The Top 5: April 2018

8th May 2018 (Last Updated December 13th, 2018 09:49)

CTA highlights the best articles from the month of April 2018

The Top 5: April 2018

There were numerous articles in April 2018 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 Operations and Multi-Regional Protocols: A Quest for Quality & Validation of Value

Registration studies for oncology indications will likely continue to expand multi-regional enrollment, including investigational sites in new, less developed countries and centers. Some authors proposed multi-regional enrollment is caused by cost-saving for industry sponsors. However, overall cost-saving can be minimal for the conduct of complex, multi-regional trials in view of center fees, biomarker analyses, travel, monitoring, data management, inpatient requirements in some regions, and regulations requiring post-study treatment in some countries.

Will Blockchain Deliver on its Promise of Disrupting the Life Sciences?

Blockchain technology has come under the spotlight recently, creating a lot of hype and expectation mostly related to its applications in the crypto-currency space. However, the secured chain of blocks conceptualized by the mysterious Satoshi Nakamoto in 2008 has the potential of disrupting an increasing number of industries.

Data Integrity – What is the Right Level of Compliance for Legacy Systems?

The focus of this article is to reiterate that data integrity is not just a temporary focus by regulatory bodies. Furthermore, I will share personal experiences related to the challenges of identifying the right level of compliance and how that was managed – through understanding the importance of a risk-based approach.

In the Drug GMP Report, Issue No. 306 from the FDA writes, "quality experts and FDA officials predict 2018 will bring more streamlined FDA inspections and a greater focus on digital records and data integrity."

Merck Makes Inroads in Australia

The last month has been significant for Merck down under.

On Feb 21, the company announced the acquisition of Viralytics, an Australian biotech specializing in the development of oncolyptic immunotherapies.

Fast forward a matter of weeks, Immutep, another biotech based in Sydney, revealed it had formed a partnership with Merck to trial a combination product and its effect on multiple tumors.

Both moves are symbolic in that they strengthen Merck’s presence in Australia as the company expands its vast immuno-oncology portfolio.

Universal Health Coverage for All

On World Health Day, Shahana Chowdhury delves into the issues behind universal health coverage.

Recent studies outline that at least half the world lacks access to essential health services. The number of people that need health services is growing which shows there is a vital need for universal health coverage.

 

In case you missed the CTA Oncology Week, click here to read exclusive articles delving into the current issues and concerns involving oncology trials.

PHOTO CREDIT: Rob Nguyen