The second book in our Risk Management Book Club, The Fifth Risk (W.W. Norton, 2018), highlights a common occurrence with potentially huge impacts:  Turnover.

If you're a Michael Lewis fan who enjoyed The Blind Side, Moneyball, or The Big Short, you might be surprised by the decidedly more somber tone of The Fifth Risk, which chronicles to the rocky transition from the Obama administration to the first Trump administration. 

The Fifth Risk is not a "how-to" business manual, but rather a surprisingly compelling account of how government agencies work, how much risk they manage, and how much they depend on continuity of expert staff - a dependency that's interrupted when one administration succeeds another in the White House.

The first chapter recounts an interview with John MacWilliams, a risk manager at the Department of Energy (DOE) in the Obama administration.  In 2016, the DOE team was prepared to begin the transition process to either the Clinton or Trump team the day after the election. After Trump won, a month went by before a representative from Trump's team was assigned to the DOE.  He met with the DOE team for an hour and took no notes.  The Chief of Staff suggested that he return each day until the inauguration, which he agreed to do - but never showed up. 

The book's title comes from MacWilliams's assessment of the risks faced by the country at the time of this transition: nuclear accidents; nuclear attacks from North Korea and Iran; an attack on the electrical grid; and project management, "the fifth risk." MacWilliams, a professional risk manager, believed the seamless transition of responsibility at DOE was key to its ability to protect the country. 

In clinical research, we are familiar with the concept of "regime change."  Biotechs are acquired, CROs merged, vendors switched, and assets sold with alarming frequency. Even at the micro level, things change hands. Most CROs report average turnover rates between 12 and 25%, but of course we've all worked on studies where there is a new sponsor project manager every six months, or five different CRAs at a site over the course of a year. 

Most companies use transition plans for acquisitions, vendor changes, and personnel shifts, but things fall through the cracks. For example,

• One company acquires an asset and takes over its clinical trials.  Months after the transition, the new sponsor discovers the TMF is missing key documents.
• The sponsor project manager leaves, and the study is passed from one overworked person to another.  Months later, when new leadership is brought in, they discover that the team has started using a laboratory without qualifying them, because each new project manager thought the previous one had taken care of it. 

The Fifth Risk reminds us that the baton is most likely to be dropped during the handoff. We should plan accordingly, with additional controls for transitions big and small.