Community Research and Development Information Service - CORDIS

H2020

IDEAS Report Summary

Project ID: 633567
Funded under: H2020-EU.1.3.1.

Periodic Reporting for period 1 - IDEAS (Improving Design, Evaluation and Analysis of early drug development Studies)

Reporting period: 2015-01-01 to 2016-12-31

Summary of the context and overall objectives of the project

Drug development is a long and costly process which suffers from the major shortcoming that frequently failure is often only determined during the final stage. Recently, it has been recognised that more care needs to be taken during the early stages of development to avoid going into lengthy and costly confirmatory studies with ineffective or harmful treatments. Furthermore the number of new drugs approved annually has decreased drastically in the last 50 years. Once more early drug development is key to identify promising treatments that have the potential to transform patient's lives. To achieve this goal it is essential to implement efficient methods for the design and analysis of such early development studies. The expertise in this area is, however, limited at the moment and adequate methodology is only partially available. This network seeks to improve methods for studies in the early stages of the drug development process in order to reduce the effort put into unsuccessful development programmes and to enable effective and safe treatments to reach patients quicker. The network will train researchers in methods for early phase studies and offer a range of research projects within this area. The main goals of the network are to

(a) train early-stage researchers in state of the art methods for designing, evaluating and analysing early phase studies;
(b) develop novel methodology for early phase studies through individually supervised, collaborative, research projects;
(c) provide an international, collaborative environment in which the academic research experience is paired with the challenges of undertaking drug development within the private sector;
(d) raise awareness about cutting edge methods for designing and analysing early phase studies among trialists and clinicians alike.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first part of the project one focus has been to ensure the network develops to its full potential. Crucial to this has been the development of a sense of belonging to the network which has been achieved by formal team building activities, in-depth discussion sessions around commonalities and synergies between the individual researchers projects and regular communication between participants.

Training the researchers in the fundamentals of drug development with a focus on quantitative skills and training on transferable skills has also played an important role during the first half of the project. This was achieved by a combination of network-wide training and individual training activities. Two week-long network-wide training events have been organised as well as a three day Think Tank meeting. The objective of each of these meetings was to train the researchers in methods for drug development, provide transferable skills training, foster networking/collaborations and share their research progress.

In terms of research all researchers have made good progress on their respective projects. The majority of the 14 researchers have already submitted at least one article for publication or are in the final stages of preparing the first manuscript. Moreover several articles have been accepted in high quality peer-reviewed journals. The work is also regularly disseminated at conferences, workshops and in discussion with applied researchers. To disseminate the work of the network widely and clarify the role of statistics in drug development a number of other outreach and dissemination activities have taken place. Most notably a blog-series (available on the IDEAS website) about the role of statistics in the different phases of drug development has been created by the researchers on the basis of a questionnaire.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Beyond the scientific contributions to the field which are emerging from the project the IDEAS network is impacting both the researchers career prospective and training in quantitative methods for drug development more broadly.

The extensive course program ensures cutting edge statistical expertise in designing, conducting, analysing and assessing innovative early phase trials. Statistical courses provide a well-founded basis in traditional topics relevant for early development to ensure that the graduates have a broad and in-depth competence on efficient methods considering the various aspects of early drug development.Through the dedicated training programme the researchers are uniquely trained for a career as research scientists in academia, the pharmaceutical industry, contract research organisations, statistical software developers, regulatory bodies and for entrepreneurs embarking on statistical start-up companies. The network provides all its researchers access to European key opinion leaders, clinical trials experts, statistical software developers and stakeholders in the public and private sector. The researchers are therefore not only highly trained in the field but also equipped with an invaluable network of experts which will make the researchers highly desirable future employees.

At the same time the IDEAS network showcases how dedicated training in quantitative methods for drug development can look like and illustrates the value of close collaboration of academic, industry and regulatory agencies which has the potential to transform training in the field for the future.

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