CALL US +44 (0)1462 440 084 | +1 919-882-2016 | Contact | Submit RFI

The Trend in Biosimilar Development and Recent FDA Guidance

Statistical Consultancy Team

At the present time, the regulatory and drug development communities are adapting to a rising trend in biosimilar development in a number of therapeutic areas.

The regulatory framework for biosimilars in the US is still evolving; the number of biosimilars approved by the FDA in 2015 was 1, this rose to 4 in 2016 and is set to increase in 2017. The FDA is developing and consulting on draft guidance documents that will shape future trials, and at this early stage there are a number of legal issues to be agreed around licencing conditions, such as the period of exclusivity and the applicability of the biosimilar to all approved indications of the reference product. To put this in context with the European landscape, biosimilars have been approved and used in the EU for over a decade without highlighting any major safety concerns. As of April 2017, there were 28 approved biosimilars in the EU on 11 different biologics. However, there are aspects of the emerging FDA guidance that will almost certainly be reflected in the evolution of trial designs in the future, for products aimed at the US market.

Read More
Topics: Regulatory Requirements, Pharmacokinetics and Pharmacodynamic, FDA, Clinical Study Design, European Medicines Agency, Bioequivalence, PK Analysis, Demonstrating Biosimilarity, Biosimilars

Should We Be Integrating Mobile Health Apps in Clinical Trials?

Statistical Consultancy Team

Wearables and mobile health (Mhealth) apps collect subject/patient data from mobile or purpose built devices to record data in real time. The rationale behind this type of technology is to reduce the burden on subjects by eliminating unnecessary procedures, streamlining routine procedures and reducing time spent at clinical trial sites. It is evident from the review of a range of literature that studies integrating some form of mobile health technology can be broadly categorised into a few phases of development: studies on the development of new devices, studies on the validity of functional wearable devices, studies comparing new device and conventional endpoints, and finally those studies which trial the device as a health intervention. This article aims to briefly discuss these phases with reference to examples of recent studies demonstrating some safety or efficacy endpoint relating to a newly developed device.

Read More
Topics: Clinical Trials, Clinical Study Design, Biostatistics Consulting, Technology Trends, Wearables in Clinical Trials, Wearables, mHealth

Outcomes Research Programming vs Traditional Clinical Trial Programming

Clinical Programming Team

Outcomes research aka health outcomes research, is the study of the end results of particular health care practices and interventions, in other words it is the study of what happens in the real world to patients when they are given a certain treatment or a certain method of care. Outcomes research studies are used to improve the quality and value of healthcare for patients.

Read More
Topics: Statistical Programming, Clinical Study Design, Clinical Programming, Accessible Data, Big Data, Outcomes Research, Real World Data, Teradata SQL

Nick Burch Discusses Big Data in Clinical Trials [Video]

Nick Burch

Nick Burch, CTO at Quanticate discussed Big Data in Clinical Trials at the 4th Annual Clinical Data Integration and Management conference this year in Princeton, NJ. His presentation is titled: 'The Myth of the Big Data Silver Bullet - Why Requirements Still Matter'

Abstract

We've all heard the hype - Big Data will solve all your storage, processing and analytic problems effortlessly! Some moving beyond the buzzwords find things really do work well, but others rapidly run into issues. The difference usually isn't the technologies or the vendors per-se, but their appropriateness to the requirements, which aren't always clear up-front.

Big Data, and the related area of NoSQL, are actually a broad range of technologies, solutions and approaches, with varying levels of overlap. Sadly it's not just enough to pick "a" Big Data solution, it needs to be the right one for your requirements. In this talk, we'll first do a whistle-stop tour of the different broad areas and approaches of the Big Data space. Then, we'll look at how Quanticate selected and built our Big Data platform for clinical data, driven by the needs and requirements. We won't tell you what Big Data platform you yourself need, but instead try to help you with the questions you need to answer to derive your own requirements and approach, from which your successful Big Data in clinical trials solution can emerge!

 

Big Data in Clinical Trials Video 

 

Read More
Topics: Clinical Trials, Clinical Data Storage, FDA, Clinical Study Design, Large Datasets, CRO Efficiency, Visualization, Accessible Data, Mobile Device, Big Data, Drug Development, Technology Trends

How Big is Big Data in Clinical Trials – Tall, Grande, Venti Data?

Nick Burch

 

Today, Big Data is one of the hot topics within almost every Industry, especially in clinical trials. May saw the biggest ever European technologists conference on this, Berlin Buzzwords, while the likes of O'Reilly's Strata conference pull in huge numbers of attendees keen to learn how to adapt to this new world.

Read More
Topics: Clinical Trials, Clinical Data Storage, Clinical Study Design, Medical Device, Big Data

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.

Read More
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. 

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

Complex Randomization in Clinical Trials Need Not Be Complex

Statistical Consultancy Team

 

Whilst delivering statistical consultancy to one of our clients, we designed a clincial trial with five treatment arms: three were various doses of the active compound, one arm was a positive control and the final arm was a negative control.

Read More
Topics: Statistical Programming, Clinical Study Design, Interim Analysis, Randomization

How a Centralized Approach to Data Impacts Clinical Study Design

Statistical Consultancy Team

 

In today’s environment, one of the keys to accelerating drug development decisions comes from ready access to historical data. The introduction of the Centralized Service Provision (CSP) enables data across study phases and programmes to be accessed as easily as within the same study, due to the commonality of structure.

Read More
Topics: Standardization, Clinical Study Design, Centralization, Biostatistics Consulting, Visualization

Welcome to The Quanticate Blog

We aim to provide information and support written by our experienced staff. We want to share our knowledge and create an archive of information that you will be able to engage with, share and comment on.

Subscribe to Email Updates

Blog Suggestions

Posts by Topic

Expand all