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Action Kidney Cancer are members of the Coalition for Reducing Bureaucracy in Clinical Trials. Sharon Deveson Kell attended a meeting last week when the activities of the coalition over the past year were discussed and plans for the next phase of activities for 2023/24 were presented.
The coalition started as a group of clinical researchers in haematology, who published a paper in the British Medical Journal (BMJ) warning about the increasing administrative burden in clinical trials. The coalition started with a roundtable meeting with mainly people from haematology and some from oncology. The coalition has grown to include medical societies and patient organisations.
The Coalition Statement was published in September 2020. Working groups were formed with experts on safety reporting, informed consent, regulatory, and a policy group who developed the Coalition Recommendations in November 2021. Since then, the coalition has worked to increase awareness of these recommendations.
The coalition works closely with its members and with other groups, such as the Good Clinical Trials Collaborative (GCTC), to reduce bureaucracy in clinical trials, both for clinical researchers and patients.
The next phase of the coalition’s work will build on the work already started, and will focus on three main topics:
- The coalition has listed the contract research organisations (CROs) and the Ethics Committees in Europe with an aim to discuss with clinical trial sponsors (pharmaceutical companies and government organisations), CROs, and Ethics Committees how to move forward with the Coalition Recommendations. There will be different roundtable meetings to focus on: informed consent, safety reporting, regulatory guidelines and ethics. They have already reached out to sponsors and CROs, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of Clinical Research Organisations (ACRO). They hope to work with the Good Layman Summary Practice on developing patient-friendly informed consent forms for clinical trials.
- The next area is the optimisation of regulatory guidelines. The coalition is responding to the current Good Clinical Practice Guidelines consultation and are in contact with European Medicines Agency (EMA), where they have presented the Coalition Recommendations, safety reporting, informed consent forms as well as harmonisation of guidelines and regulatory documents across Europe. The coalition has been working with the Good Clinical Trial Collaborative (GCTC) on the current Good Clinical Practice Guidelines consultation.
- The coalition will continue to build awareness of their activities, keep their website updated, and advertise consultations and workshops on an events page. They will continue actively disseminate the work and the activities that they do to a wider audience, and will try to have some more regular publications of the Coalitions work in policy journals.
If you would like to know more about the work of the Coalition for Reducing Bureaucracy in Clinical Trials, please email us.