Document 1088
 DOCN  M94A1088
 TI    Patient advocates as experts to improve patients' information before
       they enroll in a clinical trial.
 DT    9412
 AU    Fontenay F; Dagron N; Prestel T; Ahouanto M; Volny-Anne A; Meyer P;
       Rey-Coquais X; ARCAT-SIDA, Paris, France.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):211 (abstract no. PB0859). Unique
       Identifier : AIDSLINE ICA10/94371487
 AB    OBJECTIVE: To improve information and informed consent forms which are
       given to prospective clinical trial participants by improving their
       readability, their thoroughness and their appropriateness. METHODS: A
       team work agreement has been established between the ANRS (the French
       National AIDS Research Agency) and TRT-5, a network of patient advocates
       from five French community-based AIDS organizations. Protocols are
       reviewed by TRT-5 before being implemented. Comments and concerns are
       then forwarded to principal investigators. RESULTS: So far, four
       protocols have been reviewed between July and December 1993. A large
       part of the reviewing process revolved around informed consent forms. We
       rewrote them using layman's language, and tried to make them clearer and
       more informative about trials' rationale and objectives. Full protocols
       were necessary to clarify practical modalities involved, sush as
       schedule of visits, types of exams, number of blood samples taken, etc.
       In addition, we often had to include additional legal information about
       issues of confidentiality, insurance coverage and patients' rights.
       DISCUSSION: Team work seems to truly improve the quality of information
       documents since the majority of our comments and suggestions were taken
       into account. Revised documents were more appropriate at both legal and
       practical levels. A survey is presently going on to evaluate patients'
       perception of these documents and to fine tune our work. Similar team
       work agreements are currently being negociated with drug companies which
       are running independent trials in France.
 DE    Acquired Immunodeficiency Syndrome/*THERAPY  *Clinical Trials  Human
       Informed Consent  *Patient Advocacy  *Patient Education  MEETING
       ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).