The Tropical Clinical Trials Unit (TCTU) is a specialist unit that is being set up with a specific remit to design, conduct, analyse and publish clinical trials in resource poor settings. It has the capability to provide specialist expert statistical, epidemiological and other methodological advice and coordination to undertake successful clinical trials in these settings benefiting from LSTM’s unique experience in this field.
The TCTU ensures that robust systems are established which guarantee that the conduct and the delivery of clinical trials in resource poor settings are of the highest quality standards.
The unit advises on all aspects of study, including trial registration, method and results reporting as well as funding issues. In close conjunction with LSTM’s research office it provides assistance and guidance in the following areas:
- Study design (standard study designs / cluster random-isation; step wedge; adaptive designs and stratified medicine).
- Trial management, particularly overseas and multi-site
- Data management / sharing / analysis / interpretation
- Research Governance / Governance Oversight / GCP
- Support in writing scientific papers / reports (including those to donors and funders)
- Standard Operating Procedures for effective management and safety of clinical trials in resource poor settings.
LSTM has signed up to the AllTrials campaign. This campaign was set up in 2013 and is now supported by thousands of individual patients, practitioners and researchers as well as over 500 organisations. It states that trials with negative results are twice as likely to remain unreported as those with positive results, which means that those people making medical decisions are not aware of all the information relating to treatments that are used every day.