Two-day Clinical Research Conference. Open Dialogue with the goal of modernizing Greece in the fields of Pharmaceutical Medicine and Clinical Research

  • On 31 Ιουλίου 2020

Two-day Clinical Research Conference.
Open Dialogue with the goal of modernizing Greece in the fields of Pharmaceutical Medicine and Clinical Research.

The Online Two-Day Conference on Clinical Research organized by the Hellenic Society of Pharmaceutical Medicine (EL.E.F.I.) on June 16 and 17 with the central theme: “Translating Innovation into Clinical Benefits for Patients, Modern Clinical Research & Future Clinical trials», was the first virtual clinical research conference of Hellenic Society of Pharmaceutical Medicine.

More than 200 scientists, members and non-members of EL.E.F.I., representatives of European fora, Patients Associations leaders, Health and Research stakeholders and certified Health Journalists joined the Two-Day Conference open dialogue regarding the priorities of Clinical Research in Greece, in order to realize the clinical research potential of the country.

The President of EL.E.F.I., Varvara Baroutsou, stated in this regard: “We are particularly pleased with this year’s Clinical Research Biennale, as it has been an interactive forum enlightened by the participants’ insights on key issues in the field of Pharmaceutical Medicine and Clinical Research, promoting the development of a collaborative culture and systematic engagement between Scientific Societies, Clinical Researchers, Greek Patients’ Association, Institutions, the Pharmaceutical Industry, CROs and the Health Authorities.

On Day 1 of the conference, the participation of Patients’ Associations in the creation of educational material on Clinical Trials arose as a top priority and the Greek version of the EUPATI educational material, was proposed to be edited jointly with Greek Patients’ Association, National Medicines Agency-E.O.F. and EL.EF.I.  A follow up action on the importance of a meaningful and fully understandable patient informed consent process in Clinical Trials, ensuring patients’ rights, safety, confidentiality and data privacy at all levels emerged as the 2nd co creation initiative. The 3rd key activity, in progress already, relates to facilitating patient awareness and access to clinical trials, through EOF and the Greek Patients’ Association website ‘serving’ as recruitment hub for approved clinical trials in Greece enrolling new patients.

The second key theme of Day 1 was the upcoming implementation of EU CTR in 2021 in the country, as the big bet for Greece’s readiness and competitiveness to boost its full potential in clinical trials. In Greece, the challenges that need to be addressed for the implementation of the New Regulation relate with the transformation of clinical research culture in hospitals and financial institutions managing the research accounts (ELKE / ELKEA), namely the optimization of their procedures and the development of skills for effective and rapid change management.

The focus of interest on Day 2 of the Conference included the latest advances regarding the development of innovative therapeutic solutions. In particular, the evaluation of the new adaptive clinical trials design and the understanding of the challenges they present for patients, clinical research teams and regulatory authorities were emphasized. However, the quality and rapid implementation of clinical trials with new innovative designs in clinical sites require constant support from sponsors, to minimize the degree of difficulty for both investigators and patients.

In addition, the continuing education of clinical investigators regarding the requirements of the protocol, the effective communication with regulators and the continuous empowerment of patients play a key role in the smooth conduct of modern clinical trials.

During Day 2 last session of the Conference, a consensus was reached on the need to use Real World Data (RWD) as complementary models to enhance the design of Clinical Trials, accelerate the recruitment of patients and support regulatory –health technology assessment requirements in the direction of integrated documentation of health outcomes. Finally, the urgent need to fill the gap in the legal framework regarding pharmacoepidemiological studies (non-interventional clinical studies) was highlighted, as they are an important source of Medical data from the Public Health Care system (e.g. disease registries, e prescription system, EMRs), for academic and clinical research in Greece.

EL.E.F.I. Board concluded the Conference by announcing the initiative “Clinical Research & Clinical Trials Innovation Forum” to facilitate public dialogue with all partners in Clinical Research, Medical Education and Pharmaceutical Medicine. EL.E.F.I. structured the dialogue process so that:

 

  1. An Experts’ Advisory Committee will guide the Forum’s priorities for the development of best practices regarding legislative proposals and consultation, as well as to assess their feasibility and efficiency in terms of implementation.
  2. E.F.I’s Working Groups will design
    1. the continuing education on the latest technologies & methodologies of Drug Research,
    2. the development of the scientific leadership of its members and
    3. the recommendation of new certifications for the recognition of their experience.

At the end of the Two-Day Conference, the President of EL.EF.I, Dr Baroutsou gave special emphasis to the international profile of the Hellenic Society, as a partner of IFAPP & IFAPP Academy. Furthermore, she expressed her satisfaction with the digital transformation of EL.E.F.I. in the context of a series of webinars and digital events on Covid-19 impact on Clinical trials conduction, Clinical Research and Pharmacovigilance as well as on Medical Science Liaison role aspects.

The scientific activities and events were carried out with the kind support of the following companies: Creative, Qualitis, Medwork, One2One, PHOCUS and Zeincro.

More information about EL.E.F.I. and its actions can be found here www.elefi.gr