Questions and answers - Call for tender concerning a pilot project for developing and implementing successful prevention strategies for type 2 diabetes

Call for tender No SANCO/2013/C1/004 concerning a pilot project for developing and implementing successful prevention strategies for type 2 diabetes

Following the rules set up by the European Commission I would like to inform you that we received the following questions and provided the answers attached:

1. We are expected to assess the outcome of the intervention at 21 months after the start of the contract (not a specific period after the identification of the intervention group!). If this is done so late in the contract, how we are expected to submit a final report within less than two months (M23)? Is there a minimum time interval from time of intervention to the time of assessment?

Please have a look at the specifications 3.Subject of contract timetable.

Timetable

The duration of the execution of the tasks shall not exceed 24 months. All periods specified in the contract are calculated in calendar days. Execution of the tasks shall start from the date of entry into force of the contract.
The period of execution of the tasks may be extended only with the express written agreement of the parties before the expiration of such period.

MONTHACTIVITY
M1Inception meeting with DG SANCO presentation of a draft methodology and full updated work plan
M2Inception report
M61st interim report
M122nd interim report
M23Final draft report

2. It mentions on page 3 that we should use preferably non-invasive tests to identify children and then on page 4 notes that we can use e.g. blood tests. What is the definition of non-invasive tests? Are blood tests considered non invasive tests?! If we have to diagnose children with diabetes, we can only do this by using invasive tests.

Blood tests are invasive. To identify children at risk, preferably non-invasive tests should be used, which does not exclude blood testing. For a definite diagnosis invasive methods are necessary, and therefore need to be done in accordance with existing rules and guidelines.

3. It is not clear whether the screening programme will be aiming to identify children at risk of diabetes or having diabetes. They are both mentioned in the specification, but I think that there are two different things and there will be different emphasis on how we develop the intervention to reduce risk to develop diabetes or to manage the diabetes. Can you please clarify?

The screening programme should aim to identify children at risk of diabetes or having diabetes type II. This specification wants to make clear that children at risk of diabetes type II, children in the state of pre-diabetes, and children with manifest diabetes type II should be identified and defined, in order to assure that the continuum from obesity to risk of developing diabetes to pre-diabetes to clinical manifest diabetes is taken in consideration.

4. Do we need to have developed the screening tool in advance? If not, we will need a much larger cohort to screen in order to calculate sensitivity, specificity, NPV and PPV. If not, how will we know the NPV and PPV values of the tool in advance?

The criteria for screening should be defined in advance by the tenderer, as screening is already defined.

5. We need to include at least 5 member states, at least one school from each state. I am not clear what this means; 20 pupils x 5 schools (one per member state) and another 100 pupils as controls? What for? To screen in the first place, or pupils identified as at risk of diabetes or having diabetes? Or is there another interpretation that I have missed?

Controls are pupils which are not exposed to the foreseen activities.

6. Page 5, it is mentioned that the most successful strategy will be disseminated. I assume that by strategy it is meant intervention. How many strategies we are expected to implement and assess? I thought that it is reasonable given the funding and time available to test one.

This is up to the tenderer.

7. What is the relevance of studying page 5 disposition to/for violence? My understanding is that diabetes does not increase the likelihood of this behaviour?

Yes, but physical activity has been shown to decrease aggression, therefore this is asking for effects of the study, which are not directly linked to the main activities.

8. The statement ‘the screening programme needs to be tested in five member states’. If it is a Member States screening programme, does this mean that it needs to be delivered in four countries outside of this Member States?

Yes, there shall be four other Member States of the European Union.

9. Questions about the organizations that can participate: what should their legal entity be? Can public organisations form consortiums with institutes (e.g. universities)/private companies? The subcontracting can be made just by the tenderer?

As a rule, all natural and legal persons, private and public organizations can participate.

Groups of economic operators are authorised to tender ("joint tender", also called "consortium") and subcontracting is allowed. Subcontracting cannot be refused out of hand, although it is possible to require tenderers to provide information about intended subcontractors.  The contracting authority is entitled to demand that exclusion criteria be applied not just to the main tenderer but also to any subcontractors proposed (especially if they earn a large part of the budget).

10. It is mentioned that the "Screening programme should be tested in schools in at least 5 member states". Does this mean that in the consortium HAVE to be minimum 5 different member states?

No, but the establish standard screening programmes shall be tested in 5 different Member States minimum.

11. Since we are talking about schools and 5 different members the ministries of education of all those should be participating?

In view of the fact that schools are usually organized at a local or regional level, the Ministries of Education do not need to be involved. However, it would be desirable if the ministries would be at least informed about the project.

12. Is there also a submission form for the description of the content of the project, besides the administrative, technical and financial parts?

No, there is not a form for the content, this is up to the tenderer.

13. Can more than one partner be involved?

Yes, it would be good to have a broad coverage of Member States as possible.

14. Does it need a European partner in addition to the UK?

It would be good to have a broad coverage of Member States as possible.

15. Budget – is the full amount awarded (100k) or do we need to cost?

Please have a look at the tender specification related to the financial part, the awarding of the call for tender is also depending on the price calculated by the tenderer.

16. I cannot see a specific application form in the attachments below, or space for us to write about the actual prevention strategy?

No, there is not a form for the content, this is up to the tenderer.

17. In the specifications for the invitation to tender, under subject of contract and Task 1 it states ‘the screening programme should be tested in schools in at least five Member States. Overall, the study should involve at least 20 pupils of each group in each of the 5 European countries and control groups consisting of the same number of pupils’. This implies that it is a total of 60 pupils (20 12 years olds, 20 13 year olds and 20 14 year olds) and therefore a total of 60 pupils in each country, 300 in total (not 100 as stated in your previous email). We would then need the same number of control pupils. Can you confirm that this is correct?

The minimum requirement is 5 Member States. Per Member States 20 pupils should be have an intervention and 20 pupils without intervention as control group. This should cover each group in total 100 intervention and 100 control group. Of course it would be better to have a broader basis but this is up to the tenderer.

18. Question No 1 - There seems to be a misunderstanding of the question No 5 –
 We need to include at least 5 member states, at least one school from each state. I am not clear what this means; 20 pupils x 5 schools (one per member state) and another 100 pupils as controls? What for? To screen in the first place, or pupils identified as at risk of diabetes or having diabetes? Or is there another interpretation that I have missed?
Controls are pupils which are not exposed to the foreseen activities.

The tenderer should carry out at least in 5 Member States of the European Union one group with 20 pupils  (5 MS x 20 pupils  are 100 pupils for the whole study)with interventions set up by the tenderer and one control group with no intervention in the same school/Member States/same number of pupils.

19. Can this be achieved in 24 months and submit a final report in month 23?  Does this mean the 21 month follow up is negotiable to fit into the 24 month timescale?

The contract is running for 2 years, therefore the  final report has to be delivered by the end of the contract.

20. Does annex I, III and IV need to be completed by only the lead clinician in the UK or a representative from each of the countries?

If you are leading the pilot project only you have to complete the annex I, III and IV.

21. Also, the finaincal declaration form, does this need to be completed as it would be a UK university or NHS Trust that would be handling the finances rather than an individual account holder?

The financial declaration has to be complete by the organisation officially responsible and leading the pilot study.