8 Amendments of Cristina GUTIÉRREZ-CORTINES related to 2012/0192(COD)
Amendment 45 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) The fact that clinical trials are conducted in both public and private centres makes it necessary to recognise them and adopt monitoring, authorisation and assessment measures that apply to both types of centre.
Amendment 46 #
Proposal for a regulation
Recital 9
Recital 9
(9) The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention. Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice. This is in particular the case where the investigational medicinal product is covered by a marketing authorisation (i.e. the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure) and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice. Those ‘"low-intervention clinical trials’" are often of crucial importance to assess standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health. They should be subject to less stringent rules, such as shorter deadlines for approval, without compromising scientific excellence, and guaranteeing patient safety at all times.
Amendment 95 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) The Member States must guarantee that clinical trials can be conducted in both public and private centres under equal conditions, subject to any statutory requirements.
Amendment 99 #
Proposal for a regulation
Recital 9
Recital 9
(9) The risk to subject safety in a clinical trial mainly stems from two sources: the investigational medicinal product and the intervention. Many clinical trials, however, pose only a minimal additional risk to subject safety compared to normal clinical practice. This is in particular the case where the investigational medicinal product is covered by a marketing authorisation (i.e. the quality, safety and efficacy has already been assessed in the course of the marketing authorisation procedure) and where the intervention poses only very limited additional risk to the subject compared to normal clinical practice. Those "low-intervention clinical trials" are often of crucial importance to assess standard treatments and diagnoses, thereby optimising the use of medicinal products and thus contributing to a high level of public health. They should be subject to less stringent rules, such as shorter deadlines for approval , without compromising scientific standards and guaranteeing the safety of patients at all times.
Amendment 112 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patientn independent ethics committee shall be taken into account.
Amendment 378 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. In the assessment, the view of at least one person whose primary area of interest is non-scientific shall be taken into account. The view of at least one patientn independent, national-level ethics committee shall be taken into account.
Amendment 531 #
Proposal for a regulation
Article 34 – paragraph 3 – subparagraph 1
Article 34 – paragraph 3 – subparagraph 1
3. Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trialll the results of that trial, both positive and negative. The results of clinical trials that have been withdrawn or suspended shall also be provided, along with the reasons why they were withdrawn or suspended.
Amendment 598 #
Proposal for a regulation
Article 53 – paragraph 2 – subparagraph 1a (new)
Article 53 – paragraph 2 – subparagraph 1a (new)
A supervision system covering the entire clinical trial process shall be established to determine liability on the part of the institutions, agencies and centres involved in the event of information on clinical trials or patients’ personal data being leaked.