Strong support. Remaining concerns

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1 EORTC opinion on the proposal for an EU Regulation on clinical trials on medicinal products for human use and the 7 th of June ENVI report on this proposal It is clear that the Commission and appointed Rapporteur have a very good understanding of the needs of clinical trials in the EU, and the proposal they have put forth includes several major advances favoring an attractive and research stimulating framework. This proposal has been further improved by amendments proposed by the rapporteur, Mrs. G. Willmott and expressed in her report of 07 June EORTC has issued several positions and joint statements with major stakeholders regarding this regulation (please see referencies 1-5). Key elements and remaining hurdles of this new framework are described below. The analysis and remarks of the EORTC focus on international clinical trials. EORTC would like to present several essential elements to be considered in the new legal framework for clinical trials in the EU. EORTC believes that without consideration of these elements, clinical research will leave Europe and result in grave consequences for public health, competitivity of Europe and patient access to innovation. For more information about EORTC, please see at the end of the document. 1. Definition of clinical trial, low-risk clinical trial and risk based approach EORTC strongly supports the change in the definition of a clinical trial. Definitions provided in the Clinical Trial Directive have been very confusing with many divergences in interpretations leading sometimes to the same project being considered as a clinical trial by some member states, but not by others. EORTC particularly supports amendments 56, 60 and 61 of the report of 07 June 2013 which crystallizes these definitions further. EORTC strongly supports the introduction of the risk-based approach to have a more proportionate regulation instead of one size fits all. This is a major achievement. The new definition of low-risk (or low-intervention) clinical trial makes reference to standard (or normal) practice and gives allowance for additional procedures with minimal intervention. It is combined with a more proportionate legal framework while providing the same guarantees for patient protection. Low-risk trial framework includes shorter timelines for approval, adapted trial monitoring and content of the trial master file, proportionate labeling and insurance requirements. For all other trials regulation it takes a multi-fold approach. The nature and extent of the trial monitoring and the content of the trial master file are to be adapted to the clinical trial characteristics. Rules on manufacturing and labeling are proposed to be appropriate and proportionate. Insurance for non low-intervention trials is adapted to the risk of the clinical trial, the potential damage, and the likelihood of the damage. Amendment 10 of the 07 June 2013 report refers to an international OECD guideline for the categorization of risk in clinical trials. This is essential to ensure a consistent approach to the notion of risk for international trials, and this amendment should be strongly supported. The added value of the defintion of the low-risk trial and its consistency with OECD guidelines could unfortunately be heavily compromised as amendments 9&58 of the 7 th of June report contain wording which may be misleading, and EORTC proposed alternative wording to the rapporteur for both amendments. Instead of a clinical trial Registered Office: avenue E Mounier 83 Bte Brussels Belgium Phone: Fax:

2 which, given the nature and extent of the intervention, can be expected to have only a very small and temporary or no impact on the subject s health and which fulfills Amendment 58 should state a clinical trial which, given the nature and extent of the additional intervention (as compared to normal practice), can be expected to have only a very small and potentially temporary or no impact on the subject s health and which fulfills. Amendment 9 should be adapted in line with the above wording. Low-risk trial definition should contribute to the overall decrease in the cost of clinical trials including for public health systems (as some trials are conducted by publicly funded organisations) while maintaining patient safety and improving and accelerating access to new standards of care. 2. Single electronic submissions portal & coordinated assessment including ethics The EORTC welcomes and strongly defends the implementation and use of a single portal managed by the European Commission for clinical trials without the need to further code data into any of the national systems. A single list of documents is also essential. The Commission proposes to assess clinical trials in a coordinated way with all general, non-country specific aspects of the trial being assessed by the reporting member state with the possibility for all other participating countries to communicate their position on these aspects to the reporter and have these taken into account in the assessment report. In parallel, other aspects of a national/cultural/local nature would be assessed separately by each member state. At issue in this process is that single approval is hopefully provided by each member state which embraces (as confirmed by the Commission) all aspects currently covered by the single Ethics Committee (EC) opinion and Competent Authorities (CA) approval. The collaboration between different bodies (CA & ECs) on the national level and an optimal mechanism of communication are essential to be able to issue an approval within the timelines specified within the legislation. This essential aspect clearly lies with each member state, and the EORTC strongly appeals to all member state regulators to urgently make necessary adaptations to their systems. 3. Reasonable timelines Draft regulation proposed very competitive timelines for evaluation of clinical trials making it very challenging for all stakeholders including trial sponsors. It has been proposed that the approval of a clinical trial would take at most 48 to 79 days depending on the type of the trial. For low-risk trials with complete application and no grounds or additional requests, a decision could even take less than 26 days. EORTC strongly supports these short timelines, as the timely start of clinical trials in all countries is essential for their success. Unfortunately, amendments proposed in the 07 June 2013 report slightly prolong these timelines and increase the maximum time for decision to days and the shortest time to 30 days. Conscious of the complexity of many issues and their implications for Member States, EORTC acknowledges the effort made to maintain the competitiveness of timelines proposed by the legislation, including prioritization for rare diseases (Amendments 7& 16) and maintaining tacit approval (Amendment 112). However, given that under the current legal framework the maximum time for approval is 60 days and some member states are able to approve clinical trials in 28 days, the timelines should not be made any longer. 2/5

3 4. Measures to optimise damage compensation for trial participants The EORTC acknowledges that the new proposal of national indemnification mechanism constitutes a radical but very positive change in the current practice. Should it be instituted by all member states, freely available for noncommercial sponsors, it would represent an important support for academic research. EORTC strongly supports Amendment 235 of the 07 June 2013 report which further clarifies this proposal. EORTC believes that this investment, seen as an additional financial buren by some member states, will be worthwhile, as it would be very beneficial for the public health. Indeed, only non-commercial sponsors are interested conducting treatment strategy trials aimed at optimizing treatment or investigating the use of marketed drugs to determine which product thoroughly delivers the best results. The relatively small scale support in a form of national indemnification mechanism to such research has the potential to optimize healthcare costs, sparing public health system funds over the long term and on a large scale. EORTC is concerned that given current budget constraints and given industrial sponsors are not specifically supporting this measure, as they frequently have global policies, the proposed national indemnification mechanism would not be supported. However, this measure is vital for non-commercial research. Consequently, we strongly recommend that member states put in place global solutions which will, at no cost for non-profit sponsors, guarantee that all patients are correctly indemnified in case of proven damage. 5. Transparency of trial results and data sharing Proposed regulation aims to increase transparency of trail results by making them available to patients and the scientific community. EORTC strongly supports measures proposed by the initially proposed text of regulation and those added by Amendment 193 of the 07 June 2013 report. EORTC would also like to emphasis that the expected level of transparency would not serve its purpose without the support of Amendment 36 supporting the broad consent. Indeed, if patient consent is maintained at its current limited scope, the possibility of sharing data and results would remain theoretical and would not be feasible because it would be contradictory to patient consent in many cases. 6. Patient involvement The EORTC welcomes the mechanism proposed for involving patients and their representatives in the panel performing the assessements under the proposed regulation with respect to the authorization of a clinical trial. 7. Fees and non-commercial trials EORTC welcomes and strongly supports Amendments 19, 237, 242 and 254 of the 07June 2013 report which waive or reduce fees for non-profit sponsors and thanks the Rapporteur for the recognition of the role of noncommercial sponsors and for heaving taken into consideration specific concerns of frequently underfunded academic research conducted only in the interest of patients and society and without commercial aim. EORTC would, however, suggest adopting a stronger wording for Amendment /5

4 In the text of regulation initially proposed by the EU Commission there is no incentive for Member States to waive Investigator Driven Clinical Trials (IDCTs) from fees (clinical trial application fees, safety reporting fees, inspection fees etc.). Therefore, should amendments 19, 237, 242 and 254 be unfortunately rejected, it will have a major impact on academic research. Indeed, either it will become impossible to conduct IDCTs in some countries, or most of the public money allocated to this essential life saving research will be spent on fees instead of the research itself. 8. General simplification of safety reporting and its centralization (at EMA) Simplification of safety reporting, and particularly its centralization at European Medicines Agency, will be a major achievement and should decrease unnecessary administrative workload related to pharmacovigilance while maximizing EU capacity to detect pertinent events in time. 9. Room for flexibility Proposed regulation foresees in Chapter XVII a mechanism that would enable the Commission to adopt the delegated acts within the scope of a limited number of articles. This mechanism is essential and should be further stimulated. Indeed, the needs of science evolve very rapidly, and new technologies emerge more frequently than ever. All stakeholders are working hard to ensure this regulation will create a fertile environment for clinical research in the EU based on the knowledge of today. Unfortunately, this may not fit the realities of five years from now. Therefore, it is essential that regulation is flexible enough to be able to adapt to these new needs and realities. 10. Further simplification of paperwork EORTC believes that even though Annex I currently accommodates most Member States, it would need further improvement and clarification in order to become more practical and acceptable for general use (e.g. it should be clear that a draft contract will be requested and not a final signed one; further clarification is needed concerning the expectations and management of conflict of interest which are expected to be provided upfront by all investigators). Going beyond the clarification and in the philosophy of the EU commission REFIT program, this annex should be progressively simplified. REFERENCIES 1. EORTC position on the report on the proposal of the Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (7 June 2013) 2. EORTC position on the place for transparency in the clinical trials regulation 3. EORTC opinion on amendments to the proposal of the Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (20 February 2013) 4. EORTC opinion concerning the proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. (21 December 2012) 5. Proposal for an EU Regulation on Clinical Trials. A joint statement from non-commercial and commercial organisations. (November 2012) 4/5

5 EORTC The EORTC is a non-profit international research organisation created under Belgian law in Since its creation, the EORTC has contributed to improve the survival rates for several types of cancer through translational and clinical research. Both multinational and multidisciplinary, the EORTC Network comprises more than 2,000 collaborators from all disciplines involved in cancer treatment and research in more than 300 university hospitals in over 30 countries. Over than 30 EORTC clinical trials are open to patient recruitment at any given time. EORTC databases contain quality assured data from some 180,000 cancer patients from EORTC clinical trials. Currently, some 50,000 patients are being followed-up after treatment. The scientific activities of EORTC are strictly peer-reviewed and subject to quality assurance/ quality control programs. The EORTC operates on an independent basis, and in this capacity is able to work in partnership with the pharmaceutical industry in evaluating innovative molecules. EORTC has contributed to several success stories in term of new anticancer drugs development including registration by the FDA and the EMA. The EORTC has proven track records in establishing new standards e.g. Response Evaluation Criteria In Solid Tumors (RECIST), quality of life of cancer patients, etc. The EORTC is organizing several major annual conferences in collaboration with several prestigious US groups e.g. the AACR, ASCO and the NCI. The EORTC participates currently in several EU funded projects. 5/5

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