Home - Tagged as 'clinical'

Fast tracking informative clinical trials: lessons for mental health

The 5 Principles To Guide The Future Of Randomized Clinical Trials

Enabling "Good" Clinical Research In LMICs With The Good Clinical Trials Collaborative

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.

Development of an online resource for recruitment research in clinical trials to organise and map current literature

Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice. 

INTERGROWTH-21st Fetal Growth Standards

Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.

Clinical Research Careers: an Indian Perspective

Shared panel discussion conducted about clinical research careers in India (conducted in Telugu and English), and article about research careers in India from Sreedhar Tirunagari

INTERGROWTH-21st Newborn Size at Birth Chart

Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact intergrowth21st@tghn.org.  

GCP-compliant data management in multinational clinical trials.

Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.

Clinical Data Management: Current status, challenges and future directions from industry perspectives.

Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

This publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.

Challenges of non-commercial multi-centre North-South collaborative clinical trials

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.

Ethical criteria in clinical research in developing countries: is there a global standard?

This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.

Guidelines for Clinical Trial Registration

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.