Non-interventional

EBMT Slide template

Barcelona
Prospective Studies;
7 February 2008
Development and
Approval Process

The European Group for Blood and Marrow Transplantation

The European Group for Blood and Marrow Transplantation
 Non-interventional prospective
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study, what is it?
• The study does not interfere with choice of treatment,
therefore no randomization or insurance are needed
• Prospective data collection of “standard treatment”
• Possibilities to collect additional (Med C) data
• Centres can easily participate (no EC approval
necessary in most EU countries)
• Centres can participate at any time point during the
study
• Development is feasible in short time

The European Group for Blood and Marrow Transplantation

 Non-interventional
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study, when? Some examples
• To collect data on rare diseases like T-PLL or AL-
Amyloidosis, regular MED B + follow-up will suffice

• To collect data on side effects of drugs or other

aspects of treatment like DMSO; often this requires
collection of additional data

• To monitor ‘new’ standard treatment that has only

recently been accepted; regular MED B possible,
follow up required

• To monitor the value of recently developed

prognostic systems; this might require collection of
additional data and follow up

The European Group for Blood and Marrow Transplantation

 Step 1: Non-interventional Prospective Study: Concept Presented to WP
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Brief outline: objectives, eligibility, endpoints, number of patients, estimation of
study (Budget availability,

Accepted by (subcommittee chair and) WP chair => Notification to

P. Ljungman/C. Ruiz, for verification that it really is non interventional

If applicable: Start contract If applicable: Contact other WP chair for

negotiations for financial support cooperative study, approval needed

Accepted

Step 2: Study Coordinator develops the proposal, outline, letter of invitation,

data forms, consent form etc. of the study in collaboration with WP data office

Step 3: Final approval of documents by Study Coordinator/(Subcommittee) Chair

If applicable: Signing of Contract If limitation of centres is necessary:

Inventory of participating centres

Step 4: WP data office sends all documents to the (applicable)

EBMT centres and puts study on EBMT website

The European Group for Blood and Marrow Transplantation

 Data Collection for Non-
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interventional Prospective
Studies
Important issues:

• MED AB forms are the basis of the data collection forms to

keep data entry at the centres level possible
• Patient Unique Identification Codes are allocated as usual
(by centre, national registry or the Paris data office)
• Data from (restricted) MED AB forms are entered as usual
(by centre, nat. registry or the Paris data office)
• Additional forms are possible (data collection/entry for
these at the WP data office, data entry in separate data
base)
• Data collection form(s) should be created only once (no
updates of forms desirable)
• Estimation of duration of the study
• All necessary documents should be available on the
EBMT website

The European Group for Blood and Marrow Transplantation

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Final Guidelines will be available soon

Provisional guidelines and examples of data forms,

registration forms, letters,
outline of study (and budget)
can be obtained from
the Leiden Data Office

The European Group for Blood and Marrow Transplantation