By Ann Neuer
August 4, 2008 | Allon Therapeutics Inc., a development stage biotech company out of Vancouver, recently released results of its Phase IIa study of AL-108, an investigational Alzheimer’s treatment, just seven weeks after the final patient visit. How did they do it?
 |
| Karole Sutherland |
According to Karole Sutherland, vice president clinical operations, the quick turnaround was the result of a strong collaboration among Allon;
Ockham Development Group, a contract research organization (CRO); and
Nextrials, maker of Prism, an integrated electronic data capture (EDC) and clinical trial management solution. “The overarching theme is that all parties were able to collaborate – the technology alone doesn’t do it. There had to be a plan in order to take advantage of the capabilities that EDC offers, otherwise you aren’t going to get anything out of it,” she comments.
Sutherland describes a highly organized process in which all parties were dedicated to reaching milestones through clearly defined roles and accountability. This included clinical research associates (CRAs), the project manager, and data managers. “Once we reached about 60 percent enrollment, we met—Nextrials, Ockham, and Allon—and we created a plan for how we would proceed. We mapped out all of the tasks involved in closing the study out, and in closing the database. We checked everybody’s assumptions,” Sutherland says.
 |
| Lecia Shaffer |
Lecia Shaffer, co-founder and vice president, operations and clinical services, for Nextrials and acting project manager with Allon, agrees that the ability to turn out results so quickly was directly linked to the quality people involved, coupled with the ability of Prism to generate clean data. As Shaffer explains, Prism creates many reports such as data quality, query management, and monitoring. “Allon relied on the query report, for example, to see in real time which sites have queries, and as we got toward the end, they looked to the monitoring report, which breaks down every site and patient, and indicates what percentage of patients have been monitored and still need to be monitored,” she notes.
By linking technology with a carefully orchestrated process, Allon was able to lock the database within two weeks of last patient-last visit. Going forward, Sutherland says that she now expects to lock a database within this timeframe, and won’t accept anything longer.
It is important to point out that Allon’s Phase IIa study was small—only 16 sites—all in the United States, so the question becomes: Was this rapid turnaround a function of the small size of the trial?
“Perhaps to some degree,” says Sutherland, “but it’s about having a plan that is very scalable.” Shaffer agrees and adds that whereas Prism is scalable, there are logistical differences between a 16-site study in one country and a global trial with hundreds of sites. Yet, there can be rapid and excellent results when all parties are proactive and engage in detailed planning. For example, Nextrials has recently locked the database for a complex oncology study for prostate cancer involving 238 international sites and 953 enrolled subjects. Using a combination of thoughtful planning and Prism, the company was able to lock the database five weeks after the last patient visit, with the final dataset delivered to the sponsor the next day.
“Within a week and a half, the PIs [principal investigators] signed off on 900 patients, something that would be inconceivable in the paper world. You proactively program tables and listings, and Prism provides nightly SAS transport files, so you see the data all along and users are in a very good position once the last PI sign off happens,” Shaffer explains.
________________________________
This story first appeared in eCliniqua,one of Bio-IT World’s free e-newsletters. Subscribe here.