3. Lack of strong middle-management
"The biggest mistakes made or prevented are in middle management," says Halloran. Middle managers are a conduit to senior management, who communicate with the board of directors. They're also closest to the nitty-gritty of what's going on with clinical trials, and will probably spot issues or problems long before the higher-ups know something is wrong. "Quality is important, but sometimes that isn't always obvious to the board," explains Halloran. Board members are concerned with getting the trials done quickly and inexpensively. "Quality is most important, but sometimes that isn't always obvious to the board," explains Halloran. Board members are concerned with getting the trials done quickly and inexpensively. "Senior management really needs to understand trial status, including the potential impact that accompanies quality issues--and they need middle management to achieve that."
Companies need to be careful about who they're hiring for these positions. The right candidates should have the appropriate therapeutic area experience and have worked in a similar environment in the past. Use caution hiring people who have Big Pharma experience for a job in a small company they're used to having large teams and robust infrastructure, and lots of funding to conduct studies. Warns Halloran, "They may not be able or willing to roll up their sleeves when necessary to do the work themselves. Quality suffers when no one knows who, what or how to do things consistently."
"Alternatively, hiring people who have never done the job before are just as problematic, because they don't know what they don't know." A good middle manager doesn't have to be a physician or former Big Pharma exec; he or she just needs clinical trial experience.
Above all, the right person will have experience controlling the quality of the clinical data. Middle managers must ensure consistency in data in the entire series of studies in the data package. "At the FDA, submissions succeed or fail frequently based on the quality of their management," explains Halloran, "and it's much less expensive to build it in early than to fix it later on.
4. Clinical trials with too many objectives
The "Kitchen Sink" trial is many studies crammed into one in an attempt to minimize costs. It involves multiple primary and secondary objectives and multiple complicated endpoints, few or none of which may be achievable. "Incredibly, I see this in more than 50 percent of clinical trials," muses Halloran. The criteria for enrollment becomes so complex that it takes forever to enroll subjects, or part way through, the company revises the objectives of the trial. That means some subjects enrolled under one set of eligibility criteria and others under a different set, making the final data challenging to analyze. "In the end, many companies would have saved money if they had done several less ambitious trials rather than one big trial with many objectives."
One option to control costs is to head overseas to emerging regions where many sponsors are finding eligible and willing subjects more plentiful, and where (for now) the price to conduct clinical trials is lower. Halloran says it's a feasible plan as long as your company has enough people with experience in the regions who know how to manage your trial. And those managers shouldn't just be vendors, but people from within your company with experience working overseas.
5. Lack of exit plan
From the get-go companies should choose an exit strategy and build the company with that strategy in mind. If your goal is to be acquired, build a leaner, more virtual company. It will make you more attractive to big developers that want to acquire programs, not people. If you want to partner, decide at what stage you want pursue that. Know that your company will have to build a bigger team and to invest in appropriate infrastructure to conduct the program effectively. Keep in mind that your need for people and systems will vary greatly based on whether you have one shot on goal, or a broader platform focus.