In the past five years, there’s been an explosion of new sponsor and vendor
technology made to improve clinical research site engagement. But, these wellintentioned solutions are often custom, standalone systems that require complex
middleware and integrations. This forces sites to adopt dozens of sponsor-specific
tools and build customized processes around them. This is just one of the reasons
an estimated 3,000 clinical research sites have stopped conducting trials since
2019, according to Ken Getz, executive director of the Tufts Center for the Study of
Drug Development (CSDD).
Although most sponsors understand the urgency and value of improving sponsorsite relationships, it can be challenging to implement effective strategies that don’t
exacerbate existing technology siloes. New data from Tufts CSDD captures the
current environment for global sites. Natalie Blake, director in the global clinical
trials organization at Merck & Co., Inc., Rahway, NJ, USA (hereinafter “MSD”), and
Karen Whitson, associate director of study operations at AbbVie, share how they’ve
improved site collaboration despite these industry challenges.
“The exodus of
lower volume and
less experienced
sites with modest
infrastructure has
caused larger sites,
health systems, and
academic medical
centers to pick up
more activity.”
– Ken Getz, Executive Director of the Tufts Center for the Study of Drug Development
Unpacking current conditions
for clinical research sites
The majority of the 3,000 sites that have stopped conducting trials were small,
community-based independent centers conducting one or two clinical trials
annually. “This exodus of lower volume and less experienced sites with modest
infrastructure has caused larger sites, health systems, and academic medical
centers to pick up more activity,” says Getz.
These complex protocols worsen existing technology silos for sites. According to
a recent Society for Clinical Research Sites survey, over 60% of sites use more than
20 systems daily. On average, site staff spend 5-15 hours a month learning how
to use new technology. This limits the time that site staff can spend with patients.
This added stress can compound site burden. Grappling with chronic issues like
difficult budgeting processes, low patient recruitment, and high CRA turnover
results in lower-performing sites. This begs the question: how can companies help
orchestrate and streamline technology for sites?
Building collaborative relationships with clinical research sites
As an industry pioneer in site-centricity, MSD has worked to address the
perception that sponsors sit above their site partners and do not consider their
needs. “To effectively partner with sites, we must give them a seat at the table
and incorporate their valuable input into MSD’s decisions as a sponsor,”
Natalie Blake explains.
MSD is moving away from process-driven site-sponsor relationships toward a
consultative and dynamic mindset. The company implemented the Clinical Site
Partnership (CSP) program to support this shift. The company has partnered with
30+ global sites to develop clinical trial technology strategies that work for site
staff, sponsors, and patients. CSP includes focus groups, live site observations,
surveys, workshops, and user experience sessions.
“As we design and develop new technology, we want to incorporate site experience to ensure what we
are designing is meeting end-user needs.”
– Natalie Blake, Director, Global Clinical Trials Organization, MSD
Since implementing this program, MSD has garnered feedback on over a dozen
initiatives in areas like clinical supplies and data management. The company also
implemented a “menu” of operational enhancements to make it easier for sites to
conduct clinical trials. CSP sites deliver a high proportion of patient enrollment,
including over 20% of MSD’s oncology portfolio.
Sites participating in the initiative say that CSP opened lines of communication
between MSD and site monitors. “As long as sites are willing and available, they
will welcome the opportunity to collaborate with sponsors,” says one head of site
management. Dr. Mustafa Erman, head of preventative oncology at the Hacattepe
University Cancer Institute, echoed that sentiment. “Being a part of CSP has
allowed me to communicate freely and frequently with MSD to optimize processes.
It’s also improved screening, recruitment, and patient care.”
Clinical research
sites in MSD’s
partnership program
enroll over 20% of
the total oncology
portfolio
Four steps to improve site engagement
Karen Whitson’s team at AbbVie has been focused on finding ways to improve their
collaboration with sites, automate document exchange, and streamline their study
startup process. In July 2023, her team launched a program-specific campaign using
Veeva Site Connect with eight studies and 1,600 sites. Since then, they’ve seen:
- 100% of studies in the initial rollout now use Site Connect
- 410% increase in connected studies
- 78,488 safety letters distributed through Site Connect via email
Here are four steps Whitson’s team took that helped AbbVie improve site
collaboration:
Sponsors who choose not to invest in technology can still prioritize site-centricity by establishing an
advisory board or leveraging positive site relationships to gather input on trial decisions.
When searching for ways to improve site collaboration with technology, look toward
unified solutions that automate information flow across trial partners, processes,
and systems. Modern site collaboration solutions should have features like:
- Single sign-on to give sites easy access to all sponsor technologies through one ID
- A simple, free app to easily manage site content like ISF and delegation logs
- Centralized study logins to simplify access to sponsor technology
- Streamlined information and data exchange to improve collaboration between
sponsors and CROs
Making a strategic effort to refocus on the fundamentals is the key to improving site
collaboration in the long term. Engaging sites and giving them a seat at the table will
lessen the transactional nature of site-sponsor relationships and streamline study
execution. The site-centric approach can be straightforward: prioritize site input and
foster collaboration to ensure better clinical trial outcomes for all.
Hear Jim Reilly, vice president of R&D strategy at Veeva, discuss ways companies can improve collaborations with research sites.