Selecting the infrastructure of a research initiative is foundational to its success. What qualities are most important to you when selecting a contract research organization (CRO)?
Bryce Miller: All three panelists in this discussion work for companies that prioritize efficiency, and finding a CRO that will work effectively with us is key. I want a CRO to assure me that the team to whom I am introduced during initial meetings is the same team that will work on my project. Institutional and experiential knowledge is lost each time a new team from a CRO is introduced to a project. Getting them up to speed takes time, which is a resource in great demand during high-stakes clinical research.
Aggie Malloy, MS: The relationship you have with a CRO is a two-way street: if you resource them properly and are organized, then you’ll likely have a smooth rapport during the entirety of a project. Getting buy-in from the CRO is a function of the way you respect them from the beginning of the project.
Harman Hansra: Clinical operations directors select CROs with reputations of flexibility and low employee turnover. During the COVID-19 pandemic, we found that nimble and proactive CROs helped us execute our plans. Employee retention, too, speaks about team continuity. If the CRO you’re working with keeps their roster intact, then you can alleviate concerns about new members onboarding in the middle of the study.
How do clinical operations teams determine which sites are best suited to the trial?
Ms. Hansra: Similar to how I value staff continuity at a CRO, I am attracted to sites whose research coordinators and principal investigators (PIs) have an established relationship. I specifically look at the dedication and commitment of the coordinators, who are the backbone of the sites. Although we get recommendations from the CRO, we take the ownership of final selection ourselves.
Ms. Malloy: Selecting a site is similar to interviewing a candidate for a job: we must clearly outline the requirements during feasibility evaluations and honestly assess a site’s capacity to conduct research. Sites tend to overestimate their capabilities, and we need to adjust for that tendency.
Mr. Miller: I prefer to rely on my personal relationships when it comes to selecting sites in the United States. I want to make sure that we select partners I can easily reach and whose commitments align with our overall mission. When seeking new investigators, I have found success relying on referrals from trusted PIs whose former trainees are now ready to participate in clinical studies. As long as a researcher with a proven record can vouch for a potential investigator’s credibility and commitment, I trust that they’ll be a dependable partner. I also prefer to work with sites that focus on only a few studies at a time, rather than a site that is recruiting for dozens of studies. When it comes to selecting sites outside of the United States, I rely on CROs to evaluate the feasibility of various sites.
In the same way that sites are competing for studies, so are sponsors competing for sites. What can a clinical operations team do to make its study more attractive to potential sites?
Ms. Hansra: Clinical operations teams need to think critically about what they ask sites to do. Building a relationship with the coordinators and providing resources to address potential gaps can make or break the trial. Conducting home-based blood draws or health assessments of study patients, for example, may reduce a study staff’s burden. If we can increase our study staff’s bandwidth by taking responsibility for logistical challenges, sites may be more willing to take on our study.
Ms. Malloy: Gathering and acting on feedback from sites and their patients improves the experience for everyone involved. During the pandemic, for example, we found that patients had specific requests about safety protocols in the cars used by our transportation service. The safer they felt in the car, the more likely they were to arrive on time at the clinic, leading to an overall smoother experience for both.
We have found that sites appreciate personalized tools for patient management. Providing an outline for coordinators to use during conversations with patients has been particularly useful: researchers have a guide they can rely on for patient education, and patients are given consistent messaging about why their role in the study is critical to its success.
Recruitment remains a challenge. Which elements of recruiting can clinical operations directors influence?
Mr. Miller: Some challenges to recruitment are out of our control. If you are recruiting for a study in a particular disease state and there are other trials trying to recruit similar patients, that means you’ve entered the field in a challenging climate. Other challenges are protocol-driven. For example, strict entry criteria can depress enrollment rates. Experienced clinical operations directors who can identify unnecessary enrollment criteria as well as cumbersome procedures are essential to reducing the number of recruitment obstacles faced by sites. Still, there is a limit to their influence, as clinical science teams prioritizing specific endpoints have ultimate say on study design.
Just as it falls on clinical operations directors to eliminate bureaucracy, so too must we eliminate potential recruitment snags unrelated to study design. Would patient stipends make recruitment easier? Is transportation to and from the clinic needed for this patient population? If you empower sites to recruit by giving them the tools they need, then they cannot come back to you with excuses as to why their recruiting numbers are lower than expected.
Ms. Hansra: Working with sites where the PIs are younger and more eager to participate may lead to more efficient recruitment, although such sites sometimes require more guidance. Experienced research coordinators are valuable in such scenarios, as PIs can rely on their direction.
Sharing best practices amongst study staff is generally welcomed. And generating healthy competition amongst sites by providing periodic screening and enrollment activity across all sites motivates both PIs and coordinators.
Ms. Malloy: Communication with study sites is a must, and sites must feel comfortable querying clinical operations teams for help with any number of issues. I tell our sites that no issue is too small. When clinical operations teams help research teams resolve small hiccups, trust builds between the study site staff and their industry partners.
Research continues to grow with an increasing number of clinical trials being initiated. What are some final thoughts on key aspects of ensuring efficient trial execution?
Mr. Miller: Accurate and efficient communication among all parties involved, especially the CROs and sites, is vital. Communications from the sponsor to the CRO to the site can be a game of whisper down the lane, and sites sometimes receive inaccurate messaging from CROs. If something is imperative (eg, enrollment closure, data locks), I encourage clinical operations directors to communicate with a study site directly.
Ms. Hansra: I advise other clinical operations directors to select a proactive, experienced, and accountable CRO that values communication and clarity, both of which are imperative to your trial’s success. Likewise, study sites should be held responsible for recruitment. We lay out specifics in the contract so the teams are aware of expectations regarding number of patients enrolled.
Ms. Malloy: Partnership with the CRO is essential, and it falls upon us to work with CROs as equal partners. Similarly, it is on us to conduct an honest site feasibility assessment and draw on that when selecting the right sites. By taking ownership of site selection and framing a relationship with CROs as one of collaboration, you can set up your trial for success.
