Innovative new approaches for infrastructure / suggestions for additional items to mandate
Please complete and return to SCTO at the latest by 15. June 2014
Purpose: For new approaches for infrastructure (beyond the mandate) it was suggested, that all CTUs can suggest their ideas and that the BCD finally chooses a maximum of 3 ideas per taskforce. A general budget line for innovative investment will be added. This may allow further activities and new approaches in future without endangering the core budget when submitting the budget to the SERI and parliament.
New may also mean new for the network (example: phase I services offered on a harmonised, national level)
CTU / contact / CTU Basel / Prof. Dr. med. Christiane Pauli-MagnusContact person / Thomas Fabbro, PhD
Date / 13.06.2014
Project 1
Title / Platypus: An integrated Web-Application for Clinical ResearchersTaskforce concerned / QA/SOP
Project owner: Dr. med. Ramon Saccilotto
Description / Background:
Management of clinical trials is a complex and often daunting task for clinical investigators. Knowledge about good clinical practice and project management has to be learned, legal regulations have to be fulfilled and many practical problems must be solved not only during study planning but also while conducting the trial. In addition trial documentation and data must be securely archived for many years after the trial has ended. Many CTUs already offer respective services and best practices to support researchers. However those services are not always known to all researchers and central solutions are not available in all cases.
Aim:
It is our goal to provide clinical researchers with an online-platform that will guide investigators through the process of planning a clinical trial, serve as a platform for all relevant documentation and provide up-to-date information on all personnel involved. In addition we aim to integrate contact options for professional services and trainings provided by the clinical trial unit and selected collaboration parties.
Methods:
Due to the scope of this web-application we will split the development into separate projects that will be implemented modularly.
A. Framework: Gathering of requirements from clinical researchers and scientific professionals (e.g. CTU). Development of administrative overviews and a visual and technical framework to foster the development of the subsequent implementation of all subprojects. This will include the development of an central user repository to provide researchers with a single-sign-on procedure
B. Web-Based System for Quality Management of Clinical Trials: Implement a quality management module providing researchers with standardized processes that can be adapted to study specific standardized operating procedures. Resulting responsibilities of study personnel will be also recorded in the system
C. Web-Based System for Consulting and Support of Clinical Trials: Guidance of researchers through the process of planning a clinical trial by dynamic forms and best practice recommendations. Automatic submission of study-information to external registers. Central version controlled repository for all relevant study documentation (electronic trial master file)
D. Development of a national training and education platform:
Integration of a regional training and education platform to provide study personnel with a comprehensive overview of professional trainings available.
The platform will be operated by the informatics department of the University Hospital Basel, but is planned to be released as an open source application after an initial adoption phase. The integration of further features is planned according to feedback of researchers after the rollout-phase.
Link to strategy / mandate / This innovation project will provide researchers with a central platform to handle clinical trials and deliver for the first time an extensive overview of all steps and processes involved while conducting a clinical trial. This will greatly reduce the administrative work for clinical researchers, lead to significant quality improvements and increase the efficiency of clinical research.
Budget / Ad A. Platypus Framework: 1 FTE per year during the whole funding period to develop and operate the central framework and web-application platform and implement the respective sub-modules. Further funding is budgeted in respective separate projects
Time schedule / Year 1: Development and implementation of the central framework and administrative overviews as well as a central user repository
-- Platform Release Q 3 Year 1 --
Year 2: Implementation of an interactive quality management module
Year 3: Implementation and refinement of the consulting and study management module
Year 4: Development of the training and education module
Implementation of the training and education module
Varia / Further details are provided in separate proposals concerning the respecting area of the web-application. Please consult the accompanying diagram for clarification.
Project 1 - B
Title / B. A Web-Based System for Quality Management of Clinical TrialsTaskforce concerned / QA/SOP
Project owner: Julia Maurer, PhD
Description / Background:
User-friendly tools for academic researchers helping them to through all key processes required for the planning and conduct of clinical trials in accordance with ICH GCP and regulatory requirements are a key factor to assure high quality research. So far, processes and tools enabling researchers to rapidly get familiar to the required processes and to easily adapt them to a specific project are missing.
Aim:
It is our goal to provide a fully web-based quality management system for clinical research providing researchers a) with all processes, templates and tool relevant to their specific research project and b) allow the web-based assignment and training of project-specific roles and responsibilities
Methods:
Development of ICH-GCP-relevant processes, templates and tools within the scope of the Platypus project
Link to strategy / mandate / This innovation project is part of an integrated approach that will provide researchers with a central platform to handle all quality aspects of their clinical trials and research projects in an efficient and intuitive way.
Budget / 0.5 FTE per year during the whole funding period to develop and maintain the processes, templates and tools to be integrated in Platypus.
Time schedule / Year 1: Development of processes and tools
Year 2: Roll out and adaptation
Year 3-4 : Maintenance and continuous improvement
Varia / Further details are provided in a separate proposals concerning the development of the web application (Project 1: Platypus An integrated Web-Application for Clinical Researchers). Please consult the accompanying diagram for clarification.
Project 1 - C
Title / C. A Web-Based System for Consulting and Support of Clinical TrialsTaskforce concerned / Project Management
Project owner: Anna Egger, PhD
Description / Background:
Good conception, planning and conduct are key factors to assure high quality and success of a clinical research projects. In the past, CTUs have invested major resources in the setup of methodological and statistical consulting as well as services to support clinical researchers in the different phases of their research projects. However, an approach integrating all these efforts in a single platform helping researchers to choose the right services at the right time are missing.
Aim:
The goals of this project are the followings:
a. to present a comprehensive overview and central access to all consultancy and support services available at a specific CTU
b. to administer all research projects at an institution via one single portal
c. to build interfaces to national and international study registries and submission portals thereby reducing the administrative burden of a project
d. to integrate document management functions (electronic Trial Master File) to assure GCP compliant document management and archiving.
Methods:
Development of a fully web-based access to available consultancy and support service for clinical trials with integrated interfaces to other systems (registries, submission portals and document management systems).
Link to strategy / mandate / This innovation project will allow user friendly access to available CTU consultancy and support services as key factor for high quality clinical research. This innovation project is part of an integrated approach that will provide researchers with a central platform to handle all consultancy and support requirements for specific research projects.
Budget / 0.5 FTE per year during the whole funding period to define and structure the content of the platform, build interfaces and an electronic document management tool to be integrated in Platypus.
Time schedule / Year 1: Development of processes and tools
Year 2: Roll out and adaptation
Year 3-4 : Maintenance and continuous improvement
Varia / Further details are provided in separate proposals concerning the development of the web application (Project 1: Platypus An integrated Web-Application for Clinical Researchers). Please consult the accompanying diagram for clarification.
Project 1 - D
Title / Development of a national training and education platformTaskforce concerned / EDU I
Project owner: Barbara Peters, PhD
Description / Background:
Training and education has a major impact on the overall quality and performance of clinical study sites. Several training providers in the greater Basel region have established a great number of high-quality training programs over the past years. A tool to present the overall portfolio of training and education offers, however, is missing.
Aim:
The goal of this project is to create a nationally available technical tool
a. to present a comprehensive overview of all trainings available,
b. to administer all trainings via one single portal, and
c. to provide a feedback forum for customers.
Methods:
Development of a fully web-based platform to allow transparent access to training and education offers and allowing remote course administration and management of feedback.
Link to strategy / mandate / This innovation project will create transparency regarding the national offers in clinical research training and education programs. The central portal will allow up-to-date overviews, convenient booking and a feedback forum which may in turn enhance the customer-related development of training programs.
Budget / 0.5 FTE per year during the whole funding period to define, structure and maintain the content of the contents of the platform to be integrated in Platypus.
Time schedule / Year 1: Development of processes and tools
Year 2: Roll out and adaptation
Year 3-4: Maintenance and continuous improvement
Varia / Further details are provided in separate proposals concerning the development of the web application (Project 1: Platypus An integrated Web-Application for Clinical Researchers). Please consult the accompanying diagram for clarification.
Project 1 – Overview Diagram (German)
Project 2
Title / Career development for non-MD on-site study staffTaskforce concerned / EDU II
Project owner: Barbara Peters, PhD
Description / Background:
The majority of responsibilities in clinical study planning and conduct at the study site are usually being managed by non-MD on-site study staff (study nurses, on-site study coordinators/managers, etc.). The knowledge and expertise of this professional group has a major impact on the quality of (academic) clinical research. An education and career pathway, however, is completely missing in this field.
Aim:
The goal of this project is to define competence levels and corresponding education standards for Swiss on-site study staff. Additionally, a concept and tools to measure the effects of structured training on the performance of on-site study staff need to be developed and implemented.
Methods:
A gap analysis of existing training programs will be performed as starting position to assess if new training programs or formats need to be developed. All Swiss University Hospitals will be offered to adopt the concept.
Link to strategy / mandate / This innovation project will have an overall positive influence on the performance of Swiss study sites. Academic clinical research as well as pharmaceutical industry is supposed to profit from well-trained on-site study staff. Swiss education standards may become an international role model.
Budget / 0.5 FTE per year during the whole funding
200,000 CHF for 3 years for subsidization of trainees from participating hospitals
Time schedule / Year 1: Development of concept and presentation of concept at all Swiss University Hospitals; gap analysis and development of programs/formats needed
Year 2: Development of missing training programs/formats and adaptations of existing training offers; development of evaluation concept and tools
Year 3: Implementation of concept at interested hospitals and application of evaluation tools and continuous evaluation
Varia
Project 3
Title / Best practice statistical platformTaskforce concerned / Biostatistics / Methodology
Project owner: Thomas Fabbro, PhD
Description / Background:
The statistical issues encountered in clinical studies often evolve around certain, recurring topics.
Aim:
Implementation of a platform for presenting and discussing best practices for statistical issues used in clinical studies.
Methods:
This platform should present real life examples of statistical queries and suggest possible solutions. It also contains a selection of topics that can be changed and commented by the statisticians in the CTUs. Changes would be moderated and the information would be centrally maintained. For each topic the scientific background (original publications), related regulatory documents (e.g. from EMA), and details about the most up to date implementation (e.g. in R, SAS, etc) should be given.
Example for topic “Baseline Table”:
General discussion of the topic for different study types, link to chapter in the book by Senn 2007, link to most important points in consort statement, and pro and contras of different implementations discussed.
Link to strategy / mandate / This collection of statistical recommendations would allow a) individual researchers to see how they can implement and perform their analysis and b) promote and support the discussion among professional statisticians within the SCTO-network.
This would significantly increase the efficiency and quality of statistical analyses especially for projects where local expertise is not readily available. In addition, the collection would officiate as a national knowledge centre sourced by the local hot spots of knowledge.
Budget / Year 1: 0.5 FTE for the technical implementation of the platform and preparation of the initial content - mainly transferring already collected topics to the new structure and updating the containing information.
Year 2-4: 0.2 FTE for maintenance
Time schedule / Platform with skeleton and initial content could be provided within 6 months, maintenance ongoing afterwards
Varia / This platform should be implemented using statistical subject headings (StaSH) that would be developed in a separate project (please find details below)
The result of this project should be made publically available but with a clear link to the SCTO-network.
Project 4
Title / StaSH – Statistical Subject HeadingsTaskforce concerned / Biostatistics / Methodology
Project owner: Thomas Fabbro, PhD
Description / Background:
Medical subject headings (MeSH) is a controlled vocabulary thesaurus created by the National Library of Medicine to categorize and index articles for the PubMed publication database. This thesaurus allows researches to find relevant information very fast. To date, no such thesaurus exists for statistical terminology.
Aim:
To develop an initial structure and basic content for the StaSH terminology as well as a central repository for documentation and continuous revisions.
Methods:
Development of suitable terms in both alphabetical and hierarchically structured manner in analogy to the MeSH thesaurus. Implementation of a central version controlled public repository (i.e git-repository or webpage).
Link to strategy / mandate / The StaSH terminology would allow categorization of statistical documents and information and thus would strongly facilitate a) individual researchers to find relevant information and b) the SCTO-network to corporate and share statistical knowledge.
Budget / Year 1: 0.5 FTE for implementation of the terminology and supporting structures
Year 2-5: 0.2 FTE for continuous revision of the StaSH terminology
Time schedule / The logical and technical implementation is estimated to take about 5 months, structures (interface) for maintenance would take another 2 months.
Varia / The result of this project should be published and released under a free licence. A tight integration with best practice statistical platform project is planned.
Project 5