Syneos Health

Ken Lee

When one thinks about recent innovations and hot topics in clinical development, big-ticket items like AI, technology, data science, and analytics come to mind. Advancements in each of these fields are now being more widely used and finally making a positive impact on bringing new drugs to market more efficiently. Other ‘hot’ areas include data privacy, health equity, clinical trial diversity and the need to manage R&D’s impact on the greenhouse effect. All in all, these elements make this one of the most interesting times to work in clinical development.

However, when I get asked by teams to support projects, I find myself time and again coming back to more basic strategies that involve the culture and behaviors of such teams – especially when it comes to challenging the status quo and acting with a sense of urgency. These are not often discussed as they are somewhat opaque and fuzzy in an industry that prizes things in black and white, standard operating procedures, governance and formality. Until humans are replaced by the technologies I alluded to at the start of this piece, we will always need to manage culture and relationships. If managed well, they drive performance.

I will share two small actions in a little more detail to illustrate what I mean. I was recently asked to support a project team charged with accelerating a clinical trial expanding into Asia Pacific. Upon assessing the situation, we identified several target areas to focus on. Firstly, we noticed that it sometimes took more than a month to schedule site initiation visits after all the other formalities were completed. When the usual approach didn’t work, the team didn’t waste time before asking the customer’s medical director to make contact, given their scientific seniority. Amazingly, one of these visits was brought forward by a whole month.

Another obstacle we identified was the long time translations were taking–a key step for document preparation in Asia. We discovered the source of the problem was the customer's preferred translation vendor. Rather than just accept this, we requested a change to our preferred translation vendor, with whom we had a long working relationship and established processes in place. In return, we gained a 50 percent decrease in translation times.

In both cases, by not accepting the status quo and demonstrating urgency, the team used rather simple, low-tech interventions to make significant improvements in how quickly we were able to start this study.

Simple interventions like these become easier when strong relationships are built between teams, vendors, investigators and site staff, often outside of a project delivery setting. Clinical research associates (CRAs), for example, can draw upon the relationships built during face-to-face investigator engagements when encouraging site staff to push a little bit harder to enroll participants in a clinical trial. The beneficial effects are enhanced when a CRA has a long-standing and positive relationship with site staff, built over many interactions over many clinical trials. However, building relationships might come more naturally to some than to others. A CRA might purposefully keep note of the study coordinator's life events so that on their next monitoring visit, they can ask, "How was your daughter's first soccer game?" I want to be clear that the benefit does not merely lie with collecting relationships akin to friendships but in being able to leverage those relationships to enhance quality delivery on a clinical trial. So, the followup question after “How was your daughter's soccer game?" could be "How are we going with finding new patients for the study?” or “How are those data queries going?

It is hard to scale and measure this type of activity in an industry where everything is so data-driven. However, imagine if all of our teams were able to take such actions independently, including proactive negotiating and compressing timelines in responsible ways, how this would sustainably enhance management of a large portfolio of projects.

Today, I gave an example of the speed of site activation, as it is one of the metrics that are most often looked at and remains tremendously complicated. AI, data, and analytics are helping in so many aspects of this complex process, from translating documents, tracking progress, workflow management, and highlighting risk. But at the end of the day, you still need a human being to go to a site to perform an SIV, which involves interpersonal communications skills – and oftentimes, creative problem-solving -- to schedule a visit when all stakeholders at the site can be present. These behaviors and tactics also apply to patient recruitment, answering queries for a database lock, pumping out a clinical study report, and a myriad of other important deliverables in a project.

It is not possible in such a short piece to discuss in depth project team and corporate culture and dynamics, but I hope in this simple but frequently encountered example, you will see why I am repeatedly humbled by how something as simple as a picking up a phone and having a coffee with someone can solve a problem or spark a creative solution, out from under technology’s shadow. This ‘human dimension’ to the work of getting medicines to patients faster deserves more attention from leadership.