The pharmaceutical industry's failure to list cancer trial information on ClinicalTrials.gov remains a concern to FDA, Oncology Drug Products Division Director Richard Pazdur, MD, said May 12.

"After every [end of] Phase II meeting and industry meeting we have a written bullet that is part of the minutes to that meeting that specifically informs the sponsor of the existence and their obligation to list the website," Pazdur told a House Government Reform Committee hearing.

Ranking Member Henry Waxman (D-Calif.) lamented the finding of an FDA report which concluded that only 47% of industry-sponsored studies have been posted on ¹ ClinicalTrials.gov (² Also see "ClinicalTrials.gov Postings By Industry Increase, But Still Appear Incomplete" - Pink Sheet, 23 June, 2003., p. 34). By comparison, 91% of studies sponsored by NIH have been posted, he noted.

"We've taken a concerted effort talking to industry about this," Pazdur maintained.

"We have got an education program. At every meeting we are asking them and informing them of their obligation to do so. In addition to that we have a massive process during professional education to encourage physicians and to encourage patients to utilize this resource."

FDA has also enlisted the support of patient groups to advocate for commercial sponsors to list their trials.

The lack of enforcement tools to require clinical trial registration has drawn fire from the academic community (³ Also see "ClinicalTrials.Gov Registry Needs Legislative Boost, JAMA Editorial Says" - Pink Sheet, 28 July, 2003., p. 7).

"We are somewhat limited on what we can do," Pazdur acknowledged. "We can educate. We can talk."

FDA has been trying to figure out why industry is reluctant to participate in the clinical trials registry.

"One would think they would have every reason to place the trials on. If we're talking about poor accrual in clinical trials, industry can't cry about poor accrual for clinical trials if they're not putting it on the website," Pazdur asserted. "There may be some concerns of confidentiality, listing trials on www.clinicaltrials.gov. I really don't buy that," he declared.

Waxman chided industry for not participating in the hearing. "I am disappointed that the Pharmaceutical Research & Manufacturers of America, which was invited to testify, has been unable to send a witness to this hearing."

Waxman also expressed puzzlement over industry's unwillingness to post trial information.

"While they're refusing to comply fully with the government website," Waxman said, ⁴ PhRMA's clinical trial website "often lists clinical trials that are not listed on the government website, but on their website they frequently don't include eligibility details on clinical trials [or] try to provide contact information."

The hearing was called to discuss ways to increase the rate of participation in cancer clinical trials. In his opening remarks, committee Chairman Tom Davis (R-Va.) listed "lack of patient and physician education about clinical trials, problems traveling to trial sites, strict eligibility criteria and third-party payer reimbursement policies" as enrollment obstacles.

Pazdur updated the committee on progress of the FDA/National Cancer Institute Interagency Oncology Task Force. HHS Secretary Tommy Thompson said the collaboration will result in "vast improvements" in the speed of cancer drug development (⁵ Also see "Cancer Drug Development To See “Vast Improvements” In Speed – Thompson" - Pink Sheet, 22 March, 2004., p. 31).

The task force is "currently developing resource materials that will assist investigators in preparing the data needed for FDA's regulatory process," Pazdur said.

Other task force activities include development of electronic IND applications, imaging biomarkers and surrogate endpoints for cancer clinical trials, he said.

Rep. John Carter (R-Texas) asked the panel if intellectual property issues are "becoming a stumbling block" for cancer drug development. "Could we change our intellectual property laws to get a longer time after approval?"

IP "issues are certainly a problem, particularly for combination treatments, particularly when we want to look at a much broader range of cancers than the more narrowly focused FDA approval pathway," NCI Cancer Treatment & Diagnosis Division Associate Director Michaele Christian, MD, said.

"It is possible that incentives might encourage industry to work more broadly with NCI, with each other."

ClinicalTrials.gov Noncompliance Remains An FDA Concern

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