Canada is considered one of the most attractive places to live in the world, with…
Monitoring the progress of clinical research is fundamental to obtaining successful outcomes because it ensures that constraints to success are identified, and then resolved in a timely and effective manner. This is particularly the case for the complex environment of oncology clinical research, and is even more an important consideration with virtual monitoring.
The centrality of monitoring to the success of research studies, combined with the increasing complexity within the field of oncology clinical research, means leading sponsors are increasing focus on this function and the role of clinical research associates (CRAs).
How CRAs Impact Successful Trial Outcomes
Open communication with sites is essential to detect risks before they become an issue. According to a collaborative study conducted by CRO Analytics and ACRP, the majority of 300 Sites surveyed expressed that frequent and open communication between Sites, Sponsors and CROs is the most important factor in clinical trial quality.
Each study is uniquely designed, but CRAs are generally the ones tasked with ensuring that all contributors to the clinical trial production chain work effectively on time, within expected scope, on budget, within regulations, and safely for all patients involved. This reality makes the function of CRA the most important contact that a Site has with the Sponsor. It follows, that how CRAs are assigned to an oncology program represents an important success factor for smooth and optimal study conduct.
Why CRA Assignment Strategy Makes a Difference to Your Trial
CRAs are often assigned to trials based on their overall workload, with no real consideration for therapeutic experience, or which Sites will be involved in the given projects. In fact, it is not uncommon to see different monitor teams leading the feasibility, start-up and site activation, and enrollment phases of a project. And monitoring is often conducted by CRAs who tend to be treated as a pooled resource, graded on their percentage of full-time equivalent (FTE) availability or their ability to take on more projects.
While this approach to allocating CRAs on a per trial basis is a common practice in the industry, it has serious drawbacks – the most important one being the inability to develop trusted relationships with the Sites.
What’s Trust Got to Do With It?
It really comes down to trust. When you enter someone else’s territory, and expect them to do things for you the way you want them done, and when you want them done; knowing how and what to ask is ever so much more effective when you have an existing, solid relationship with them.
Scimega is a CRO that works exclusively with full-time, permanent, local CRAs and has a track record of 24 years of organizational experience actively collaborating with the over 50 Canadian cancer research centers located across the country.
Most Scimega CRAs have prior experience working at these Canadian research centers, and this first-hand knowledge is invaluable to understanding the challenges faced by site personnel. Rather than a lot of back-and-forth, a CRA who knows how site personnel may see a situation can anticipate their perspective, concerns and objections and will more often than not provide an immediate and complete answer to any questions site personnel may have. This saves time and avoids frustration for everyone. This level of empathy builds trust, and promotes honest communication.
CRAs provide the eyes in the field for your clinical trial. Given Scimega’s well-established relationships with cancer centers, further enhanced by its consistent site assignment strategy for CRAs phone calls are always answered, and site staff are comfortable sharing internal directions and upcoming changes.
Every Site is Unique
Seen one, seen them all simply does not apply. Every site has slight nuances in the way they operate. An important building block to a good relationship is a willingness to understand and adapt to these particularities. For instance, site personnel appreciate it when a CRA learns how the site team is organized and thereby contacts the correct team member with a certain request or inquiry. Saving everyone time.
In addition, site personnel notice and appreciate when a CRA communicates with them according to the site’s schedule. If a phone call is needed to check in on potential patients, the afternoon or morning after a clinic day might be the best time. Perhaps a study coordinator sets aside an administrative day every week and therefore appreciates an email on that particular morning to remind them of the data entry and/or queries in need of their attention.
By making a conscious effort to adapt to site personnel preferences, a CRA is seen as an understanding team-player. As a result, site personnel are more likely to reciprocate by communicating their needs and any concerns that could become a study risk if not addressed in a timely, efficient manner. Additional compelling reasons for a CRA site assignment strategy.
More than Meets the Eye
Extraordinary CRAs have skills beyond what appears on their resumé. The effectiveness of their soft skill set leads to team coherence between the CRA and site personnel. Why not give them every opportunity to make the most of this skill set by assigning CRAs consistently to the same sites in order to ensure that the best possible outcomes for your clinical trial are obtained?
A quality risk management plan is only ever as good as the CRAs involved in assuring it is effectively implemented on an ongoing basis with their site personnel colleagues. One of the best ways to support CRAs working together to assure the quality of the Sponsor’s clinical trial is to employ a consistent CRA site assignment strategy.
Making the Right Choice
Mobilizing an expert Canadian team significantly enhances study start-up and overall performance. In keeping with the targets shared with its Sponsors, the Scimega team delivers consistent clinical trial start-up times 50% faster than the North American average, with trial sites often among top enrollers in global oncology studies.
Scimega is a Canadian niche oncology CRO that serves small to medium size biotech companies in clinical development of cutting-edge oncology therapies in Canada. We consistently deliver our services with a strategic focus on Sponsor program success, and our team’s ability to engage oncologists and site teams at the highest level is unparalleled. Even under the current pandemic circumstances.
Contributed by: Julie Martin, CEO