A Guide to Efficient Trial Management

by The Trial Manager's Network

This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)

13th May 2018 • comment

Are you interested in improving global public health? Are willing to live in Zambia for a year? Do you have a Master’s degree? The Centre for Infectious Disease Research in Zambia (CIDRZ) is the largest independent non-governmental healthcare and research organisation in Zambia. They conduct locally-relevant, leading-edge healthcare research, strengthen primary health care systems in multiple focus areas, and run a state-of-the-art medical and research diagnostic laboratory.

13th February 2018 • comment

The Nigerian Regional Faculty ran a workshop about Biostatistics on May 20th-21st, 2017. The workshop was well attended with 61 participants, and covered a useful range of topics. You can download the presentations from the day here.

26th May 2017 • comment

Do you have research ideas for using big data to fill gender data gaps? Announcing the Big Data for Gender Challenge! Research proposals are due on July 7, 2017

24th May 2017 • comment

Invitation to complete quick survey to improve Kaplan-Meier plots (KMunicate)  ProblemThe standard way to present time-to-event data, such as survival, is with Kaplan-Meier plots. These are formatted by journals and reported in a number of ways, but we find they commonly lack some key information. The key problems are:

  1. Expressing how many people are contributing data at any point in the graph, including the  pattern of censoring
  2. Expressing that the uncertainty of the estimate increases over time
  SuggestionWe have some initial suggestions on how to improve Kaplan-Meier plots, but we need your help to know which would be the most useful and most acceptable to a wide audience.

23rd May 2017 • comment

This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.

14th March 2017 • comment

This is a great video of a talk given at the Oxford Martin School by Professor Kevin Marsh.

10th March 2017 • comment

Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.

23rd December 2016 • comment

AREF is calling for researcher applications to participate in its 2nd Essential Grant Writing Skills Workshop, to be held in Dakar, Senegal, in May 2017.

19th December 2016 • comment

The following invitation to take part in trials methodology research comes from the Network of Hubs for Trials Methodology Research (HTMR) which was established by the UK Medical Research Council (MRC) to improve the quality of clinical trials.

14th December 2016 • comment

The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).

17th November 2016 • comment

Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.

24th October 2016 • comment

In this BMJ blog, Richard Smith discusses the challenges and process of getting research evidence into policy and practise

4th October 2016 • comment

This video seminar describes research to develop a low-cost, field-based test to detect several slow-clearing ACT drug compounds from unprocessed fingerstick blood samples

28th September 2016 • comment

Please see this Sky News interview where we were asked by Sky News to comment on the announcement about this bold vision to tackle all diseases.

26th September 2016 • comment

Today,The Global Health Network launches Mesh: a new online platform co-created by its users and aiming to improve Community Engagement with health in low and middle income countries.

20th September 2016 • comment

How the war in Syria is decimating human resources for health and health systems.

20th July 2016 • comment

The team interview panel members talking about the Novartis Access Initiative's work on NCDs.

20th July 2016 • comment

Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.

20th July 2016 • comment

This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate that there is scope for an individual participant-level database, to allow for standardised analyses.

28th June 2016 • comment

Professor Scheffler provided a conceptual framework that shows how pay for performance works in health, and discusses the results of selected case studies.

20th June 2016 • comment

The European Mobile Laboratory, EMLab, was the first EBOV diagnostics unit deployed to the outbreak epicentre by WHO in March 2014.

14th June 2016 • comment

Obstetric fistula is an important global health issue that negatively affects the lives of countless women, and the team highlight what can be done to prevent and treat fistula.

31st May 2016 • comment

This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.

23rd March 2016 • comment

This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.

22nd March 2016 • comment

Travel Medicine and Infectious Diseases have evolved rapidly in recent decades as outbreaks such as SARS, Avian Influenza, Ebola, MERS, Chikungunya, and Zika virus have demonstrated how quickly infections can cross international borders.

18th March 2016 • comment

Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.

14th March 2016 • comment

Greg Martin talks about four areas of competencies needed to be effective in public health and global health. He places particular importance on management, leadership and governance.

22nd February 2016 • comment

The objective of the study was to develop maternal, fetal, and neonatal composite outcomes relevant to the evaluation of diet and lifestyle interventions in pregnancy by individual patient data (IPD) meta-analysis.A two-generational Delphi survey involving members of the i–WIP collaborative network (26 members in 11 countries) was undertaken to prioritise the individual outcomes for their importance in clinical care. The final components of the composite outcomes were identified using pre-specified criteria. The study has identified the components of maternal, fetal, and neonatal composite outcomes required for the assessment of diet and lifestyle interventions in pregnancy by IPD meta-analysis.

19th February 2016 • comment

The Zika virus is another wild card dealt to us by nature. It was first discovered in 1947.

17th February 2016 • comment

Video seminar by Chelsea McMullen, Operational Support Officer, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), presented at the University of Oxford, 21st October 2015

16th February 2016 • comment

Quality of care assessment is one of the ways of evaluating what the health system is providing, however, such monitoring depends on an ability to measure quality with the availability of high quality data.

11th February 2016 • comment

Malaria remains a major global health threat. In the last fifteen years there has been remarkable progress in reducing cases and deaths due to malaria.

14th January 2016 • comment

Deployed in April 2015, we have established proof-of-principle for real-time genomic surveillance by generating over 40 genome sequences in as little as 48 hours from obtaining a patient sample and feeding the information back to the Ebola central coordination team.

11th January 2016 • comment

This talk covers several research projects we are undertaking to assess the Electronic Health Record landscape in Kenya and current large-scale projects to roll out Open Source EHR systems to public hospitals.

23rd December 2015 • comment

Building on the concept of rapid learning health systems, Dr. Peek’s seminar focuses on the use of health information technology to address epidemiological and public health questions and to accelerate the translation of research findings to clinical practice.

22nd December 2015 • comment

From our colleagues at the African Society for Laboratory Medicine (ASLM) - The Role of Public Health Institutes in Achieving Public Health Goals

17th December 2015 • comment

Looking for a job in global health? A 4 part series that takes a look at what you need to do to get your career in global health off to a good start.

15th December 2015 • comment

Damalie Nakanjako (MBChB, MMED, PhD) is an internist whose work focuses on optimizing HIV treatment outcomes and reducing HIV-associated morbidity and mortality in sub-Saharan Africa.

14th December 2015 • comment

Twitter plays role in information distribution during emergencies, and it is widely used by public health organisations during public health crises.

11th December 2015 • comment

Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.

27th November 2015 • comment

Video of Professor Peter Horby, the University of Oxford, on how he and his team set up clinical trials in the heart of the Ebola outbreak.

26th November 2015 • comment

East African Leaders Join Together to Develop Country-Specific Plans for Point-of-Care Testing.

25th November 2015 • comment

Two great articles from the African Society for Laboratory Medicine looking at the increasing risk posed by antimicrobial resistance.

20th November 2015 • comment

New articles from the African Society for Laboratory Medicine (ASLM).

13th November 2015 • comment

Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.

19th October 2015 • comment

Difficulties in behaviour and communication are core problems in children with neurodevelopmental disorders, and often cause the most stress to parents and families living in resource poor areas of Africa.

19th October 2015 • comment

Randomised controlled trials are the gold standard of health research evidence. Tension often exists between people wanting to use a new intervention, and the scientists who are generating evidence through a controlled evaluation study. One way that has emerged to balance this is the stepped wedge randomised controlled trial design.

19th October 2015 • comment

Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.

22nd July 2015 • comment

The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.

21st July 2015 • comment

Schistosomiasis, is a chronic, debilitating disease. Uganda began a National Control Programme in 2003 with annual MDA of praziquantel. MDA on this scale provides strong selective pressures on the parasite population with an associated risk of drug resistance developing.

21st July 2015 • comment

Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh

16th June 2015 • comment

In this video of a seminar delivered at the University of Oxford in June 2014, Professor Nicholas White talks about the challenge of antimalarial resistance.

11th June 2015 • comment

Anders Björkman is Professor of Infectious Disease at the Karolinska Institute. In this video, Anders talks about how the efficacy of antimalarials is a major obstacle in the path towards full malaria elimination.

11th June 2015 • comment

Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.

5th June 2015 • comment

In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.

3rd June 2015 • comment

Dr Nat Segaren - Medical Director of the Caris Foundation, presents on 'The Haiti National Early Infant Diagnosis of HIV Program'

27th May 2015 • comment

New Public Management (public sector reforms which draw on business ideology) are increasingly seen in African ministries of health. This talk concentrates on the effects of NPM reform on Ethiopian hospitals and how efforts to be 'more business-like' have many unintended consequences for hospitals and patients.

15th May 2015 • comment

Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.

14th May 2015 • comment

In this seminar Professor Kevin Marsh describes how knowledge of immunity to malaria in humans has developed over the past thirty years and what impact this has for future research.

13th May 2015 • comment

Professor Mike English explains how KEMRI-Wellcome are ''working with government to generate patient level data from a network of Kenyan hospitals as a platform for research'.

12th May 2015 • comment

This article published in PLOS Medicine on April 14th, 2015 discusses how best to test Ebola treatment.

15th April 2015 • comment

Rigorous and transparent systematic reviews are recognized internationally as a credible source for evidence of effectiveness. However, in the field of nutrition, despite attempts at developing consensus on actions and interventions to reduce undernutrition and micronutrient deficiencies, there is lack of coordination among various groups. Each of these methodological choices influences the findings of the reviews, and lack of standardization across these domains increases the complexity for users of systematic reviews in interpreting results. There is a need to develop a consensus on methodologies for nutrition reviews, criteria for assessing the evidence and possibly facilitating development and collation of the evidence in the subject area.

14th April 2015 • comment

Managing clinical trials

by Barbara Farrell, Sara Kenyon, Haleema Shakur

Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.

25th March 2015 • comment

26 studies were reviewed to identify barriers and facilitators for Research Utilisation in nursing practice.

27th February 2015 • comment

The authors in this paper describe the development of a reporting guideline, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015). PRISMA-P consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review. Funders and those commissioning reviews might consider mandating the use of the checklist to facilitate the submission of relevant protocol information in funding applications. Similarly, peer reviewers and editors can use the guidance to gauge the completeness and transparency of a systematic review protocol submitted for publication in a journal or other medium.      

4th February 2015 • comment

Conclusion: After 3 months of implementing the nurses’ hypertension management educative interventions program, knowledge, skills, and attitudes regarding prevention, detection, risk assessment, patient education, and HBP management increased significantly. The pilot study demonstrated the feasibility of implementing a multimodal evidence-based educational intervention in a low resource environment.

2nd February 2015 • comment

The methodology of systematic reviews—although laid out three or more decades ago—is continuously and rapidly updated by scientists specializing in research synthesis. Now, Systematic Reviews is publishing a series of articles including methods and examples of accelerating approaches to conducting literature reviews.      

16th January 2015 • comment

WHO recommends daily co-trimoxazole for children born to HIV-infected mothers from 6 weeks of age until breastfeeding cessation and exclusion of HIV infection. We have previously reported on the effectiveness of continuation of co-trimoxazole prophylaxis up to age 2 years in these children. We assessed the protective efficacy and safety of prolonging co-trimoxazole prophylaxis until age 4 years in HIV-exposed children.

18th December 2014 • comment

Internet-based systems for epidemiological studies have advantages overtraditional approaches as they can potentially recruit and monitor a wider range of individuals in a relatively inexpensive fashion. We studied the association between communication strategies used for recruitment (offline, online, face-to-face) and follow-up participation in nine Internet-based cohorts: the Influenzanet network of platforms for influenza surveillance which includes seven cohorts in seven different European countries, the Italian birth cohort Ninfea and the New Zealand birth cohortELF. Follow-up participation varied from 43% to 89% depending on the ohort.Although there were heterogeneities among studies, participants who became aware of the study through an online communication campaign compared with those through traditional offline media seemed to have a lower follow-up participation in 8 out of 9 cohorts. There were no clear differences in participation between participants enrolled face-to-face and those enrolled through other offline strategies. An Internet-based campaign for Internet-based epidemiological studies seems to be less effective than an offline one in enrolling volunteers who keepparticipating in follow-up questionnaires. This suggests that even for Internet-based epidemiological studies an offline enrollment campaign would be helpful in order to achieve a higher participation proportion and limit the cohort attrition.

10th December 2014 • comment

Professor Peter Piot, LSHTM, talks about Ebola and implications for Africa and understanding future epidemics at the Martin School, University of Oxford, 16th October 2014.

17th October 2014 • comment

Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.

14th October 2014 • comment

When publishing observational research, what information should journals make available to the medical community before a result can be considered sufficiently reliable to inform patient care or health policy? The PLOS Medicine editors, in recent consultation with our editorial board, endorse measures in four areas to advance transparency in the analysis and reporting of observational studies.

1st September 2014 • comment

This extensive toolkit was developed by TDR, and explains how to conduct implementation research. This toolkit was designed to help people learn a standard process that would lead to results that could be compared across regions and countries. It is designed to help identify system bottlenecks and the stakeholders to be involved, formulate appropriate research questions, conduct the research and develop a plan for implementing the study results.

29th July 2014 • comment

On the 8th of July 2014 The Global Health Network launched the Global Health Research Process Map, the first digital toolkit designed to enable researchers anywhere in the world to conduct rigorous global health research.

22nd July 2014 • comment

This good practice document of the ESSENCE on Health Research initiative is designed to provide broad guidance on how best to strengthen research capacity with the maximum possible benefit. 

21st July 2014 • comment

A retrospective study of the health profile of neonates of mothers with anemia in pregnancy and pregnancy induced hypertension in Lagos, Nigeria

by Olusola Funmilayo Sotunde, Silifat Ajoke Sanni, Oluseye Olusegun Onabanjo, Ibiyemi O. Olayiwola, Mure Agbonlahor
14th July 2014 • comment

AuthorAid is a great online tool whose aim is to support developing country researchers in publishing their work.

1st July 2014 • comment

We have recently obtained permission to share some very interesting videos from Global Health Videos by Greg Martin. This video series covers issues relating to research methods and study designs in Global Health.

2nd June 2014 • comment

In this collection of papers researchers dismiss the Omran model as relevant to contemporary developing countries and suggest the foundation for a new framework better suited for guiding and understanding past and future epidemiological changes within these populations.

22nd May 2014 • comment

Musculo-skeletal disorder risk factors among nurses in low resource settings: a cross sectional case study in Uganda

by Ian Munabi, William Buwembo, David L Kitara, Joseph Ochieng, Erisa S Mwaka
10th April 2014 • comment

An introduction into and overview on the mathematics and practice of Bayesian (adaptive) clinical trials.

31st January 2014 • comment

The ESSENCE on Health Research initiative has created a good practice document on Planning, Monitoring and Evaluation Framework for Capacity Strengthening in Health Research.

31st January 2014 • comment

ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs. 

18th December 2013 • comment

This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.

2nd December 2013 • comment

The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.

1st January 2013 • comment

This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.

1st January 2013 • comment

Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon

by Nchangwi S Munung, Godfrey B Tangwa, Chi P Che, Laurent Vidal, Odile Ouwe-Missi-Oukem-Boyer

Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist's potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics.

15th August 2012 • comment
19th July 2012 • comment

Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.

25th May 2012 • comment
26th March 2012 • comment

This article explains the process of data management operations within clinical trials from start to finish.

17th January 2012 • comment

Ethical issues in human genomics research in developing countries

by Jantina de Vries, Susan J Bull, Ogobara Doumbo, Muntaser Ibrahim, Odile Mercereau-Puijalon, Dominic Kwiatkowski, Michael Parker

Genome-wide association studies (GWAS) provide a powerful means of identifying genetic variants that play a role in common diseases. Such studies present important ethical challenges. An increasing number of GWAS are taking place in lower income countries and there is a pressing need to identify the particular ethical challenges arising in such contexts. In this paper, we draw upon the experiences of the MalariaGEN Consortium to identify specific ethical issues raised by such research in Africa, Asia and Oceania.

11th July 2011 • comment

We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.

27th May 2011 • comment

During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.

13th May 2011 • comment

An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings

24th January 2011 • comment

A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.

29th November 2010 • comment

This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.

5th November 2010 • comment

An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.

1st November 2010 • comment

This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview

26th October 2010 • comment

This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish

24th August 2010 • comment

The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH

10th August 2010 • comment

What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.

2nd February 2010 • comment

Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.

21st November 2009 • comment

Considerations for pharmacovigilance and safety reporting.

21st November 2009 • comment

Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.

21st November 2009 • comment

The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.

21st November 2009 • comment

The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.

21st November 2009 • comment

What is the definition of a clinical trial? Is there an international consensus? Read on to find out.

21st November 2009 • comment

Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.

21st November 2009 • comment

Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.

21st November 2009 • comment

From concept protocol through to the final approved version, it is important to have input from a variety of stakeholders to ensure a successful trial.

19th November 2009 • comment