clinical trial design

HOW INFORMED IS 'INFORMED CONSENT'?

... Volunteer Patients Have Unreliable Memories, It Seems Participants in a I 6-week clinical trial of the effects of a new anti-inflammatory agent in RA were given a test afterwards to check whether they had understood the information given at the beginning about the conduct and risk of the study and the nature of their informed consent. Of the I 8 patients I 7 (9 females, 8 males; aged 23-68) completed the questionnaires and interview.

e Two thirds did not remember having been told (at least 3 times verbally, and on paper) of the risk of peptic ulceration. e Some patients remembered information (relating to blood donation, for instance), but made errors about the content of the_

discussion. e Others gave wholly fallacious information, such as 'this medication is safer than other anti-inflammatory agents'. Thus-

'Two thirds of the participants in the piroxicam study lost (or never had) the factual basis for making a rational judgment about entering the study or withdrawing from it at a later time'.

The informed consent procedure could possibly be improved by group meetings in which the participants in a clinical trial can discuss the protocol and risks of the study. Obtaining consent again, after initial anxiety has decreased, may improve comprehension.

What type of people volunteered, and why? 8 Demographic data showed that the most likely participants in trials are not necessarily poor and black, as is sometimes

suggested. All volunteers in this trial were white, and two thirds were from the middle class (median family income, $13,000).

I> They agreed to participate to help their own and others' arthritis and took pride in their self-sacrifice and friends' commendations for their altruism.

Hassar, M. and Weintraub, M.: Clinical Pharmacology and Therapeutics 20: 379 (Oct 1976)

INPHARMA 20th November, 1976 p13