linical trials have always required a huge number of interconnecting elements to operate, but the recent proliferation of patient centricity-enabling clinical trial technologies is compounding this complexity. In an open letter to sponsors and contract research organizations (CROs), the Society for Clinical Research Sites said: “As our industry undergoes rapid change and transformation, sites are experiencing unforeseen, unprecedented, and historic increases in costs centered around patient-facing research staff and overhead.”

Fortunately, this is a solvable paradox. The solution is cross-sector, strategic partnerships between vendors, along with flexible technology that provides wraparound care for patients, while never eroding site oversight or creating logistical nightmares for staff.

The Tension

This has been accentuated in recent years by a drive towards patient centricity. The rationale is simple: by making it as easy as possible for people to take part in research, sponsors can increase recruitment and retention, thereby streamlining development, reducing costs, and maximizing their ability to address unmet needs.

According to a report from The Economist Intelligence Unit, patient-centric phase 2 and 3 trials (defined as trials designed to make participation as easy as possible through remote or wearable technologies to reduce visits) were about 20% more likely to succeed than those built on traditional models. In addition, on average, they took about three months less to recruit 100 participants.

In addition, regulators such as the US FDA and European Medicines Agency (EMA) are increasingly asking for sponsors to demonstrate how they have included the patient voice and participant preferences in their studies.

The concern, however, is that spiraling numbers of solutions lead to spiraling training needs, communication hurdles, and documentation requirements that take researchers away from their core role of caring for patients. Not only does this negate the very point of patient-centric research, but it can also result in delays and poor data quality that undermines the validity of results and may even cause study failure.

The Solution

Instead, sponsors need to work hand in hand with their sites:

• Find out which platforms and solutions they are already using.
• Work to understand their processes and practices, and how any proposed solutions will fit within them.
• Opt for vendors that minimize administrative burden around singular functions, such as payments and reimbursements.
• Utilize strategic partnerships to consolidate the logistics of working with multiple platforms.
• Reduce site burden by providing the necessary platform training, as well as ongoing technical support, preferably through a single point of contact.

Case Study

Such initiatives have the potential to offer sponsors a “best of both worlds” approach, delivering access to the latest, patient-centric innovations, and a single contact for sites.

For example, one vendor whose eSource technology platform includes Direct Data Capture (DDC), electronic Clinical Outcomes Assessments (eCOA), patient engagement, eConsent, and digital biomarkers has joined forces with an expert, next-generation payment company to offer sponsors a suite of advanced solutions. Similar partnerships between companies with a digital protocol automation tool and companies with clinical trial business collaboration platforms have also been announced in recent months.

Conclusion

By looking for providers that are willing and able to put the needs of research above a wish to block competition, sponsors can get the best of both worlds. In short, partnerships working among technology providers can deliver the very best patient experience across all elements of clinical trials, while never overwhelming the sites and forcing them to move their attention away from participants.