Your mix of trial solutions does matter
The way clinical trials are conducted is and always will be an evolution, adapting to the constant developments and advancements in healthcare, technology, and patient requirements.
Hybrid, remote, virtual, and decentralized are all terms used extensively in recent years to describe an array of solutions that Sponsors can put in place to run trials, but what solution gets implemented depends on what Sponsors are trying to achieve. Is the objective more diverse and inclusive trials and representative patient populations? Engaged research facilities? Holistic support for participants? More geographically dispersed trials? Effective and efficient data collection and management? Overall faster timelines? All of the above?
While these solutions aim to create more efficient and successful trials for all stakeholders, it is the consideration of each individual trial’s unique challenges that should determine the most viable trial design and solution options. Often, one standalone service or product won’t be the answer, but rather a combination of solutions, designed to be implemented and coordinated together to best serve each individual trial.
The adoption of innovative trial design and patient-centric solutions has had a slow climb over the last two decades. While these solutions, when embedded in drug portfolios can drive improved recruitment and retention, stakeholder engagement, and ultimately return for patients and sponsors, their widespread utilization remains far from mainstream.
It's important that the Sponsor strikes the right balance between trial and patient considerations and works closely with vendors to fully understand the solutions available and the possible return. This transparent discussion is required to indicate which solutions can have the greatest impact.
The decision of which solutions to utilize is not only impacted by a Sponsor's budget, types of products under study, clinical trial phase, geographic location of trial sites, and patient population, including interactions with patient advocacy or other patient support1, but also the Sponsor’s willingness and ability to incorporate hybrid and remote trial solutions or technology platforms.
The right mix of solutions for a trial should address the most considerable challenges for that protocol and will have shared objectives between the Sponsor, sites and patients.
The design of this ecosystem is paramount and can be thought of as a synergy between solutions and objectives for each individual protocol.
• Healthcare Professional conducting in-home clinical visit• IMP administration & logistics• Sample collection, processing & logistics• Data collection through eSource direct into EDC system• Site & Pharmacy relationship management• Equipment & supplies management• Quality & risk management• Patient safety oversight• Telemedicine, eDiary, eConsent• Sensors & wearables
• Sponsor size and budget• Clinical study phase• Patient Population• Indication• Geographic location of study sites• Types of drugs/devices under study• Site/Investigator/Patient perspectives
