Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory and Practical Consequences of the New Clinical Trial Regulation (EU) No 536/2014 for the Clinical Trial Application Processes of Pharmaceutical Companies and CROs ***

Dr. Michael Türck (Abschlußjahr: 2016)

Summary
Language: English
The trend of the past decades for ever-increasing costs in pharmaceutical industries, due to R&D expenditures for innovating new medicinal products, has led to the birth of CROs by necessity for cost reduction. Whilst in the early beginnings only a limited range of tasks was outsourced to this new branch of service providers, these facilities have quickly co-evolved to an industry of its own with large and globally-acting companies at the top. Thereby and over time the joint operations of both industries have led to mutual dependencies, and for the largest companies in their fields, this has resulted in virtually inseparable connections, in particular for the realisation of multinational clinical trials all over the world. This global market for clinical trials is regulated by national and since the late 1990's also increasingly by supranational regulatory and legal requirements. The globalisation of clinical trials was pioneered by ICH-GCP as an industry standard ensuring the scientific and ethically sound conduct of clinical trials with investigational medicinal products on human subjects. With the highest global R&D intensity, the pharmaceuticals & biotechnology sector has also a huge economic impact by sponsoring of clinical trials. Thereby, globalisation has led to competition among the developed nations, but emerging nations have entered into competition for global market share, too. Taken together, clinical research takes place between the poles of regulatory requirements and economic driven approaches for cut of costs. As a result, it is not surprising that changes within the regulatory landscape can have a high impact on the attractiveness of countries and regions as places for conducting clinical trials. The EU/EEA, with currently 28 + 3 Members States, is globally one of the most attractive regions for the conduct of clinical trials, but also one of the most regulatory complicated. The new clinical trial Regulation (EU) No 536/2014 is the most recent legislation within the EU/EEA to further harmonise the regulatory requirements and to ensure that this region remains attractive. Besides harmonisation, this shall be achieved by streamlining of clinical trial application processes. Eventually, this means acceleration of submission timelines. That sounds fine, but in consequence, this means that pharmaceutical sponsors and their sub-contracted CROs will in particular face a challenge upon requests for additional information from regulatory authorities. In practice, they will have 10 or 12 calendar days within the validation or assessment of their submitted clinical trial application dossiers to deliver on requests or their application lapses. With regard to inflated and often less efficient communication structures in industries, these are actually short deadlines. To keep pace with this upcoming provisions by the new clinical trial Regulation and in regard to practical and economic considerations the hypothesis was formulated that an adaptation of existing structures and processes of pharmaceutical and CRO industries is required and that such adaptive changes need to be implemented into already existing processes and have to make use of existing resources. Further considerations on this topic were made by a regulatory decision making from a high level perspective in order to generate alternative basic approaches and concepts for sponsors and CROs. On base of criteria deemed appropriate, to reflect project and process requirements, the derived concepts were evaluated regarding to their fulfilment of these criteria. To this end, it was found that sponsors may adapt by an increase of in-house study start-up and CROs may adapt their existing processes by a more dedicated study start-up for sponsors and/or increased outsourcing to allow internal restructuring of regulatory delivery. One concept that was found in common for both, sponsors and CROs, is to realise a better interaction for joint operations by a concept for quicker liaisons. These concept has also the advantage that it can be supported by the other suitable-deemed concepts. Hence, it is most likely that better interaction approaches between sponsors and CROs will be the best strategy to be prepared for the streamlined and accelerated clinical trial submission timelines and the resulting essential need for capacities to allow faster interactions as required by the new clinical trial Regulation (EU) No 536/2014.
Pages: 77; Annexes: 1, pages: 13