Clinical trial participants generally appreciate efforts to inform them promptly of study results, although the degree of satisfaction may depend on the particular communication channel used, suggests a recent paper by researchers at the University of Rochester Medical Center in New York.

A team led by Dr Ray Dorsey from the US Center’s Department of Neurology surveyed responses to a communication programme developed for a multi-centre, randomised, placebo controlled trial of ethyl-eicosapentaenoic acid (ethyl-EPA) in 316 adults with Huntingdon’s disease. The 12-month study was conducted at 41 sites in the US and Canada and results, as well as the outcome of the communication programme, were reported in the December issue of Archives of Neurology (vol. 65, No. 12).

As the Medical Center points out, researchers in the US only have to inform participants in situations where new information arises that may affect the subjects’ willingness to continue with the trial. Neither federal guidelines nor institutional review boards generally require the disclosure of results at the end of a study, even if the trial is halted early.

In recent years, there have been a number of high-profile examples of either clinical trial information being withheld from participants (and the general public), subjects not being informed directly of study results, or participants learning about negative results indirectly from other sources such as the media.

“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 unfavorable results – abandoned before it is submitted for regulatory approval,” the Center notes.

Within 48 hours

In the ethyl-EPA trial, the researchers sought to inform participants directly of the results – which, in this instance, showed no significant differences in effect between the active drug and placebo – within 48 hours of the official results release. Federal securities law requires companies to disclose results publicly if they have a material financial impact.

The communications programme included a mixture of electronic media and personal contact. A press release from the investigators was posted to the study website and e-mailed to members of the Huntingdon’s disease community within a day of the sponsor company’s (Amarin Bioscience) press release going out.

In addition, study co-ordinators telephoned each of the participants directly and a conference call open to all participants was held by the study’s principal investigator and the chief executive officer of Amarin Bioscience, two weeks after the results were released.

In the subsequent survey of 217 study participants, 114 (52.5%) of whom responded, 73.1% of the respondents said they first learned of the trial results via the telephone call from site staff and 46.3% learned of the results within one day of Amarin’s press release.

A large proportion of respondents reported high or complete satisfaction with the telephone call (89.3%) and the conference call (82.1%), but fewer were satisfied with the sponsor’s press release (50.0%). Most respondents said they gained a good understanding of candidate drug’s risks and benefits as well as the next steps for their participation in the study.

“Individuals who volunteer to participate in clinical research frequently expose themselves to risks, both known and unknown,” Dorsey commented. “Because of their participation, they should be informed of the results of these studies in a timely and personalised manner.”

It was critical, he added, “that we treat participants as partners in research. It is our hope that the commitment that the investigators and sponsor made to communicate the results of the clinical trial in a timely and personalised manner to research participants will set the standard for future clinical trials”.