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A group of participants that does not receive any interventions during a clinical study.
Indicates whether a clinical study allows people who do not have the condition or related conditions or symptoms being studied to participate in that study.
The clinical study is ongoing. That is, participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
An unfavourable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study is over. This may or may not be caused by the intervention being studied.
Any change to the terms of a study, including to the protocol or other supporting documentation, made after a Health and Disability Ethics Committee has approved the study.
The person who submits an application to a Health and Disability Ethics Committee (HDEC). Where the applicant is not also the Coordinating Investigator (CI) for the study, the CI must have authorised the application.
Any substance or article, other than a medical device, that is manufactured, imported, sold, or supplied wholly or principally—
A medical check-up can involve a physical exam and number of different medical tests. This may include blood and urine tests, and exercise and heart rate tests. Medical check-ups are often conducted at the beginning of a clinical trial to determine whether or not a person is able to participate in the trial. Medical checks-ups are also conducted at the end of a clinical trial. They can sometimes be conducted during the clinical trial too. Researchers compare the test results to see if any improvements occurred over the trial period.
A drug, or biological product that is used in a clinical trial but has not been approved (the drug is either not available for a doctor to prescribe or, is available, but not approved by the for the use being studied).
Informed consent describes the process of giving your written agreement to participate in a clinical trial. Everyone taking part in a clinical trial must give ‘informed consent’. In some instances, a parent, guardian or other legally authorised person can give consent for you.
As part of the informed consent process, the research team will provide you with information on the clinical trial, including a ‘participant information sheet’ and a ‘consent form’. These documents explain the purpose of the clinical trial, outline any treatments and procedures, and explain any benefits and risks.
You will be provided with an opportunity to ask questions and have these answered by the research team. You will also have a chance to talk it over with family, whānau, friends and the healthcare professionals involved in your care.
The Health Research Council Ethics Committee ensure that independent ethical assessment of any proposed research submitted for a Health Research Council (HRC) grant has been carried out either by the HRCEC itself, or an ethics committee approved by the HRCEC. The HRCEC approves ethics committees to carry out this function.
A clinical trial that selects its participants from a population, or group of people, decided on in advance by the researchers. These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The group can recommend to the study sponsor that the study be stopped if it is not effective, if it is causing harm to participants, or if it is not likely to serve its scientific purpose. Committee members are chosen based on the scientific skills and knowledge needed to monitor the particular study. Also referred to as a Data Safety and Monitoring Board (DSMB).
Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A during a later phase. So during the study, participants “cross over” to the other drug. All participants receive drug A and drug B at some point during the study, but in a different order, depending on the group to which they are assigned.
All clinical trials follow a set of rules, or ways of doing things. This set of rules is called the clinical trial protocol. The clinical trial protocol describes:
A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial – related activities were conducted, and the data were recorded, analysed and accurately reported according to the protocol, sponsors standard operating procedure (SOPs), Good Clinical Practice (GCP) and the applicable regulatory requirements
A group or subgroup of participants in a clinical trial who receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
A general description of the clinical study arm. It identifies the role of the intervention that participants will receive. Types of arms include Experimental, Active comparator, Placebo comparator, Sham comparator, and No intervention.
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age and gender, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
A research study using human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies.
In epidemiology, a group of individuals with some characteristics in common.
Formerly known as the ‘principal investigator’; the chief investigator of a study in the New Zealand, or the investigator assigned responsibility for the co-ordination of investigators at different centers participating in a multi-center study. In New Zealand, the CI has primary responsibility for the design and conduct of the study in New Zealand, including compliance with all relevant legal and ethical standards. All applications for Health and Disability Ethics Committee (HDEC) review of a study must be submitted or authorised by the study’s CI.
A clinical trial that is conducted principally for the benefit of the manufacturer or distributor of the medicine or item being trialled.
A collaborator is an organisation other than the sponsor that provides support for a clinical study. This may include funding, design, implementation, data analysis or reporting.
A disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues such as lifespan, quality of life, and health risks.
Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants’ consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.
If someone is unwell and is given treatment and then gets better it could be due to the treatment, or it could be due to something else, such as normal recovery. For example, if someone with a sore throat is given antibiotics and recovers, it could be due to the antibiotics, or due to this person’s immune system getting rid of the virus. To test whether a new treatment in a clinical trial is working it needs to be compared to a control group receiving another treatment or a ‘placebo’ (link to defintion).
If you join a clinical trial, you may be put into one of the following groups:
The aim of the trial is to compare what happens in each group. If there are differences between the groups, this may show to what extent the new treatment is working.
A contract research organization (CRO) is an organisation that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis
The key standards that people who want to participate in a clinical study must meet or the characteristics that they must have. These include inclusion criteria and exclusion criteria. For example, a study might only accept participants who are above or below certain ages.
A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected.
The New Zealand Health and Disability Ethics Committees (HDECs) are
Ministerial committees (established under section 11 of the New Zealand Public Health and Disability Act), whose function is to secure the benefits of health and disability research by checking that it meets or exceeds established ethical standards.
Good Clinical Practice (GCP) is a standard for the conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate and that the rights, integrity, and confidentiality of trial subjects are protected.
The factors (or reasons) that prevent a person from participating in a clinical study.
The process by which a Health and Disability Ethics Committee (HDEC) checks, in accordance with the Standard Operating Procedures, that a new application (or substantial amendment to a previously approved application) meets or exceeds established ethical standards.
A Non-Government Organisation is a non-profit organization that operates independently of any government, typically one whose purpose is to address a social or political issue.
This code sets specific rules for agencies in the health sector to better ensure the protection of individual privacy. The code addresses the health information collected, used, held and disclosed by health agencies. For the health sector the code takes the place of the information privacy principles. Health Information Privacy Code 1994
A process or action that is the focus of a clinical study. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include non-invasive approaches such as surveys, education, and interviews.
An ‘intervention model’ is the general design describing the strategy in which interventions will be assigned to participants in a clinical study. Types of intervention models include Single group design, Parallel design, Crossover design, and Factorial design.
An ‘intervention type’ is the general category for the intervention being studied. Intervention types include Drug, Device, Biological, and Procedure.
The Health Research Council is the agency responsible for managing the Government’s investment in health research. The HRC’s committees provide advice on gene technology, accredit health and disability ethics committees and institutional ethics committees, monitor the safety of large clinical trials and review applications to use new medicines in trials.
A drug, or biological product that is used in a clinical trial but has not been approved (the drug is either not available for a doctor to prescribe or, is available, but not approved by the for the use being studied).
An organisation responsible for a hospital, health centre, surgery or other establishment or facility in New Zealand at or from which the procedures outlined in the protocol of a study are to be conducted.
‘Locality review’ is the process by which a locality assesses its suitability for the safe and effective conduct of an intervention study.
A national or international health organization that has authority over the clinical study.
Some products that are considered to be medical devices by other regulators are regulated as medicines in New Zealand. Sponsors of medical devices need to be aware of these differences and ensure that their products follow the correct regulatory pathway. The definition of a medicine is contained within Section 3 of the Medicines Act 1981.
A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study). See also Ethical Guidelines for Observational Studies;
Observational study model (Design):
The general design, describing the strategy for identifying and following up with participants during observational studies. Types of observational study models include Cohort, Case-control, Case-only, Case-crossover, Ecologic or community studies, Family-based, and Other.
Describes a clinical trial in which masking is not used. That means that all parties involved with the trial know which participants have been assigned which interventions.
Studies that are currently recruiting participants, will be recruiting participants in the future, or involve drugs that are available for expanded access.
A planned measurement described in the protocol that is used to determine the effect of interventions on participants in a clinical trial. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include Primary Outcome Measure and Secondary Outcome Measure.
Describes a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel design involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A “in parallel” to participants in the other group receiving drug B.
An individual who actively participates in a study. Health and Disability Ethics Committee (HDEC) review of a study may be required where participants are recruited in their capacity as: consumers of health and disability support services, or relatives or caregivers of such consumers, or healthy volunteers in clinical trials.
Biomedical clinical trials of experimental drug, treatment, device or behavioural intervention may proceed through four phases:
Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug’s most frequent and serious adverse events are and, often, how the drug is metabolized and excreted. A small group of participants (e.g., 20-80)
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied. Several hundred participants.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Several hundreds to several thousands of participants.
Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug’s safety, efficacy, or optimal use.
Some clinical trials use ‘placebos’. Placebos look the same (or are used in the same way) as the actual treatment used in the trial, but do not contain active substances. For instance, you may receive a pill that looks like the new treatment, but is actually made out of sugar. The placebo treatment has no known health effect and will not have any effect in your body. Using a placebo allows the researchers to compare results in people taking the active substance (treatment) with people taking the inactive substance (placebo). Generally you are not told whether you are receiving a placebo or an active treatment until after the trial is finished. Placebos are not used if you would be put at risk, for example in trials for treatment of serious diseases. You will be told if placebos will be used in the trial before you agree to participate, but you will not know whether you have received a placebo until after the trial finishes.
Sometimes people report an improvement in their health or symptoms while taking a placebo and think they are on active treatment. This is called a ‘placebo effect’ and is quite common. It could be that your health is improving on its own, or you are taking more notice of times when you feel well – so you feel better generally as a result. If you experience a placebo effect it is nothing to worry about, and the researchers will take this into consideration when working out the results of the study.
An item of business (such as an amendment, annual progress report, final report, protocol deviation/violation, or notification of conclusion of study) submitted for review following Health and Disability Ethics Committee (HDEC) approval for a study.
The date that the last participant in a clinical study was examined or received an intervention and that data for the primary outcome measure were collected. Whether the clinical study ended according to the protocol or was terminated does not affect this date. The “estimated primary completion date” is the date that the researchers think will be the primary completion date for the study.
The planned outcome measure in the protocol that is the most important for evaluating the effect of an intervention. Most clinical studies have one primary outcome measure, but some may have more than one.
The main reason for the clinical trial. Types of primary purposes include treatment, prevention, diagnostic, supportive care, screening, health services research, and basic science.
The investigator with primary responsibility for the design and conduct of a study, including compliance with all relevant legal and ethical standards. All applications for ethics committee review of a study must be submitted by its PI.
Published scientific articles or abstracts about a clinical study. A publication reference, also called a citation, may be submitted to ClinicalTrials.gov at any time. It can also be automatically identified by the NCT Number, which is indexed in MEDLINE®, a database of biomedical and life sciences journal citations.
When you join a clinical trial you may be allocated to a group through a process called ‘randomisation’. Randomisation means that you are allocated to a group by chance. Computers are able to do this by generating random numbers that are assigned to each participant – much like your name being drawn out of a hat. Randomisation also means that the researcher and your healthcare professional do not have any choice about which group you are in. This helps reduce bias and strengthens the results of the study.
Indicates the current stage of a clinical study and whether it is or will be open for enrollment. The possible recruitment statuses are:
|Open Studies||Not yet recruiting||The study has not started recruiting participants.|
|Recruiting||The study is currently recruiting participants.|
|Available for expanded access||An Expanded Access program is currently available for this study intervention.|
|Closed Studies||Active, not recruiting||The study is ongoing (that is, participants are receiving an intervention or being examined), but potential participants are not currently being recruited or enrolled.|
|Completed||The study has ended normally, and participants are no longer being examined or treated (that is, the “last subject, last visit” has occurred).|
|Terminated||The study has stopped recruiting or enrolling participants early and will not start again. Participants are no longer being examined or treated.|
|Suspended||The study has stopped recruiting or enrolling participants early, but may start again.|
|Withdrawn||The study stopped early, before enrolling its first participant.|
|Enrolling by invitation||A study that selects its participants from a population, or group of people, decided on in advance by the researchers. These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.|
|Temporarily not available for expanded access||An Expanded Access program is not currently available for this intervention but is expected to be available in the future.|
|No longer available for expanded access||An Expanded Access program was available for this study intervention previously but is not currently available and will not be available in the future.|
|Approved for marketing||Applies to an Expanded Access program. The intervention has been approved for sale to the public.|
|Open or Closed Studies||Unknown||A study with a status of Recruiting; Not yet recruiting; or Active, not recruiting and whose status has not been verified within the past 2 years. Studies with an Unknown recruitment status are considered open studies or closed studies, depending on their last known recruitment status|
The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the public, such as the Australian New Zealand Clinical Trials Registry (ANZCTR) or ClinicalTrials.gov.
A structured online system, such as Australian New Zealand Clinical Trials Registry (ANZCTR) or ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies.
A grouping of participants in a clinical study that is used in summarizing the data collected during the study. This grouping may be the same as or different from a study arm.
The sponsor, sponsor-investigator, or sponsor-designated principal investigator who is responsible for submitting information about a clinical study to a registry and updating that information.
A structured online system, such as the Australian New Zealand Clinical Trials Registry (ANZCTR) or ClinicalTrials.gov results database, that provides the public with access to summary results and registration information for completed or terminated clinical studies.
The process of submitting and updating summary information about the results of a clinical study to a structured, public Web-based results database, such as the Australian New Zealand Clinical Trials Registry (ANZCTR) or ClinicalTrials.gov results database.
The timeframe within which an HDEC must give a final opinion on a new application or a substantial amendment to a previously approved application.
SCOTT is the Standing Committee on Therapeutic Trials; a standing committee of the Health Research Council (HRC) whose function is to make recommendations to Medsafe regarding the approval of clinical trials of new medicines under section 30 of the Medicines Act 1981.
A planned outcome measure in the protocol that is not as important as the primary outcome measure, but is still of interest in evaluating the effect of an intervention. Most clinical studies have more than one secondary outcome measure.
Serious adverse event; an untoward occurrence at any dose that: results in death, or is life-threatening, or requires inpatient hospitalisation or prolongs hospitalisation, or results in a persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
Describes a clinical trial in which all participants receive the same intervention.
If a clinical trial is ‘blinded’ or ‘masked’, it means that the participants and/or the researchers don’t know which group is receiving the new treatment and which group is not.
If a clinical trial is ‘single blind’, it means that the participants in the trial do not know which treatment they are receiving, but the researchers and medical staff do.
If a clinical trial is ‘double blind’, it means that none of the researchers, the medical staff, or the participants know who is receiving which treatment.
Blinding is used in a trial so the researchers or participants cannot influence the results of the study by knowing which treatment a participant is on.
In the event of an emergency where you doctor needs to know which treatment you are receiving to provide the care you need, the blinding can be ‘broken’ and your doctor can find this out.
The person or organisation with responsibility for the initiation, management and financing arrangements of a study
The organisation or person who oversees the clinical study and is responsible for analyzing the study data.
The person who both initiates and conducts the clinical study.
A new treatment is often compared with a standard treatment in a clinical trial. A standard treatment is a treatment that is already commonly used and is known to be helpful. This makes it possible to see if the new treatment works better than one that is already being used.
The date that the final data for a clinical study were collected because the last study participant has made the final visit to the study location (that is, “last subject, last visit”). The “estimated study completion date” is the date that researchers think will be the completion date for the study.
The clinical study stopped before enrolling its first participant.
Describes the nature of a clinical study. Study types include Interventional Studies (or Clinical Trials), Observational Studies, and Expanded Access.
Suspected Unexpected Serious Adverse Reaction; an SAE (Serious Adverse Event) that is suspected to be linked to the medical product being investigated, and the nature or severity of which is not consistent with the applicable product information (for example as provided in the investigator’s brochure).
The clinical study has stopped recruiting or enrolling participants early and will not start again. Participants are no longer being examined or treated.
A collection of human tissue or other biological material derived from humans that is stored for potential use in research beyond the life of a specific research project.
An administrative check carried out by the Health and Disability Ethics Committee (HDEC) secretariat to verify that an application or other item of business is complete and may be assigned for review through the full or expedited review pathway.
The clinical study has stopped recruiting or enrolling participants early, but it may start again. A type of Recruitment Status.