Study identification

EU PAS number

EUPAS1000000786

Study ID

1000000786

Official title and acronym

Characterisation of complex clinical trials in the European regulatory context

DARWIN EU® study

No

Study countries

Austria
Germany
Sweden

Study description

The project aims to identify and categorize Complex Clinical Trials (CCTs). Definitions of “complexity” will be developed based on a review of relevant literature and regulatory documents. Clinical trials registered in the Clinical Trials Information System (CTIS) will be identified and categorized accordingly. The search strategy will combine natural language processing (NLP) and text-mining techniques with manual review.
A Delphi process will be conducted to establish a harmonized framework for CCT categorization, taking into account multiple dimensions of complexity, such as operational, regulatory, methodological, statistical, and ethical aspects. This process will ensure input from experts with diverse backgrounds, including CTIS end-users, CTIS application assessors, and professionals with regulatory, ethical, operational and methodological expertise.
A validation study will assess the accuracy and reliability of both the search strategy and the proposed categorization framework. Based on these findings, the project will provide recommendations for identifying complex trials within CTIS and suggestions for improving future processes to facilitate easier identification. The results, including both technical and conceptual insights, will be disseminated through comprehensive reports and webinars.

Study status

Ongoing
Research institutions and networks

Institutions

Medical University of Vienna
Austria
First published:
26/02/2024
Institution Educational Institution Hospital/Clinic/Other health care facility
Austrian Agency of Health and Food Safety

Networks

CONsortium For Innovation in Regulatory Medical Statistics (CONFIRMS)

Contact details

Franz König 0000-0002-6893-3304

Primary lead investigator
ORCID number:
0000-0002-6893-3304

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Regulatory

Was the study required by a regulatory body?

Unknown

Is the study required by a Risk Management Plan (RMP)?

Not applicable