Coalition Recommendations

RELEVANT INITIATIVES AND COLLABORATIONS

 

BioMed Alliance Taskforce on Academic Clinical Trials

A main pillar under the Reducing Bureaucracy in Clinical Trials Coalition, this BioMed Alliance taskforce develops and supports a range of initiatives in support of academic clinical trials.

https://www.biomedeurope.org/regulatory-affairs/academic-clinical-trials-task-force.html

 

Good Clinical Trials Collaborative

Funded by Wellcome, the Gates Foundation and the African Academy of Sciences, the GCTC has set out to review the principles of randomised clinical trials for all types of healthcare interventions.

https://wellcome.org/what-we-do/our-work/good-clinical-trials-collaborative

 

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Global consortium of regulatory authorities and pharmaceutical industry aiming to harmonize the development and registration of safe, effective and high-quality medicines. Currently the revision is under way of the ICH E6 guideline “Good Clinical Practice (GCP)”.

https://www.ich.org

 

EORTC Manifesto on Treatment Optimisation

Launched at a joint event with the BioMed Alliance and the European Parliament’s STOA Panel in January 2019, this manifesto calls for establishing Treatment Optimization as part of personalized medicine development. EORTC and its fellow signatories call for turning the regulatory approval-oriented clinical research landscape into a truly patient-centered system combining drug development with comparative effectiveness studies and long-term safety monitoring.

https://www.eortc.org/app/uploads/2020/05/Manifesto-29052020.pdf

 

 

PUBLICATIONS

 

De Waele JJ, De Lange DW. Organising international research in critical care medicine: current challenges and potential solutions, Lancet Respir Med, December 2019, doi: 10.1016/S2213-2600(19)30475-8

 

Gribben J, et al. Reducing Bureaucracy in Clinical Research: A Call for Action, HemaSphere, March 2020 doi:10.1097/HS9.0000000000000352

 

Lacombe D et al. Clinical research in Europe: Who do we do all that for? Journal of Cancer Policy, March 2020 doi: 10.1016/j.jcpo.2020.100217

 

Perez-Gracia JL, Awada A, Calvo E, et al. ESMO Clinical Research Observatory (ECRO): improving the efficiency of clinical research through rationalisation of bureaucracy, ESMO Open, May 2020 doi: 10.1136/esmoopen-2019-000662

 

Rule S, LeGouill S. Bureaucracy is strangling clinical research, BMJ, March 2019 doi: 10.1136/bmj.l1097

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