By designing site-centric trials, sponsors can ensure their clinical trials also become patient-centric, said an expert at a conference.
It is vital for sponsors to reduce the burden on the site if they also want to lessen the strain on patients, said Shantheri Pai, associate director clinical operations for oncology at Gilead while presenting at the Outsourcing in Clinical Trials West Coast conference, taking place in San Francisco.
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“It goes hand in hand,” Pai explained. “We need to make sure that site feedback is incorporated into future studies. We can’t just hear feedback, we need to be actively listening and executing. While we must also be transparent that we may not be able to incorporate 100% of that feedback right away, the feedback should be considered for future process and trial design improvements”.
Pai shared several ways that sponsors can plan more site-centric studies; like improving collaboration with sites, ensuring streamlined communication, and providing better estimates for supply built into forecasts.
Sites are often burdened and overwhelmed with the number of studies they are running, she said. For example, Pai shared that the MD Anderson Cancer Center currently has 1,413 active oncology studies. As a result, sponsors must make all information easy to understand for sites.
“Keep [the information] on one page and make clear, bulleted points that are relatable to the site. Sponsors don’t need to tell them what kind of data cleaning they are doing, sites just want to know the date their last query can be raised, the date that data entry will be cut off, and when they will receive the snapshot. They don’t need to know too many details – it’s overwhelming,” Pai explains.
Reducing the burden on a site, in turn reduces the burden on patients, Pai went on to explain.
For example, sponsors need to ensure drug and kit supplies are in order before they get to the patient to avoid delays.
Another important consideration, Pai said, is to ensure a sponsor is clear with sites on which patients would qualify for trials from the very start when feasibility is considered. “If you do not drill down to the core of the inclusion and exclusion criteria, the projections you make will be skewed, because after you get to the bottom of it, you’ll realise that only a small portion of the population they mentioned actually qualify for the trial,” Pai adds.
By making sure this is clear from the outset, it can reduce burden on sites and sponsors, Pai concluded. The Outsourcing in Clinical Trials West Coast conference is organized by Arena International, a part of GlobalData, which is also the parent company of Clinical Trials Arena.
Note: The views and quotes presented are those of the speaker and do not necessarily represent the views of the speaker’s employer.
