Start using electronic data capture in clinical trials

A recent publication suggests that Electronic Data Capture systems, or EDCs, should be implemented in clinical trials. The EDC software can reduce the overall trial costs by an estimated $347,600 in a phase ll trial of 20 sites, 10 patients per site and a duration of 12 months plus data cleaning. See the table.

Forrester-Research-Paper-versus-EDC-cost-comparison1

Table: Forrester Research Paper versus EDC cost comparison.

In this example, monitor visits still costs $ 180,000. Vitaphone CTS provides solutions to make subjects monitor their vital signs at home. This can also enhance their trial compliance. Re-activity is a top priority to create better and more efficient clinical trials. The tools developed by Vitaphone CTS will send biosensor data immediately and thus ensure almost real-time data. Our medication adherence support system (MASS) stimulates the study subjects to take their study medication.

Remote monitoring and support enables pharmaceutical, biotechnology and medical device industries to focus on the development of the best drug or device.

Using telemonitoring solutions, investigators can improve patient safety. This might be achieved through faster notification of adverse events to the Principal Investigator, CRO or Sponsor. This will support earlier and better decision-making. Embrace technology.

Author: Indy Kavelaars

Source: Clinovo

 

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2 thoughts on “Start using electronic data capture in clinical trials

  1. Its a very nice idea with obvious benefits. But isn’t a limitation the number and type of vital signs that can be measured at home versus what the clinical trial design calls for? You can measure BP, weight, lung function, a basic ECG, blood glucose, INR … what else? More blood tests and biomarkers? I don’t think so! Scans? No. What else? Do these limitations actually limit the scope of remote vital sign measurement in trials? Thoughts?

  2. Vitaphone says:

    Thank you for your question! Of course there are limitations on home vital signs monitoring. But when designing a clinical trial you have to view all the possibilities to make the trial as efficient as possible. That means embracing the technology that is possible. The technology doesn’t limit the scope of the trial it enhances it, because before efficient technology wasn’t an option, now it is. What can’t be monitored (yet) at home, still can be monitored at the study site.

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