The Top 5: October 2017

6th November 2017 (Last Updated December 12th, 2018 10:44)

CTA highlights the best articles from the month of October 2017

The Top 5: October 2017

There were numerous articles in October 2017 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)

How can the Internet of Things Help Design a Patient-Oriented Clinical Trial? – Part I

The Internet of Things (IoT) is defined as physical devices that are instrumented to capture and transmit data covering everything from environmental conditions to usage patterns and user behaviors. (1) It is considered the next wave of information technology advancement.

The development of fitness IoT gives individuals the opportunity to manage their health by establishing and following a diet, setting up and monitoring physical exercise programs. Wrist-worn fitness and heart rate monitors are popular because they can provide data to individuals helping them to follow-up training and record simple health datapoints like heart rate variation with exercise or blood pressure. (2)

Conducting Trials in Unstable Regions: A Primer on Things to Consider

A recent review of the NIH registry listed approximately 54,000 clinical studies either posted as ‘recruiting’ or ‘not yet recruiting.’ Of these studies, there were 12,254 oncology studies. More alarming, among the 12,254 studies, there were 20 interventional studies listed for Merkel cell carcinoma, which is a rare form of skin cancer with an annual U.S. incidence rate of 0.6 in 100,000 growing at a rate of 1,600 new cases per year. (1)

Advanced Therapies: Patient-Centric Heaven or Supply Chain Hell?

It seems a new age is dawning in the pharma industry. Advanced therapy medicinal products (ATMPs), are receiving major coverage in the media. (1) This article discusses the massive supply chain challenges ahead and whether they could burst the bubble of patient and media expectations.

On exploring the issues in some depth, we conclude that only re-engineering the pharma supply chain can offer a sustainable solution to advanced therapy challenges.

Rescue CRO: Thoughts for Taking the Ultimate Step to Save the Study

Last February, I wrote in these pages some thoughts about when sponsor/CRO relationships go off the rails: what can cause it and strategies for repairing it. In this article, let’s go a step further and map out a strategy for the ultimate step: employing a rescue CRO for some or all of an ongoing study.

Generally, we consider bringing in a rescue CRO for all or part of a troubled study for one of two reasons: 1) the study is falling behind in enrollment, or 2) the CRO has failed to deliver results in some other, irreparable way, such as submissions not done (or of poor quality), sites not initiated, monitoring visit reports not done, poor quality data in the database, or other significant quality issues. These two are not mutually exclusive, as slow startup will almost certainly result in slow enrollment.

The 5 Dos and Don’ts to Résumé Writing

1) Don’t Recycle your Resume – Always Modify and Adapt

Applying to jobs can be an arduous process. Oftentimes finding a new role could be considered a job in itself – submitting applications again and again. It would be easier and more convenient to send off the same resume to multiple jobs at the same time.

However, each job, regardless of whether you’re applying to similar positions, has different specifications. Always modify and adapt your resume. It may be time-consuming, but it makes all the difference. Pick out the relevant keywords from the job description and portray those skills in your resume. If the role requires someone who has strong time management skills, highlight in your resume how good you are at managing time, and show examples.