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Celebrating International Clinical Trials Day

Marketing Quanticate

Happy International Clinical Trials Day! For those of you who do not know, International Clinical Trials Day is celebrated each year on 20th May. The event was created to commemorate the day James Lind started the first ever clinical trial to try and cure the deadly disease scurvy.

The clinical trial James Lind conducted consisted of using citrus fruit to cure scurvy. At the time the concept of vitamins were unknown, today we know scurvy is a result of vitamin C deficiency. James Lind was the first to study the effects of citrus fruits by conducting a systematic experiment on sailors in 1747 which is now regarded as one of the first clinical experiments in the history of medicine. 

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Topics: Clinical Trials, Ethics, Clinical Data Services, Statistics, International Clinical Trial Day

Remote Monitoring During Clinical Trials, a Risk Based Approach

Medical Writing Team

 

Within the last few decades the number and complexity of clinical trials has increased considerably, not only across the industry but within individual companies.  With this increase comes the enhanced pressure of effectively monitoring these trials.

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Topics: Regulatory Requirements, Clinical Trials, Good Clinical Practice (GCP), Clinical Data Storage, Case Report Form (CRF), Remote Monitoring, Adverse Events (AEs), Ethics, On-Site Monitoring, Risk Based Monitoring, Centralized Monitoring

Ben Goldacre Discusses Clinical Data Transparency [Video]

Statistical Consultancy Team

Dr Ben Goldacre, author of 'Bad Pharma' presented a keynote speech at the Clinical Data Live! symposium on clinical data transparency. 

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Electronic Medical Record (EMR), Adverse Events (AEs), Historical Data, European Medicines Agency, Clinical Trial Documentation, Clinical Documents, Ethics, Accessible Data, Data Transparency

An Overview of Efficacy Endpoints in Oncology Studies

Clinical Programming Team

This blog provides an overview of efficacy endpoints in oncology studies. We will focus on RECIST (Response Evaluation Criteria In Solid Tumours).This is a method of assessing how solid tumours change over the course of a study. We will cover the measurements taken for RECIST assessments (Target lesions, Non target lesions, New lesions) and the possible outcomes, (complete response, partial response, stable disease, progressive disease) and what they mean – for example; patient recovered, stayed the same or got worse. We will also cover how visit windows and censoring can be handled. How and why measurement methods are important.  We will cover other endpoints relevant to oncology such as Overall survival, Objective Response Rate, Best overall response, Disease control at X weeks and quality of life.

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Topics: Clinical Programming, Ethics, Oncology

Data Transparency in Clinical Trials Q&A with Ben Goldacre [Video]

Statistical Consultancy Team

Q&A on Data Transparency in clinical trials with Dr Ben Goldacre, Katherine Hutchinson & Kevin Carroll at Clinical Data Live!

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Topics: Regulatory Requirements, Good Clinical Practice (GCP), FDA, Adverse Events (AEs), Historical Data, European Medicines Agency, Ethics, Phase 3 Studies, Accessible Data, Phase 4 Studies, Data Transparency

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