アイコンは製薬、バイオテクノロジー、医療機器産業を対象とした開発受託業務を提供するグローバル CRO です。当社は開発戦略策定のサポートから第 IIV 相臨床試験に至るまで、臨床開発を支える各プログラムの戦略的開発、マネージメント、データ解析を専門としています。

細分化が進む製薬業界において、 アイコン は国や地域単位、またグローバル規模の臨床試験や開発プロジェクトを実施できる規模と専門性を備えた数少ないグローバル CRO1 つです。

アイコンは、スタンドアロンのサービスでも、またフルサービスでも開発業務を提供できる柔軟性を備えています。


ICON Reports First Quarter 2015

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ICON Views

Patient-reported outcomes (PRO) offer valuable post-market insight for drug and medical device manufacturers, but they can also be leveraged to provide input into practices that can enhance treatment development during the course of a clinical trial. ICON's own Todd Saretsky recently presented a poster at the FDA's 2015 Office of Regulatory Science and Innovation Symposium which addresses the potential of developing a standardized PRO tool to measure treatment effects in Hospital-Acquired Bacterial Pneumonia (and will present similar work at ISPOR in Philadelphia). This work is being overseen by ICON Directors Kellee Howard and Sarah Clifford and members of FNIH.

Titled 'Signs, Symptoms, and Existing Patient-Reported Outcome (PRO) Measures in Hospital-Acquired Bacterial Pneumonia (HABP): A Comprehensive Literature Review,' the poster examined data pulled from MEDLINE and EMBASE databases, ultimately focusing on six specific studies that met inclusion criteria. The results of the analysis revealed that current HABP clinical trials have not considered symptoms and health-related quality of life in the evaluation of treatment efficacy. Furthermore, no PRO instruments assessing HABP symptoms have been developed. The ICON team in conjunction with FNIH also discovered that very few articles have focused exclusively on HABP, as authors typically grouped HABP with other forms of nosocomial pneumonia or community-acquired pneumonia and healthcare-associated pneumonia.

The poster identified the most frequent signs and symptoms associated with HABP, including fever, cough, purulent sputum, dyspnea, rales, chest pain, elevated respiratory and heart rate, and elevated white blood cell count. It also stated that the HABP literature has historically focused on clinical global impressions of change to evaluate treatment efficacy and there is currently limited evidence assessing the impact of antibiotic therapies on patient-reported symptoms in HABP patients. The conclusion describes the importance of developing clinically relevant endpoints in accordance with FDA PRO Guidance when evaluating antibacterial drugs intended to treat HABP.

The original poster is available to download from the ICON website.
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Innovative clinical trial designs are increasingly turning to new technologies in an effort to not only improve data collection but also enhance patient engagement. As with many incorporations of mobile technology into clinical trials, one of the latest developments involves the use of a consumer-oriented health product to inform early-stage data gathering.

Medidata, which offers a
Clinical Cloud solution for trial monitoring, has partnered with Garmin to use its Vivofit product to gather patient data. Vivofit is similar to many step-counting products worn on the wrist that also measures the amount of calories burned in a given day, along with the number of hours of sleep that the wearer gets per night.

With no need to remove and recharge the device (the battery lasts for up to one year), the flow of data collection is constant - and Medidata hopes that the convenience offered by uploading this information directly to the cloud will offer a proof of concept for including more wearable mobile health devices in future trial designs. In addition to better compliance (due to its automated reporting), Vivofit also offers an economic advantage to both study participants and study principals by potentially reducing the need for clinical visits.

While a consumer-facing medical device like Vivofit might not be able to offer the broad scope of clinical data needed by the majority of trials in its current iteration, it would be a mistake not to consider the importance of mobile health technology in the transformation of future patient / clinician interaction. By leveraging automated data gathering, as well as improved patient engagement through remote access to their own trial progress via a cloud interface, Medidata and Garmin are pointing towards a brighter and more economically viable future for distributed clinical trials.

Benjamin Hunting
ICON Blogging Team
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