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HEALTH

 

1. For proposals involving clinical work, at the time of submission is compulsory to have the answer of the ethical committee?

2. SME Instrument - PHC12-2014/2015 Topic related questions - What is the definition for a Known biomarker? What do you understand by drug biomarker? How do I need to interpret the and/or in the Health call?

          2.1 Feasibility assessment: could this be clinical trials?

          2.2 Isn't PHC-12 funded at 100% in Phase 1 as well?

 

3. European Commission FAQ

 

 

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HEALTH

1. For proposals involving clinical work, at the time of submission is compulsory to have the answer of the ethical committee?

A proposal can be submitted “even if they did not present yet the application to the committee”. In this case the answer is not available and an explanation of current status should be provided, as you second highlighted text indicates.

Exceptionally for the topic PHC 15, on the “Scope” it is very clear that authorisation or evidence of regulatory engagement is required. If the proposer has not yet approached the committee they risk the reviewers consider them having a handicap.

The European Commission published the Questions and Answers for some specific topics.

-         ICT for Health and Wellbeing:

PHC-26-2014: Self-management of health and disease: citizen engagement

and mHealth

-          PHC-34-2014. eHealth interoperability

http://ec.europa.eu/information_society/newsroom/cf/dae/document.cfm?doc_id=4465

 

Advancing active and healthy ageing with ICT:

PHC-19-201  Advancing active and healthy ageing with ICT: service robotics within

assisted living environments

PHC-20-2014  Advancing active and healthy ageing with ICT: ICT solutions for

independent living with cognitive impairment

HCO-01-2014  Support for the European Innovation Partnership on Active and

Healthy Ageing

HCO-02-2014 Joint programming: Co-ordination action for the joint programming

initiative (JPI) 'more years better lives the challenges and opportunities of

demographic change'

https://www.euresearch.ch/fileadmin/redacteur/European_Programmes/FAQs_on_Active_and_healthy_ageing_with_ICT_updated_version_2.pdf

 

 

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2. SME Instrument - PHC12-2014/2015 Topic related questions - What is the definition for a Known biomarker? What do you understand by drug biomarker? How do I need to interpret the and/or in the Health call?

Please use the definitions as shown here (and please see also the corresponding literature)

A biomarkeris a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention (NHI Biomarkers Definitions Working Group; 2001)

Avalid biomarkeris defined as “a biomarker that is measured in an analytical test system with well-established performance characteristics and for which there is an established scientific framework or body of evidence that elucidates the physiologic, toxicological, pharmacologic, or clinical significance of the test results

(FDA. Guidance for industry - pharmacogenomic data submissions. 2005) 

 

 

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2.1. Feasibility assessment: could this be clinical trials?

No, the feasibility assessment in phase 1 is addressing activities like risk               assessment, description of bottlenecks, market study, user involvement, IP regime, partner search etc. Clinical studies are activities planned in phase 2. 

 

 

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2.2. Isn't PHC-12 funded at 100% in Phase 1 as well?

Yes for the PHC topic, funding rate is 100%.

 

 

 

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