Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
Protocol Title : A Randomised, open labelled study in anti ... - EME
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
9 TRIAL COMMITTEES<br />
!<br />
9.1 Trial Management Group (TMG)<br />
The Trial Management Group normally <strong>in</strong>cludes those <strong>in</strong>dividuals responsible for the<br />
day-to-day management of the trial, such as the chief <strong>in</strong>vestigator, statistician, trial<br />
manager, research nurse, data manager. The role of the group is to monitor all<br />
aspects of the conduct and progress of the trial, ensure that the protocol is adhered<br />
To and take appropriate action to safeguard participants and the quality of the trial<br />
itself. The TMG will meet monthly.<br />
9.2 Trial Steer<strong>in</strong>g Committee (TSC)<br />
The role of a Trial Steer<strong>in</strong>g Committee will be to provide overall supervision of the trial and ensure<br />
that it is be<strong>in</strong>g conducted <strong>in</strong> accordance with the pr<strong>in</strong>ciples of GCP and the relevant regulations.<br />
The Trial Steer<strong>in</strong>g Committee will be chaired by:<br />
Decisions about cont<strong>in</strong>uation or term<strong>in</strong>ation of the trial or subst<strong>anti</strong>al amendments to the protocol<br />
will be the responsibility of the Trial Steer<strong>in</strong>g Committee. The TSC will meet every 6 months and<br />
may take the form of a teleconference or face-to-face meet<strong>in</strong>gs.<br />
9.3 Data Monitor<strong>in</strong>g and Ethics Committee (DMC)<br />
The role of an Data Monitor<strong>in</strong>g Committee will review the accru<strong>in</strong>g trial data and assess whether<br />
there are any safety issues that should be brought to participants’ attention or any reasons for the<br />
trial not to cont<strong>in</strong>ue. The Data Monitor<strong>in</strong>g Committee is <strong>in</strong>dependent of both the <strong>in</strong>vestigators and<br />
the funder/sponsor. It will meet 6 monthly which may take the form of a teleconference or face-toface<br />
meet<strong>in</strong>gs. It will makes it recommendations to the Trial Steer<strong>in</strong>g Committee. The <strong>in</strong>dependent<br />
chair is: Dr. M. H. Buch, Section of Musculoskeletal Diseases, Leeds Institute of Molecular<br />
Medic<strong>in</strong>e, University of Leeds, Leeds, UK<br />
10 PUBLICATION POLICY<br />
This is an <strong>in</strong>vestigator led trial; sponsored by the CI’s subst<strong>anti</strong>ve employers, QMUL. The data<br />
collected will not be used to license/ register any pharmaceuticals. Authorship of the f<strong>in</strong>al<br />
manuscript(s), <strong>in</strong>terim publications, or abstracts will be decided accord<strong>in</strong>g to active participation <strong>in</strong><br />
the <strong>study</strong> design, trial management group and accrual of eligible patients. Contribut<strong>in</strong>g centres<br />
(and participat<strong>in</strong>g Investigators) will be acknowledged <strong>in</strong> the f<strong>in</strong>al manuscript. Representatives for<br />
the<br />
Sponsor will be added, as appropriate, as co-authors. No participant may present data from his/her<br />
centre separately from the rest of the trial results unless approved by the trial management group<br />
and the Sponsor .<br />
11 REFERENCES<br />
1. Silman AJ. Epidemiology of rheumatoid arthritis. Apmis 1994;102:721-8.<br />
2. Scott DL, Symmons DP, Coulton BL, Popert AJ. Long-term outcome of treat<strong>in</strong>g rheumatoid<br />
arthritis: results after 20 years. Lancet 1987;1:1108-11.<br />
3. Breedveld FC, Weisman MH, Kavanaugh AF, et al. The PREMIER <strong>study</strong>: A multicenter,<br />
randomized, double-bl<strong>in</strong>d cl<strong>in</strong>ical trial of comb<strong>in</strong>ation therapy with adalimumab plus<br />
methotrexate versus methotrexate alone or adalimumab alone <strong>in</strong> patients with early,<br />
aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis<br />
and rheumatism 2006;54:26-37.<br />
4. Kristensen LE, Kapetanovic MC, Gulfe A, Soderl<strong>in</strong> M, Saxne T, Geborek P. Predictors of<br />
response to <strong>anti</strong>-TNF therapy accord<strong>in</strong>g to ACR and EULAR criteria <strong>in</strong> patients with<br />
established RA: results from the South Swedish Arthritis Treatment Group Register.<br />
Rheumatology (Oxford, England) 2008;47:495-9.<br />
Study: R4RA EudraCT: 2012-002535-28 35 / 34