From the sponsor perspective, a handful of metrics are particularly important: timeline, action completion and follow-up,
scope control, budget management, and turnover. In addition, depending on the scope of the study, site and patient enrollment
may also be key. Increasingly companies are creating "dashboards" to give executives a quick overview of what is going well
and what is not.
Escalation Failure
As problems emerge, team members need to bring them up through the hierarchy to the proper level so they can be resolved.
But survey participants said that often didn't happen. Sometimes issues languished to the point of jeopardizing critical path
activities. Other times, teams struggled to identify parties who were empowered to make decisions on scope of work, quality,
or risk/benefit ratios.
It is crucial to have a highly defined escalation path naming specific points of contact and their authority to resolve various
sorts of problems. Once the areas of concern have been identified, the paths mapped, and the whole plan agreed upon, it is
important to test it before the study, making sure that people are aware that they're part of the path and understand their
responsibility in it. Again, higher-level executives need to understand and support the plan in advance.
Loss of Lessons Learned
Clinical research organizations today handle hundreds or thousands of trials at a time. And in a rapidly changing environment,
they frequently learn valuable lessons, either about things that went wonderfully and can possibly be replicated elsewhere,
or about things that went badly and should be avoided in the future. But often at the end of studies, sponsors and providers
are both so geared to moving on to the next step that they skip the process of looking at what went right and what went wrong.
When that happens, lessons are lost—mistakes are repeated across projects, providers, and sponsors; and experience becomes
dependent on people rather than becoming institutional.
Solutions include:
- Enforce the need for documentation
- Instill openness and collaborative resolution from the start
- Periodically survey the team for clear examples of what is and isn't working
- Review collective materials at study conclusion and take appropriate actions.
Because so many lessons get lost at the ends of projects, it might be useful to build in a capture mechanism earlier in the
cycle. Some pharmaceutical companies use a midway review. They select a point halfway through the study and have a formal
dialogue between internal employees and their CROs about what's been successful, what hasn't, how things can be improved,
and what ideas could be used elsewhere.
In our own organization, we have conducted an standard operating procedure sharing exercise. Our client was managing the trial
itself. The scientific results delivered by the company and by our organization were the same, but there were differences
in various areas of service or activities that led to either faster results or more effective results. Both companies got
together and shared policies and standard operating procedures, and both came away with some useful ideas.
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