Author: MRN
A new year brings new opportunities to address the needs of patients and sites alike and with the landscapes of Pharma and Biotech, constantly shifting, it is critical to start the new year on good footing.
With the right approach, 2025 can be the year that you get your clinical trial(s), to more patients and maximize on ROI. Ultimately getting much-needed therapies to-market, faster and, in turn, to all the patients that need them.
The key to this success? Improved patient recruitment and retention through patient-centered trial design, supported by decentralized and hybrid solutions. When the full potential of these solutions is harnessed, improved recruitment through reducing patient choice dropouts can result in shorter overall study duration, reducing study management costs. This is even without accounting for the significant increase in sales if drugs get to market, and patients, sooner.
To ensure that you are truly maximizing your ROI, the decentralized and hybrid trial approach should not be used as a contingency plan, for a very small percentage of patients nor introduced midstream. Rather it should be considered, assessed and included in the initial trial design. Retrospective inclusion of these services can lead to reworking systems and additional activities for sponsors and sites, incurring additional costs that could have been avoided (for example set up, management or site costs).
When it comes to developing your trial design, transparency between sponsors and vendors regarding needs, concerns, and questions is imperative for a strong working relationship and to produce an accurate budget and scope of work. Incorporating new approaches into clinical trials can be challenging; there are many considerations and unique attributes to discuss and scrutinize to develop the right strategy for a given trial.
Hybrid and decentralized trials (DCTs) should be patient-focused, and therefore require significant engagement and support from sponsors, vendors (including project managers, couriers, and in-home healthcare professionals), and site personnel, in shifting burden from patients. Before implementing, a Sponsor and vendor should be aware if there are additional risks involved (financial, operational, etc.). These need to be carefully understood and managed to determine whether the benefit outweighs the costs.
When it comes to implementing decentralized solutions, one size does not fit all and there are many options in the decentralized trial landscape that can be utilized to support patients. To ensure that the right solution is reached you will need to:
- Consider the experience of the patient – their ability to travel (before and after receiving treatment), their family and work obligations, if they have a caregiver (and the caregivers needs) and, most critically, their time. The amount of time they will need to commit to both travel and study activities can influence all the above and play a substantial role in their decision to enroll and remain in the trial.
- Discuss your proposed DCT set up costs with your vendor and consider how sites and patients will be supported to utilize the services. Set-up costs will exist for all services and the overall cost per patient can be high if adoption is low.
- Consider your hybrid / DCT strategy upfront and build it into the trial. Pivoting or changing the approach mid-way through can result in duplicated costs and significant re-work creating delays.
- Work closely with sites and local country teams to engage and support them through the decentralized model. Low adoption can result in additional costs with reduced value to the trial.
- Implement additional site support where required to help with recruitment, retention, data collection, data entry or any other clinical or non- clinical requirement.
Ultimately, for hybrid and DCT solutions to deliver the most value, sponsors need to encourage uptake to arrive at a cost effective or even cost saving position. Encouraging uptake requires that the sponsor, the site and the patient decide which solutions are best for them and best for the trial.
MRN are the experts in the development, implementation, and execution of hybrid and DCT clinical trial design and delivery. Contact us today to learn how our expert teams can create a customized solution to help your trial achieve its maximum ROI potential.