Tag Archives: Efficacy

WHAT CLINICAL BENEFIT DO YOU WANT TO PROVE IN YOUR STUDY?

Defining the clinical benefit or the efficacy parameters for your product in a clinical study is a challenging but critical activity: Do I aim to show the effect of product itself or that of a treatment as a whole, what … Continue reading

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CLINICAL EVIDENCE DILEMMAS: IS MY CLINICAL STUDY POPULATION THE RIGHT ONE?

Is my study population the right one, or in other words: Does my clinical study population represent the patients the study product is meant for? An essential question to answer when designing a clinical study to collect clinical evidence regarding product … Continue reading

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CLINICAL EVIDENCE DILEMMAS: CONTROLLED CLINICAL TRIAL OR DAILY PRACTICE?

Designing a clinical study, often faces discussions that can be traced back to the type of clinical evidence one is looking for: Are you aiming to evaluate the product effect in a controlled clinical study environment, or in a real … Continue reading

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EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE

The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading

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