Perverse incentives
The perverse incentive for the high costs of medical devices and delay to market The CRO outsourcing model and high US hospital prices result in higher total CRO profits via higher costs to companies developing innovative medical devices. These costs are passed down to consumers after FDA clearance. We’ll take a look at the cost […]
When is patient compliance important in medical device clinical trials?
In this post, Danny Lieberman, founder of flaskdata.io , discusses when patient compliance is crucial for your medical device clinical trial and when patient compliance is a negligible factor to success of the study. From adverse events to patient compliance My original goal for Flaskdata.io was to use machine learning to predict onset of adverse events […]
Israeli Medical device innovation for high patient compliance
One of the most challenging problems in medical device clinical trials and in real-life is how to achieve high levels of patient compliance to the protocol. Automated patient compliance technology in medical device clinical trials is confronting CROs with an unpleasant status-quo of SDV as a low-value-add, high-cost, time-consuming activity for patient compliance assurance. The approach […]
Why paper is not an option for your medical device clinical trial
This is a piece David wrote a couple of years ago originally entitled “Why you cannot afford to use paper in your first Phase I efficacy trial for your medical device”. David’s premise is that people do not like change. We have heard the axiom change is good all throughout our lives, but the fact remains that […]
A structured 7 step process for risk assessment of a decentralized clinical trial
In this essay, I discuss a systematic methodology for evaluating risk in your decentralized clinical trial. This is a methodology that has proven itself in hundreds of security and privacy compliance risk assessment projects in a wide variety of healthcare, clinical and IT scenarios. It is a given that the people charged with your clinical […]
What does risk-based monitoring mean for CROS?
Contract research organizations (CROs) should implement risk-based monitoring (RBM) as a top priority for medical device clinical studies. Use of modern data technologies for remote risk-based monitoring can help reduce non-value added rework, and dramatically improve patient compliance in medical device clinical trials and help speed up time to statistical report. The goal of a […]
How to sustain high patient compliance in medical device trials
A comparison between pharma trials and medical device clinical trials The differences between medical device trials and drug efficacy studies are similar to the differences between starting a law firm and starting a business training runners – while both are businesses in a basic sense, they each have specific criteria to adhere to regarding government […]
Is social networking a threat or an opportunity for patient compliance?
How social networking helps medical device clinical trials achieve high rates of recruitment and patient compliance.
The role of your biostatistician for success in medical device clinical trials
The importance of biostatistics in medical device clinical trials In order to understand the importance of biostatistics in medical device clinical trials we talked to Dr. Lisa Deutsch. Lisa Deutsch, Ph.D is a Managing Partner at BioStats Statistical Consulting Ltd. Lisa is one of the rare breed of biostatisticians that are specialized practitioners in biostatistics […]
Risk based monitoring. It’s about the people.
It will come as no surprise to anyone who is actively involved in clinical trial operations that the heart of the matter in clinical trial monitoring is people. I have written here, here and here about how people are the key assets and vulnerabilities in medical device clinical trials. Understanding people and providing timely and high-quality communications rests is a key to […]
