Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The sixth installment in our Clinical Research 101 series is by Judy Needham, Project Manager at CHÉOS. The following is an overview of clinical trial registration, including why it is important and what is required.
Ms. Needham has more than 9 years’ experience providing leadership and oversight in the management and coordination of investigator-initiated and industry-funded clinical research studies and is an experienced research program administrator. She is one of many project managers who work for CHÉOS. The Centre’s project managers are experts in the regulatory, policy, budgeting, and implementation requirements for clinical research studies. If you would like to inquire about our services, please submit your request here.
What is a clinical trial registry?
A clinical trial registry is a publically accessible catalogue of clinical trials involving human participants. Such registries are commonly free to the public, web-accessible, and electronically searchable and are intended to provide information about clinical trials that involve a wide range of diseases and conditions.
Why is clinical trial registration important?
A registry platform is important to improve clinical research transparency and ultimately strengthen the validity and value of evidence-based research.
Clinical trial registration aims to:
- maintain scientific integrity by increasing transparency and preventing selective publication and selective reporting of research outcomes
- improve awareness of similar studies with the aim of preventing duplication and reducing burden on participants
- help researchers identify potential collaborators and/or identify gaps in clinical trial research
- assist research ethics boards in determining appropriateness of studies under review (e.g., harms, benefits, relevancy/redundancy)
- allow potential participants to find studies into which they might want to enrol
- meet obligation to register by:
The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014 (TCPS2)”]“All clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE).” (TCPS2: Article 11.3)
The ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry at or before the time of first patient enrollment as a condition of consideration for publication.
For US Food and Drug Administration (FDA) regulated studies, FDAAA801 requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov.
Failure to register a clinical trial, or keep the information up to date or submit false/misleading information may lead to the inability to publish results in an ICMJE-associated journal. Failure to comply with FDAAA 801 could result in civil monetary penalties and, for federally funded studies, the withholding of grant funds.
Where do I register a study?
ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or on ClinicalTrials.gov, which is a data provider to the WHO ICTRP. Most studies are registered on ClinicalTrials.gov however some funding agencies may prefer a specific registry.
What studies do I need to register?
Clinical trials that meet one of the following clinical trial definitions must be registered:
ICME defines a clinical trial as:
- “any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.
- Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioural treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Health outcomes are any biomedical or health related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”
TCPS2 states that a clinical trial is:
- “any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products, process-of-care changes, preventive care, manual therapies and psychotherapies.
- Clinical trials may also include questions that are not directly related to therapeutic goals — for example, drug metabolism — in addition to those that directly evaluate the treatment of participants.”
FDA requires registration for:
- any trials of drugs and biologics: controlled clinical investigations, other than Phase I investigations, of a product subject to FDA regulations
- trials of biomedical devices: controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric post market surveillance.
It is recommended that all clinical studies whose data is intended to be submitted for publication in a medical journal, are registered with either ICTRP or ClinicalTrials.gov.
Who is responsible for registering a clinical trial?
- For Industry-sponsored trials, the sponsor is responsible for registration. For more information about what is required of clinical trial sponsors see Sponsor Responsibilities 101.
- For Investigator-initiated trials, regardless of funding source, the principal investigator (PI) is considered the sponsor and is responsible for registration. Read the fourth instalment of our Clinical Research 101 series for more on the responsibilities of an investigator in a clinical trial.
It usually takes about 1–2 hours to register a study.