The price is wrong: Poor pay = uninspired research
Sponsors should change the way they pay
Clinical research (CR) sponsors continue to impede the industry's overall productivity and efficiency by sticking with a one-price-fits-all model that simply does not work, a research expert charges.
"One price does not fit all sites, and yet sponsors continue to offer just one price," says Daniel M. Ulrey, MBA, president and chief executive officer of Midwest Clinical Support Inc. of Rolling Meadows, IL. Ulrey spoke about investigator budgets at the 45th Annual Drug Information Association meeting, held June 22-25, 2009, in San Diego, CA.
Everyone in society agrees that clinical research is a good thing, and people want to see it continue in the United States, but the problem is that research compensation to clinical research sites sometimes is too low, Ulrey says.
"Clinical trial sites and investigator sites that are for-profit sites have to make a good income to do what the sponsor wants so they can execute the study well and have the necessary patient population available," Ulrey says. "So the idea that a site in California needs to be paid the same amount as another site in Iowa or Nebraska is ludicrous because the [infrastructure] costs are completely different."
This would be like if medical payers offered one scale of reimbursement to physicians, regardless of where and how they practiced medicine, he adds.
The other problem with CR reimbursement is how sponsors pay clinical trial sites.
"They only pay doctors for each visit they have with the patient, and there's a lot more activity that goes on in a site before the study is initiated," Ulrey says. "There's a tremendous amount of time spent on preparing for that study, and they don't get reimbursed for it at all."
Poor reimbursement often leads to unenthusiastic research participation and poor study results.
"If reimbursement for a trial isn't adequate to justify a site's time and expense, then the site will shift resources to some other study," Ulrey says.
One of the reasons often cited for this inefficient compensation system is the government's crackdown on physician kickbacks and the potential for undue influence in doctor-industry contracts, he notes.
This has become such a public issue that Pfizer has announced that it will have a database of every doctor to whom it has paid more than $100, regardless of whether the physician is a clinical practice doctor or a research physician, Ulrey explains.
"I don't think that's a good idea," he says. "What will happen is people will see certain doctors being reimbursed X number of dollars, and the media will pick up on that, putting another pall over clinical research."
These types of transparency measures overlook the big picture, which is that patients need these medications and treatments, he adds.
Midwest Clinical Support has 391 CR sites and has been involved in more than 5,000 studies over the past 15 years, Ulrey says.
"We're selective about the protocols we take because we believe we have the very best sites in the United States, as part of our network," he says.
For a fee, the company identifies opportunities for CR sites and helps sites determine the study's feasibility
Clinical trial sites also contribute to the industry's inefficiency by over-committing themselves, Ulrey notes.
"Many sites will intentionally over-commit and have too many studies because they're never sure if they'll be successful," he says.
So the site will take a study without knowing for certain if they'll be able to enroll the necessary subjects or have adequate time to work on a particular study.
"They'll take a study rather than turn it down because they want to see if they can get patients enrolled to recur some of their expenses," Ulrey says.
It's more efficient to collect data about a site's capabilities first and then use this information to decide whether or not a study will be worthwhile to conduct.
Ulrey offers these suggestions for how to make the CR process more efficient:
1. Sponsors should pay fairly and more quickly.
"I don't think sponsors intentionally decide to not pay sites well, but they just don't know how to pay them well," Ulrey says. "They don't take into consideration the different geographical locations."
Then there are sponsors who have the attitude that they'll pay a set amount, and if site A balks at the reimbursement, then they'll go sites B, C, and D, until they find someone who will take it.
However, the sites who will accept less than adequate fees often are newer sites that will not be able to deliver what they promise for a trial, and so the research will suffer and the process becomes inefficient.
"Good sponsors will be receptive to a site that says, 'I'd like more money for the following reasons,' and if the reasons are justified, the sponsor will pay it," Ulrey says. "There are some excellent sponsors who pay very well and who pay on time."
However, timeliness of payment is another major inefficiency in the system.
"The average receivable now is 141 days," Ulrey says. "That's ridiculous, and it hurts sites' cash flow."
While sites wait to be paid for work that has long been completed, they have to pay salaries and other expenses.
"So sites should try to negotiate an agreement where they are paid every 30 days," Ulrey says. "Unfortunately, sponsors won't do it; at best you get a quarterly payment, and at worst it'll go two quarters."
2. Sites and sponsors should collect data on CR timelines and enrollment rates.
Each clinical research site should know some basic information about how well it performs, on average, with a clinical trial. Some of the information it should collect is as follows:
- How many patients over a set period of time are enrolled in a particular type of study?
- How many of people who are screened end up as screen failures?
- What does it cost in marketing a study per person eventually enrolled?
3. Sponsors should pay some successful sites more and stop using unsuccessful sites.
"Suppose I say the cost for a patient enrolled in a trial is $10,200," Ulrey says. "So we recruit 100 sites, and then 20 sites give us 80% of the data, and the rest give us 20% of the data."
But the cost per site is the same unless some of the low performers have been shut down, he says.
Then a low performing site isn't shut down, the sponsor is paying for monitoring a site that hasn't enrolled patients.
It's not very difficult to select only successful sites for a trial, but it's just not standard CR practice.
"They don't keep the site performance metrics," Ulrey says. "It's a big problem in this industry, where everything is driven by relationships instead of metrics."
Sites can collect their own metrics, showing their costs and success rates. Then they could use these as bargaining tools when discussing reimbursement with sponsors, he suggests.
"Show them the costs and why particular visits should be raised in reimbursement, and then you wind up with maybe 20% more," Ulrey says.
Clinical research (CR) sponsors continue to impede the industry's overall productivity and efficiency by sticking with a one-price-fits-all model that simply does not work, a research expert charges.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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