What is clinical research?

Clinical research includes the development and validation of diagnostic methods and questionnaires in studies. It also involves the development of new treatment interventions for mental disorders and the evaluation of efficacy and effectiveness of interventions and the establishment of risk profiles for patients. Clinical research also provides methods that can include the patients’ perspective into randomized clinical trials.

Why is it important for mental disorders?

Clinical research is of particular importance for mental disorders, mainly because of the low validity of animal models in humans so far and because of the sub-optimal definition and stratification of mental disorders.

The complexity of treatment strategies combining pharmacological therapies, psychotherapy and other medical devices also requires clinical trials supporting evidence-based medical practice. Specific methodological issues have to be addressed, including commonly agreed outcome measures. Clinical research on mental health therefore represents a highly multidisciplinary activity.

How are the relevant questions of clinical research addressed in ROAMER?

After the first year of ROAMER and its first results a gap between basic neuroscience research and the clinical reality for patients with mental disorders regarding clinical research was identified by the members of the Stakeholder and Scientific Advisory Board. This gap was decided to be covered by a newly formed task force consisting of several ROAMER WP members providing their expertise on clinical aspects of all ROAMER themes. Therefore a Clinical Research Task Force was established on December 19^th, 2012 within ROAMER.

The main objective of this task force is to define a strategy for clinical research in psychiatry in Europe.

In order to achieve its main goal the Clinical Research Task Force aims to identify important new developments in the field of clinical research of disorders, addresses questions including new horizons for innovative research and gaps to be addressed in future research. An important area is related to the ‘how’ of research, in terms of methodological innovation, quality assurance and prevention of poor research.

Prof. Christina van der Feltz-Cornelis

Prof.Jim van Os

Dr. Rebecca Kuepper

Dr. Iman Elffeddali (WP 2)

Prof.Jacques Demotes (WP 3)

Prof. Eduard Vieta

Prof.Gunter Schumann (WP4)

Prof.Hans-Ulrich Wittchen

Dr. Susanne Knappe (WP5)

Prof. Kristian Wahlbeck (WP 7)

Prof. Don Linszen, Chair of the Scientific Advisory Board, participates as observing member

The Clinical Research Task Force identified expert researchers in the field of clinical research and performed a Delphi study, the results of which are described in an interim report (May, 2013) and a final report (October, 2013).

Subsequently, the priorities for clinical research are integrated within the list of research priorities of ROAMER.

Priorities identified for clinical research

The top priorities that emanated from the Delphi process were the following:

1. the need for development and evaluation of new interventions for mental disorder;

2. the need to understand the mechanisms of disease related to treatment for mental disorder;

3. the need to develop interventions specifically for somatic-psychiatric comorbidity, in view of the complexity of this comorbidity and the required treatment, as well as the high mortality rates in this patient group;

4. the importance of patient centered clinical research was stressed by the experts.