Medical Device Link.

Originally Published EMDM November/December 2004

Industry News

European clinical trials are now subject to more standardized procedures thanks to the passage of ISO 14155: Clinical Investigation of Medical Devices for Human Subjects. Anyone conducting a trial in Europe should now follow that document instead of EN 540: Clinical Investigation of Medical Devices for Humans, experts told attendees at September’s MEDTEC Ireland conference in Galway.

In particular, the division of responsibilities between the investigators and sponsors has been clarified, and there is more guidance on document and data control, patient tracking, and informed consent procedures in ISO 14155.

“There is more of an emphasis on quality assurance and quality control for clinical investigations,” said Danielle Giroud, president of d-Target (Yverdon, Switzerland). “The need to perform a detailed risk analysis is emphasized.”

She noted that the ISO document outlines all the elements that should be on the informed consent forms, but added that, “in terms of confidentiality needs, you should go farther than what ISO says. In most cases, you just have to explain what data [are] being collected and where [that data] will go. But some countries, including Sweden, France, Norway, and Denmark, have additional procedures. The Data Protection Directive says that what you do in one country is OK for all the others. That is not always true.”

The ISO document demands careful accounting for all patients who withdraw from a clinical study. “You must document them very clearly,” Giroud said. “Otherwise, authorities might ask if you are trying to hide something.”

Among the elements that must be included in a clinical investigation plan (CIP) are:
• The objective of the study and the supporting rationale.
• The design of the clinical investigation: what is the product being compared to, and why?
• Statistical considerations expected to be taken into account.
• Methods for reporting adverse events experienced in the trial.
• Conditions for an early termination of the investigation.

It’s important to the competent authorities that all this information be presented clearly, said Barbara Tucker, medical assessor for medical devices at the Irish Medicines Board (Dublin).“I feel that [a plan] should read like a story,” she said. “Often leaps are made from one section to another without justification of scientific rationale.”

She also emphasized that the product design should be frozen once the CIP has been submitted to the competent authority. “There is no time for the competent authority to revisit amendments,” she said. “Avoid this by getting to a design freeze.”

Further refinements of the standard are needed, however, Giroud said. “It just says that investigators shall allow auditing. But by whom? The sponsor? The competent authority?” Another issue, she said, is that there is no consensus on how ethics committees should be constituted.

Another goal is to harmonize ISO 14155 better with the International Council on Harmonization’s good clinical practice documents. However, Tucker said, the documents include a lot of pharmaceutical terminology.

Copyright ©2004 European Medical Device Manufacturer