Blog
Through obstacles and beyond: the value of building site relationships
Evaluating the lessons learned about trial sites from COVID-19 to form new strategies and improve patient safety for the future.
Mark Brown, Vice-President, Global Patient and Site Services, IQVIA
Jan 12, 2021

By now, the industry is quite familiar with how COVID-19 impacted the clinical development landscape. Working through the pandemic challenge is one thing. But, as an industry, we know roadblocks are always possible elsewhere in the [clinical research/clinical trial/something like that] process. Having a strong, adaptable site strategy is a critical component of clinical development for sponsors and site teams to maintain trial continuity.

Recognizing the value in site relationships

As part of a comprehensive site strategy, the pandemic has taught us how critical an ongoing relationship with sites is to the trial process. Sites and their patients are valued partners, where engagements can build beyond one-off programs, potentially going into other therapeutic areas and more. In facing roadblocks or to increase efficiencies, we’ve long needed existing relationships with sites to help sponsors and clinical research organization (CRO) partners adapt strategies quickly for trial continuity.

When mapping out how to potentially work with each site in their network as needs arise, sponsors and CROs need to consider classifying sites based on several factors. This way diverse “go-to” site networks are ready to activate, and sponsors can evaluate their site options as they design and build clinical trial programs.

As some countries experience resurgences in COVID-19, sponsors need to stay ready as sites may temporarily close or need to make quick adjustments.

As part of a proactive strategy, sponsors should keep an up to date list of which sites can or cannot be included in trial programs. This practice is vital for addressing study challenges and maintaining diverse partnerships that can help match trial needs with individual site capabilities.

IQVIA’s site network structure categorizes relationships in key groups of elite, therapeutic, and specialty sites. For elite sites that have a long-standing relationship with IQVIA, these networks often work across multiple therapeutic areas or in single, high-volume therapeutic spaces, and aim to surpass industry benchmarks to meet trial requirements. At IQVIA, these sites typically leverage our tech-enabled solutions and data insights to meet our customers’ key study deliverables.

For therapeutic and specialty sites, IQVIA may partner with a research institution or site that has a proven track record of quality performance in managing studies and meeting anticipated needs within varying therapeutic spaces. Working with expert sites and investigators in specialized fields (e.g., rare diseases, cell and gene therapy, etc.) is key to ensure the appropriate capabilities are in place to meet the trial and patient needs.

Helping site partners make quick adjustments

In realizing that sites are partners in the process, CROs need to have support services in place to help sites continue recruiting patients when the trial hits a roadblock such as a pandemic.

For example, in the initial months of the pandemic, patient recruitment was a significant concern for sponsors and CROs, especially as patient interest in trial participation increased. To not miss that opportunity, sponsors and CROs needed to step in and create another way—outside of traditional investigator-led recruitment—to reach patients and connect them to trials. At IQVIA, we relied on proprietary healthcare data assets and modeling algorithms using artificial intelligence and machine learning to create a direct-to-patient recruitment model. We first worked through partner sites with large, eligible patient populations and then widened the search beyond the site to rapidly recruit patients. We launched targeted, multi-channel campaigns (e.g., social media, pharmacies, labs, patient communities, etc.) to raise awareness of trials in local markets.

As sites reopened and interested patients were again ready to participate in trials, sponsors and CROs needed to help keep on track sites that were already behind in trial timelines as a result of limited site staff and resources. To avoid further enrollment delays, IQVIA re-engaged furloughed site staff using sponsor funding, temporarily designating that staff as part of our global site network infrastructure. It was dually beneficial as sites could reduce onboarding time while bringing back employees who knew the trial protocols well.

Future challenges are unknown to us, but we know that patient needs are only growing, making site relationships and related long-term yet adaptive, agile strategies crucial in our work as an industry to bring therapies to market.

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