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.
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What is an umbrella study in clinical trials?
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. In umbrella trials, patients receive treatment based on the specific mutation or biomarker found in their cancer.
What are umbrella and basket trials?
Basket trials refer to designs in which a targeted therapy is evaluated on multiple diseases that have common molecular alternations. Umbrella trials, on the other hand, evaluate multiple targeted therapies for a single disease that is stratified into subgroups by molecular alternation.
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 a master protocol?
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 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 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’s a basket trial?
Listen to pronunciation. (BAS-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.
What is a basket trial design?
Basket trials are a novel design for testing targeted therapeutics in oncology, by evaluating a drug or combination of drugs directed at one or more targets (eg, genetic alteration), regardless of the pathology or organ involved (figure).
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 is the difference between a blockchain and a protocol?
In short, a blockchain network is the blockchain ledger plus everyone contributing to that ledger; a blockchain protocol is the rules that govern the network. These two terms may seem to be used interchangeably, but as a rule they should not be.
What is the difference between a platform and a protocol?
These platforms, along with the products built on top of them, abide by conventions and procedures defined in their respective protocols. Protocols are the set of rules that govern the network. Blockchain protocols usually include rules about consensus, transaction validation, and network participation.
How many blockchain protocols are there?
There are three basic types of blockchain: public blockchain, consortium blockchain and private blockchain [2]. Each type of blockchain has different application scenarios. The adopted consensus protocol thus needs to fit the demands of specific application scenario.
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 Platform 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 a triple blind study?
In a single-blind study, only the participants are blinded. In a double-blind study, both participants and experimenters are blinded. In a triple-blind study, the assignment is hidden not only from participants and experimenters, but also from the researchers analyzing the data.
Is double blind and double dummy the same?
Double blind: Both the patient and the investigator are blinded. Neither of them knows which participants are receiving experimental drug and which are receiving placebo (or another therapy). Double blind, double dummy: Both the patient and the investigator are blinded.
What is the purpose of a single-blind study?
A type of clinical trial in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over. A single-blind study makes results of the study less likely to be biased.
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.
What are the 3 phases of clinical trials?
Phases of Clinical Trials
- Phase I trials test if a new treatment is safe and look for the best way to give the treatment.
- Phase II trials test if one type of cancer responds to the new treatment.
- Phase III trials test if a new treatment is better than a standard treatment.
What are the 4 phases of FDA approval?
Content current as of:
- Step 1: Discovery and Development.
- Step 2: Preclinical Research.
- Step 3: Clinical Research.
- Step 4: FDA Drug Review.
- Step 5: FDA Post-Market Drug Safety Monitoring.