Gilmore, N

Lebouche, B

Routy, J

English

PubMed

Springer - Publisher Connector

BioMed Central
Page 1 of 1
(page number not for citation purposes)
Retrovirology
Open AccessPoster presentation
P15-02. Participation in immune-based therapy trial excludes 
participation in future trials: solving this problem
J Routy*, B Lebouche and N Gilmore
Address: Immunodeficiency Service and Division of Hematology, McGill University, Montreal, Canada
* Corresponding author    
Background
Participation in clinical trials to evaluate immune-based
therapies generally results in subjects being excluded from
participating in any other trials. Reasons include trial-
required structured treatment interruptions and possible
bias due to persistent effects of the immune therapy. They
include preventive vaccine, specific immunotherapy trials
such as Quest and Remune/ALVAC, dendritic cell therapy
and cytokine-based trials such as Esprit and Silcaat(IL-
2)and IL-7. Therefore, there is a need to look for ethically
justifiable ways whereby immune-based trials can con-
tinue to recruit participants successfully and participants
can be allowed to enter subsequent trials.
Methods
Ethicists, clinicians and HIV-infected spokespersons, from
France and Quebec, were asked to examine this problem
and identify particular issues that merit analysis.
Results
Whether participation in future clinical trials should con-
tinue to be prohibited elicited positive and negative
responses, qualified by whether the future trial is a drug or
immune-based one and by the immune intervention to
which participants had been exposed. There was agree-
ment that exclusion has to be thoroughly disclosed for
participation in a first immune-based trial. There was con-
cern that exclusion could reduce or skew first trial recruit-
ment. Interim ways to allow future participation are
needed, such as incorporating a parallel or roll-over arm
in a trial. This would also offer long-term, ongoing surveil-
lance of the effects of the earlier immune-based interven-
tion or treatment interruptions.
Conclusion
Exclusion of subjects in immune-based trials from future
trials is a concern for participants and investigators that
includes: 1) full disclosure of exclusion is required for
valid consent to participate in immune-based trials; 2)
impact of exclusion on recruitment to a first immune-
based trial is unknown; 3) the potential impact of
immune-based interventions on a clinical trial were par-
ticipants allowed to enter future trials is undefined; 4)
studying this problem will help define, analyze and show
how to accommodate it in future trials.
from AIDS Vaccine 2009
Paris, France. 19–22 October 2009
Published: 22 October 2009
Retrovirology 2009, 6(Suppl 3):P203 doi:10.1186/1742-4690-6-S3-P203
<supplement> <title> <p>AIDS Vaccine 2009</p> </title> <editor>Anna Laura Ross</editor> <note>Meeting abstracts – A single PDF containing all abstracts in this Supplement is available <a href="http://www.biomedcentral.com/content/files/pdf/1742-4690-6-S3-full.pdf">here</a>.</note> <url>http://www.biomedcentral.com/content/pdf/1471-2105-10-S12-info.pdf</url> </supplement>
This abstract is available from: http://www.retrovirology.com/content/6/S3/P203
© 2009 Routy et al; licensee BioMed Central Ltd. 


P15-02. Participation in immune-based therapy trial excludes participation in future trials: solving this problem

Abstract

Similar works

Full text

Available Versions

Springer - Publisher Connector

Crossref

Directory of Open Access Journals