Tag Archives: Clinical studies

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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High Blood Pressure After Acute Ischemic Stroke Is Associated With Poor Clinical Outcomes

Recently published data from the Fukuoka Stroke Registry in Japan clearly suggest that a high poststroke blood pressure was significantly associated with unfavourable clinical outcomes in patients with acute ischemic stroke. This indicates the importance of thorough blood pressure monitoring in these patients.

Telemonitoring could play a major role here: patients do not need to travel whilst they are safely monitored by healthcare professionals.

This kind of monitoring is one of Vitaphone’s core competencies. The actual measurement of blood pressure at a patient’s home is one thing, but the service delivered once the data are sent is another one. On this, Vitaphone has been a key player over the last ten years, delivering services, from our unique in its kind, ISO-certified telemedical service centre.

For more info, please visit our website: www.vitaphone.nl

Author: MSc, PhD Erik Fransen @ Vitaphone Netherlands

Source: Fukuoka Stroke Registry

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American adherence average grade: C+

A study to research the medication adherence has been conducted among American adults of 40 years and older with an ongoing prescription of chronic medication. This study was commissioned by the NCPA, National Community Pharmacists Association, and conducted by the research firm Langer Research Associates.

The National Report Card on Adherence is based on an average of answers to questions on nine non-adherent behaviors. Whether or not, in the past 12 months, patients:

  1. Failed to fill or refill a prescription;
  2. Missed a dose;
  3. Took a lower or higher dose than prescribed;
  4. Stopped a prescription early;
  5. Took an old medication for a new problem without consulting a doctor;
  6. Took someone else’s medicine; or
  7. Forgot whether they’d taken a medication.

The medication adherence of this target group, which represent 30% of all adults, scored a poor C+. This means that most of this group had one or two non-adherence behaviors over the last year. 1 on 7 people scored a F, which means four or more non-adherence behaviors in the last year.

Non-adherence can threaten patients’ health individually as well as ad vast costs to the health care system – an estimated $290 billion annually.1 The PICO Medication Adherence Management System reduces the non-adherence behaviors significantly. PICO notifies the patient and/or the caregiver when needed. Through medication prepackaging the PICO not only supports the patients with their medication intake but also helps to reduce medication errors.

PICO connects with the patient and restores their independence.

National Medication Adherence Report Card

National Medication Adherence Report Card
Amount of non-adherence behavior(s) last year:
A: No
B: One
C: two
D: three
F: four or more

Source: NCPA

1 “Thinking Outside the Pillbox: A system-wide Apporoach to Improving Patient Adherence for Chronic Disease.” NEHI. 2009.

Author: Indy Kavelaars

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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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