Academic Clinical Trials Task Force

Description

The task force provides a platform for discussions on academic clinical trials. It facilitates an exchange of best practices and pinpoints the challenges that researchers face in this field. It also aims to better communicate the value of researchers’ work in society and the value of academic clinical trials. It is committed to providing recommendations to reduce inconsistencies in the regulatory framework and advocates for adequate funding.

Chair

This task force is chaired by Dr. Denis Lacombe and co-chaired by Prof. Martin Dreyling.

Highlights

  • Successful roundtable on treatment optimisation

    The EU roundtable organised in February 2020 by the BioMed Alliance and EORTC brought together a large number of stakeholders around the central question ‘’How can current EU policy initiatives pave the way towards treatment optimisation as part of health systems?’’. The discussions, led by a high-quality panel, concluded that treatment optimisation must be better embraced in our health system if we want to address the current gap in the research and development process for innovative treatments that results in a lack of information relating to the use of novel therapies in real-world settings.  Read more about the webinar in our February Update here

  • Interactive webinar on treatment optimisation with MEP Maria da Graça Carvalho and MEP Dolors Montserrat on February 3, 2021 from 15:00-17:00.

    How can current EU policy initiatives pave the way towards treatment optimisation as part of health systems?

    The EORTC and the BioMed Alliance, together with key members of the European Parliament, will organise a webinar bringing together important health stakeholders to share fresh and diverse perspectives on what can be implemented in the current EU policy programmes to advance Treatment Optimization as part of health systems.

    The agenda is available here.

    You can register to the online event here.

  • Reducing bureaucracy in clinical trials: now is the time!

    Medical societies and patient advocates across disciplines call for urgent action to make clinical trials less bureaucratic and more patient-centered, efficient and cheaper.
    To achieve this, stakeholders cooperate in a new coalition addressing excessive bureaucracy in clinical trials and the BioMed Alliance plays an active role.

    Excessive administrative demands lead to rising costs and complexity, stagnation of clinical research in Europe, fewer academic clinical trials, and limited access to innovative treatments. Unnecessary, inefficient, overly complex or ambiguously worded regulations, guidelines, safety reporting requirements and informed consent procedures pose a threat to exactly that which they were designed to protect: the quality of clinical trials and the safety of patients.

    Read the statement here.

    The Coalition to reduce bureaucracy in Clinical trials is continuing its work through working groups which aim to formulate proposed solutions and recommendations for each of the main issues identified in the statement.

    Read more on the website of the Coalition here.

  • BioMed Alliance Response to consultation on the pharmaceutical strategy

    The BioMed Alliance has submitted feedback for the consultation on the new Roadmap for the Pharmaceutical Strategy for Europe. In the response, we stress the need for coordinated action in a number of policy areas that are crucial in the lifecycle of pharmaceuticals including support for biomedical research, academic clinical trials, health data sharing and cooperation on Health Technology Assessment. Read the BioMed Alliance feedback to the Roadmap on the Pharmaceutical Strategy here.

  • Manifesto on Treatment Optimisation

    Together with other stakeholders, we support the EORTC Manifesto on Treatment Optimisation. The manifesto lists necessary and changes in order to enhance treatment optimisation and facilitate personalised medicine.
    The manifesto is available here and a related STOA study can be found here.

  • Policy paper: Moving forward from drug-centered to patient-centered clinical research

    BioMed Alliance members contributed to a White Paper initiated by EORTC on academic clinical research.

  • European Respiratory Journal Article

    An updated version of the white paper entitled: ‘Moving forward from drug-centred to patient-centred research’ was published in the European Respiratory Journal in February 2019. This article includes the patient perspective and describes specific policy angles to tackle related issues. The article can be found here.