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 2 nd 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)