Contributed Commentary by Shaun Williams and Neal Herman

November 13, 2019 | Clinical trial success hinges on the commitment of the participating investigators and their clinical staff, and their enthusiasm is highest at study start. Sponsors and contract research organizations (CROs) must leverage technology, people and systems to fuel the sites’ excitement—and to keep them engaged through the study’s duration.

Yet the clinical development industry has not mastered early and sustained site engagement.

In a recent survey, researchers at Duke University’s Duke Clinical Research Institute found that 28.9% of principal investigators elected not to pursue additional trials. These one-and-done responders cited balancing trial implementation with other work obligations and opportunities (63.8%) and carving out the necessary investigator and staff time to initiate and implement the trial (63.4%) among their key deterrents to future trial participation. Those concerns surely also diminished their experience of the study they did undertake.

To carry more of the start-up burden for the sites, three key functional teams within the sponsor or CRO must collaborate before the study even begins. Together, Feasibility and Site Identification, Site Contracting, and Site Payments can integrate technology and process to best support the sites.

Feasibility and Site Identification

The new investigator’s first contact with clinical research often is a feasibility survey from the sponsor or CRO. For many, completing that survey can feel like applying for a job online: all those painfully compiled answers disappear into cyberspace with not even an echo back. Every interaction between Feasibility and the site reflects on the sponsor. Gratitude for the investigator’s willingness to enter the selection process is a minimal first step toward a solid relationship. The site must receive updates on the evaluation process and timing and the final decision.

Communication between the Feasibility and Site Contracting teams at this stage benefits both. For example, Site Contracting holds insights into specific sites’ past performance. This first-hand knowledge rounds out the performance metrics from internal and external databases that Feasibility uses to select and screen potential sites. At the same time, Feasibility’s updates on the site selection process give Site Contracting a jumpstart on defining contract needs and streamlining the study-specific contracting schedule.

Site Contracting

When a site is selected, the Site Contracting team moves quickly to negotiate the contract and ready the site for study activation. To track the details of contracting with multiple global sites, the industry best practice is to deploy a cloud-based tracking system (e.g., GoBalto, Vault Study Startup, etc.).

These programs track progress of contract negotiation and start-up tasks such as investigational review board (IRB) approvals, regulatory submissions, contract status, etc. The systems also automate a “green light” for site activation activities, which can save crucial time in the start-up process.

The Site Contracting team works closely with the sponsor to accelerate contract negotiations. To lessen the contracting burden for sites, the sponsor and CRO should reach upfront approvals on the contract and budget templates, establish a communication plan as well as an escalation pathway, and set robust thresholds and budget parameters to avoid case-by-case negotiations for multiple sites and tasks. They also can standardize their process by replicating budget templates and costs across similar studies.

Similarly, Site Contracting can help repeat sites by using a previously negotiated contract as a template. Beyond saving time for the sponsor and work for the site, this approach makes the site’s experience more consistent across studies for the same sponsor and/or CRO.

At the same time that Site Contracting is negotiating with the sites, the team can collaborate with Site Payments. For example, our team has developed site contract and budget templates that upload directly to the clinical trial management system (CTMS) for efficient payments set up.

Site Contracting also pares study start-up cycle times by notifying Site Payments the instant contracts are executed. This works most smoothly when the same organization provides site contracting and payment services, but notifications can be configured between separate vendors, too.

Site Payments

With the executed contract in hand, the Site Payments team builds the key parameters into the payments system. Industry best practice is for the systems to marry the study protocol, contract and budget to define payment triggers and milestones. These can be integrated with the electronic data capture (EDC) system to automate as many costs as possible.

Site Payments also loads “study standards,” or specific study start-up costs into the payments system. These costs include such charges as advertising, IRB fees, site activation tasks, etc. that the first-time investigator may not anticipate. Once sites have met their initial milestones, their first payment needs to arrive quickly. This first disbursement is critical for the site’s satisfaction with and commitment to the study.

The sponsor or CRO also can lessen the sites’ burdens and build trust by creating an intuitive tool for sites to check payment status and history. A secure Internet portal, for example, gives sites visibility into their own payments in near real time and at their convenience.

The portal further provides the sponsor and CRO a way to give sites study pipeline information—and for Site Payments to push information back to the Feasibility and Site Identification Teams. This can be a game changer: The Duke survey also found that of the 54.2% of investigators who had participated in only one clinical trial, 44.4% were interested in doing so again. They just had not found another opportunity.

The functional service teams can develop innovative tools and processes to best fulfill their responsibilities to each study and site. They also must integrate with one another, as noted above, to optimize their combined services. This comprehensive approach promises to alleviate site burden, which increases engagement on current studies while encouraging participation in future trials, too.

Shaun Williams, Vice President, Investigator Management Solutions, Syneos Health, has over 15 years’ experience directing operational activities in FDA-regulated industries. Currently the head of Syneos Health’s Investigator Management Solutions business unit, Shaun holds a Bachelor of Science in Mechanical Engineering from the United States Military Academy at West Point and is a certified Project Management Professional (PMP). Shaun can be reached at shaun.williams@syneoshealth.com.

Neal Herman, Associate Director of Site Start Up at Syneos Health, has more than 12 years of clinical research industry experience focused primarily on site contracting and site start up.  His work has included overseeing sponsor-dedicated teams and developing study start up processes. Neal has a Bachelor of Science in Business Management from North Carolina State University. Neal can be reached at neal.herman@syneoshealth.com.