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Frequently Asked Questions about Clinical Trial Registration
(Last updated April 2011)
Which organization/institution do I register through?
For investigator-initiated studies, where registration is the responsibility of a McMaster-affiliated PI and funds are held in a McMaster research account, then McMaster University should be identified by the PI as the "Sponsor" (or Hamilton Health Sciences or St. Joseph's Healthcare Hamilton if the funding is administered through a research account at either of those institutions instead of McMaster) and the funding source (e.g. CIHR, Heart & Stroke, etc.) should be noted as the "Collaborator".
How do I register a trial with ClinicalTrials.gov?
If you determine that you need to register your clinical trial and wish to do so through ClinicalTrials.gov (http://prsinfo.clinicaltrials.gov/) you will require a user account:
- We recommend that PIs apply through the Organizational (User) Accounts of either McMaster University, Hamilton Health Sciences or St. Joseph's Healthcare Hamilton as appropriate (when in doubt, contact one of the PRS Administrators indicated below).
- Funded studies should be registered through the organization account of the institution where the funds are administered (e.g. the institution that signed the grant application, received the grant funds and reports to the funding sponsor, or signed the funding agreement with the sponsor);
- Unfunded studies should register through the organizational account of the institution where the research is being conducted;
- Jointly funded studies (i.e. funding from multiple sponsors at 2 or more institutions) should register through the institution where the majority of the funding is administered.
Is your organization already registered with the PRS? Please note that YES, each of McMaster University, Hamilton Health Sciences and St. Joseph's Healthcare Hamilton have PRS Organizational Accounts. The PRS Administrators are indicated below:
Contact the appropriate PRS Administrator above and a User Account will be created so you can register your trial(s).
If you have any questions about the registration process, please feel free to email email@example.com or contact your PRS Administrator as noted above.
Your User ID and password are valid for multiple registrations.
- For McMaster University:
Ms. Wendy Hollinshead, Manager
Health Research Services
Faculty of Health Sciences
1280 Main St. W., Room HSC-1B7
Hamilton, ON L8S 4K1
PH: 905-525-9140, ext. 22465
- For Hamilton Health Sciences:
Ms. Katie Porter, Clinical Research Agreements and Contracts Specialist
Office of Integrated Research Services
Hamilton Health Sciences
293 Wellington Street North, Ste. 103
Hamilton, ON L8L 8E7
PH: 905-521-2100, ext. 74559
For St. Joseph’s Healthcare Hamilton:
Ms. Emma Kapetanovic, Research Officer - Regulatory, Quality & Contracts
St. Joseph's Healthcare Hamilton
St. Joseph's Charlton Campus
3rd Floor Martha Wing, Room H330
50 Charlton Avenue East
Hamilton, Ontario L8N 4A6
PH: 905 522 1155, ext. 32993
The International Committee of Medical Journal Editors (ICMJE) announced that in order for clinical trial results to be considered for publication in journals that adhere to ICMJE standards, all clinical trials that start recruiting patients or volunteers on or after July 1, 2005 must be registered with a public registry before the enrolment of the first subject. Ongoing trials not registered at inception will be considered by the ICMJE for publication if they are registered before September 13, 2005. All trials with recruitment completed before July 1, 2005 need not register.
Details of the ICMJE requirement are described at the ICMJE website at http://www.icmje.org/
Why the need to register?
As outlined by the ICMJE, the purpose is "to promote the public good by ensuring that everyone can find key information about every clinical trial whose principal aim is to shape medical decision-making" and to foster conditions in which decisions about care "rest on all of the evidence, not just the trials that authors decided to report and that journal editors decided to publish".
How is "clinical trial" defined?
Initially, the ICMJE http://www.icmje.org/ required registration of all clinically directive trials, which it defined as "any research project that prospectively assigns human subjects to intervention or comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome." In May 2005, the ICMJE clarified this definition to exclude preliminary trials designed to study pharmacokinetics or major unknown toxicity (phase 1 trials). However, the ICMJE recognizes the potential benefit of having information about preliminary trials in the public domain, because these studies can guide future research or signal safety concerns.
Consequently, the ICMJE is expanding the definition of the types of trials that must be registered to include these preliminary trials and adopts the WHO's definition of clinical trial: "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes." Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. As previously, purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE member journals will start to implement the expanded definition of clinically directive trials for all trials that begin enrollment on or after July 1, 2008.
Note this important advice from the ICMJE: "Those who are uncertain whether their trial meets the expanded ICMJE definition should err on the side of registration if they wish to seek publication in an ICMJE journal".
What about registering clinical trial results?
Over the time during which registration of trial methods has become common practice, several forces have begun advocating for registration of trial results. The ICMJE recognizes that the climate for results registration will probably change dramatically and unpredictably over coming years.
For the present, the ICMJE will not consider results posted in the same primary clinical trials register in which the initial registration resides as previous publication if the results are presented in the form of a brief, structured (<500 words) abstract or table. The ICMJE favors a standard abstract format for results reporting, and the CONSORT (Consolidated Standards for the Reporting of Trials) group’s forthcoming guidelines for abstracts related to trials may be one such option. The ICMJE believes that parties interested in results registration should consider requiring the deposition of such an abstract in the registry 24 months after closure of data collection if results are not published in a peer-reviewed venue by that time. The registered abstract should either cite any related full, peer-reviewed publications or include a statement that indicates that the report has not yet been published in a peer-reviewed journal. Researchers should be aware that editors may consider more detailed deposition of trial results in publicly available registries to be prior publication. When submitting a paper, authors should fully disclose to editors all posting in registries of results of the same or closely related work.
Does the need to register trials apply only to industry-sponsored clinical trials?
No. It makes no difference who the sponsor is or whether there is an external sponsor.
Which trials registries are acceptable to the ICMJE?
Acceptable registries must:
- be accessible to the public at no charge
- open to all prospective registrants (investigators are able to register without
restriction by geographic location, academic affiliation, patient demographics, or
- managed by a not-for-profit organization
- have a mechanism to ensure the validity of the registration data
- electronically searchable
- must include the required data elements
The ICMJE (http://www.icmje.org/faq_clinical.html) has reviewed the following registries and are certain that they meet the above criteria as of January 2006.
In addition to the above registries, starting in June 2007 the ICMJE will also accept
registration in any of the primary registries that participate in the WHO International
Clinical Trials Portal (see http://www.who.int/topics/clinical_trials/en/).
How do I register a trial with ISRCTN?
If you wish to register through ISRCTN, access the on-line application at http://www.controlled-trials.com/isrctn/submission/ . You can log-in immediately and register your trials. Once the form has been submitted, you will get an email confirming receipt of your application, which you may print out for your records if you wish. The ISRCTN editorial office will then check whether the application is eligible. An administrative charge will then be requested – the 2011 rate is £167 per trial. All users will have permanent free access to the information in the ISRCTN Register. If you have any questions about the registration process, please feel free to email firstname.lastname@example.org
Does the local Research Ethics Board need to approve the study before it is registered?
No. The ClinicalTrials.gov registry allows for trials to be registered 'pending' ethics approval. However, once a trial has been approved by the REB, the registry must be updated with the REB approval number.
The McMaster-affiliated REBs expect that PIs will register and will continue to update the registration information (e.g when the trial is complete or results are published).
The Application for REB Review now includes a section asking whether a clinical trial has been or will be registered. If there are no plans to register the trial, the PI is asked to justify why registration is not planned.
What about CIHR-funded RCTs and the TCPS2?
PIs of CIHR-funded randomized controlled trials, please note that with the publication of the December 2010 version of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS-2) http://www.cihr-irsc.gc.ca/e/43756.html previous CIHR policy re trial registration has been superseded. The TCPS-2 addresses registration in Chapter 11 http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/chapter11-chapitre11/#toc11-1b , and calls for registration in any WHO/ICMJE approved registry. The premise of the WHO ICTRP Platform is that unless government (or other) requirements mandate it, a clinical trial should only be registered once in a WHO/ICMJE registry http://www.who.int/ictrp/trial_reg/en/index1.html.
TCPS-2 Article 11.3 states: Clinical trials shall be registered in a registry that is compliant with the criteria set by the World Health Organization (WHO)http://www.who.int/ictrp/en/ or International Committee of Medical Journal Editors (ICMJE)http://www.icmje.org/update_sponsor.html as of November 2010. Researchers shall provide the REB with the number assigned to the trial upon registration.
Who is responsible for registering a trial?
Industry-sponsored trials - Where there is a contract between the industry sponsor, the host institution, and the PI, then the industry sponsor should register the trial. Before enrolling study subjects, every PI should ensure the industry sponsor has registered the trial. The PI should also check the registry to ensure that all ICMJE minimal data set elements are included in the registration.
Investigator-initiated trials -
(a) Where industry has supplied the study drug or grant funds, the trial should be registered by the lead PI, through the sponsoring institution (e.g. McMaster, Hamilton Health Sciences, or St. Joseph's Healthcare, as the case may be).
(b) Where the trial is either unfunded or funded through a grant from CIHR, non-profit sources, or internal sources, the trial should be registered by the lead PI, through the sponsoring institution (e.g. McMaster, Hamilton Health Sciences, or St. Joseph's Healthcare, as the case may be).
NIH-sponsored trials - Where the trial is funded through an Institute under the National Institutes of Health (NIH) umbrella, then the Institute will register the trial.
Multi-site trials - Registration should be coordinated among the study sites and registered by the "lead sponsor" to avoid multiple registrations.