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Why should I register my clinical trial?
There are several reasons why should you register your clinical trial:
- To fulfill ethical obligations to participants and the research community. The Declaration of Helsinki clearly states, "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject".
- There is a need to ensure that decisions about health care are informed by all of the available evidence and doing so, you can provide information to potential participants and referring clinicians;
- Reduce publication bias;
- Help editors and others understand the context of study results;
- Promote more efficient allocation of research funds;
- Help institutional review boards (IRBs) determine the appropriateness of a research study.
Where can I register my clinical trial?
The most common websites are:
ClinicalTrials.gov - https://clinicaltrials.gov/ct2/home
EUDRACT - https://eudract.ema.europa.eu/
What kind of information will be required?
A lot!
Mostly regarding the Study identification, Study status, Sponsors/Collaborators, Oversight, Study description, Keywords, Study design, Interventions, Outcome measures, Participant eligibility, Investigator information and References.
There are some tools available that can assist you in this task, such as as the CONSORT flowchart or reporting templates.
What are the resources available to CINTESIS researchers?
CINTESIS has an experienced Biostatiscs and Health Informatics consulting service to help you design, collect, store and analyze clinical information, a Health Scientific Communication service to help recruit participants and disseminate the results, a Pharmacovigilance service to track adverse drug reactions and train medical staff involved in clinical trials and a consultation room for researchers to welcome participants.
CINTESIS has also recently created an organizational profile in clinicaltrials.gov and at EUDRACT, to help researchers organize and post their ongoing clinical trials.
So do not hesitate to contact us to help you run your clinical trial.
António Soares
Research, Development and Innovation Manager at CINTESIS
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