ClinicalTrials.gov is a publicly accessible database, which is free to register details of your clinical trials. For ClinicalTrials.gov, you are only required to register your study if it is defined by the first four categories of question two on IRAS as either:
- Clinical trial of an investigational medicinal product
- Clinical investigation or other study of a medical device
- Combined trial of an investigational medicinal product and an Investigational medical device
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
If it doesn’t fall under any of the definitions above, you are still able to register it but you aren’t required to.
Before you register your study, please consider the following:
- If you want to register a study on ClinicalTrials.gov, you will need to post the study results on the website within one year after completion, regardless of the type of study and regardless of the outcome of the study. Once the study has been entered onto ClinicalTrials.gov it becomes part of the public domain and we need to ensure results are reported, in accordance with best practice and in light of increased awareness and scrutiny around transparency.
- If your study is registered on another database such as ISRCTN or EudraCT, it is unlikely that you need to register it on ClinicalTrials.gov as well (although you can if you would like to). There are some circumstances in which you would need to register on ClinicalTrials.gov, such as if the study has a site in the USA or if it is evaluating a drug, biological, or device product which is regulated by the United States Food and Drug Administration. If you register your trial on multiple sites, you will need to report results on all sites.
- Once your study has been registered, you must log into ClinicalTrials.gov and verify that the information on record is still accurate at least every 6 months.
- You should register your study before the first participant is recruited.
- After submitting the study record, ClinicalTrials.gov often come back with comments that need to be addressed before the record can be made public. When you are notified about comments, please address them promptly.
The outcome measures should be written in the way the data will be reported. One measurement scale per outcome measure. There isn't a way to include narrative data, so numbers will need to be in a tabular format. For example, “Number of patients with a 50 percent or greater change in pain as determined by the SPS-11 questionnaire at week 24”. You might use 'change from baseline' or 'proportion with decrease' or ‘number of patients with increases in urine metabolites.’
For further information please see SOP 022 on adding study details to public databases.
Creating an account
The Research Governance and Integrity Team is the designated 'Administrator' for registering users on ClinicalTrials.gov.
As Administrator, we will create a user account for you (upon request), giving you access to register trials on the system. We will check and release records for ClinicalTrials.gov to review once you have completed them properly. If you would like a user account, contact the Quality Assurance Facilitator requesting an account to register your trial.
- Once the Quality Assurance Facilitator has created an account for you, your log in details will be sent to you automatically from ClinicalTrials.gov via email and you will be able to register the trial.
- To register your trial on ClinicalTrials.gov you need to go to the PRS login page, not the main public view page.
- You can register on ClinicalTrials.gov whether your main employment contract is with Imperial College or Imperial NHS Trust.
Maintaining the study record
To Log In:
- Visit the PRS login page
- Complete the three fields on the login screen (as provided to you in the automatic email notification after your account was created):
Organisation: ImperialC or ImperialNHSTrust (depending on which organisation is sponsoring the study)
Username: user login name
To Create a Record:
A record may be created at a single session or created and saved for completion later. To create a record during a single session:
- Follow [Create] from the Main Menu screen. Choose “New Record"
- To create a record and save for completion later, use [Quit] to stop data entry after step b (above), or any other successive screen. Then use [Save Protocol Record] to keep your data. The record will be saved for later.
Information must be correct and readily understood by members of the public. You are required to update each clinical trial record every six months. Please update the “Record Verification” to that day’s date every time you login or update your record.
- Is reporting results considered prior publication or does it negatively impact future or current submissions for journal publication?
Publication of results on a public trial registry is not considered a prior publication; this is in line with the ICMJE guidelines (The International Committee of Medical Journal Editors).
"The ICMJE will not consider as prior publication the posting of trial results in any registry that meets the above criteria if results are limited to a brief (500 word) structured abstract or tables (to include trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events)."
The results on ClinicalTrials.gov (a registry recommended by ICMJE) are indeed presented in a tabular and brief format, as recommended by ICMJE. This is further explained RGIT_SOP_022_Public Databases.
"Reporting results on ClinicalTrials.gov, ISRCTN or EudraCT does not count as prior publication, thus results need to be reported within the required time frame regardless of the outcome of the trial and regardless of potential planned or pending publications."