Coalition Recommendations

ORIGINS AND TIMELINE OF THE REDUCING BUREAUCRACY IN CLINICAL TRIALS INITIATIVE

June-November 2021

  • Elaboration of Coalition Recommendations, taking into account feedback from stakeholders collected during the Roundtable meetings and informal consultations

August-September 2021

  • 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 )

April-May 2021

  • 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

September-October 2020

  • Launch of Coalition Statement Reducing bureaucracy in clinical trials: now is the time!
  • Coalition meeting, formation of working groups tasked with formulating Coalition recommendations

Spring-summer 2020

  • 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).

March-April 2020

  • 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

2019

  • 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.

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