The “AI state-of-play around clinical research” is a white paper recently published by the AI joint Task Force from the European CRO Federation (EUCROF) and the eClinical Forum (eCF). This is a position paper that provides information about AI and ML in clinical research around the globe, with emphasis in US and Europe.

The use cases presented include: AI to enhance clinical trial operations, feasibility exploration according to inclusion/exclusion criteria for recruitment, patient and site recruitment, applications to improve trial operations, risk-based monitoring and data management, task automation, applications for Real World Evidence (RWE), medical coding, and more.

The paper also presents clinical evaluation challenges for the development and validation of AI and concludes with the positions of the AI Task Force, including the promise for improving treatments and clinical research, the risks, and the challenge for using AI given the current state of evolving regulations.

Sofoklis Kyriazakos, leader of the AI joint Task Force, says “This white paper is an important milestone for the industry that sees the benefits of AI and puts efforts to understand the environment and how to transform the challenges into opportunities. This has been a very nice team work that underlines the importance of joining forces to make a step forward and adopt AI technologies”.

See publication: https://www.eucrof.eu/images/23_11_06_AI_State-of-Play_Around_Clinical_Research_15Sep23__vPR1_Approved_by_eCF_SC_for_Release.pdf

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Study Details

• Type: Non-interventional
• Disease: Haemophilia A
• Sites: 20 sites in Italy
• Start: January 2020
• Population: 150 patients
• Duration: 12 months

Study Description

POWER is a multicenter non-interventional study to evaluate the physical activity, bleeding incidence, and Health-related Quality of Life in patients with Haemophilia A without inhibitors receiving the standard of care treatment. the above outcomes will be collected through a Fitbit tracking device and Healthentia ePRO, customized for the purposes of the Study. This study is in partnership with a Clinical Research Organization (CRO) Cros NT and an eCRF technology provider Arithmos Life Sciences for a Top5 Pharma.

Study Design & Method

Patients will receive a Fitbit device (i.e monitoring bracelet) that will collect at a daily basis Real-World Data like activity (i.e. steps per day), sleep, and vital signs. The device will be delivered during the recruitment, a Fitbit account will be opened and the Application The collected data are then transferred to the patient’s paired device through the Healthentia application downloaded on their smartphone.

During the whole observation period, patients will report through dedicated questionnaires sent to the Power App their wellbeing status in scheduled timings or ad hoc reporting of bleeding or adverse events. A quarterly EQ 5D5L questionnaire is assessing the quality of life and monthly a VAS scale is assessing pain intensity. Absences from school/work and hospitalizations. Bleeding events, treatment adherence and doses and frequency of concomitant medicines are reported monthly.

Document physical activity, (active minutes, steps count and MET) by age categories (12-17, 18-30, and 31-50 years) in patients with haemophilia A without inhibitors

Collect information on incidence and severity of adverse events (AEs)

Profile Haemophiliac patients of different categories active vs. sedentary and severe vs. moderate in terms of dif aspects

Evaluate the relationship between physical activity (type and intensity) and bleedings

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