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)