Site-centricity: Recognizing sites as a key stakeholder in the clinical trial
The Society for Clinical Research Sites (SCRS) at the 2018 Global Site Solutions Summit presented the SCRS Eagle Award.
The award recognizes a contract research organization (CRO) and sponsor that “exemplifies a site-focused approach to clinical trial management.”
SCRS member and non-member sites vote for the winners.
To learn more, Outsourcing-Pharma (OSP) caught up with Clare Grace (CG), vice president of site and patient access at Syneos Health, which was the winning CRO of the 2018 SCRS Eagle Award.
OSP: What are some of the main challenges facing relationships between sites and CROs? How are these challenges different – or the same – between sites and sponsors?
CG: Some of the challenges are the same – for example, payment issues and ensuring sites are paid in a reasonable timeframe and don’t have to devote time and resources to tracking their money down.
Clinical trial protocols are becoming increasingly complex but the biggest change compared to just one or two years ago is how segmented patient populations are becoming with the increase in personalized medicine and targeted therapies. We are having to recruit much smaller slices of the patient population and this is having a massive impact on sites when they find they can’t recruit enough volume to recoup their costs.
The other big change we are in the midst of now is the evolution toward virtual trials or “site-less” trials, or what we at Syneos Health call “connected trials” – trials that incorporate technologies like remote data collection, virtual visits and telehealth components. These technologies require people to work in a different way, which is compounded when every sponsor and CRO has its own package of technologies for sites to use.
Even the increasing use of home visits by a nurse for data collection can be problematic for many principal investigators, who worry it distances them from the patient and limits their ability to observe things like gait, pallor or breathing pattern that might indicate a safety issue and not be reported otherwise.
Sponsors and sites both face these challenges, but from different perspectives. That is why it is important for sponsors and sites to evaluate these challenges together. It’s unacceptable to design and roll-out something – an e-consent process, for example – that may work from a sponsor perspective but not include sites in that process.
OSP: What are some of the steps CROs can take to support positive site relationships?
CG: Collaboration with sites is key.
Organizations need to be structured to enable different levels of communication with sites and have feedback mechanisms in place so that issues both large and small – from protocol design to payment and everything in between – can be surfaced at the appropriate level and responded to efficiently and enable continuous process improvement.
OSP: How would you define term "site centricity"?
CG: To me this means that sites are recognized throughout the sponsor organization and/or CRO as a key stakeholder in the clinical trial.
We’ve come a long way toward improving patient-centricity and engagement, but the same principles need to be applied with regard to site relationships and prioritizing their needs as a key stakeholder in the process.
OSP: What are some examples of the site-centric approach in practice?
CG: One way that Syneos Health puts site-centricity into action is through Site Advocacy Groups, which we launched in conjunction with SCRS. Through these groups, we’re able to listen to site feedback to streamline and facilitate payment processes, review protocols from both an operational and a scientific perspective and to engage sites in reviewing the protocols as well.
We’ve not only received tremendous feedback through this process, but it instills collaboration with sites from the beginning and sets the stage for ongoing dialogue and process improvement.
We have also completely restructured how we pay sites so that they can be paid on a 30-day basis instead of the 90-day industry standard. It doesn’t end up costing us any more as an organization but putting effort toward something like this demonstrates that you’re willing to go the extra mile to offer a benefit to sites.
There are lots of other things we do whenever we can. For example, we realized we have social listening capabilities and data that could be very useful to sites to help understand the target patient population and aid in recruitment and retention. We actively look to add value wherever we can.
Trials & Tribulations is a column dedicated to exploring the key trends and challenges facing clinical trials and the greater contract research and manufacturing industry. Have a challenge you are trying to solve? Email me at Melissa.Fassbender@wrbm.com.
