We like to highlight people that are doing interesting work in our industry, and this week we want to put the spotlight on Tracy Harmon Blumenfeld. Tracy and her company RapidTrials recently sold us a patent that covers systems and methods for evaluating the performance and progress of clinical research trials. (more…)
Big news in the past week included a few exciting stories about rare diseases as well as a groundbreaking device created at Massachusetts General Hospital that allows researchers to diagnose cancer using a smartphone camera in about an hour.
In rare disease news, the FDA announced 18 grants to encourage product development for rare diseases and a California congressman is introducing legislation that includes $400 million funding for rare disease drug development. In addition, an article was published about the IDIOM project which allows researchers to diagnose patients suffering from serious and rare diseases by sequencing their genomes to find the faulty gene behind the condition. (more…)
We’re excited to be working with The New York Academy of Sciences to present an mHealth and clinical trial-focused conference this week! The aptly named event – Mobile Health: The Power of Wearables, Sensors, and Apps to Transform Clinical Trials – will focus on the future of mHealth technology and its application in clinical trials. (more…)
Our company has been talking about the patient experience for a while, but lately we’ve been thinking about it more than usual. What’s it like to participate in a clinical trial? What motivates patients to take part in and complete a trial? And what are the pain points of the folks who participate?
To answer a number of questions along these lines and learn more about the experience, we’ve been chatting with patients who are currently participating in clinical trials or took part in one recently. (more…)
Last week’s news coverage was all over the map – from big pharma companies giving clinical trial participants mHealth wearables to the world’s first 3D printed sternum and rib cage implant. (more…)
We already talked about the peaks and valleys of the hype cycle and what it means for mHealth. So where are mHealth tools right now on the road to widespread adoption by the clinical research community? (more…)
Cancer treatments are improving in effectiveness, this much we know. Obviously there is still much ground to cover, but cancer treatments are extending life. According to the American Cancer Society, the average five-year survival rate for all cancers has increased to nearly 70 percent, up from 55 percent in the late 80s. (more…)
As we get closer to the annual Society for Clinical Data Management (SCDM) conference, the call for Bring Your Own Device (BYOD) for electronic clinical outcome assessments (eCOA) and electronic patient-reported outcomes (ePRO) is at the front of my mind. What are the challenges that still exist? Have we moved forward? (more…)
Last week’s news had no shortage of exciting stories, which included promising medical and research innovations, the release of new Apple products and forward-thinking ideas released from mHealth tech companies.
Chief Operating Officer and tech evangelist Mike Capone was particularly interested in the big data technique developed by researchers at Rice University and its implications for the healthcare industry. “This article highlights something that Medidata has been emphasizing for a while — the importance of advancing analytics and bringing real world data into clinical trials.”
Read up on all of the news coverage we shared last week plus the article Mike found notable below. (more…)
We were lucky to sit down with Steve Smith, our chief patient advocate, to chat about last month’s FDA guidance issued on rare disease drug development. For your reference, Steve has provided a detailed Q&A on the key takeaways and what the guidance means for the industry.
The FDA issued its expected guidance on rare disease drug development in late August 2015, and public responses are due in October. Behind the scenes is the buzz of collaboration between patient advocacy groups and drug developers as we analyze, exchange thoughts, and prepare our responses to this important document. (more…)
Looking back at last week’s news, we saw some notable announcements in the Pharma and Life Sciences space. I spoke with Gail Janowitz, an expert in all-things pharma who also happens to be a Vice President of Marketing, about some of the stories from last week. Gail thought two pieces of news stood out from the rest last week — the collaboration between Google and Sanofi as well as the news that the FDA and pharma companies are increasingly listening to patients’ opinions. “I found the piece about the FDA and pharmaceutical companies’ engagement with patients to have some interesting points. It underlines the importance — and challenges — of bringing patient voices to clinical trials.”
Keep on reading for the two articles Gail found noteworthy as well as all of our other news highlights from the past week. (more…)
As consumer wearables become more common and the market continues to expand, they can be seen as an easily accessible, valuable tool for capturing data and information without interfering with the everyday lives of people.
But lately there’s been questions about the accuracy of such devices. The accuracy concern isn’t due to a study not having controls, but due to the data from wearable devices being questioned by the people (often researchers and scientists) receiving it. Placing the accuracy debate on hold for a minute, I’d like to remind everyone there is a bigger picture we should consider. (more…)
- Mining Clinicaltrials.gov for mHealth Data
- A Q&A on the FDA’s New Rare Disease Drug Development Guidance
- Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
- Five Considerations For Wearable Devices In Clinical Trials
- Does Accuracy Really Matter for mHealth Wearable Devices?
We like to highlight people that ar ...Sept. 30 Media Roundup
Big news in the past week included ...What’s the Future of mHealth and ...
We’re excited to be working with ...Did My Participation in a Clinical ...
Our company has been talking about ...Sept. 23 Media Roundup
Last week’s news coverage was all ...
An Easy Problem to Solve: Speeding Up Payments to Clinical Trial Sites
Speaking for over 2,600 sites SCRS robustly supports this movement! You say sponsors want to keep sites - pay...
Taking ePRO to New Places – Replacing Paper
“Painful Memories” – How Memory Biases Affect Patient-reported Outcome Measures
In a way the patients memories are accurate if you think of them remembering "average pain" rather than "peak pain"...
Taking ePRO to New Places – Replacing Paper
Clear and concise description of Patient Cloud cost benefits vs. Paper. Used it today!
What Advocates Said to Congress During Rare Disease Week on the Hill
Great post Steve. I am mother to Hunter, a RARE terminal ill three year old with SMA Type 1. I'm...
CDISC and Industry Standards
Clinical Data Analytics
Clinical Study Design
Clinical Trial Budgeting
Clinical Trial Management
Clinical Trial Phases
Cloud Computing, SaaS and PaaS
ePRO and mHealth
FDA and Regulatory Affairs
Innovation and Entrepreneurship
Interoperability and eClinical
Randomization and Clinical Trial Supply
Security and Confidentiality
Site Engagement and Monitoring
Technology and Agile Development