Efficient management of a CTIMP requires systems to track the supply of the study medication from the manufacturing pharmacy to study sites and by the site to study participants. The system also needs to account for used and unused medication, including medication returned by participants. Medication may be returned because it has expired or because a participant fails to complete the course as intended.

Some CTUs work primarily in collaboration with the pharmaceutical industry and use distribution companies and systems provided by those companies. Applied, investigator-led studies of IMPs, for example investigating head-to-head comparisons or more cost-effective dosing regimens, do not usually have access to such systems. Some CTUs have developed in-house systems while others use less sophisticated methods, largely relying on spreadsheets.

The aim of this collaborative project is, first, to scope the CTUs’ requirements for a system to manage the IMP efficiently and, second, to develop a secure web-based application to meet these requirements in CTU-managed CTIMPs. The application would allow for efficient CTU monitoring of the IMP prescribing and use that currently is often only captured at study sites. The system will be made available to other CTUs at a nominal cost (covering maintenance of the application and help to users).

 

OMACS 

The OMACS study aims to follow-up all cardiac surgery patients who consent study in order to estimate, for example, the proportion of cardiac surgery patients experiencing a Major Adverse Cardiac Event (MACE) such as a heart attack or a stroke. These data will allow audit of cardiac surgery services and, with respect to research, provide high quality data to inform the design of future studies, e.g. the characteristics of patients having cardiac surgery, the frequencies of complications after surgery and patients’ longer term outcomes.
 
Due to the large target population, and long term nature of OMACS, we are embedding a number of sub-studies or ‘studies within a trial’ (SWAT). The first will examine different presentation styles and formats of the paper information leaflets (PILs) provided to potential participants. We will survey participants’ preferences and test whether the different formats affect the consent rate to the study. Potential participants will have an equal chance of receiving the information in three different formats, one of which is used routinely, the other two representing new styles. The content of each format will be the same. Participants will not be informed about this nested study. 
 
This SWAT has now closed, and the results will be used to inform the format of the PIL used for OMACs and other studies in our portfolio.

Both of the PhD students are supported by the Conduct II Hub 

Rachel Maishman - Outcomes in RCTs: assessment, reporting and integration in decision-making

'Assessing recovery after surgery in clinical trials is important when comparing different treatments. We need to develop an outcome measure whose component parts represent different aspects of recovery and can be measured without bias. This is important in surgical trials where the surgical team often need to know which treatment group trial patients are in. The aim of my PhD is to develop an outcome that can be used to assess recovery that will take into account information about the complications that patient’s experienced during their post-operative stay as well as other routinely collected data about their health status during their stay.'

Sia Gravani - Improving feasibility study designs and trial conduct to enhance trial quality and results

'The main aim of my PhD was to investigate ways in which trial-specific training is provided during site initiation and explore trial managers’ and site staff views on the importance of trial-specific training during study conduct (the ATLAS study). Based on the findings of ATLAS, a more standardised approach in the form of a training toolkit was developed that can be utilised by trial management teams when planning staff training within clinical trials.'