Sage-Tips

What is a platform protocol?

Platform protocols pertain to the larger, long-lasting programs aimed primarily at the collection of basic data of some particular kind or on a noteworthy sample.

What are the types of clinical trial designs?

Common clinical trial designs include single-arm trials, placebo-controlled trials, crossover trials, factorial trials, noninferiority trials, and designs for validating a diagnostic device.

Who designs the clinical trial protocol?

The actual writing of a protocol is a team effort with contributions from a medical expert, a statistician, a pharmacokinetics expert, the clinical research coordinator, and the project manager, who all provide input to the medical writer to produce the final document.

What factors should be considered when designing a clinical trial?

The study’s objective, nature of the study drug and the disease under investigation affect the choice of the adequate design, alongside patient selection criteria, randomization, blinding procedures (if any), choice of control and of course, current clinical practice and knowledge.

What is a platform clinical trial?

A platform trial is defined by the broad goal of finding the best treatment for a disease by simultaneously investigating multiple treatments, using specialized statistical tools for allocating patients and analyzing results. The focus is on the disease rather than any particular experimental therapy.

What is a platform study in clinical trials?

Background: A “platform trial” is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Conclusion: In an era of personalized medicine, platform trials provide the innovation needed to efficiently evaluate modern treatments.

What are the two basic concepts on which clinical research is designed?

Introduction. From an epidemiological standpoint, there are two major types of clinical study designs, observational and experimental.

How do you create a clinical research?

How to Design a Clinical Trial: 5 Steps

1. Make it simple.
2. Patient and associated professionals recruitment is a key determinant of success.
3. Plan the 4 phases with the goal of your clinical trial in mind.
4. Develop an adequate budget and resources plan.
5. Try to poke holes on your design and protocols.

How do you create a clinical study protocol?

1. GUIDELINES FOR DESIGNING A CLINICAL STUDY PROTOCOL.
2. Study Summary:
3. List of Abbreviations:
4. Background Information/Significance:
5. Objectives/Rationale/Research Question:
6. Clinical Study Design:
7. Inclusion and Exclusion criteria of the Subjects:
8. Informed consent form process:

How do you create a clinical trial protocol?

According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:

1. Title Page (General Information)
2. Background Information.
3. Objectives/Purpose.
4. Study Design.
5. Selection and Exclusion of Subjects.
6. Treatment of Subjects.
7. Assessment of Efficacy.
8. Assessment of Safety.

What are adaptive platform trials?

In response, researchers have proposed new RCT designs such as adaptive platform trials (APTs), which are able to study multiple interventions in a disease or condition in a perpetual manner, with interventions entering and leaving the platform on the basis of a predefined decision algorithm.

What are the three phases of clinical trials?

There are 3 main phases of clinical trials – phases 1 to 3. Phase 1 trials are the earliest phase trials and phase 3 are later phase trials. Some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.

What is the average length of a clinical trial?

There is no typical length of time it takes for a drug to be tested and approved. It might take 10 to 15 years or more to complete all 3 phases of clinical trials before the licensing stage.

What are the benefits of clinical trials?

Benefits of clinical trials. Participating in clinical trials has the potential to help both the individual participant and other individuals who have Alzheimer’s disease or are at risk of developing it: You can play a more active role in your own health care. You can gain access to potential treatments before they are widely available.

What is a platform trial?

The platform trial is an adaptive trial which adds the possibility of the introduction of new intervention arms to the study as they become available and dropping existing intervention arms that are shown to be inferior.