thorities and resources to give more emphasis to safety in the process of pre- and post-market approval of pharmaceuticals.”

Regarding audits, Dr. Breier stated: “We’ve got to be able to audit posting commitments as well as accuracy, objectivity of summaries. Who will do it and how? And who will pay for it? It will be a very large task. What are the implications for compliance lapses? How are we going to put some teeth into the compliance checking?”

Dr. Zarin described a pilot study going on at ClinicalTrials.gov in which staff are trying to reach IRB contacts and health authorities for non-U.S. trials to try to understand how much help they can provide in verifying that they, in fact, approve a trial in question, and whether they could actually verify more detailed information because the IRB has seen the protocol. She also noted that avoiding duplications is a big task, as is updating, for example, recruitment status.

Ms. Ireland called for “reasonable financial penalties” for those who do not comply. Ms. Terry asked if there were a way to “incentivize” compliance.

Lindsey Johnson from U.S. PIRG said that a “scarlet letter” for those who do not comply is not enough. “We need penalties that will resonate with the public, if we expect the public to trust the database.”

RESPONSIBILITY FOR DEVELOPING AND MANAGING THE REGISTRY

Different workshop participants suggested that a national registry might be managed by either a nonprofit organization or a trusted government agency. Expansion of the National Library of Medicine’s responsibility for ClinicalTrials.gov to include more trials and more information might be a logical way to build on existing programs. It was also noted that the FDA has some of the data that would be needed by a clinical trial registry.



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