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Cost containment is on everyone's agenda these days
Here's what the big companies are doing
One of the biggest issues facing the research industry these days is revising long-time habits and practices and instituting efficient new ways of doing business, an expert says.
"There's a natural tendency on the part of individuals to do things their own way," says Laurie Halloran, MS, CCRA, president and chief executive officer of the Halloran Consulting Group in Brighton, MA.
"What happens at both sites and sponsors is people do it the way they did it the last time, and this creates an individual process for every single person in the organization," Halloran says.
Reports analyzing the current state of the research industry discuss the inefficient research and development processes, Halloran says.
"So what I see sponsors doing, and sites can learn from this, is trying to create a more efficient process where they don't have a thousand steps that people do," she says.
For example, if a research team has to review documentation to start a study and if there are too many people involved in the review, then it ends up slowing down the process, Halloran says.
"There's a lot of critical thinking that has to go into how companies work," she says. "And critical thinking is something sorely missing in this industry."
Research professionals have lost touch with the basics and tend not to interpret regulations in a way that works for them, Halloran says.
Instead of grasping the big picture and interpreting the regulations with the flexibility that is built into the regulations, research professionals will increase documentation and create lengthy internal processes to take the place of thinking through what is really important and needed, she explains.
Another factor that plays into this problem of over-interpreting regulations is a predominant mindset among clinical trial staff.
"A lot of people who do clinical research have a rule-following mindset," Halloran says. "They follow the procedure."
What is needed is a framework in which the research organization dictates some of the process, but which allows for the process to be modified to suit any particular situation, she explains.
Another way sponsors and others in the research industry are trying to contain costs is by looking critically at how well their resources are used, Halloran says.
They need to assess who the people are on their team and look at what each person is capable of doing, she suggests.
"Then you maximize their ability to be busy, but not too busy, which is extremely difficult," Halloran says. "Clinical research organizations (CROs) do this really well because they work in a consulting environment where their only source of revenue is people time."
CROs have the mentality that they are only valuable when they are billing for staff time, and the pharmaceutical industry has never had that mentality, she notes.
So in the past, pharmaceutical companies tended to put too many resources on projects, and they didn't have any managers for whom the top concern was the efficient use of resources, Halloran says.
"That was a limited concern," she adds. "What pharmaceutical companies are starting to realize is that their resources and down time are some of the most expensive areas of their organization."
If an organization uses an employee efficiently and at the right skill level, then they've saved a lot of money, Halloran says.
"The challenge is to quantify how much you've saved," she says. "There has always been a lot of fat in pharmaceutical companies, and that fat is being sliced now."
Once an industry catches on that its old practices have created resource waste, there might be a tendency to swing the pendulum too far in the other direction.
"In the past, pharmaceutical companies have had more people than they needed, but they didn't know it," Halloran says. "Now there's a much higher level of awareness that they can't sustain that staffing level, so a lot of pharmaceutical companies are cutting costs by cutting people and outsourcing the work to CROs and contractors."
This staffing shift is fine so long as the companies cutting jobs have defined processes to follow, she notes. "If there's no definition for how you do the work, then that's a recipe for disaster," Halloran says.
Clinical trial sites have been lean all along, so there issues are different, she says.
"They take longer to do things because they also don't have a systematic way of doing their tasks, and this varies by site," Halloran says.
Some research sites are all about trying to define and communicate the most efficient way of doing things, especially when research is their top priority, she says.
"In research sites where research is tolerated by the administration, but not necessarily supported, they don't get the attention and support they need, and this slows them down," Halloran adds.
This is where the sponsors' new focus on efficiency and saving time can clash with what happens at the site level.
Sponsors and sites have a symbiotic relationship, Halloran says.
"There's an enormous amount of attention paid by sponsors on investigator site metrics, and a lot of sponsors are saying, 'Sites have X number of weeks to get started, or we won't use them,'" Halloran says. "And they'll say, 'Sites have X number of weeks to enroll patients, or we'll shut them down,' because the sponsors literally cannot afford site inefficiencies."
Site performance is going to be a heavily scrutinized area by sponsors from now on. She adds, "Merck is doing something interesting: The company has an extensive prequalification process with research sites, where they pay for time to evaluate whether the site really can deliver on its promise."
Then Merck will manage the site, and if the site promises to enroll five patients in three months, and the site fails to do so, it will receive first a warning letter and then they're closed, she says.
"What that translates into for sites is they need to manage those expectations and meet them, or they won't be used by Merck," Halloran says. "And it's only a matter of time before other sponsors start doing it."
The priority is on how quickly patients are enrolled, which is also the real reason why sponsors are starting trials overseas, Halloran says.
"So if research sites want to be ahead of the curve, then they need to think about the sponsor as a customer as much as they think of themselves as a customer," she says. "I get the sense that a lot of sites feel that working for the sponsor is something that's lucky for the sponsor because the sponsor is fortunate to have them."
It's an elitist attitude that will cost sites business, she adds.
"There are plenty of hungry young doctors overseas who are willing to make a sponsor's study their top priority," Halloran says. "Cost is secondary; time is more important."
From the perspective of pharmaceutical companies, it makes sense that there's so much emphasis placed on time. For example, if a company expects a new drug will bring in $500 million a year, then it only makes sense to spend $50 million to bring that drug to market a year sooner, because they've netted $450 million, Halloran explains.
"Sites still don't recognize that equation," she says. However, the top performing sites are learning that time is most important, and they're the ones working not to be the cast aside in favor of overseas trials.
"Only in the most well-established research sites where research is the primary business line are there recruitment specialists," Halloran says. "Most institutions don't have that position." Yet they need it to help expedite subject enrollment.
"I get the sense that a lot of physicians and research personnel are fairly uncomfortable with the whole topic of approaching patients and recruiting them," Halloran says. "They don't want to be seen as coercive, so they're very measured in approaching subjects, and that's a difficult paradigm for a sponsor to live with."
The solution is for all research sites to assign one person on the clinical research team to the role of patient recruitment, she suggests.
"Sites could write that salary into their budget and get the position covered by sponsors," Halloran says. "That could evolve into a really active function and set the site apart from others."
While sponsors have been slow to recognize how important it is to pay for these types of start-up costs, that will change as they begin to see the return on their investment, Halloran says.
"For sponsors to expect people to put their studies as a top priority and spend their time on it, there has to be some compensation," Halloran says. "And it'd be worth trying to get someone to pay for the salary of a recruiter."