Clinical Trials Standard Handed a Setback

FROM THE EDITORS

Conducting clinical trials for medical devices in Europe has long been a trend for device companies because trial results can generally be gathered more quickly there than in the United States. European regulators recognize both ISO 14155, “Clinical Investigation of Medical Devices for Human Subjects—Parts 1 and 2,” and the ICH-GCPs, The International Conference on Harmonization—Good Clinical Practices, a document designed for pharmaceutical trials.

A draft international standard (DIS) revising ISO 14155 has been in the works, but was recently voted down. That leaves device manufacturers with the 2003 version, which is still valid. But is that a good thing?

“Manufacturers in Europe will simply continue to use the previous version,” says Susanne Ludgate, MD, clinical director, devices for the Medicines and Healthcare Products Regulatory Agency in the UK. “This remains a good standard with basic principles set out and has certainly been found helpful by most European manufacturers.” Ludgate says that she does not think a new standard will be written. “One of the reasons that [the DIS] was voted against was that the revisions turned it into a guidance document [that was] trying to cover every detail rather than [being] a standard,” she says. “One of the problems of doing this is that you get into far too much detail so that countries find it increasingly difficult to accept. It is much better to have broad general and helpful principles.”

Kimber Richter, CDRH deputy director for medical affairs, says that the study group will probably continue to edit the revision. “It will eventually replace the current standard, after the comments have all been dealt with,” she says.

It is possible that the standard went down because some countries wanted additional improvements, explains Anneke Hurkens, who serves on the editing committee for the standard. She believes that a new version of the DIS will be released incorporating the comments received and then the document will be circulated for voting again. However, she adds that she has not seen any official notification from the International Organization for Standardization on the next steps.

And then there is the pharmaceutical alternative to consider. Ludgate says that the ICH-GCPs do not come into play at all because that document covers pharmaceuticals and is not appropriate for medical devices. Similarly, she says, “the Clinical Trials Directive is also not applicable to medical devices, and indeed we have had problems with some manufacturers trying to conform with these guidelines rather than the principles set out in the [ISO] standard.”

Richter, however, notes that although the ICH-GCPs document is designed for drugs, many of the terms and concepts are the same for all clinical trials. She suggests that the ISO standard be harmonized with ICH to make it convenient for firms and investigators to conduct trials. “Some countries are adopting ICH and are trying to bend it to device needs. If an updated standard does not come out eventually, we may see more governments doing so,” says Richter. Hurkens, who is a senior clinical quality specialist for Medtronic in The Netherlands, says, “We use the GCPs as guidance, but the advantage of the ISO 14155 is that it is tailor-made to the device specifics.” The definition of adverse events, for example, takes into account the specific safety aspects of devices.

It will be interesting to watch FDA's reaction, too. Would the agency recognize the 2008 version of ISO 14155 if it became a final standard? If the current version remains in effect, CDRH officials may prefer that device companies follow the stronger ICH-GCPs.

Sherrie Conroy for the Editors