MD+DI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

What to Do About Results of Failed Trials?

The New York Times today has an article spotlighting a loophole in a new law that requires device makers to publicly disclose results from all clinical trials of approved products. It does not cover trials for products that never make it to market. This is especially a concern for patients who have received an implantable device in such a trial. How will they be informed about potential problems with it down the road?

There is little incentive for a company to keep following up on products that it never marketed. This is a serious issue. Unfortunately, the Times appears to be using it as an excuse to bash industry again. This slant is apparent from the headline on. The author, Barry Meier, never considers that public disclosure and patient follow-up are two separate issues. The debate is over whether the results of trials for failed products need to be publicly disclosed. That is irrelevant to the more important question of whether patients from such trials should continue to be monitored. They should, regardless of whatever regulatory disclosures have taken place. It is up to device companies to make sure this happens -- and they have not always done a good job of doing that. The disclosure issue is minor by comparison, and little more than an excuse to continue to bash industry.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.