Managing clinical trials at the click of a mouse


Bordering a sprawling Toronto ravine, the stately, tree-lined campus of Sunnybrook and Women’s College Health Sciences Centre gives an impression of tranquility that belies the intense activity inside the buildings.

The hospital is home to almost 200 cancer clinical trials alone. Processing medical data for the thousands of patients on these trials is daunting. So is keeping track of reams of administrative data, such as ethics approvals, patient consents, budgets, expenditures and patient visits.

“We have so many studies going on, with a variety of sponsors. Every contract is a bit different so just staying on top of the funding is fairly labour-intensive,” says Kathie Roche, Manager of Clinical Trials and Epidemiology at Toronto Sunnybrook Regional Cancer Centre.

Across Ontario, hospitals have their own particular methods of managing cancer clinical trials. Data is sometimes kept in multiple databases and, at times, binders, notebooks and even recipe cards, according to a survey of 23 trial sites conducted by the Ontario Cancer Research Network (OCRN).

“Hospitals have been doing their best to cope with the huge administrative burden of cancer clinical trials,” says Janet Manzo, Director of the OCRN’s Clinical Trials Network.”But our survey found that the vast majority of hospitals are not really satisfied with the tools they are using.”

So the OCRN is setting out to dramatically improve the situation. Early this year, the organization will usher in a new and more efficient approach to managing cancer clinical trials in the province.

It’s called Clinical Trials Management System (CTMS), a unique software which assists with non-medical trials data and is already used in 5,000 centres across the U.S. After seeing it in action, the OCRN was so impressed that it purchased the package and brought it to Canada. “We believe this system will advance the management of clinical trials, saving hospitals time and money,” says Manzo.

The Toronto Sunnybrook Regional Cancer Centre (TSRCC) is one of the pilot sites, along with Toronto’s Princess Margaret Hospital. Until now, TSRCC has kept all non-patient trial data in several different – and not necessarily interconnected – databases. Now, the new software is being used on two colorectal cancer trials.

“The idea is that the software will consolidate information into one database so that you can simplify the process and extract information when you need it, quickly and efficiently,” says Roche. “This will hopefully reduce the amount of time staff spend working on finances and ensure cost recovery in a timely manner.”

Consider some of the potential benefits: faster start-up times for trials; fewer errors by reducing paperwork; better and faster tracking of study payments; more responsive reporting to sponsors and administrators; and an increase in the number of clinical trials that sites can manage.

“This is an amazingly versatile software that allows users to do everything from tracking regulatory documents and patient activities to preparing budgets and generating reports often at the click of a mouse,” says Manzo of the OCRN.

The timing couldn’t be better. Regulations and guidelines governing clinical trials are changing a lot and making it even more complex to manage trials, Manzo notes.

Not only does the software keep track of ongoing trials, it helps with planning future ones. “The software should assist with budget-building by helping people quickly figure out exactly what it costs to do a study,” Roche adds.

Early this year, the OCRN will make this information technology available at no cost to up to 25 centres conducting cancer clinical trials in Ontario. The centres will access the software through the web (but each site will see only its own data). Cancer Care Ontario will host the server.

After a year, the centres will be able to continue using the new management system at a nominal cost – dramatically cutting down on the flurry of paperwork and the time-consuming paper chase that now accompanies clinical trials.

“It’s certainly an innovative new approach,” says Manzo. “There will definitely be a learning curve, but the benefits are compelling.”

The clinical trials management software is designed by the U.S. firm, Advanced Clinical Software (ACS). The system does not collect or process trial subject data.

OCRN is a not-for-profit corporation working to accelerate the development and testing of new cancer therapies in Ontario and bring innovative treatments to patients sooner. OCRN is funded by the Ontario Ministry of Economic Development and Trade.

Margaret Polanyi is a Toronto-based freelance writer. She can be reached at416 651 2446, or