GIMEMA foundation Gruppo Italiano Malattie EMatologiche dell’Adulto

A cura del Centro Dati – GIMEMA informazione

Responsabili Marco Vignetti, Paola Fazi

Collaboratori Edoardo la Sala, Giulio D’Alfonso, Federica Passarelli

gimema@gimema.it

www.gimema.org

1982 The Gimema (Italian Group for Haematological Diseases in Adults) began in 1982, with a small group of Italian haematology centres, that realised that they could achieve scientifically significant results only by joining forces and comparing case studies.

It was the start of a journey, that has yielded unexpected successes. Over the years it has also given rise to the establishment of a network to which almost all Italian haematology centres belong. Membership requires only two strict undertakings: the rigorous adherence to clinical research protocols and the proper collation of results.

2014 Today Gimema is a recognized non-profit Foundation which operates, through its various bodies, to promote the activities of the group.

Clinical research projects are thus entrusted to the Gimema operational centre, the Data Centre, which manages the development and running of clinical trials in accordance with the complex regulations in force. Its organizational structure means also boasts complex centralized diagnosis capabilities, enabling all Italian Gimema Centres to offer patients the same level of diagnosis and treatment, no matter where they are in the country.

Running through my mind from the start of this journey to the present day, I can see the astonishing changes that have enabled us to improve our categorisation of blood diseases, from a diagnostic and a prognostic point of view, and given rise to new treatments with results that were unimaginable at the outset.FrAnco MAndEllI

GIMEMA Foundation aims at promoting academic clinical research, spreading awareness, disclosing scientific knowledge and organizing training sessions.

Academic or non-profit research is an important element of clinical research of public interest,

aimed at optimizing therapeutic strategies instead of drugs as such or their development.

It is a kind of clinical research which is essential for improving clinical practice and the daily management of disease, whose objectives are of obvious benefit to patients, for streamlining the cost-effectiveness of national health authorities, for optimizing the quality of healthcare assistance provided and for assessing and comparing the drugs marketed by pharmaceutical companies.

All this is possible thanks to the role of the “non-profit” foundations, of Cooperative Groups such as research groups, whose efficient and modern ways of working ensure the “intellectual independency” of research.

Non-profit research deals, for example, with the definition of risk/benefits of already approved drugs, establishes best therapeutic protocols and identifies combinations or sequential uses of drugs.

These are studies that in most cases originate “in the field”, from the ideas and experience of researchers who have been working within academic institutions for years and who play a key role in the dissemination of science knowledge.

In spite of the chronic shortness of resources and funds, academic clinical research also has to be conducted in accordance with tight international regulations, and logistically complex protocols. GIMEMA is structured in such a way that it manages to work within this regulatory context, guaranteeing the validity of its results and safeguarding patients’ interests.

Promoting academic clinical research

Since its foundation, 31 years ago, GIMEMA has had one objective, that of guaranteeing that all patients receive the same treatment, no matter where they come from. Given GIMEMA’s origins, this objective may seem quite ambitious. Twenty five years ago the scene was one of some cutting edge Centres, where the best available treatments were guaranteed, and of a number of other Centres where, due to a lack of resources or insufficient patient numbers, these same treatments were not available. Over the following years, GIMEMA has committed its own resources to promote the sharing of knowledge by organizing scientific discussions, conferences, meetings, and public awareness campaigns, so as to ensure that all treatments, not just those in clinical trials, follow a national standard, that even the most complex laboratory tests are accessible to everyone by centralizing biological samples.

This commitment has allowed to put down differences between Centres, to guarantee to everybody the possibility of receiving an accurate diagnosis and to be treated with state-of-the-art therapy protocols without needing to move from their place of origin.

Work carried out by GIMEMA has allowed to achieve outstanding scientific results. The GIMEMA name is becoming increasingly known on an international level and an absolute benchmark for some particular diseases, such as acute promyelocytic leukaemia. GIMEMA collaborates with the most important European cooperative groups such as EORTC (European Organisation for Research and Treatment of Cancer), MRC (Medical Research Council, UK), SAL (Study Alliance Leukaemia, Germany), and with organizations from the United States such as CALGB (Cancer and Leukemia Group B), as well as with regulatory bodies such as AIFA (Italian Medicines Agency) and EMA (European Medicines Agency).

Promoting awareness

Promoting science

To guarantee accurate diagnosis to all patients by founding state of the art laboratory technologies

To ensure that all patients will be cured in the same manner all over the Country near their home

To ensureto all patients the best therapeutic option through the use of novel drugs often not available on the market

To fund scholarship grants for young physicians in all Italian Gimema-affiliated hemaotologic Centres

To support Gimema Data Centre that ensures scientific quality and validity of research results

To organize meetings and training courses to favor interaction and share experiences between healthcare professionals.

Promoting and developing scientific research on hematologic diseases since 1982

Your donations finance these costs producing services for all

The Foundation is administered by a Governing Council made up of a minimum of three and a maximum of nine members. The Governing Council has all ordinary and extraordinary administration powers. The Governing Council is responsible for:

decisions regarding applications for inclusion or exclusion of new Associate Member Centres;

preparation of the annual report and accounts;

decisions regarding general criteria relating to the Foundation’s activities and, in particular, those regarding study, information, documentation and disclosure, as well as all other necessary initiatives aimed at fulfil the Foundation objectives.

The Governing council

Gimema Foundation operates through its various bodies. Clinical research projects are thus entrusted to the Gimema operational centre, the Data Centre, which manages the development and running of clinical trials in accordance with the complex regulations in force.

The Scientific Committee, upon request of the Governing Council:

identifies areas of interest for the Foundation’s activities and sets up study commissions on the topics deemed most relevant;

puts forward new studies, designate protocol coordinators among interested researchers;

evaluates new study proposals from Group Members, identifies which studies are to be conducted and approves biological, clinical and/or social research protocols written by the various coordinators;

promotes and maintains scientific contacts with the Italian Association of Haematology and with other national and international organizations involved in research and treatment of haematological diseases;

produces an annual report, in collaboration with the Data Centre, on the activities of the Foundation;

reviews scientific manuscripts written and proposed by the GIMEMA Group before being submitted for publication.

Scientific committee

The data centre

The main objective of the Data Centre is to ensure that the Foundation carries out its research activities by ensuring the validity and reliability of the results and, above all, the maximum protection of patients.

The main activities carried out by the Data Centre are:

The organization and design of clinical trials.

Protocol development for the conduction of clinical trials, from clinical hypothesis to statistical assessment.

The management of regulatory affairs relating to the request for authorisation of the conduction of trials to Ethics Committees and Hospital Administrations.

The conduction of clinical trials: coordination of participating centres, management and control of data coming from Centres taking part in trials.

Translational research project management.

Pharmacovigilance: coordination and management of all activity in connection with adverse events occurring to patients during the conduction of a clinical trial, in accordance with EU directives.

Software development for the conduction of clinical trials.

Statistical analysis of data collected during clinical trials.

Publication of scientific papers in medical journals, preparation of presentations and talks at national and international conferences.

To comply with international standards of Good Clinical Practice (GCP), the Data Centre has developed a series of internal standard operating procedures (SOP). This ensures the efficiency and consistency of activities within the facility and the fulfilment of all those legal duties imposed to each public or private promoter of clinical research. To this end, the Data Centre has built an operative unit of quality assurance with the task of monitoring, developing and continuously improving the quality system.

The procedures have been subjected to a process of validation and the Data Centre obtained in 2002, the UNI EN ISO 9001:2000 certification for the activities of the “Design, implementation and management of clinical trials.”

In 2011, the certification was extended to the field of education. The Data Centre has in fact, built a sector called “GIMEMA Informazione”, dealing with the organization of events and professional courses dedicated, to young people who want to venture into the world of clinical trials.

Thanks to AIL it has been possible to expand the Data Centre and in June 2008, to start many important research projects in the fields of acute myeloid leukaemia, acute promyelocytic leukaemia and acute lymphoid leukaemia.

It has also been possible to organize a training project of 30 professional data managers and to set up a clinical trials monitoring unit.

151 centers

9 laboratories

Through a network organization, which also boasts a complex centralized diagnostic tasks, all Italian centers belonging GIMEMA are able to provide patients with the same diagnostic and therapeutic possibilities regardless of their place of care.

Year 2010

Protocols LAL 0904 and LAL 1205

ß

Chronic Myeloid Leukemia

Thanks to research on CML the chance of healing from this disease have risen up to 80% over the last 10 years

â

Ph+ Acute Lymphoblastic Leukemia

By using a novel drug in the therapy of Ph+ Acute Lymphoblastic leukemia, 100% of patients now achieve complete disease remission.

Significant results have been achieved thanks to the many research projects GIMEMA has carried out. The GIMEMA name appears more and more frequently in authoritative international scientific journals and this fosters the search for new, innovative and improved therapeutic strategies for the future.

overall survivors 10 years

30%Year 2000

Protocol EIGLE

Year 2004

Protocol LAL 0201

Year 2010

Protocols LAL 0904 and LAL 1205

50%

70%

disease free survival (two years after diagnosis)

80%

20%

RC

1988 IDA

100%

50%

10%

1993 AIDA

2000 AIDA 2000

2006 APL 0406

97%

DFS

100%

80%

94% 94%

80%

90%

35%

Year Protocol

complete remission

á

Curing Acute Promyelocytic Leukemia (APL) without chemotherapy

Thanks to research on APL the chance of healing from this disease have risen up to more than 90% over the last 10 years

disease

free su

rvival

2 years

Fondazione GIMEMA

Via Casilina 5, 00182 Rome

tel +39 06.70390521

fax +39 06.70390540

email gimema@gimema.it

www.gimema.org

www.gimema.org