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Adding to IMPACT

Professor Liesbeth de Vries and Dr. Frederike Bensch of University Medical Center Groningen (The Netherlands) describe how the TraIT team is helping them to conduct a large-scale multi-centre clinical study aimed at improving cancer therapy selection.

Putting together a project proposal for innovative medical research takes a great deal of time and effort, but if you’re fortunate enough to get your project approved and funded, being able to concentrate on the science makes it all worthwhile. But what if your project is a large-scale clinical study on several hundred patients? If it is, you’ll have to devote a significant amount of time to administrative tasks, like managing the workflow so that the right data is seen by the right people at the right time. And the more time you spend on administration, the less time you have for the research.

Prof Liesbeth de Vries

When Liesbeth de Vries, Professor of Medical Oncology at University Medical Center Groningen, together with colleagues at Radboud UMC Nijmegen and VUmc Amsterdam, put together a grant application for a large clinical study on breast, colon and renal cancers using novel PET imaging tracers, she knew that the consortium had an extra tool in its armoury – the TraIT platform – to facilitate the necessary data collection, data analysis and workflow administration processes.

Creating a seamless user-interface
Liesbeth believes that the TraIT platform’s strength is not just the tool set that it offers. After all, many of them, such as OpenClinica, are open-source ‘free-to-use’ applications. Instead, she says TraIT’s greatest strength is the availability of a support team that can integrate these tools into a seamless flexible user interface that enhances project workflows, accelerates results and improves reporting.

“The breast cancer part of the IMPACT study involves 200 patients, each of them undergoing four PET scans during diagnosis and treatment in addition to their normal therapy, and each PET scan needs to be reviewed by different clinicians in different hospitals,” says Liesbeth. “In the past, we would have had to physically mail CD ROMs containing the PET scan images to all those involved.”

Now however, the process is much simpler. By creating appropriate links between OpenClinica and the National Bio-Medical Imaging Archive (NBIA) – the TraIT team created a system that allows the clinicians to directly download the PET scans from the patient’s OpenClinica case record.

Eliminating bias
To improve the objectivity of the PET scan reviews, the TraIT team also helped to build the trial in OpenClinica in combination with a specific system of access rights that limits a reviewing clinician’s view of the case record to the immediate information needed to carry out the review.

“Normally if you access a case record in OpenClinica you can see everything, including any reports that other people have appended,” says study doctor Dr. Frederike Bensch. “Thanks to the TraIT team, we can now restrict a reviewing clinician’s view to only the information we want them to see, without all the information on the trial itself or the history. Only at the end of the review process are they allowed to see all the reports so that they can discuss the results.”

Enhancing workflow management
To reduce the back-office administration involved in keeping everyone informed about what needs to be done and when, the TraIT team also integrated the Ldot research workflow management / logistics tool into the system.

“The IMPACT study has quite a complex workflow, involving many different people, such as local centre coordinators, data managers, clinicians and researchers, who need to enter data, upload the PET scans, review them or oversee the process. Up until recently we had to manually send emails to the people involved, which was very time consuming,” says Frederike. “Very soon now, Ldot will do this in an automated way, via triggers in the workflow that automatically inform the next person in the chain that something is ready for them to action. At the same time, it will give us a status of the review process in each centre.”

According to Professor de Vries, having solutions like Ldot to deal with the logistics may make it easier to get clinicians involved in research projects.

“Clinicians are often so overloaded that they worry about the extra workload of participating in clinical studies,” she says. “But thanks to TraIT, when it comes to organizing future studies the logistics will be taken care of, so it won’t be possible for it to be cited as a reason for not participating.”

Both Liesbeth and Frederike also agree that working with the TraIT team has been a very enjoyable and rewarding experience.

“Around twice a year we have a meeting of the entire IMPACT consortium to go over data procedures etc. and TraIT has always been represented there. They’ve always been extremely interested in what we are doing and highly innovative when it comes to providing solutions,” says Liesbeth. “It’s been an excellent working relationship, and I would recommend that anyone organizing a large data-centric multi-centre clinical study who thinks that things are not possible, should talk to the TraIT team first before making that assumption.”

*The ‘Towards patient tailored cancer treatment supported by molecular imaging IMPACT: IMaging PAtients for Cancer drug selecTion’ study is funded by the Dutch Cancer Society / Alpe d'HuZes

Back to newsletter December 2016