Clinical data management, payment for outcomes
Payment for outcomes using GCP metrics is a way to significantly reduce clinical operations costs and increase value-for-money from your CRO or DCT vendor. Payment for outcomes using GCP metrics shifts study costs from billable activities to measurable results. Professional service activities are hard to control. GCP metrics are hard to contest. In this post, […]
GCP for clinical trials – patterns of low-concern and high-impact
How to assure GCP for clinical trials in the best way? In this post, we will show you how to assure good clinical practice in clinical trials. According to Cancer.gov, GCP (Good Clinical Practice) is an international set of guidelines that helps make sure that the results of a clinical trial are reliable and that […]
Why you do not want to unify data in your clinical trial
Unified clinical data sets – good or bad? Unification of data from patient medical records, hospital reports and clinical trial protocols is a tempting yet extremely dangerous idea. In this outstanding guest post, security and privacy expert, Veronika Valdova from Arete-Zoe explains why merging medical records, hospital reports, and clinical trial data is a very bad idea. How data breaches […]
Knowledge Prostitution in clinical data
Friday, a client asked me about privacy, data security and social networking in clinical trials. The client told me that they were considering using a physicians‘ portal to market their digital therapeutic product after they completed their pivotal clinical trial. (See my article on 4 strategies to get FDA approval for your medical device ). […]
Career development for clinical data managers
A good clinical data manager is an essential piece of running a clinical trial. A well-trained and responsibility clinical data manager is a an important part in study execution. A good clinical data manager will want to have a career development plan. A clinical data manager on an individual contributor track, needs to develop […]
Did you wait until the last minute to choose vendors for your clinical trial?
Your dream outcome. Helping cancer patients. Doing it right. Recruiting quickly and efficiently and getting a diverse population into your study. You have noble intentions and great science. So – why are you accumulating months delay even before the first patient is recruited? There are a lot of things on the science and recruitment side, […]
Data capture by sites is activity, not achievement
Never mistake data collection activity for an achievement Recruiting and caring for patients (whether at home or on site) is a research site responsibility. Capturing pages (note the paper paradigm!) is one of the key billable metrics for a site. While data collection, detection of exceptions and action to close issues are all activities essential […]
Patient compliance in clinical trials – the elephant in the room
Clinical trials cost a fortune. When a patient is non-compliant during the run-in/washout period, he/she is dropped out of the study. This costs the sponsor 5X: site costs for 2 patients, recruitment costs for 2 patients and loss of time. In other words, retention is more important than recruitment. This raises the question: why is […]
Living in an ideal world where the site coordinator is not overwhelmed by IT
Tigran examines the idea of using EDC edit checks to assure patient compliance to the protocol. How should I assure patient compliance to the protocol in my clinical trials? I get asked sometimes whether automated patient compliance deviation detection and response is not overkill. After all, all EDC systems allow comparing input to preset ranges and […]
Are you neglecting security incident response in your DCT?
Let me ask you 3 questions. If you answer Yes to all 3 – read this post, if not, then move on. Do you assume that your DCT vendor has a security incident policy – based on the Web site? Are you VP R&D or CEO or regulatory and compliance officer at a drug company. […]
