In the world of medical research, reaching the recruitment target for a clinical study is always a significant milestone. But when the aim is to recruit a whopping 2,400 patients for a comprehensive clinical validation study, successfully enrolling 2,382 participants despite a myriad of global challenges is nothing short of extraordinary. The Mobilise-D consortium is celebrating its impressive recruitment achievement despite having to overcome a long string of serious adversities in the process.
A Long Journey
Our journey began in 2019 when we embarked on the groundbreaking Mobilise-D project in collaboration with academia, industry, and pharmaceutical companies as part of the Innovative Medicines Initiative (IMI). The objective of our Clinical Validation Study was ambitious: recruiting 2,400 patients across four cohorts (Parkinson’s Disease, Multiple Sclerosis, Chronic Obstructive Pulmonary Disease and hip fracture) with an extensive two-year follow-up. Little did we know that our journey would be dotted with many significant obstacles from the very start.
The Global Challenges we Faced
Recruitment to the study was originally scheduled to close after six months, but a range of global challenges occurred that tested our resilience and determination. Because of this we quickly realised we needed to extend our recruitment window, to maximize our chances of reaching our targets.
The COVID-19 Pandemic: Undoubtedly, the most significant challenge was the global COVID-19 pandemic. Lockdowns, access restrictions, and increased strains on all healthcare systems made patient recruitment immensely challenging. However, our teams adapted swiftly, implementing remote recruitment strategies while ensuring the safety of both patients and staff.
Sensor Shortage: The scarcity of essential sensors required for the study was another hurdle. Supply chain disruptions and increased demand during the pandemic caused delays, but our team found creative solutions to source these critical components, with new collaborations being formed in addition.
Cyberattacks: In an era where cyber threats loom large, our project was not spared. We faced several cyberattacks that aimed to disrupt our operations but were able to mitigate these risks. The safety and security of data is one of our top concerns and dedication to our participants.
Geopolitical Instability: Global geopolitical changes, such as Brexit and ongoing conflicts, introduced uncertainties that could have derailed our progress. However, our collaborators and partners rallied together, demonstrating the strength of our unified mission to challenge the research field and bring forth new insights into monitoring mobility parameters in the real-world environment.
Natural Disasters: Mother Nature also posed some threats of her own with an earthquake occurring near the sensor factory, temporarily disrupting production. To add to the list of challenges, some of our study sites experienced flooding due to extreme weather events. These environmental challenges tested our flexibility and adaptability as we ensured the safety of both patients and data.
The Success of Collaboration
Despite these formidable obstacles, we did it!
Within a year, we reached the target numbers for three of our cohorts and even slightly surpassed our target of 600 participants in each. But also the hip fracture cohort, consisting of our oldest and frailest participants, came close to target inclusion and with 566 participants recruited, it is currently the world’s largest hip fracture cohort. Achievement of these recruitment numbers in the face of adversity was truly awe-inspiring and a testament to the dedication of our research teams.
We successfully recruited 2,382 patients, making this one of the largest Clinical Validation Studies ever conducted as part of an IMI project with a partnership spanning academia, industry, and pharmaceutical companies.
Our achievement is a testament to the power of collaboration, the resilience of scientific curiosity, the unwavering commitment of our teams, and the persistent pursuit of knowledge in the face of adversity.
