Tag Archives: Patient Population

Clinical Trial Probability of Success? Just How Probable Is A Great Outcome.


The cost and time of well-designed clinical trials is growing rapidly, but just how probable is it that the data will be sufficient to support regulatory approval and market success? Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the … Continue reading

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Clinical Trial Success: How Do You Define Success?


When you complete your clinical trial and review the results, how do you define success? Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the different aspects and relevance of clinical trial success. The study is complete. All patients have … Continue reading

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CLINICAL DEVELOPMENT: THE CLINICAL TRIAL CASE REPORT FORM AND CLINICAL TRIAL MONITORING


A key aspect of clinical development and clinical trial operational success is getting the data right. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the importance of the Case Report Form and Clinical Monitoring to ensure the quality of … Continue reading

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Ensuring Clinical Trial Data Quality


A key aspect of clinical trial operational success is getting the right data. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses managing clinical assessments and laboratory procedures to ensure the quality of data acquisition. Last week I discussed operational … Continue reading

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CLINICAL DEVELOPMENT: THE CLINICAL TRIAL SAMPLE SIZE


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, discusses clinical trial sample size as an important aspect of the clinical trial protocol. This week I would like to discuss certain considerations around clinical trial sample size in defining a successful … Continue reading

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Clinical Development: The Clinical Trial Protocol Patient Population


Dr Michael Silverman, principal at BioStrategics Consulting Ltd, continues his discussion this week on the Clinical Trial Protocol. To achieve a successful protocol, the choice of the patient population is critical. This week I would like to discuss a make … Continue reading

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