Just last August, we at Arena International set out to create a website that focused solely on the industry, with content written from the perspective of industry professionals. The site was designed with the purpose of providing in-depth, actionable insights into each facet of the clinical trials space. Over the past year, we've gone from strength to strength providing cutting edge content exploring patient centricity, examining the impact of mHealth on clinical trials, the effect Brexit could have on UK clinical research, and more. As we celebrate our first birthday, from everyone at Clinical Trials Arena, we want to thank you, our readers, for your support.
On the site and across social media throughout the week, we will be bringing you a range of our highlights from the past year. This will be a chance to take a look back at some of your favourite articles, whitepapers and videos.
Below are some the best stories you might have missed in the last year... (click the headline to finish reading the story)
The scale of the 2014-2016 West African Ebola outbreak was unprecedented, and led to a global response. As part of this response, clinical trials of the most promising candidate Ebola prophylactic vaccines were fast-tracked for testing in both affected and non-affected countries. Through the EBOVAC1 consortium of global health and research institutions, a collaboration between the London School of Hygiene & Tropical Medicine, the College of Medicine and Allied Health Sciences (Sierra Leone), and Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) was established to coordinate the EBOVAC-Salone clinical trial of a prime-boost Ebola vaccine regimen developed by Janssen. Operating in a compressed timeframe, and with the epidemic still claiming lives across Sierra Leone, the team met significant challenges particularly in the fields of regulation, operationalizing the trial, and community mobilisation.
In recent months, health authorities across South America have been tackling a rising epidemic in the form of the Zika virus. Having originated from the Zika Forest in Uganda, the virus, carried by the Aedes mosquito (pictured), has been linked to birth defects after a spate of infants across countries in South America were born with microcephaly, a condition affecting brain development.
Since the Zika virus made headlines earlier this year, the pharma industry has stepped up efforts to combat the outbreak. Recently, CTA spoke to Lisa Ganley-Leal, Director of Infectious Diseases and Vaccine Development, STC Biologics, to discuss a biologic STC is developing to tackle the virus.
In the industry there is a big confusion in terminology used to describe new methods of study monitoring. At least partially this is caused by the fact that at least 3 major organizations (CTTI Project, FDA, EMA) are producing guidance documents in the area of quality in clinical trials and each touches on monitoring practices in a different way as part of an overall Quality and Risk Management approach to clinical trials. TransCelerate have delivered a Position Paper based on these guidance documents called 'Risk Based Monitoring Methodology'.
The intent of this article is to have a more practical look at the definitions. We recommend using Risk Based Monitoring term only when a monitoring approach has the three features discussed below.
Over the years, Clinical Data Management (CDM) has come a long way having its ups and downs, for a while being viewed as a commodity that could easily be outsourced or off-shored. Even today it isn't one hundred percent clear what CDM is all about. In this brief article I - completely biased - refer to CDM as the function that provides the skills, processes and tools to capture, store, manage, code, check, and present any data related to the health of patients including the meta-data, the derived data and calculated data. The source of the data may be multifold since I do not think CDMs should only be those referred to as working in a CRO, Biotech or Pharma company, mainly in the clinical operations groups. I think one also needs to take a look at other areas where it may be truly beneficial to have CDMs involved.
As a group, the four Tier-2 Asian countries have a strong potential to be knocking on the door of the lone Tier-1 giant, Japan. The one common factor that has brought these countries this far is a strong government commitment and 360-degree vision to be competitive with the West. This aspiration to be on a par with Western standards of quality and good clinical practices has resulted in exponential improvements in facilities, infrastructure, human resources and streamlining of regulations.
From the perspective of both timelines and costs, biotech companies in the US and Europe would do well to consider an Asia-first clinical development strategy. In particular, for four therapeutic areas - Cancer, Heart disease, Diabetes, and Infectious Diseases - South Korea is an attractive place to start.
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