Basket trials evaluate therapy for various diseases that share a common molecular alteration, while umbrella trials evaluate multiple targeted therapies for a single disease that is stratified into subgroups based on different molecular alterations/ risk factors.
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What are umbrella trials?
Listen to pronunciation. (um-BREH-luh TRY-ul) A type of clinical trial that tests how well new drugs or other substances work in patients who have the same type of cancer but different gene mutations (changes) or biomarkers.
What are basket trials?
A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In basket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer.
What is an umbrella protocol?
An umbrella protocol refers to a type of master protocol designed to evaluate multiple investigational therapies administered as single drugs or as drug combinations in a single disease population.
What is a basket cohort?
Basket Clinical Trials
Patients with that factor who agree to be study participants are grouped together in one cohort, or “basket,” to receive an experimental product which is designed to work, or to work best, in that specific category of disease (see Figure 1).
What are the types of clinical trials?
Types of clinical trials
- Pilot studies and feasibility studies.
- Prevention trials.
- Screening trials.
- Treatment trials.
- Multi-arm multi-stage (MAMS) trials.
- Cohort studies.
- Case control studies.
- Cross sectional studies.
What is the potential importance of basket trials?
Basket trials are designed to assess a single investigational drug or drug combination in different disease populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics [11].
What is a Phase 2 Basket trial?
2.2 Study design and participants
This trial is a Japanese multicenter, single-arm, basket phase 2 study in patients with solid cancers harboring HER2 amplification that have progressed with standard treatment, or rare cancers for which there is no standard treatment.
What is remap cap?
REMAP-CAP is an international (15 countries) adaptive platform trial in community acquired pneumonia, that was specifically designed to be employed in a pandemic to evaluate multiple interventions simultaneously in critically ill patients.
What are master protocols?
A master protocol is defined as a protocol designed with multiple substudies, which involve coordinated efforts to evaluate one or more investigational drugs, in one or more disease subtypes, with one or more objectives, all within the same overall trial structure.
What is a platform study in clinical trials?
Platform trials are a type of randomized clinical trial that allow simultaneous comparison of multiple intervention groups against a single control group that serves as a common control based on a prespecified interim analysis plan.
What is double dummy study?
Double dummy is a method of blinding where both treatment groups may receive placebo. For example, one group may receive Treatment A and the placebo of Treatment B; the other group would receive Treatment B and the placebo of Treatment A.
What are adaptive trials?
What is Adaptive Design Clinical Trial. An adaptive design is defined as a design that allows modifications to the trial and/or statistical procedures of the trial after its initiation without undermining its validity and integrity. [8] The purpose is to make clinical trials more flexible, efficient and fast.
What is a platform protocol?
A platform protocol refers to a type of master protocol that tests multiple, targeted therapies for a single disease simultaneously. Platform protocols often include an adaptive design that may eliminate or add treatments based on interim analysis.
What is NCI match?
NCI-MATCH, also known as MATCH, is a precision medicine cancer treatment clinical trial. In this trial, people with cancer are assigned to receive treatment based on the genetic changes found in their tumors through genomic sequencing and other tests.
What are the two types of trials?
The two main types of trials are civil trials and criminal trials. Civil trials resolve civil actions, which are brought to enforce, redress, or protect private rights. In general, all types of actions other than criminal actions are civil actions.
What are the 4 stages 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 Trials
- Phase 1 Clinical Trial.
- Phase 2 Clinical Trial.
- Phase 3 Clinical Trial.
- Monitoring Post-FDA Approval.
Which are the two main types of clinical studies?
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
What is a master protocol trial?
Initially designed for oncology, master protocol trials are intended to simultaneously evaluate more than one investigational drug and/or more than one disease type within the same overall trial structure.
What is a bucket trial?
(BUH-ket TRY-ul) A type of clinical trial that tests how well a new drug or other substance works in patients who have different types of cancer that all have the same mutation or biomarker. In bucket trials, patients all receive the same treatment that targets the specific mutation or biomarker found in their cancer.
What is a multi platform trial?
Adaptive Multi-Arm Platform Trials: Benefits and Efficiencies. Presented by Dr Todd Graves. A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously.