Flaskdata.io Says KISS Low-Quality Clinical Trial Data Goodbye
November 25, 2019 – – Flaskdata.io, an information technology and services company based out of Modlin, Israel, is reaching out to the wider community to share several methods by which the risks of collecting low quality data in clinical trials may be reduced. Flaskdata.io assists in patient compliance automation in clinical trials, accelerating trials, improving patient outcomes and assuring revenue. More information about the company can also be found at the following link: https://www.linkedin.com/company/10224748.
Flaskdata.io says, “In the field of medical science, especially when you are conducting clinical trials, it is vital that you have quality data. If you are collecting low-quality data, it more than likely means that your trial will fail. You will not be able to prove or disprove the scientific hypothesis of your medical device clinical trial. You will have wasted your time. The truth is that you cannot outsource quality, you have to build it into the trial design from the beginning of the process. However, there are methods by which you can reduce the risk of collecting low quality data in your clinical trials.”
The first method to reduce the risk of low quality data, according to Flaskdata.io, is to measure a Clinical Research Coordinator (CRC) time metric, which refers to how long it takes the site CRC to enter the data into the EDC system after the patient visits the website. According to the company, this metric should be 1-2 days at the most and anything more than that would mean that the site staff are losing touch with the data. Another method is to measure non-compliant subjects that continue to visit the site and to measure informed consent CRFs that were not signed.
The company also suggests another vital method: KISS—Keep It Simple, Stupid. Flaskdata.io says implementing the KISS strategy in the data model design of an experiment would mean resisting the temptation to collect lots of extra data points just because it can be done. The company emphasizes that more data often means less attention to quality.
As Flaskdata.io explains, a data model can become excessively complicated if an overabundance of parameters relative to the number of data points is collected. This can lead to overfitting, which means the statistical model can describe the random error in the data rather than the relationships between variables.
The same concept applies to data validation edit checks, says Flaskdata.io. Too many edit checks can hobble the sites from on-time data entry, and on-time data entry is a clinical researcher’s primary quality metric. More methods to reduce risks in clinical trials can be found at the following link: https://www.flaskdata.io/10-ways-to-reduce-clinical-trial-risk-and-they-are-all-free/.
“The unfortunate truth is that many pharmaceutical companies waste hundreds of millions of dollars each and every year on protocol deviations in their clinical research,” says Flaskdata.io’s spokesperson. “Under extreme pressure to get a product on the market, clinical protocols are often flawed. The reality is that patients can be excluded due to a flawed protocol design—necessitating the recruitment of more patients—which is already a tough job in many therapeutic areas. The faster the patient recruitment, the better for the clinical research and, subsequently, the faster a new, better and safer drug is released to patients. The best way for you to make your whole clinical trial process faster is to use the services of Flaskdata.io.”
The company claims that the Flaskdata.io patient compliance automation platform is a comprehensive solution for everything from decentralised clinical trials and patient-centric interventions to digital therapeutics and site-less trials. The platform integrates EDC, mobile ePRO and connected devices using a continuous data feed, and the platform’s Detect & Respond sub-system processes the continuous data feed to provide an immediate picture of protocol compliance for patient-centric research.
According to the company, automation can eliminate non-value-added people and paper activities and saves 90% of the study’s monitoring and clinical data management costs. Interested parties can find information on pricing and more at the following link: I Want To Go Real Fast.
The Flaskdata.io platform currently supports studies at over 350 investigational sites in Europe, United States and Israel. Flaskdata.io works with life science sponsors and CROs to design, implement and operate patient-centric clinical trials. The Flaskdata.io platform integrates continuous data feeds from patients, investigators and connected devices with automated detection and response to protocol violations in real-time. Additionally, the Flaskdata.io ‘Powered by Flask’ program is providing digital therapeutics, digital health and medtech developers with free and open access to the Flask API and reduces their time to market for HIPAA and GDPR-compliant patient management solutions.
For more information about Flaskdata.io, contact the company here:
48 Emek Ayalon