How Able Assess Helps Pharma and CROs to Integrate Grip Strength into Clinical Research and Healthcare

Key Takeaways | Grip Strength and Able Assess for Pharma and CROs

• Grip strength is an objective biomarker in observational and non-interventional studies for disease progression or recovery.
• Able Assess supports the use of grip strength as a validated, scalable outcome across the clinical research continuum.
• Grip strength measurement with Able Assess provides a functional, easy to measure endpoint for hybrid and remote decentralized and randomized controlled trials (RCTs) by tracking muscle strength, mobility, and treatment impact.
• Able Assess fits seamlessly into standard care without added burden.

Evidence Supporting the Value of Grip Strength Data

Grip strength serves as "an indispensable biomarker of overall health, including longevity and frailty." Research demonstrates its importance across multiple disease areas including cardiovascular health, diabetes, respiratory disease, oncology, renal disease, and functional decline.

According to peer-reviewed evidence, "grip strength is an important biomarker of health" capable of identifying diverse health issues and functioning as a vital sign throughout the lifespan. Studies establish predictive links between grip strength and "all-cause mortality, future function, bone mineral density, fractures, cognition, and depression."

Notably, "the relation between grip strength and future mortality appears not only in older people, but also in middle-aged and young people."

GripAble Provides Superior Accuracy for Grip Strength Measurements

The GripAble sensor, integrated within the Able Assess solution, features a "modernized approach to measuring grip strength with its digital and high-accuracy measurement system." Peer-reviewed research validates its superior accuracy and effectiveness in real-world clinical settings.

Studies confirm "excellent interrater reliability in measuring grip strength, with studies endorsing GripAble as a reliable and valid tool." The device demonstrates "high sensitivity and robust" performance with features including portability, digital data tracking, remote assessments, longitudinal monitoring, and risk stratification capabilities.

This combination enables "broad applicability in a range of clinical caseloads and environments."

Able Assess: Benefits for Pharma and CROs

Able Assess establishes grip strength as a powerful digital endpoint, delivering advanced data insights to enhance research studies and clinical trials.

Clinical-grade precision

Able Assess provides unmatched accuracy, sensitivity, inter-rater, and test-retest reliability, enabling precise monitoring and reliable, regulatory-quality data. It is designed for research and regulation-quality measurements, outperforming the incumbent gold-standard Jamar with superior sensitivity, accuracy, and reliability.

Patient-friendly data capture

Able Assess offers a simple electronic clinical outcome assessment (eCOA) with a lightweight portable sensor and fully digital platform supporting remote patient assessments.

Flexible and scalable

It seamlessly supports in-clinic and remote use for decentralized studies and longitudinal patient monitoring.

Integration-ready

Able Assess is the only fully digital grip strength solution on the market, designed to integrate seamlessly with existing data platforms, enabling harmonization with current reporting systems.

Operational efficiency

GripAble is the only hand dynamometer sensor with a digital data platform with capability for API integration. It streamlines data collection for enhanced trial performance and operational efficiency.

Built for compliance

Able Assess demonstrates unmatched regulatory compliance across internationally recognized quality, safety and data standards. It meets the highest standards of international data, quality, safety, and regulatory standards to ensure secure, audit-ready performance.

HEOR, RWE/RWD, Population Health, and Registries

Able Assess provides a real-world measure of functional health, resilience, quality of life, and ability to perform Activities of Daily Living (ADLs). It supports frailty, aging, and health economics and outcomes research (HEOR) with real-world evidence (RWE) and real-world data (RWD).

Post-Marketing and Label Expansion Studies

Able Assess delivers real-world functional outcomes to complement safety and efficacy data, highlighting broader value and patient-reported impact.

Case Study: Leveraging Able Assess in a Pioneering Decentralized RCT

Study design

This was a groundbreaking clinical trial to advance ME/CFS research and treatment. There is no known cause or cure for this condition with symptoms including extreme fatigue and impaired cognitive function. Patients enrolled via decentralized methods for a more streamlined, patient-centric, inclusive approach, making participation easier from home. Traditional trial designs have been unsuitable for CFS patients, as the debilitating nature of the condition limits participation and therefore drug development.

Role of Able Assess

Able Assess measured grip strength as a secondary outcome as part of an innovative virtual trial design involving remote monitoring. It evaluated changes in muscle strength (peak force) and functional improvement at the start and end of both active and placebo treatment periods.

Impact

Able Assess provided an evidence-based functional dimension to evaluating drug efficacy. It demonstrated the value of Able Assess in enhancing trial performance and enabling future innovations in digital endpoints. A digital-forward, decentralized approach expands access and exemplifies how technology can drive patient-empathetic trial design, ensuring those with unmet needs are included in the innovation pipeline.

Able Assess for Pharma and CROs

Able Care is a pioneering functional health company, leveraging its proprietary GripAble sensor and advanced data platform to integrate grip strength into clinical research and healthcare.

The Able Assess Grip Strength Platform has been designed for CRO integration:

• Scalable and efficient: Designed to streamline operations for both in-hospital and decentralized studies, promoting proactive remote patient monitoring.
• Seamlessly integrated: Flexibility to harmonize with existing CRO platforms, ensuring smooth adoption and compliance.
• Best-in-class: The platform stands out against its competitors for superior clinical validation, operational efficiency, and regulatory compliance.

Additionally, the Able Assess Falls Risk Screening Platform is "the world's first platform to measure four key metrics for falls risk screening, including grip strength." It provides a standardized, scalable and low-cost solution for falls prevention using a multifactorial, evidence-based approach.