Applied Clinical Trials
Commitment, skill, leadership, a clear focus, performance metrics, and a proven process will keep your cross-functional team from dysfunction.
Cross-functional teams have been fashionable across many U.S. industries for at least 20 years. The idea seems greatcorporations are divided into departmental fiefdoms by definition. Such silos create poor communication and competing interests that do not serve the greater good; the answer is to develop products through teams of individuals from each silo. The results are supposed to be cooperation instead of warfare, goal-oriented employees instead of politically motivated employees, and innovation instead of stagnation. The concept has been famously applied to everything from automobiles to computers, and yes, pharmaceuticals. Cross-functional teams are great, except when they arent. Too often we see cross-dysfunctional teams.
Concern arises whenever a process or organizational fad is adopted in sweeping fashion by those who are not prepared properly for applying the wisdom hidden inside the fashion. Almost every biopharmaceutical company develops its products, particularly in clinical development, using cross-functional teams. But the creation of such a team does not by wish or magic create synergy, cooperation, and efficiency.
Signs of dysfunction
Do you recognize these signs of dysfunctional teams?
The cost of a dysfunctional team
An ironic and very common indicator that your company is guilty of dysfunctional teams is when a handful of outstanding team players are assigned to as many teams as possible. So many, in fact, that they have no time for their real job, or even sufficient time to make all their teams successful.
And most damaging are teams which perform poorly in a crisis (and every project has crises). Its easy for your team to shine when the trials are rolling along, youre meeting your targets (more or less), and proving your endpoints in sprightly fashion. When things are smooth, you may not ever be aware a dysfunctional team is lurking beneath the surface. Its when the problems start to hitlike the inevitable shortfall in subject recruitment, the equivocal trial result, the CRO cost overrun, or a shift in executive prioritiesthat you learn how functional your team really is, or isnt.
Whats the problem with a less than perfect project team? Isnt the organizational model so superior it can tolerate wide variances in quality? I would say no. A poorly performing team really is worse than effective and professional individual departments whose members just happen to communicate poorly. The sheer waste of time that a poorly functional team creates is like a black hole, sucking in scarce resources and even scarcer hours.
Indeed, a single effective leader, empowered to command resources across departments when (and only when) needed, and equipped with the right process, is more likely to get the best of both modelsprofessional competency reinforced through departmental verticality, and good planning and smooth handoffs from all involved. This is a solution to dysfunctionality that is highly unfashionable, but worth exploring.
Elements of a functional team
Lets assume that ultimately, a well-run, well-trained, well-staffed cross-functional team is a highly desirable model for clinical development. What should you be looking for to ensure your team is indeed functional? The first element is commitment: team members must be sincerely and honestly committed to the achievement of the teams objective and willing to be an honest and involved participant. The second element is skillall team members must know or be taught the dynamics of an effective team, the responsibilities they are taking on, and have the ability (either innate or learned) to work in the unique collaborative manner that teams demand.
The third key element of effective cross-functional teams is a strong, empowered, and properly trained leader. Each of these characteristicsstrong, empowered, and trainedare important and distinct. A team does not lead itself, nor is a leader simply a facilitator. Indeed, it is often recommended that a team designate separate roles among its members for leader, facilitator, and rapporteur (documenter). The leader must welcome the role and be willing to take command. He or she must be empowered by both the clinical development leadership and his or her own vertical department so that the teams decisions will be endorsed, funded, and supported. And the leader must be trained in the special skills the leader needs, as distinct from a participant.
The fourth key element is clarity and focusthe team must have clear objectives and be able to focus on them without distractions or unnecessary changes in direction. So, too, team members must be allowed by their departments to focus on team participation and not be pulled away constantly to other duties. Ideally, participants should feel that their personal interests match the interest of the team. This will ensure that the teams performance will serve the corporations self-interest.
The fifth key element of effective cross-functional teams is a mechanism for measuring performance. The team should know how to develop relevant and feasible metrics so that it can determine, or even anticipate, performance problems and increase the predictability of those inevitable crises, leading to a more rapid and effective response.
But the most important element of an effective cross-functional team is that which lies at the heart of effective clinical developmenta well-understood, proven, and documented process for clinical trial conduct. If your organization has not figured out how to do clinical trials well under the conditions of your companys special circumstances, even the best trained and most well-intentioned team will founder. This is perhaps the most overlooked piece of the cross-functional fad; these teams will be only as good as the process they are asked to implement.
Cross-functional teams have proven themselves in our industry and others as a way to focus the energies of talented multidisciplinary staff on a common goal. But sitting down with an organizational chart and picking one person from each department will not be sufficient to realize the value in this approach. With commitment, skill building, a strong leader, clarity of objectives, performance metrics, and a good clinical trial process to implement, your cross-functional teams will live up to their expectations. o
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