The Top 5: September 2016

4th October 2016 (Last Updated July 18th, 2018 11:50)

CTA highlights the best articles from the month of September 2016

The Top 5: September 2016

There were numerous articles in September 2016 that covered a wide range of topical issues. Here are five of the best stories you might have missed... (click the headline to finish reading the story)

Clinical Trials Budgeting and Forecasting: Six Simple Steps to Immediately Improve Accuracy

While it may be easier for an even-toed ungulate to go through the eye of a needle than to generate an accurate clinical trial forecast, many teams make the endeavor even more difficult than necessary. Few would dispute the complexities and challenging nature of forecasting for clinical trials, especially given their annoying tendency to never go exactly as originally planned. So without further ado, I hereby present the six immediate practices your company can implement to immediately improve your clinical trials budgets and forecasts.

eSource & Data Integrity

Let’s start with what we mean by eSource. eSource is the concept of capturing clinical study data electronically at the time of data generation. eSource Platform/Applications reduce the use of paper to capture source data during clinical visits and transcription error. eSource Direct Data Entry (DDE) models combine source documents and case report forms (CRFs) into one application, allowing for the real time collection of clinical trial information to sponsors and other oversight authorities, for example.

Clinical Trials in Asia: Tale of the Tiger or Tiger by the Tail? Part IIIa – India and China

Asian countries can offer great value as locations for clinical study sites. This is the third of a five-part series on getting the best out of your Southeast Asia clinical trial strategy. In parts IIa and IIb, we focused on South Korea, Taiwan, Singapore and Hong-Kong - the so-called “Tier 2” Asian countries. This article – Part IIIa – will address the two Asian giants in the Tier-3 Asian countries: India and China. Finally, in Part IIIb, the last piece in this series, we’ll round off with the up and comers in Tier-3: Malaysia and Thailand.

The Changing Paradigm of Monitoring and the Evolving Role of the CRA

Perhaps the most dramatic change in the clinical trials implementation is the evolution of the electronic Case Report Form (eCRF). In-house data entry has all but disappeared and sponsors have more real-time access to data without the need of physically sending a CRA out to collect paper CRFs. Rapid access to data has been the impetus for most innovations in data management, from initially having sites send in completed triplicate CRFs, transmit forms via fax, and some optical character recognition systems. Today’s EDC systems can be very sophisticated and include point-of-entry edit checks, internal calculations, and some rudimentary logic checks.

Wearables yet to reach tipping point, says expert

Over the last few years, a lot of excitement has been generated by the use of mHealth (mobile health) technologies in clinical trials. The likes of Purdue Pharma and GlaxoSmithKline, for instance, have turned to emerging platforms, such as Apple’s ResearchKit, as they look redefine the ways they gather data. Such efforts indicate pharma’s willingness to embrace the new technologies available to them.

But in an industry notoriously known for its slow moving processes, can the use of mHealth mark a new paradigm in the way the industry operates?

CTA spoke to Ray Dorsey, Professor of Neurology, University of Rochester, who has been a wide adopter of mHealth technologies in the clinical research he’s conducted over the years. In this interview, Dorsey feels that while the signs are promising, mHealth is yet to reach its defining moment.