A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary.

The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled "Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science" that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient involvement. From the 3 breakout sessions, it was concluded that patient-reported outcomes (ie, the report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else), was considered as an important tool when deciding endpoints.

From protocol to published report: a study of consistency in the reporting of academic drug trials.

Background: Unacknowledged inconsistencies in the reporting of clinical trials undermine the validity of the results of the trials. Little is known about inconsistency in the reporting of academic clinical drug trials. Therefore, we investigated the prevalence of consistency between protocols and published reports of academic clinical drug trials.

Innovation of Medical Products: The Evolution of Regulatory Science, Research, and Education.

We present a commentary on the international aspects of the evolution of regulatory science as a multidisciplinary, multistakeholder academic discipline of education and applied research emphasizing the need for seamless interaction between stakeholders such as regulatory authorities, the pharmaceutical industry, universities, payers, and patient organizations. Regulatory science is the science of developing new tools, standards, and approaches to evaluate the efficacy, safety, quality, and performance of medical products in order to assess benefit/risk and facilitate a sound and transparent regulatory decision making throughout development and life cycle management.

[Simplification of procedures for clinical drug trials in the EU is coming up].

A proposal for a new regulation on clinical trials that will replace the Clinical Trials Directive has been launched by the EU Commission the 17 July 2012. The proposal contains ideas that undoubtedly will lead to a greater harmonisation within the EU, a more smooth approval procedure, and a lowering of the administrative burden. Details are still to be discussed, and waiting until 2016 when the new rules are adopted is definitely a problem, but all together the new proposal is to be regarded as good news for clinical drug research.

Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005.

Aim: The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology.

Methods: A review of 386 approved applications of academic clinical drug trials submitted to the Danish Medicines Agency 1993-2005 was carried out.

[Effect of the GCP Directive on academic drug trials].

Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

Objective: To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark.

Design: Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006.

Review Methods: Applications for drug trials for alternate years were classified as academic or commercial trials.

Good clinical practice is now obligatory in academic clinical drug research in the European Union.

By May 2004, all clinical trials in the European Union (EU) on medicinal products have to be initiated and conducted in compliance with the principles in the new directive on Good Clinical Practice (GCP). This requirement will also apply to non-commercial trials involving registered drugs and may therefore restrain the academic clinical drug research. In Denmark, three public GCP units connected in a national network and associated with the university hospitals in Copenhagen, Odense and Aarhus have been established.