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Subject:

RSS Medical Section & Merseyside Local Group joint meeting, 31/01/06

From:

Ingrid Harper <[log in to unmask]>

Reply-To:

Ingrid Harper <[log in to unmask]>

Date:

Tue, 3 Jan 2006 15:12:41 +0000

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (121 lines)

Royal Statistical Society Medical Section / Merseyside Local Group
Tuesday 31st January 2006   2pm-5pm
Thompson Yates Lecture Theatre, Thompson Yates Building, University of
Liverpool

Please contact Catrin Tudur Smith ([log in to unmask]) to register a place

Stuart Pocock (London School of Hygiene and Tropical Medicine)

Current Controversies in Data Monitoring

This talk will cover a range of controversial issues concerning Data
Monitoring Committees (DMCs) and statistical stopping guidelines in
clinical trials:

1)  What constitutes a sensible statistical stopping boundary for claiming
benefit of a new treatment.

2)  Some challenging examples of trials where DMCs decision to stop (or
not) has a major bearing on future clinical practice.

3)  Sample size re-estimation, including the controversial adaptive designs
whereby unblinded interim data are used to determine eventual trial size.

4)  Organizational matters in DMC conduct, such as when to stay blinded,
interactions with sponsors and the role of independent statistician.

5)  The ethical dilemmas in trial data monitoring, balancing the
responsibilities to patients in a trial, society's need for convincing
evidence of therapeutic progress, and the dangers of stopping a trial too
soon.

Tony Johnson (MRC Biostatistics Unit, University of Cambridge Institute of
Public Health)

Trial Steering Committees, Trial Management Groups, Data Monitoring
Committees: What do they do in the Management of Clinical Trials?

The conduct of clinical trials in UK now requires the setting-up of a
formidable management structure to safeguard their integrity without
exposing patients to unwarranted risk of adverse events. Despite the
publication of guidelines on research governance and trial management there
are several models being used by different funding agencies and some
confusion about the way in which the separate committees operate,
communicate, and interlink. Such confusion can result in problems that are
easily avoidable as will be illustrated with examples that have arisen in
recent studies. Some suggestions for the operation of these committees will
be made based on experience of clinical trials in psychiatry, epilepsy, and
transfusion medicine.

Matt Sydes, on behalf of the DAMOCLES group (MRC Clinical Trials Unit)

Damocles: Issues In Data Monitoring For Randomised Controlled Trials

DAMOCLES was a multi-method study conducted in 2001-2003. Systematic
reviews, surveys and interviews were used to investigate how Data
Monitoring Committees (DMCs) for randomised controlled trials (RCTs) are
utilized and organised, how they make decisions, and how the quality of
decision-making of DMCs could be improved. The results indicated that a
variety of processes and procedures are employed, and that coherent
guidance is not easily available for many issues relating to DMCs; in some
cases, there is no clear consensus on how contentious issues ought to be
addressed.

The research findings(1) informed the development of a template for a
Charter for DMCs(2). This provides a structure to outline the roles, remit
and organisation of a DMC throughout the trial. The Charter is to be
completed by the trial investigators together with the DMC members prior to
the start of the trial. Data monitoring issues are addressed systematically
and transparently, together with justification, advice and illustrative
examples. The Charter forms a logical framework allowing the DMC and
investigators to cover both general DMC issues and aspects of data
monitoring which are often neglected.

Several RCTs are now beginning to use this Charter and finding it helpful.
It is envisaged that more widespread adoption will help DMCs and
investigators to address many aspects of DMC functioning more consistently,
effectively and efficiently.

(1) AM Grant, DG Altman, A. B. Babiker, MK Campbell, FJ Clemens, JH
Darbyshire, DR Elbourne, SK McLeer, MKB Parmar, SJ Pocock, DJ,
Spiegelhalter, MR Sydes, AE Walker, SA Wallace, and and the DAMOCLES group.
Issues in data monitoring and interim analysis of trials.
Health Technology Assessment monograph series 9 (7), 2005.

(2) DAMOCLES study group. A proposed charter for clinical trial Data
Monitoring Committees: helping them to do their job well.  The Lancet
365:711-722, 2005.



Dr. Helen Clough,
Lecturer in Risk Analysis and Statistics,
Department of Veterinary Clinical Sciences,
University of Liverpool,
"Leahurst",
Neston
S. Wirral CH64 7TE

Tel + 44 151 794 6173
Fax + 44 151 794 6005

---------- End Forwarded Message ----------

---------- End Forwarded Message ----------



********************************************************
Ingrid Harper
University of Liverpool
Department of Mathematical Sciences
Division of Statistics and Probability
Mathematical Sciences Building
Peach Street
Liverpool L69 7ZL

Tel:  0151 794 4751
Fax: 0151 794 4754
********************************************************

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