A treatment arm of a clinical trial is a group of patients that receive a specific treatment (or even no treatment). A single study could have two or more treatment arms with separate comparable outcomes.
What is an arm of a clinical trial?
An arm of a clinical trial is a group of patients receiving a specific treatment (or no treatment). Trials involving several arms, or randomized trials, treat randomly-selected groups of patients with different therapies in order to compare their medical outcomes.
Can a new treatment arm be added to an ongoing trial?
This review investigates the addition of a new treatment arm to an ongoing trial within the following scope: the trial has already begun recruitment and the randomisation is still open when the new treatment is added, the trial has a confirmatory primary objective, the trial is designed using frequentist methodology.
Why do Phase 3 trials use a single arm?
While Phase 3 trials are frequently randomized in order to provide more precise data on safety and effectiveness outcomes, a Phase 3 trial might use a single arm if a small target population makes conducting a randomized trial impractical.
What is the purpose of a clinical trial?
Advertisement. A clinical trial is a research study conducted with human beings to see if a new medical device, medication or other treatment is effective and safe. Some study participants will be assigned to a “control arm” or “control group” in the study.
What is a 3 arm clinical trial?
A multi-arm trial is defined as a randomized clinical trial that uses a parallel-group design but has 3 or more groups. For describing the intervention groups in clinical trials, the terms “arms” or “groups” may be used interchangeably, although the term “multi-arm” is used for these reporting guidelines.
What is meant by study arm?
Study Arm(s) means the sub-studies of the Protocol. The arms are studies of an agent or treatment in a group of patients whose tumors manifest particular molecular features.
How many arms are in a clinical trial?
One scientifically attractive alternative design is to have a 3-arm trial consisting of the intervention, the active control, and a placebo arm.
What is the difference between an arm and a cohort?
Multiple arms allow the effects of different interventions to be compared. Participants in a control arm may receive no intervention, placebo, or an intervention with a known effect. In observational studies, a pre-defined population may be observed over time and is termed, a cohort.
What is a treatment arm?
Treatment Arm: A group or subgroup of participants in a clinical trial. Each group receives a specific intervention, study drug dose, or sometimes no intervention, according to the study protocol.
What is a 4 arm study?
A Four Arm Study to Evaluate the Safety and Efficacy of 3 Different Doses of RVX-100 Versus Placebo in Subjects With Irritable Bowel Syndrome Accompanied by Diarrhea (IBS-D) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
What is a 2 arm study?
For a two-arm study, with two short-term outcomes, study participants are randomised to either the control or active intervention arms.
What is 2 arm randomized controlled trial?
In trials with randomized and controlled design (e.g., a two-armed study with parallel groups), the effects of the study treatment (intervention) are compared with those of a control treatment and the patients are randomly assigned to the two groups.
What are the 4 phases of clinical trials?
Each stage of a clinical trial has its own purpose in ensuring that a treatment is safe and effective for use by the public....Phases of Clinical TrialsPhase 1 Clinical Trial. ... Phase 2 Clinical Trial. ... Phase 3 Clinical Trial. ... Monitoring Post-FDA Approval.
What is a treatment cohort?
In medicine, a cohort is a group that is part of a clinical trial or study and is observed over a period of time.
What are the 3 types of clinical trials?
Types of clinical trialsInterventional trials aim to find out more about a particular intervention, or treatment. ... Observational studies aim to find out what happens to people in different situations. ... Feasibility studies are designed to see if it is possible to do the main study.More items...•
What are the 3 types of cohort studies?
There are three general types of comparison groups for cohort studies.An internal comparison group.A comparison cohort.The general population.
Abstract
Incorporating an emerging therapy as a new randomisation arm in a clinical trial that is open to recruitment would be desirable to researchers, regulators and patients to ensure that the trial remains current, new treatments are evaluated as quickly as possible, and the time and cost for determining optimal therapies is minimised.
Background
Confirmatory clinical trials can take many years to run, requiring considerable resources. During this time, evidence for a new promising treatment may emerge. It may be advantageous to incorporate the emerging treatment into the ongoing trial as a new randomisation arm.
Conclusions
Recent initiatives in clinical trials are aimed at speeding up research by making better use of scarce resources.
Acknowledgements
DRC is funded by a National Institute for Health Research Doctoral Research Fellowship. This paper presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Appendix
Topic = (adaptive near/3 design* or adaptive near/3 method* or adaptive near/3 trial* or flexible near/3 design* or flexible near/3 method* or flexible near/3 trial* or multi$stage near/3 design* or multi$stage near/3 method* or multi$stage near/3 trial*) AND Topic = ( (adding or additional or incorporat* or extra) near/4 (arm* or treatment* or group* or therap* or randomi* or hypothes*)).
Rights and permissions
This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.
What is an arm in a clinical trial?
Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.
Why are participants assigned to receive one or more interventions?
In interventional studies, participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
What is adverse event in clinical trials?
Adverse Event: Any undesirable experience associated with a drug or procedure, also sometimes described as a side effect or negative reaction. Adverse events can range from mild to severe.
What is clinical research?
Clinical trials, also known as clinical studies or clinical research, are studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. When deciding whether to enroll in a clinical trial, you will likely encounter many terms related to clinical research and what the specific trial entails.
What is outcome measure?
Outcome Measure: 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 is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment.
What is an observational trial?
Observational Study: In an observational study, investigators assess health outcomes in groups of participants according to a research plan or protocol.
How many phases are there in a clinical trial?
There are typically four phases of a clinical trial. Phase I is the administration of a drug or device to a small group to identify possible side effects and determine proper dose. Phase II is done to gauge whether the treatment is effective while continuing to evaluate safety. Phase III compares a new drug or device against the current standard ...
What is the FDA?
Food and Drug Administration (FDA): An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, ...
What does it mean when a participant provides informed consent?
Informed Consent: When a participant provides informed consent, it means that he or she has learned the key facts about a research study, including the possible risks and benefits, and agrees to take part in it. Intervention: The treatment, drug or procedure that is being studied in the clinical trial.
Methods
Literature on The Methodology of Adding Arms
- Only seven publications were identified that discussed any methodological considerations when adding an arm to an ongoing trial. These were reviewed in detail to assess and summarise the research previously carried-out and the recommendations or methodology discussed. Phillips et al. [8] summarise discussion points on adaptive designs from the Statisticians in the Pharmaceu…
Literature on Adaptive Designs in General
- The assessment of summary, regulatory, guidance and review documents on flexible or adaptive designs in general was undertaken as described in the methods section. In addition to the documents previously referenced [3-8], a further 13 were identified for detailed review from the MEDLINE search [19-31]. None of these documents discussed the addition of a trial arm. The st…
Key Statistical Considerations When Adding A Treatment Arm to An Ongoing Trial
- This literature review on methodology when adding arms and on adaptive designs in general generated the identification of a number of statistical considerations with relevance when amending ongoing clinical trials by adding a new treatment arm based on external evidence. The main considerations identified are illustrated in Figure 2, and summarised...
Practical Examples of Ongoing Trials in Which An Arm Has Been Added
- A search of the literature only identified three examples of trials in which an arm had been added, two results papers and the Sydes et al. publication, which also includes the methodological discussion [14]. However, the direct contacts described in the Methods section suggested 30 unique trials. Eight trials were identified to be within scope. All of these trials had obtained appro…
Statistical Considerations in Practice
- The statistical considerations that were identified within the methodological literature have been addressed to varying extents in practice. Note that not all considerations need to be addressed in each case because of the nature of the trials and their objectives. When designing or critically evaluating the results of different trials, it should be determined for each trial whether the conditi…