Keep clinical trial patients ‘in the loop’, say researchers

18-Dec-2008 - Last updated on 18-Dec-2008 at 12:06 GMT

There is no formal requirement to inform clinical trial participants of the results of the study, a situation which can leave them “confused, frustrated and, in some cases, lacking information that may be important to their health,” according to a report in the journal Archives of Neurology.

At present, clinical researchers are only required to inform participants in instances when new information arises that could affect their willingness to continue participation.

But neither federal guidelines nor institutional review boards generally require disclosure of results at the conclusion of a study – even if the study is stopped early – any many participants are never told the outcome.

The authors, from the University of Rochester Medical Centre in the US, have drawn up a method to routinely inform patients of study results, based on the publication of a media release from the investigators immediately after a press communication from the sponsor, a phone call to the participants from site staff, and a conference call for research participants two weeks after the results were released.

They used the approach to follow up with participants in a trial of an experimental drug (ethyl-EPA) in Huntington disease, which enrolled 316 patients in the US and Canada. The results showed no beneficial effect for the drug versus placebo.

Nearly three quarters (73 per cent) of those who responded to the survey said they had first learned of the results from their site’s telephone call, while 46 per cent said they learned the results within one day of the sponsor’s press release.

Just under 90 per cent of participants reported “high or complete satisfaction” with the site telephone call, but the reaction to the press release was less favourable with just 50 per cent of those surveyed giving it that score.

Despite recent federal efforts to mandate communications in instances when the product is approved, researchers are still not required to disclose results in instances when the drug or device has been tested in patients but – because of unfavourable results – abandoned before it is submitted for regulatory approval.

"Individuals who volunteer to participate in clinical research frequently expose themselves to risks, both known and unknown," said neurologist Ray Dorsey, the report's author.

"Because of their participation, they should be informed of the results of these studies in a timely and personalised manner."