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Is Lack of Data the Biggest Challenge for Early Phase Pharmacovigilance?

Pharmacovigilance Team

We recently hosted a webinar on the challenges of Pharmacovigilance in early phase clinical trials. During the registration process we had the chance to survey members of the industry, 70% of the respondents were from pharmaceutical, biotechnology or medical device companies. We wanted to present the data from the 150 respondents in this blog.

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Topics: Regulatory Requirements, FDA, Phase I Studies, Adverse Events (AEs), Pharmacovigilance, Serious Adverse Events (SAEs), Clinical Trial Phases, Oncology

The Different Phases of Clinical Trials

Medical Writing Team

The development of investigational new drugs (INDs) involves performing clinical trials (or studies) to assess the safety and efficacy of the IND in humans.  These trials are usually classified into 4 phases of development (Phase 1 to 4), with each potentially lasting for several years.  Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Pre-Clinical Study, Clinical Trial Phases, Phase 3 Studies, Phase 4 Studies, Phase 2 Studies

A Guide to Phase 1 Clinical Trial Designs

Statistical Consultancy Team

The primary aims of Phase 1 clinical trials are to determine the safety, tolerability and pharmacokinetics (PK) of a compound.  Trials have historically been conducted in the logical sequence of single ascending dose, multiple ascending dose, examination of preliminary effect of food on exposure, and potential drug drug interaction, with assessments to determine the effect of gender, age, bioavailability and bioequivalence performed as necessary.

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Topics: Pharmacokinetics and Pharmacodynamic, Phase I Studies, Phase I Study Design, Clinical Trial Phases, Phase 3 Studies, Peadiatric Assessments, Bioequivalence, Drug-drug Interaction, Bioavailability

7 Frequently asked Questions on Clinical Study Design

Statistical Consultancy Team

Quanticate has released several white papers around Clinical Study Design in the area of Bayesian Statistics and a focus on Phase 1 studies. Our statistical consultancy team was pleased to receive feedback and questions from our clients and piers on these papers which we would like to share with you all below.

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Topics: Bayesian Statistics, Bayesian Study Design, Bayesian Methods, Phase I Studies, Clinical Study Design, Interim Analysis, Biostatistics Consulting, Phase I Study Design

Using Historical Data to Inform Future Decisions in Clinical Trials

Statistical Consultancy Team

The majority of companies within the Pharmaceutical Industry have large historical clinical databases, much of which may never be used beyond its original purpose: to prove that the drug in question is safe and efficacious. This historical data can be used to better inform future decisions in clinical trials. 

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Topics: Bayesian Statistics, Programming R, Phase I Studies, Adverse Events (AEs), Clinical Study Design, Historical Data

The Promise of Electronic Data Capture - How Soon is Now?

Stuart Cook

 

Do you remember where you were when you heard the slogan, ‘Cleaner data faster’? That was the promise of Electronic Data Capture (EDC). A brave new world. Those of us at the forefront of EDC, or Remote Data Entry as it really was, may well remember the change resistance demonstrated by various stakeholders combined with the enthusiasm of early adopters.

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Topics: CDISC, Phase I Studies, Case Report Form (CRF), Remote Monitoring, Remote Data Capture, Tablets, Electronic Data Capture, ePRO, e-Clinical, eCRF, Electronic Medical Record (EMR), Source Data Verification (SDV)

Biomarkers in Drug Development

Statistical Consultancy Team

The identification of novel and effective biomarkers in drug development is considered a key feature in the optimization of the drug development process. But what exactly is a biomarker? As defined by Grutolla et al. [1], a biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Examples include concentrations of particular proteins in the blood or bone marrow, liver function tests or PET imaging as indicators of disease state or therapeutic benefit.

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Topics: Bayesian Study Design, Phase I Studies, Biomarkers, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design, Drug Development

Economical Designs for Phase I Studies

Statistical Consultancy Team
The objectives of the Phase I development plan are many. Alongside establishing the safety, tolerability and pharmacokinetics (PK) of single and multiple doses in humans and ascertaining the maximum tolerated dose, it is often important to explore at least some of the following:
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Topics: Statistical Programming, Pharmacokinetics and Pharmacodynamic, Phase I Studies, Interim Analysis, Specialist Biometrics CRO, Biostatistics Consulting, Phase I Study Design

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