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“Very often when you do investigator-initiated trials or trials with an inexperienced group, the study starts in one direction and then it morphs [to take] another direction,” says Hermine Brunner, MD, MSc, MBA, FACR, professor of pediatrics, endowed chair and director of the Division of Rheumatology at Cincinnati Children’s Hospital Medical Center.
In a recent interview with The Rheumatologist, she outlined five important elements to look for when considering a clinical trial collaboration.
- Clear scope, tangible objectives: Make sure the trial has a clear goal and timeline. “A lot of times people don’t have a clear focus,” she says. “A couple years into the study, nobody has a publication, the money is running out, and people are upset.”
- Training: The National Institutes of Health offers free materials online that outline what to look for when taking on clinical trials, as well as the legal implications. “[The resource] is very useful,” Dr. Brunner says. “[The training] is a bit time consuming, but at least you will understand what you are getting into.”
- Long-term commitment: Brunner says most clinical trials take about “five times as much time as spelled out” in a proposal, adding that agreements between universities need to be renewed every year, which can be a “nightmare.” Relying on other sites to produce and exchange data can be a challenge. “You have to constantly interact,” she says.
- Leadership: The best collaborations have clear leadership, so make sure roles and responsibilities are well defined. “Collaborate when you know what the timelines are, what the objectives are, the deliverables, and you know who will analyze the data and what the publication line is,” she says.
- Beware of hidden costs: Investigators won’t get reimbursed for $50 worth of dry ice if dry ice is not specifically outlined in the budget. Annual reviews and safety reporting can take a lot of time and, Dr. Brunner warns, might not be reimbursable. “You don’t want to lose money when you do a study,” she says. “You need to be very careful in the budgeting process.”
Richard Quinn is a freelance writer in New Jersey.