News Briefs

25% of patients don’t complete clinical trials

Only 75% of patients that begin clinical trials for drugs fully complete, according to a recent study by Cutting Edge Information in Research Triangle Park, NC, noting several reasons for this low completion rate.

The reasons for departure from a study vary from boredom to inability to get to the examination sites to feelings that the trials are not helping their ailment. Additionally, patients often complain that the risks and requirements of the study were not adequately reported to them prior to enrollment.

With the average per-patient cost of clinical trials ranging from about $5,500 in Phase I to $7,600 in Phase III, pharmaceutical companies stand to lose a great deal from such high patient turnover rates.

One way companies have been trying to improve retention of participants is through communication initiatives. The study said that at the beginning of a trial patients must be fully aware of the parameters and have access to communication avenues for questions. The best results involved treating patients as clients. Companies must treat patients with respect, define the trial for them, and keep them informed throughout the process.

Critic: Trial transparency system doesn’t need law

With a bill kicking around the halls of Congress related to clinical trial transparency, some are scratching their heads over a need for such legislation.

"The bill would mandate public disclosure of not only active clinical trials," says Dan McDonald, the vice president of Thomson CenterWatch in Boston, "but also clinical trial result information, which is in itself a very noble cause."

He’s not sure the proposed law is essential. McDonald agrees that companies should make data available for consumers, but many already do just that through various registries, and his chief concern lies in the bill’s requirement of posting on a central internet registry.

Such an effort already has created the www.clinicaltrials.gov web site, though that has had light usage at best. The national registry, which went live in 2000 after being established through a $215 million appropriation, has yet to receive full compliance. McDonald says not quite half the trials that should be on the www.clinicaltrials.gov web site are posted.

"There have been no FDA crackdowns on pharmaceutical companies that we know of, to get them to post this information," McDonald says. "So our point is that it really hasn’t worked, not the way it was intended."

Instead, companies have posted clinical trial data on commercial registries, and have done so for about a decade. With a system already in place, McDonald says there isn’t necessarily a need for legislation such as the Fair Access to Clinical Trials (FACT) Act of 2005, which Sens. Christopher Dodd (D-CT) and Charles Grassley (R-IA) introduced in February.

Its authors have proposed that the law create a registry on information for all clinical trials conducted to test the safety or effectiveness of any drug, biological product or device, including approved products, intended to treat serious or life-threatening diseases and conditions.

McDonald adds that pressure for a government-mandated clinical trials registry also is coming from the International Committee of Medical Journal Editors.

But the FACT Act is of concern to companies that fear submitting proprietary information to the registry.

"It would disclose detailed information about the design of studies, the indication targeted and a little bit about the molecules themselves to competitors," McDonald says. "Obviously, that’s a big concern."

Other worries for companies relate to gathering the volumes of data to comply with requirements for such a registry, as well as determining which results, positive or negative, are worth reporting.

The FACT Act, also labeled S.470, has been referred to the Senate’s Committee on Health, Education, Labor, and Pensions. In addition to Dodd and Grassley, other co-sponsors include Sens. Ron Wyden (D-OR), Tim Johnson (D-SD) and Lincoln Chafee (R-RI).

More pediatric device development needed

As part of last year’s Medical Devices Technical Corrections Act, which came out in April and clarified language in the Medical Device User Fee and Modernization Act of 2002, the FDA was asked to issue a report to Congress on barriers of availability to devices intended for treatment and diagnosis of diseases that affect children.

After publishing a notice in the Federal Register asking industry for comments on what the sector needed. Additionally, last fall the FDA began meeting with professional organizations, health care providers, academia, consumers and other stakeholders, including a series of meetings sponsored by AdvaMed.

Overwhelmingly, according to Joanne Less, PhD, associate director of clinical research and government affairs in the FDA’s Center for Devices and Radiological Health, the barriers identified by participants fall into three categories: economic, clinical, and regulatory.

Less spoke during the annual Device Submissions Workshop sponsored by the Advanced Medical Technology Association (AdvaMed) in May in Washington, DC.

Companies feel that the development costs are much too prohibitive, she explained, adding that companies perceive considerable added liability issues in the pediatric market.

"Some of the smaller manufacturers would say that if they could make a million dollars, they’d be interested in exploring the market," Less said. "Some of the larger companies would say that they weren’t even interested for a million."

Other issues include a lack of reimbursement from Medicare and Medicaid, combined with an absence of a mechanism for patent exclusivity.

Drug companies often are able to take advantage of the Pediatric Research Equity Act, or PREA. If a company conducts studies to show how its drug works in a pediatric population, PREA allows FDA to grant some level of exclusivity on the drug’s indication — for both adult and pediatric populations.

"As a result, so many companies feel that it is not worth their time or money cost to bring pediatric devices to market," Less said.

On the clinical side, she said there is a belief that pediatric trials are unethical and that enrollment is limited by parental reluctance, concerns about testing exposure — X-rays and blood samples, for example — and geographic constraints because the populations are so small and so spread out around the country.

"It is much harder to get pediatric patients to come back on a regular schedule when they’re not hospitalized," Less said.

When it comes to government’s role, Less said companies think that regulatory requirements aren’t clear and there needs to be more device-specific guidance for new devices and modifications to existing devices.

Frequent size changes are needed for smaller anatomy, requiring additional regulatory activity, retooling and manufacturing.

Some of the proposed solutions include more government grants for research and development for companies deciding to enter the market.

Also mentioned as a possible incentive are tax credits, as well as expedited reimbursement decisions from the Centers for Medicare & Medicaid Services.

In the regulatory arena, industry says it is looking for more guidance from FDA and perhaps even revised regulatory requirements in the form of new 510(k) applications specifically for pediatrics.

Less said the FDA currently is working on a targeted survey to see what can be done to facilitate development under current laws and how to encourage invention through changes to policy.

OHRP telephone numbers change

In June, the Office of Human Research Protections (OHRP) of the U.S. Department of Health and Human Services announced new phone numbers for all its employees.

The main OHRP phone number is (240) 453-6900. The area code has changed as well as the office number. Other organizational phone numbers are available at the office’s web site. Go to www.hhs.gov/ohrp/about/phonstfa.htm to see an alphabetical listing by staffers’ last names.

Callers using the old numbers will hear a recorded message directing them to the new numbers.

OHRP’s toll-free phone number, (866) 447-4777, is unchanged.