Clinical research and biomedicine

Question 1

indirecg effects of eu level funding

Answer 1

1. what is ethical (bc eu determined what research shall NOT be funded)
2. convergence research methods (expert meetings)
3. by allowing eu funding can allows multinational clinical trials to study orphan diseases, which may not be feadi le in indicidual nation countries
4. legislstive developments EU funding can serve as an incentive dor member states to adopt policies that they might otherwise be reluctant to implement

Question 2

why waz the CTD adopted

Answer 2

BEFORE CTD, 3 main differences per member state were
1. differences in confidentiality and informed consent
2. differences in inclusion of culnerable populations
difference in application dor clinical trials

CTD aimed to
1. PROTECT individuals by focusing on harmonizang clinical practice and informed consent
2. harmonize safety, surveillance reporting
3. stresmline application process to speed up scientifix progress

Question 3

why was the CTR adopted

Answer 3

The number of clinical trials did not increase after the CTD so there were still issues in the application procedure of clinical trials. CTR aims to overcome this issues

Question 4

How does CTR aim to stresmline the application

Answer 4

1. centralised information system
2. simplify rules for low intervention trial
3. extend tacid agreement principle to the whole authorization process. if CA does not respect the timeline , you have your authorization of the trial
4. commision controls MS
5. reduction requirements for non-commercial sponsors e.g. inspection fees
6. info regarding authorization and results publicacly available

Question 5

which criteria exist to decide if a product is a medicinal product

Answer 5

functinnal criterion: is the product administered with the view of therapeutix or diagnosing function?
presentstion criterion; is the product presented as sych ? is it suggested to have therapeutic effect?

if a average wellinformed cosyner gains the impression it must be a therapeutix, it is regarded as a medicinal product

Question 6

definiton cliniczl study

Answer 6

any study on HUMANS (not embryos/animals) where there is an intervention when a medicinal product

Question 7

clincial trial defintion

Answer 7

type of clinical study that fulfills any of the followinf xonditions
1. therapeutic does not fall in the clinixal practice of the member state OR
2. at the same time it is decided to prescribe the medicial product and inlude patient in the study OR
3. additional diagnostic monitorinf procedures in addition to normal clinical practice (so not off label but we will add some diagnostic / folllow up adverse events more closely) LOW intervention trial

Question 8

differend clinical study and clinical trial

Answer 8

clinical study can also be for example purely observational while in a trial there is always an intervention

Question 9

what does the CTR NOT apply to

Answer 9

non-interventional studies
psychological research
research into medical devices
research into tissue organs or blood
embryo research

Question 10

CTD seems to suggest non therapeutic trials in minors is unlawful . why?

Answer 10

4e and 4i

Question 11

aspects to still be regulated by the member states

Answer 11

-some ethically sensitive topics such as cloning
-all the rest in the CTR highlighted in green

Question 12

aims of horizon

Answer 12

Framework programmes are about coordinating and research. The framework programme is called Horizon. The programme from 2014-2020 was Horizon 2020, now we moved into Horizon Europe (2021-2027), which is the 9th framework programme with a budget of 95.5 billion euro. Apart from funding, you can find what kind of research is funded (coordination). The European Research Council is responsible for granting this funding. Horizon is not just directed to health but also for example space research. Most of the EU funding is aimed towards facilitating the exchange of information, methodologies and ideas (enable EU level networks like expert meetings).

Question 13

why harmonization? 3 things were different before adopting the directive

Answer 13

1. principles of confidentiality and disclosure of patient information
2. inclusion of vulnerable group e.g. children and mentally incapacitated
3. different structures for application of clinical trials

Question 14

CTD aimed to

Answer 14

1. PROTECT individuals by focusing on harmonizang clinical practice and informed consent
2. harmonize phase 4
3. stresmline application process to speed up scientifix progress

Question 15

definition medicinal product

Answer 15

Any substance or a combination of substances presented for treating or preventing disease in human beings (presentation criterion)

Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered as a medical product (functional criterion)

Question 17

scope of CTR

Answer 17

1. definition clinical study/clinical trial (CTR)
2. not no non-interventional trials
3. medicinal product definition (not in CTR)
4. does not apply to:
   -non-interventional trials (article 1)
   - psychological research
   - research on tissue, blood
   - embryo research

Question 18

Safety reporting in the context of a clinical trial

Answer 18

Electronic database for safety reporting (40)
Reporting of adverse events and serious adverse events by the investigator to the sponsor (41)
Reporting of suspected unexpected serious adverse reactions by the sponsor to the Agency (42)
Annual reporting by the sponsor to the Agency (43)
Assessment by Member States (44)
Commission may conduct controls (79)

Question 19

Compare legislation CTD and CTR concenring minors and mentally incapacitated, what are the differences

Answer 19

-interview not optional but obligatory
-medical condition of the incapacitated subject
Wihtdrawing has to be respected by investigator ipv considered