Research

Healthcare research (Real World Evidence & Data Analytics)

The NTD database enables NeuroTransData GmbH to continuously record patient data from everyday healthcare practice across a range of different indications. The database is currently active on the indications of bipolar disorders, dementia, epilepsy, migraine, multiple sclerosis (MS), Parkinson’s disease and motor disorders and schizophrenia. The modular nature of the database means that further indications from the fields of neurology and psychiatry may be added at any time.

The NeuroTransData GmbH database also allows for the development of innovative and pioneering procedures and tools for supporting continuous treatment control and optimisation, therapeutic decision-making and improving quality of life and treatment outcomes for patients.

Prospective data collection

Prospective data collection can be carried out via the NTD database for the above indications at any time. The desired criteria are determined in a survey protocol and NeuroTransData GmbH runs the project from there. In the main, the purpose of this type of data collection relates to healthcare research matters. Data collection results then undergo statistical analysis and are published in leading journals.

Retrospective data analysis

Retrospective data analysis also mainly relates to healthcare research issues. A research question and list of criteria are established in the first instance, followed by a statistical analysis plan, in order to extract the specific data sets required for answering the question from the database. NeuroTransData GmbH offers the full range of services from concept design to the publication of results.

Development of innovative procedures in support of
diagnostics and treatment

As a network of physicians, NeuroTransData GmbH is extremely committed to improving existing diagnostic and therapeutic methods and procedures and identifying new opportunities for improving quality of life and treatment outcomes for individual patients (key term “personalised healthcare”).

Back in 2012, the network set up a database module for optimising existing multiple sclerosis treatments, which recommends a change of treatment to the physician when certain threshold values (e.g. EDSS and relapse rates) deteriorate. Obviously, the decision to switch treatments remains the sole responsibility of the treating physician.

The database and associated modules have gradually been extended to a comprehensive digital platform (DESTINY®), representing a pioneering concept for the outpatient neurological sector via the inclusion of various IT components. Through the active involvement of physicians and patients in DESTINY®, the individualised treatment of patients with the assistance of personalised healthcare at practices in the NeuroTransData network is already a reality.

Clinical research

NeuroTransData GmbH conducts both phase II to IV clinical studies and non-interventional studies (NIS). Depending on the project and parties involved, NeuroTransData GmbH assumes the role of Site Management Organisation (SMO) or Clinical Research Organisation (CRO). NeuroTransData GmbH also develops its own ideas and concepts, testing them independently via its own study design in investigator-initiated trials (IIT).

Site Management Organisation (SMO)

As a Site Management Organisation (SMO), and in its role as a network of physicians, NeuroTransData GmbH is responsible for the coordination and guidance of the NTD centres involved. As the sponsor, the individual pharma company is ultimately responsible for the proper conduct of the study. In most cases, the individual pharma company will commission another Clinical Research Organisation (CRO) to conduct and manage the study. As an SMO, NeuroTransData GmbH takes on the task of Site Management of the CRO, with the following benefits for the sponsor and the CRO:

  • Access to a large number of experienced study centres in the physician network
  • Quick and easy centre identification via the NTD Intranet (CRO/sponsor ultimately selects the centres).
  • Central contract management via the NTD, where the negotiated conditions apply to all NTD centres.
  • Rapid and direct intervention with any problems, difficulties or deviations from the plan.
  • Continuous central flow of project status information via the NTD study platform, direct communication between CRO/sponsor and NTD.

Clinical Research Organisation (CRO)

As a Clinical Research Organisation (CRO) and in contrast to SMO activities, NeuroTransData GmbH is directly involved in the planning and implementation of clinical studies.The pharma company (sponsor) tasks NTD with carrying out the study in the role of CRO. Amongst other things, this includes producing the necessary documentation (study protocol, patient information and consent form etc.), submitting the study to the competent authorities and the Ethics Committee, centre identification (the sponsor is responsible for the selection), distribution of study documents, programming an electronic case report form for the study (eCRF), management during the study, pharmacovigilance, data management and the statistical evaluation and publication of results.

Pharma companies see the following benefits when they commission NTD as CRO:

  • Cost savings compared to engaging an international CRO.
  • Study planned and conducted with the participation of registered practising physicians, providing a practice-based study setting.
  • Direct contact with the clinical investigators, as they are NTD members.
  • Rapid handling of problems, difficulties and deviations from the plan by NTD.
  • Data entry via the NTD database (eCRF), for which NTD doctors and nurses receive special training.

Investigator-initiated trials (IIT)

NeuroTransData GmbH sets up and runs in-house ideas and concepts under its own responsibility as Investigator Initiated Trials (IIT). NTD is the study sponsor in this instance. Either internal resources or research funds acquired via public tenders or pharma companies with an interest are used for the study. NeuroTransData GmbH then publishes the project results in leading journals.