Company:

MID-Frail

MID-Frail Study

Summary

Programme Coordination

Clinical responsibilities included:

Protocol Development and Adherence: Design and implement trial protocols, ensuring alignment with regulatory requirements and scientific rigor.
Patient Safety and Monitoring: Prioritize participant safety through regular monitoring of adverse events and adherence to Good Clinical Practice (GCP) guidelines.
Data Collection and Quality Control: Oversee accurate and thorough data collection, ensuring integrity and reliability in trial results.
Regulatory Compliance: Maintain compliance with regulatory agencies like the FDA or EMA, addressing Institutional Review Board (IRB) approvals and reporting requirements.
Medical Oversight: Provide clinical expertise to manage and evaluate unexpected medical issues or deviations during the trial.

Managerial Responsibilities

Project Planning and Coordination: Establish timelines, budgets, and resource allocation to meet trial objectives effectively.
Team Leadership: Manage interdisciplinary teams, including researchers, clinicians, and support staff, fostering clear communication and collaboration.
Site Management: Oversee trial sites, ensuring they are adequately equipped, staffed, and compliant with protocols.
Stakeholder Communication: Maintain transparent communication with sponsors, regulators, and institutional stakeholders, providing updates on progress and challenges.
Risk Management: Identify and mitigate potential risks, from participant recruitment issues to operational disruptions.

What our client said

"The NST team demonstrated their versatility and broad range of abilities in a trans-European study involving 74 trial sites. The project would not have been able to go forward without Niche and the consortium were congratulated by the commission for being one of the successful Horizon 2020 initiatives."

Professor Alan Sinclair

MID-FRail

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Project background

The MID-Frail study was a significant European research project aimed at evaluating the impact of a multi-modal intervention on frailty and quality of life in older adults (aged 70 and above) with type 2 diabetes. Recognizing the growing challenges posed by type 2 diabetes in ageing populations, this initiative sought to develop practical solutions to improve health outcomes and reduce disability. Supported by a €6 million grant from the European Union, the study spanned 4 years and involved 16 centres across seven European countries. The project was led by experts including Professor Leocadio Rodríguez-Mañas from Spain and Professor Alan Sinclair from the UK and managed by the NST team. It enrolled approximately 1,718 participants who were randomized into two groups: one receiving standard diabetes care and the other participating in a comprehensive intervention program. The intervention combined supervised resistance exercises, dietary guidance, and educational support, targeting improvements in physical performance, functionality, and overall quality of life. Participants in the intervention group demonstrated better outcomes in physical performance measures such as the Short Physical Performance Battery (SPPB) compared to the control group. The findings suggested that such interventions could potentially prevent up to 700,000 diabetes-related disabilities annually across Europe and save approximately €3 billion in healthcare costs. The MID-Frail study underscores the value of integrated care approaches for managing frailty in older adults with chronic conditions like diabetes. It highlights the importance of combining exercise, nutrition, and education to not only address medical issues but also enhance the quality of life for elderly populations.

Delivery

On MID-Frail, the Niche team were identified as the partners for delivering the communication platform, building the strategic communications plan and coordinating our dissemination and exploitation activities. Just after the trial was initiated, the contracted CRO pulled out of the project. The Niche team willingly stepped into the study execution role, ensured that the project achieved its objectives and delivered the study efficiently.

During the project delivery the NST team demonstrated versatility and a broad range of abilities in a trans-European study involving 74 trial sites. The project would not have been able to go forward otherwise and the consortium were congratulated by the commission for being one of the successful Horizon 2020 initiatives.

Running a major clinical trial research initiative involved both clinical and managerial responsibilities, each critical to ensuring the trial’s success and compliance with ethical and regulatory standards.

Effective management of these responsibilities ensured the trial was successfully delivered ethically, scientifically, and operationally. It required robust planning, precise execution, and the ability to adapt to challenges while safeguarding patient welfare, budget and data integrity.

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