FDA should consider incorporating overseas clinical trial tracking capabilities into domestic databases currently under development, an HHS Office of the Inspector General report suggests.

Noting that FDA "lack[s] important information on the extent of foreign research," IG recommends the agency "explore ways to track information" about pharmaceutical research conducted at sites overseas. The report was released Oct. 2.

FDA is developing two databases on domestic clinical trials, one to register institutional review boards and one to track patients demographics, IG noted. The agency "should consider ways in which it could develop them to facilitate the tracking of information on foreign research," the report suggests.

"FDA could analyze this data to determine which regions of the world are hosting FDA-regulated clinical research for the first time and which countries are experiencing rapid growth in clinical research," IG suggested.

IG conducted the inspection to assess FDA's ability to assure human protection in overseas trials. The report "provides an early warning signal that FDA does not have adequate assurance of human subject protections in a growing proportion of the research submitted in support of NDAs."

IG acknowledged that its recommendations "may require additional regulations or additional resources on the part of FDA."

FDA has indicated interest in the database approach. In Aug. 14 comments on a draft version of the report, the agency asked for clarification of the IG's original, more general recommendation that FDA improve its data collection on the "location and oversight" of research submitted in NDAs.

The databases could be used to direct FDA's overseas educational efforts, including technical assistance to non-U.S. institutional review boards, IG noted.

OIG cited FDA's "information void concerning the performance of foreign institutional review boards" as a "particular concern for emerging sites with little experience in conducting clinical research for NDAs and in providing human subject protection."

"As the amount of foreign research contained in NDAs continues to grow, particularly in areas where boards may have little experience, FDA's lack of information about the review of human subject protections... becomes increasingly problematic," the report states.

While FDA gains limited understanding of overseas IRBs through reviews of clinical investigators and NDAs, "neither of these processes provides the degree of information that can emerge from an on-site review of the board itself," IG maintained.

IG suggested two ways FDA can fill the gap. One option is to encourage countries to oversee their review boards and share performance information with the agency, "particularly in cases where [the IRBs] review a substantial amount of research to be used in support of an NDA," the report states.

A more proactive option would be to "selectively conduct some reviews of institutional review boards at sites where such research is occurring and where FDA has minimal information about board review."

Reviews of overseas IRBs are becoming increasingly necessary as companies begin moving research efforts into new countries, IG said. Seventy-nine countries conducted drug research in 1999, versus 28 in 1990, as tracked by FDA.

While FDA does not have comprehensive data on the number of foreign research sites, agency overseas inspections increased to 64 in 1999 from 22 in 1990, IG said. Clinical investigators conducting research under INDs increased 16-fold in the past decade, to 4,458 in 1999 from 271 in 1990.

Public Citizen's Health Research Group maintains that FDA is unable to keep up with overseas research, noting that none of Poland's 290 investigators or Argentina's 393 investigators registered with the agency between 1994-1999 had been inspected.

HRG criticized the report for not going far enough. While IG's ideas are "laudable...there is simply no sense of urgency in the report's recommendations, despite the data-collection disaster it describes."

FDA Overseas Clinical Trial Tracking, IRB Inspections Suggested By IG

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