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Table 5 Survey of trial investigators with non-registered studies as of April 2020

From: Towards full clinical trial registration and results publication: longitudinal meta-research study in Northwestern and Central Switzerland

Topic

36 of 60 investigators filled out the questionnaire, 24 did not respond

General awareness of Researchers

Prospective registration is required by law

Registration is required before first participant enters the study

Swiss National Clinical Trials Portal (SNCTP)a is not a primary registry

Registration is reasonable

27 (75.0%)

26 (72.2%)

14 (38.9%)

32 (88.9%)

Study support by service team

Clinical Trials Unit

Contract Research Organisation

Others

No support service

7 (19.4%)

3 (8.3%)

2 (5.6%)

24 (66.7%)

Knowledge of primary registries

ClinicalTrials.gov

German Clinical Trials Register (DRKS)

EU Clinical Trials Register (EUCTR)

ISRCTN-Register

32 (88.9%)

13 (36.1%)

14 (38.9%)

7 (19.4%)

Perceived Barriers to study registration

Insufficient knowledge of primary registries/ registration processes:

Limited time/ resources for registration process

Missing reminder of obligation to register the study

Othersb

8 (22.2%)

18 (50.0%)

13 (36.1%)

6 (16.7%)

Stated reasons for non-registration

- Study postponed/ unclear study start date (n = 2)

- Missing local SOPs for registration (n = 1)

- Unclear interpretation of regulations for Phase I studies (n = 1)

- Study not considered as clinical trial by investigator (n = 4)

- Unaware of the obligation to register (n = 2)

- Short study, retrospective registration considered as unnecessary/confusing (n = 1)

- One researcher responsible for all registrations in the research institute (n = 1)

- No reason specified (n = 24)

  1. Abbreviations: ISRCTN International Standard Randomized Controlled Trial Number, SOP Standard Operating Procedure
  2. aIn Switzerland every study approved by an ethics committee and registered in a primary registry will be listed on the Swiss National Clinical Trials Portal (SNCTP)
  3. bOthers included unclear definition of the study, unclear responsibilities for registration within institution, COVID-19 induced delay