STICH trial is embedded in a larger trial (CHIEDZA) which is investigating the provision of a comprehensive package of SRH services with integrated HIV services.
Trial design
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Trial design

baby on mother's knee with doctor and papers

For LSHTM staff and research partners seeking help in any aspect of planning, design, implementation or analysis of a trial, please contact us at trialsnetwork@lshtm.ac.uk and we will link you up with an appropriate expert.

LSHTM also offers training that supports the delivery of high-quality clinical trials, including:

Patient and Public Involvement and Engagement

LSHTM is committed to including patients, the public, carers and community groups in a meaningful way in its clinical trials.

We believe that it is not just the right thing to do, but that trial design, conduct and dissemination strongly benefit from including these voices. These activities are variously described as:

  • patient and public involvement and engagement (PPIE)
  • community engagement
  • participatory research.

These activities help ensure that trials address research questions that are important and relevant to those most affected. They also help ensure that the way the trial is conducted is equitable and ethical, to ensure that the relevant information is given to potential participants so they can make an informed decision, and to help ensure that the trial population is diverse and representative.

These processes help ensure that the outcomes are not merely academically or clinically interesting but are meaningful to patients and the public.

Community engagement 

LSHTM has been involved in a range of innovative community engagement activities. These include the Youth Research Academy in Zimbabwe which trains researchers aged 18-24 years on the concept and purpose of research and on the research process (from planning qualitative and quantitative research questions to data collection, analysis and dissemination). Following a two-week residential training, youth researchers are offered the opportunity to carry out supervised research, often nested within an ongoing trial, working with a dedicated mentor alongside a highly experienced research team. 

The DEPTH research group has conducted numerous studies to understand the implications and effects of community involvement and dialogue in promoting health, planning health services, and quality improvement of existing services. 

Methodology

Our statisticians, trialists and health economists guide the design, feasibility, conduct, analysis and reporting of studies and we have strong links with the Centre for Statistical Methodology.

Our team are specialists in:

  • trial design
  • trial conduct
  • statistical analyses
  • statistical monitoring
  • health economic evaluation
  • cost-effectiveness modelling
  • report writing and publication
  • dissemination of trial results.

We have expertise in the development of statistical and trial methodology, analysis and interpretation of large-scale trials as well as providing educational resources for the explanation and implementation of these key concepts in clinical trials. This methodological and educational work is undertaken to directly improve current and future clinical trials.

We are also skilled in using statistical methods to monitor trial data as it is collected. This is an efficient and cost-effective way to ensure data quality, patient safety and trial integrity. Statistical methods are used to highlight errors and omissions, detect outliers, check for low variance to identify unusual correlations that may suggest scientific misconduct or improper data collection. By identifying which trial sites require on-site monitoring and source data verification, support can be focused where it is most needed, reducing the environmental impact and cost of travel.

We have special expertise in the design and analysis of cluster-randomised trials and stepped wedge trials. These trials, in which groups of individuals are randomly allocated to different study arms, are often used to evaluate the effects of community-wide interventions, or to capture the indirect effects of interventions provided to a large proportion of a population. Such trials require special methods of design and analysis because data from individuals in the same cluster are generally correlated. We have been closely involved in the conception, design, conduct and analysis of many such trials in both low- and middle-income and high- income settings. We have carried out methodological work on the design and analysis of such trials with a particular focus on statistical methods for trials with a small number of clusters and for stepped wedge trials.

Health economics

When designing a trial to test the effects of an intervention it is always worth considering whether a health economic evaluation should also be completed as part of the trial.  Although it is tempting to think that issues of cost-effectiveness need only be addressed once a successful clinical trial has been performed, this is to be avoided where at all possible as the same issues, and more, that are relevant to estimating effectiveness also apply when estimating cost-effectiveness.

Health economic support for trials run by the Clinical Trials Unit (CTU) is provided by a team of LSHTM health economists as part of the Global Health Economics (GHECO) Centre.  Anyone planning a trial should consider whether including a health economic assessment is appropriate.  Experts within GHECO are happy to discuss the options around including a health economic assessment with prospective principal investigators and study teams and encourage a conversation at an early stage before the trial design phase is completed.

Please contact: globalhealtheconomics@lshtm.ac.uk   

Trials governance

Research governance, integrity and ethics

While all research must adhere to principles of ethics and good governance, the standards and rigour applied to clinical and randomised controlled trials are particularly stringent. LSHTM’s Research Governance and Integrity Office is responsibility for research governance, integrity and ethics, and trials must also adhere to the requirements of the trial sponsor. 

Research governance covers a broad range of regulations, principles and standards of good practice that exist to achieve, and continuously improve, research quality across all aspects of healthcare in the UK and worldwide. It applies to any health-related research which involves humans, their tissue and/or data.

The Research Governance and Integrity Office supports and promotes high quality research, compliance with regulations and guidelines, provides research SOPs and training opportunities, as well as conducting audits and investigations into allegations of research misconduct.

All research involving staff or students must be appropriately referred to and approved by one of the LSHTM Research Ethics Committees. All clinical trials conducted by LSHTM must follow ICH Good Clinical Practice and the Good Research Practice Policy.

Also, all researchers using human material should comply with LSHTM’s policy on the Human Tissue Act (2006). 

Updates
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Updates List
Practical Issues in Trials Seminar recording

The first in a series of seminars on Practical Issues in Trials took place on Tuesday 6 February 2024, attended by over 130 participants. The theme was Public and Patient Involvement and Engagement and Community Involvement. Professor Cari Free, Dr. Armel Zemsi and Dr. Eugene Ruzagira shared examples based on their experience of running trials in the UK, The Gambia and Uganda. 

The recording is now available to watch.

The second seminar on Starting a Trial / logistics will run from 12pm-1pm GMT on Tuesday 16 April (not 9 April as previously advertised)Joining details will be posted soon.

London CTU visit to MRC/UVRI & LSHTM Uganda Research Unit
CTU visit MRC Uganda

The Directors of the London-based LSHTM Clinical Trials Unit (CTU) were hosted by colleagues at MRC/UVRI & LSHTM Uganda Research Unit from 6-9 February 2024. The purpose of the visit was to strengthen collaboration on randomized controlled trials.   Dr. Eugene Ruzagira, Senior Scientist, and Geofrey Kimbugwe, Head of Research Governance, organised an extensive programme, including visits to long-standing research sites in Kyamulibwa and Masaka and a tour of the Entebbe hospital, labs, biobank and clinical research facility.  During their visit, Prof. Cari Free, Dr. Charles Opondo and Dr. Shirine Voller from the London CTU met staff and students working on a range of clinical trials and discussed challenges facing each unit and opportunities to work together.  

Ideas which will be progressed include: running a second LSHTM Trials Day in November 2024 in Entebbe and online, linking up trial managers and data managers for reciprocal review of trial documentation and exchange of experience, and collaborating on grant applications for capacity strengthening in trials. During the week, the group, together with CTU colleagues in The Gambia, also hosted the first in a series of seminars on Practical Issues in Trials, with over 130 participants dialling in. The second seminar in the series is on 16 April. 

The MRC/UVRI & LSHTM Uganda Research Unit is keen to collaborate with LSHTM scientists and external partners on new clinical trials, leveraging their extensive clinical and laboratory facilities and experience in infectious diseases, non-communicable diseases and social science. The Kyamulibwa Population Cohort, for example, has been running since the late 1980s and comprises 25,000 individuals, while Masaka and Entebbe - including the new Clinical Research Facility - each offer excellent facilities and capacity. 

Practical Issues in Trials online seminar series

The Trials Network is running a series of six seminars through 2024 on Practical Issues in Clinical Trials.  The seminars are open to all and will be run as online webinars.

The seminar series will feature speakers from across LSHTM and our research partners.  Each seminar will include a brief overview of current practice, theory and evidence, followed by worked examples from different presenters.

In the first seminar, Professor Caroline Free, co-director of the LSHTM Clinical Trials Unit, Dr Armel Zemsi, Head of the Clinical Trials Unit at the MRC Unit The Gambia at LSHTM and colleagues from the MRC/UVRI & LSHTM Uganda Research Unit will present on the state of current evidence and practice around patient and community involvement in research, and share concrete examples from their respective regions in order to provide an overview on what works and the lessons learned.

Future seminars in the series:

  • 9 April 2024 : Starting a trial/logistics
  • 4 June 2024 : Running a trial - Part 1: Protocol compliance, monitoring
  • 3 September 2024: Running a trial - Part 2: Recruitment and follow up
  • 5 November 2024: Running a trial - Part 3: Data and Safety Monitoring Board (DSMB) options
  • 28 January 2025: Closing down a trial and dissemination: Publication, including PPI in dissemination, media.
     
LSHTM event
Inaugural Trials Day

The inaugural LSHTM Trials Day took place successfully on 6 November 2023 with 120 people attending the event in person and online. The event was very productive enabling participants to meet other trialists, share ideas and benefit from learning about the range of randomised controlled trials across LSHTM.

There was a packed agenda covering many aspects of trials, including high impact trials portfolios and current trials in a range of areas: infectious diseases, non-communicable diseases, social and behavioural studies and trials methodology. Representatives from the MRC Unit The Gambia and MRC LSHTM Uganda Research Unit shared their experience of practical issues in running trials, LSHTM’s new professor of health economics, Luke Vale, discussed when and how to incorporate health economics into trial design and delivery, and Professor Andrew Farmer from the NIHR Health Technology Assessment Programme and Dr Caroline Harris from the MRC discussed the current and future funding landscape for trials.

Find out about the Trials Network research outputs and see some of the presentations from the day:

High impact trials:


Infectious diseases, non-communicable diseases, trials methodology:


Practical issues in trials:


Social and behavioural, other:

 

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Trials Network at EDCTP

The Eleventh European & Developing Countries Clinical Trials Partnership (EDCTP) Forum is taking place in Paris, France from 7-10 November 2023. Several members of the Trials Network are attending and delivering presentations including:

  • 10:45 – 12:30 h, 10 November, Parallel session: Capacity strengthening

    ‘Creating a whole that is more than the sum of its parts: an emerging collaboration between clinical trial units in the UK, West and East Africa’

    Armel Zemsi, Head of MRC Unit The Gambia CTU

The EDCTP Forum is a biennial event providing a international platform to share research with representatives from across the scientific community.

See the programme for more details.

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AMBITION-cm wins 2023 European Hector Research Award in HIV

The AMBITION-cm study has won the 2023 European AIDS Clinical Society's European Hector Research Award in HIV for the best clinical and/or epidemiological paper in HIV research. The award was presented for the team's paper published in the New England Journal of Medicine:

AMBITION-cm  was the world’s largest clinical trial of treatment for HIV-associated cryptococcal meningitis. The phase 3 randomised, controlled, noninferiority trial was conducted in five African countries and recruited over 800 participants. The trial showed that a single, high-dose of liposomal amphotericin B was as good as the WHO recommended standard of treatment of a week-long course of amphotericin B deoxycholate and flucytosine. The results led to WHO updating its guidelines to recommend this simpler and safer treatment. 

logo with writing AMBITION-cm, ambisome therapy optimisation
LSHTM Trials Day

The LSHTM Trials Network is hosting an inaugural Trials Day as a hybrid event at Mary Ward House on Monday 6 November 2023. The day will showcase a selection of LSHTM’s vast experience and innovation in randomised controlled trials. The agenda includes short presentations on topical issues in trials, invited speakers, a funder panel, and a session on innovations in trial methodology and practice. See the agenda (pdf).

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