Study identification

PURI

https://redirect.ema.europa.eu/resource/17582

EU PAS number

EUPAS11867

Study ID

17582

Official title and acronym

Evaluation of Effectiveness of Amyvid Reader Training (I6E-AV-AVBE)

DARWIN EU® study

No

Study countries

Italy
Spain
United Kingdom

Study description

Florbetapir 18F solution for injection (Amyvid) is a member of a class of diagnostic radiopharmaceuticals for positron emission tomography (PET) imaging. Because physicians are likely to be unfamiliar with florbetapir scan interpretation, reader training programmes have been developed, tested, and will be provided as a component of the risk management system for the product. While such programmes have been successful in training readers within the setting of clinical trials, it is important to assess the effectiveness of these reader training methods when used by physicians as part of routine clinical practice. The objective of this study will address this by assessing the effectiveness of the different florbetapir training methods agreed in the European clinical setting to ensure that accuracy in routine practice is in line with expected accuracy from the clinical trials.

Study status

Ongoing
Research institution and networks

Institutions

Avid Radiopharmaceuticals,Inc.

Contact details

Anupa Arora

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Study protocol
Initial protocol

2016-01-29-AVBE-Non_interventional PASS Protocol_REDACTED

English (285.44 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)