Info & Opinion
April 25, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
The project manager’s lot in life is not always glamorous and filled with the drama of a James Bond movie. But as with any job in any industry, the project manager’s role in clinical trials has unappreciated complexities that make the role especially indispensible in multi-year projects orchestrated by multiple organizations.
Some of the sessions at the 2010 annual Drug Infornmation Association DIA meeting in Washington, D.C., offered hints of how project management can be seen not just as another job description but as a sort of special forces of clinical development—an elite squad that, if used judiciously, can change the odds of success of a much larger campaign.
We are relatively confident that Angela Stambauch, a global project manager at Amgen, was never trained as an Army Ranger. We are equally confident that her value to Amgen would be comparable to one of those ready-for-anything soldiers. Stambauch’s presentation was a glimpse into the world of projects that go on for so long that not all participants may have a full recollection of what decisions were made—or why. “Don’t assume that management knows much about enrollment or timelines,” Stambauch advised.
Project managers, she said, have a unique perch from which to contribute to discussions as projects move from Phase III to the market. The project manager may be able to remember the discussion around various trial end points, to cite one example. Part of the project manager role’s uniqueness relates to its centrality as the pivot point for different silos of expertise. That's something project managers should use to their advantage. “When in doubt, pick up the phone and check it out,” she said.
Good notes of a discussion about a compound over time, she said, can be an invaluable aid to reminding the team of what its predecessors did. “It’s important to have clearly documented minutes for people who may be in doubt about what has been decided in the past,” she said. In effect, the project manager can serve as a historian of a compound.
On the topic of patient recruitment, Stambauch observed that the pace of finding patients was undoubtedly the biggest variable, the one most likely to delay the entire trial. “If you can, obtain industry information on enrollment projections for a particular indication,” Stambauch said. As many in the audience would agree, not getting the patient recruitment time lines right can mean a 6-7 month delay, or a protocol amendment, or both.
Other speakers at the conference estimated that $500,000 might be a starting point for the advance work to prepare for the end of Phase III encounter with FDA. For her part, Stambauch allowed that there is not always that muich time to prepare. But if possible, she advised that sponsors conduct several dry runs of that exercise.
Ideally, she said, those mock sessions would begin three months prior to when your firm will be facing the FDA. “Repetition is good,” she said. “Focus on the top fifteen questions that you think the agency is going to want answers to, and find thorough answers to them. Otherwise, the team is going to brainstorm everything under the sun.”
For any fellow project managers in the room, Stambauch recommended a certain professional detachment from the vagaries of the decisions of senior management. Extraneous factors (charisma, politics, ownership of a project) may come to the fore in some high-level decisions at some companies. So be it. “Try not to get caught up in the churn,” Stambauch said. “Senior management will make decisions that don’t always make sense. We as project managers need to embrace that.”
The key is to make sure that the facts are assembled. “Put all options on the table so that management can see what you actually thought about to do your due diligence.”
It's clear that the industry's project managers, like its clinical data managers, are flexing their organizational muscles and seeking a bit of recognition for what they have been doing all along. At companies with the most complex projects, the project management role has been more strategic than other clinical trial professionals have believed.