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CLINT: facilitating international prospective clinical trials in stem cell transplantation

CLINT: facilitating international prospective clinical trials in stem cell transplantation. CLINT Project Summary June 2007. Aim.

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CLINT: facilitating international prospective clinical trials in stem cell transplantation

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  1. CLINT: facilitating international prospective clinical trials in stem cell transplantation CLINT Project Summary June 2007

  2. 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

  3. 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

  4. Partners • EBMT • CIBMTR* • Univ of Central Lancaster (UCLAN) • Imperial College * Associated partner

  5. 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)

  6. CLINT steering committee • Jane Apperley • Zoe Doran • Carmen Ruiz & Mary Horowitz • David Coles • Ronald Brand • Myriam Labopin • Fiona McDonald

  7. 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

  8. 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

  9. 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

  10. WP2: finance • Total 102K (85K plus 17K overheads) • 35K per annum bioinformatics programmer (70K) • 15K meetings

  11. 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

  12. 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)

  13. 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

  14. 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)

  15. 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

  16. WP5: finance • Total 84K (70K plus 14K overheads) • 32.5K per annum, part salary of post-doctoral fellow (65K) • Meetings (5K)

  17. 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)

  18. 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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