Document 1086
 DOCN  M94A1086
 TI    A team work agreement between investigators, activists and PWAS to
       improve clinical trials in France.
 DT    9412
 AU    Lestrade D; Chambon JF; Dagron N; Fontenay F; Prestel T; Meyer P;
       Rey-Coquais X; ACT UP Paris, France.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(2):212 (abstract no. PB0862). Unique
       Identifier : AIDSLINE ICA10/94371489
 AB    OBJECTIVE: To identify, solve and prevent problems which are experienced
       by clinical trial participants, through cross-examination of various
       protocols by patient advocates. METHODS: Five French community-based,
       non-profit AIDS organizations networked to organize a common structure,
       named TRT-5, to work around research and treatment issues. To reach our
       goal of improving clinical trials, we designed a team work agreement
       with the ANRS (the French National AIDS Research Agency) which controls
       a large part of clinical AIDS research in France. Each ANRS study
       protocol is reviewed by TRT-5, and comments and suggestions are then
       forwarded to principal investigators. RESULTS: So far, four protocols
       have been reviewed by TRT-5 between July and December 1993. Comments and
       suggestions were presented about both full-length protocols and informed
       consent forms, and addressed gaps and discrepancies around issues of
       feasibility and ethics. All informed consent forms were entirely
       rewriten. DISCUSSION: The large majority of TRT-5's comments and
       suggestions were accepted by researchers and included in full-length
       protocols and informed consent forms. Thus, TRT-5' work helped to
       improve both clinical trial's design and patients' information. In order
       for trials to truly answer the needs of PWAs, it is necessary to include
       patients' interests in their design. Today, patient advocates who form
       TRT-5 are considered as experts of a different kind by investigators.
       This team work between researchers and TRT-5 allows persons with HIV
       disease to become bona fide partners in AIDS research.
 DE    Acquired Immunodeficiency Syndrome/*THERAPY  *Clinical Trials  France
       Human  Informed Consent  Patient Advocacy  Patient Education  Patient
       Participation  MEETING ABSTRACT

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