Tag Archives: Clinical trial

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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Free download: Targeting the Triple Aim on the Arizona-Mexico Border – A Summary of a Hypertension Remote Patient Monitoring Trial

The objective of this trial was to identify whether:

  1. The combination of remote patient monitoring of Home Blood Pressure Monitoring (HBPM) using alert thresholds and a Telemedicine Service Center, together with a provider team including experienced Family Care Coordinators could positively affect hypertension trends in just 30 to 60 days.
  2. The combination of remote patient monitoring described above with Family Care Coordinators could produce a positive patient experience, encompassing the patients’ perceived ease of use of the devices, interaction with staff, interest in continuing the program, and whether the patients would recommend the program to others.

Click here to get your free download of a Summary of a Hypertension Remote Patient Monitoring Trial >

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Clinical trials are flourishing in developing countries

This is no surprise because clinical trials are heavily depending on labor costs of healthcare professionals. These professionals are just cheaper in developing countries. But we do not think this is the only way clinical trials can save money and be more accurate too. Vitaphone is convinced that technology is key in this. Most of our technology is self-explaining to the user and needs to be setup once by the healthcare professional.

The article “Clinical trial logistics and the globalization of clinical trials” also stated: “In Large parts of the Western world, there is an increasingly bureaucratic and expensive regulatory system. Over recent years, the regulations governing clinical research have become progressively more complex meaning companies have to be more cautious when it comes to compliance and associated concerns. Such regulations are designed to improve the quality, reliability and efficiency of clinical trials, but are often deemed to be uncoördinated and increasingly complex to understand.”

We can’t change politics, but we can offer technology that really helps CROs to work efficient. We can provide accurate and promptly available digital patient data!

Source: Journal for clinical studies

Author: Indy Kavelaars

Editing: René Stenvert

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Reviewed: ACRON Symposium Clinical Trials

Vitaphone presented its telemedicine solutions for clinical trials during the “ACRON Symposium Clinical trials in an Electronic World and the impact of technology on patients”. We did this through a live demonstration of our ECG monitoring and medication adherence systems.

We really turned some heads when dr. Erik Fransen (our CMO) recorded his own ECG and the audience received this ECG within seconds after recording on their smart phone!

Our medication adherence support system, the PICO, goes further than that; it tracks the intake of the study medication, and it supports the study patients in this. This ensures an optimal medication adherence and more legitimate study results.

One of the quotes heard, was that; “Clinical trials did not change for the last century and they really need to. With help of modern technical solutions all kind of trial processes can be optimized”. With Vitaphone’s ECGs recorders e.g. patients can record and send ECGs from their home, from all around the globe. No more traveling to the hospital for this. Our motto is “move data, not patients”.

We generally noticed that more and more people involved in clinical trials recognize the huge advantages telemedicine could bring for them. Therefore, we think we are on a verge of a digital revolution in the clinical trials world, and we are front-runners in that.

Author: Indy Kavelaars

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ACRON Symposium Clinical Trials

ACRON, the Association of Contract Research Organizations in the Netherlands, organizes a symposium aimed on clinical trials in an Electronic World and the impact of technology on patients. ACRON likes to share their vision of clinical studies and discuss the future of these clinical studies.

Vitaphone will present solutions that can optimize results of clinical trials.

So sign up and visite us at the ACRON symposium!

When:       Thursday 20 June, from 13.00 – 17.00

Where:      Hotel De Klepperman te Hoevelaken

http://acron.nl/Meetings-en-activiteiten/Agenda/Acron-symposium-klinisch

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Synchronous telehealth intervention reduces costs

A quasi-experimental clinical study in Taiwan has researched the cost-effectiveness of a synchronous telehealth service for seniors and non-seniors with cardiovascular diseases. Conclusion of the study is that synchronous telehealth intervention may reduce costs, decreases all-cause admission rates and decreases durations of all-cause hospital stays in cardiovascular disease patients, regardless of age. Our experiences tell us the same.

In the study, 3 components of telehealth services were provided. Firstly, real-time transmission of biometrics from the patients was sent to the health care team, including blood pressure, pulse rate, electrocardiography, oximetry, and glucometry. Glucometry was performed in patients with diabetes mellitus and those with impaired fasting glucose and impaired glucose tolerance. Nondiabetic patients did not have glucometry as a telemonitoring module. Each transmitted clinical biometric was recorded in health record clouds that were under synchronous surveillance by the Telehealth Center at NTUH. Second, there were telephone exchanges between the health care team and patients for communication and health promotion. Third, full-time case managers and cardiologists were in charge of care 24 hours a day. The telehealth services included health education, diet therapy, fluid status evaluation, drug adverse effects evaluation, drug compliance monitoring, mood or emotion care, and patient surveillance through the advanced information technology-based monitor system.

We are impressed by the integration of all telehealth components. Vitaphone is a full telehealth service provider and it is stimulating to see the results. Especially with cardiovascular diseases, because we are a leading partner in ECG monitoring. We expect to see telehealth be implemented not only for cardiovascular disease but also for people with other medical conditions. Care support at everyone’s fingertips for a more cost-effective healthcare!

Author: Indy Kavelaars

Source: JMIR

Please leave a comment below!

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Mobile, the future of clinical trials

Patient reported outcomes (PROs) are getting increasingly important for all phases of clinical studies to provide accurate information on the status of a patient’s health condition and how they are being affected by certain treatments. There are also concerns going on about the, now in use, paper-based PRO tools because of the lack of adherence and the low levels of control. Mobile technology is going to be much more important in the future because it can aid cost-efficiency and secure patient adherence to medication. This is will be very important particularly in global clinical trials.

The mobile device acceptance is at least reaching 86% of the global population by 2011, totaling almost 6 billion connections, I think is the perfect tool to get the most reliable data collection. With a mobile device you can not only check if the medication has been taken or not, you can also deliver support so the medication, if forgotten, is still being taken. Vitaphone is convinced that a mobile device is the easiest way for people to answer questionnaires and remind them of such, that it will play a vital role in providing accurate, secure and sustainable reporting.

Vitaphone offers exactly this tailored clinical trial services >

Also read the article below, page 27 about clinical trials.

Journal Patient Compliance volume 3, issue 1

1=International Telecommunication Union. Key statistical highlights: ITU data release June 2012

Sources: Patient Compliance Media, http://www.patientcompliancemedia.com/

Author: Indy Kavelaars, LinkedIn

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DIA EuroMeeting Reviewed

René demonstrating RemosECG 100BT

René demonstrating RemosECG 100BT

At DIA EuroMeeting 2013 many exhibitors presented their solutions to the audience. Vitaphone demonstrated the medication adherence improver PICO and RemosECG 100 monitoring device. With the ECG device a patient can make ECG recordings from his/her own surroundings and the ECG will be send automatically to an ISO certified service center. Kai Langel, Director eClinicalHealth liked it that much that he mentioned our solutions in his blog.

Kai Langel wrote about us:

“Vitaphone, a telemedicine provider had some very interesting products on display. I was especially impressed with their Vitaphone RemosECG product, which is an ECG meter that offers the kind of patient usability I’m looking for. Basically, it’s a remote ECG device, which you simply hold to your chest and press one button to start recording your ECG, which the device then automatically sends to a central server where it can be reviewed by a medical professional. In a clinical study setting, this device can help eliminate unnecessary visits and make life a little bit easier for both the patient and the site personnel.”

Source: eClinicalHealth blog

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Door middel van technische oplossingen betere randomisatie clinical trials

Bij clinical trials speelt altijd het risico van het bevooroordeelde resultaten. Niet adequate randomisatie technieken en onjuiste encryptie van gegevens zijn daarvan de oorzaken. Slechte randomisatie kan leiden tot een verminderde waarde van clinical trials. Door gebruik te maken van nieuwe  technologieën, die door bedrijven zoals Vitaphone zijn ontwikkeld, kunnen randomisatie fouten tot een minimum worden beperkt.

Door: Vitaphone Netherlands

Bron: Dovepress

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