CLINT: facilitating international prospective clinical trials in stem cell
transplantation
CLINT Project Summary
June 2007
Aim
To support the development of the infrastructure necessary for the conduct of trans-European prospective clinical trials activity in autologous and allogeneic stem cell transplantation
Goals
Establish methodology to support prospective clinical trials
Standardise data collection with CIBMTR Achieve consensus on regulatory
requirements Develop portal for information exchange Improve biostatistical methodology Disseminate results as widely as possible
Partners
EBMTCIBMTR*Univ of Central Lancaster (UCLAN) Imperial College
* Associated partner
Management structure
Scientific and technical: a CLINT steering committee comprised of the project director (JA) and the work package chairs
Financial (Imperial College)
Management (Imperial College)
CLINT steering committee
Jane Apperley Zoe Doran Carmen Ruiz & Mary Horowitz David Coles Ronald Brand Myriam Labopin Fiona McDonald
WP 1: establishing methodology for the conduct of prospective trials
Establish industry advisory committee
Develop a review process for each study
Develop SOPs
Conduct clinical trials
WP1: finance
Total 96K (80K plus 16K overheads) 20K per annum contribution to CTD (40K) 30K 2nd year for data monitor (30K) 4K per meeting, one per annum, (8K) 2K administration
WP2: standardise essential data collection and develop trial database
Compare data collection forms from EBMT, CIBMTR and NMDP
Agree final core data Design and implement new collection forms Link unrelated donor registries to database Create a trials database
WP2: finance
Total 102K (85K plus 17K overheads) 35K per annum bioinformatics
programmer (70K) 15K meetings
WP3: overcome ethical problems of transnational access
Analyse national legislative uptake of EU Clinical Trials Directive
Analyse differences in consent procedure and data protection in Europe
WP3: finance
Total 48K (40K plus 8K overheads) 9k per annum, 25% salary of research
assistant (18K) 5K per annum, senior supervision (10K) Workshops at EBMT annual meeting (10K) Reports (2K)
WP4: design and maintain a portal for information exchannge
Collect information re content Design portal Test portal Implement portal guidelines Establish inventory of databases to be linked Build database software Add clinical and scientific contents Link with AGNIS
WP4: finance
Total 96K (80K plus 16K overheads) 35K per annum, 40% salary of information
technologist (70K) 10K software (10K) Server to be provided by University of Leiden
(20K)
WP5: improve statistical analysis of prospective clinical trials
Design inventory of existing methodology for analysing SCT related survival
Make new approaches available to wider community
Encourage deposition of analyses on portal Design analyses incorporating multiple end-
points Develop standardised guidelines for analysis
WP5: finance
Total 84K (70K plus 14K overheads) 32.5K per annum, part salary of post-
doctoral fellow (65K) Meetings (5K)
WP6: disseminate results
Appoint project officer for CLINT website Establish and maintain contacts with partners Organise information workshops at annual
meetings Source information on patient-donor websites
throughout Europe Link websites of key interest groups Project officer 15.5K per annum (31K + 6.2K)
WP7: management
Appoint project officer (Imperial) Organise co-ordinating meetings Compile and submit reports in timely manner Liaise with EU project and financial officers Project officer 12.5K per annum (25K) Audits reports (4K) Total 34.8K (29K plus 5.8K)
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