ORIGINS AND TIMELINE OF THE REDUCING BUREAUCRACY IN CLINICAL TRIALS INITIATIVE
The Coalition for Reducing Bureaucracy in Clinical Trials led by Prof. Martin Dreyling (European Hematology Association/BioMed Alliance) together with the Good Clinical Trials Collaborative led by Prof. Martin Landray (also active for the European Society of Cardiology) has submitted a joint commentary, responding to the public consultation on Good Clinical Practice (GCP) E6(R3) launched by the International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2023.
The letter and the Appendix can be read in full below.
The Coalition for Reducing Bureaucracy in Clinical Trials participated in the ACT EU multi-stakeholder platform kick-off Workshops at the European Medicines Agency in Amsterdam as a panellist speaking on what needs to be put in place to have an invigorated clinical trials environment.
Commencing on January 31, 2023, all applications for clinical trials must be submitted exclusively through the Clinical Trial Information System (CTIS).
During the fall we have been gathering quotes from real-life observations of the bureaucracy in clinical trials, reviewing our work and achievements and planning our next steps for the Coalition. This has lead to the development of a trunk article that nicely sums up the Coalition’s work, achievements and reasons for being.
Please find the trunk article below and feel free to disseminate it to help us spread the word of the important work the Coalition for Reducing Bureaucracy in Clinical Trials do!
- Presentation of the Coalition’s work at a joint meeting of the EMA working parties for Health Care Professionals and Patients & Consumers.
- The Coalition Recommendations are discussed at meetings of the Cancer Medicines Forum, the BioMed Alliance and EFPIA.
- Scoping of potential follow-up actions to promote awareness and uptake of the Coalition Recommendations in conversations with various stakeholders.
December 2021-February 2022
- Dissemination of the Coalition Recommendations. Additional endorsements are received from medical and patient associations as well as from clinical research collaborative groups and initiatives such as HOVON, TranspariMED and ECOG-ACRIN.
- Publication of a summary of the Coalition Recommendations by and for patients (link).
- The EU Clinical Trials Regulation comes into effect on January 31, 2022. The Coalition Recommendations are welcomed by the European Commission and used for updating the CTR Q&A (see ‘Resources’).
- In January, the Accelerating Clinical Trials in the EU (ACT EU) initiative is announced by the European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). ACT EU is foreseen as platform for collaborative action by regulators and stakeholders – including the Coalition – aimed at transforming how clinical trials are designed and conducted in the EU. Several Coalition priorities are among its objectives: reducing administrative burdens, patient-centricity, increased support for academic investigators, and better integration of ethics committees in the clinical trials lifecycle.
- Elaboration of Coalition Recommendations, taking into account feedback from stakeholders collected during the Roundtable meetings and informal consultations
- Coalition response to and expression of support for the Guidance for Good Randomized Clinical Trials drafted by the Good Clinical Trials Collaborative (https://9d402d47-d266-4158-8297-ee7a38f21970.filesusr.com/ugd/1e382c_22516529369a46eaba9ae1d3b69c794a.pdf )
- Multistakeholder roundtables on Regulatory Guidelines (30 April), Informed Consent (3 May) and Safety Reporting (17 May). Regulators, the European Commission, industry, ethics committees, academic clinical research organisers and the Good Clinical Trials Collaborative are invited to comment on the draft Coalition Recommendations and share their own views and concerns.
November 2020-March 2021
- Drafting of Coalition Recommendations
- Informal consultation with stakeholders
- Alignment with the Good Clinical Trials Collaborative and the ICH E6 revision process
- Launch of Coalition Statement Reducing bureaucracy in clinical trials: now is the time!
- Coalition meeting, formation of working groups tasked with formulating Coalition recommendations
- The emerging coalition of medical societies and patient advocates, coordinated by EHA in close conjunction with the BioMed Alliance, begins drafting a joint statement to raise awareness of bureaucratic obstacles in clinical research and to call for collaborative multi-stakeholder action to address them.
- Various coalition members take part in the ICH E6(R3) Good Clinical Practice workshop through the EMA Working Parties for patients and consumers (PCWP) and healthcare professionals (HCPWP).
- Publication of Reducing Bureaucracy in clinical research: a Call for Action in HemaSphere (Gribben et al., April 2020)
- Cross-disciplinary meeting on bureaucracy in clinical research hosted by EHA
- EHA facilitates a dialogue between a group of clinical researchers in hematology and the European Medicines Agency, soon involving patient advocates and other stakeholders, around the issues raised by Professors Simon Rule and Steven Le Gouill in their article Bureaucracy is strangling clinical research, published in the British Medical Journal in March 2019.
- Public Meeting on ICH E8(R1) – General Considerations for Clinical Studies. During this meeting in Silver Spring (USA) it is clear that representatives from European medical societies (EHA, ESMO, ESC) and patient advocates have similar concerns about increasing administrative pressures on investigators and participants in clinical trials.