Important Research Growing Complex, Redefining Sponsor/CRO Partnerships
By John Potthoff, PhD, president and CEO, Theorem Clinical Research
Improving (And Complicating) Research By Involving Patients
As therapies become more targeted, so does the research to develop those therapies. That means more complex, subject-specific research and more advanced intersections between diagnostics, drugs, and delivery methods to make high-precision medicine possible. This is a future the clinical research community is aware it’s facing. Look no further than the advocacy of patient-centric (and/or patient-centered, contingent on where the interest emanates) research as patients are asked to play a more active role in monitoring their health and, in some cases, administering their medicine, especially as individualized medicines demand varied regimens.
Companies with the clout (and enormous financial incentive) to make the far-fetched a reality are joining the movement to involve patients in their health. The Microsoft Health, Google Fit, and Apple ResearchKit platforms will conjure rapid mass adoption and influence the perceptions of how involved people can be in their health, and by extension, clinical research. In fact, five studies — for asthma, breast cancer, cardiovascular health, diabetes, and Parkinson’s disease — were initiated with the launch of ResearchKit. Apple is conducting these studies in conjunction with Massachusetts General Hospital, Stanford Medicine, the Dana-Farber Cancer Institute, and other major research groups.
The sweeping adoption of these platforms, along with the utility of mobile medical applications, inbuilt hardware (e.g., accelerometers and proximity, light, and sound sensors) and connected hardware/devices (e.g., glucometers, ECGs, blood pressure monitors), will provide more access to more individualized data than ever. Taking it a step further, consider oncology research, where treating specific gene loci is the new normal. Already, we’re amassing libraries of genomic information as more effective and efficient ways of capturing and managing information arise. As the sheer amount of individualized data increases, so too does the overall potential value of the compiled data (the so called “network economics” of data). Consider the advantages visual analytics technologies offer today, and imagine your research team browsing a sort of Google Map of patient data in the future. Therein lies the crux of why important research is becoming more complex: To improve the end product, the product development and clinical research processes have to improve. This has always been the case, but at an increasing pace, advancements in technology and data generation/collection have given us, in some cases, potential beyond our capability.
By nature, our job is to simplify increasingly difficult work, and the convergences taking place to make individualized medicines possible demand a new breed of CRO — one that is flexible, globally capable, and project-centric. Standardized, unadaptable practices simply won’t work as the research itself becomes less standardized. So, how will CROs harness the power of new analytical technologies, more comprehensive means for patient engagement, and more data to perform more intricate research and develop individualized treatments?
Separating The CRO Of Today From The CRO Of Tomorrow
For CROs, the future premise is clear: If you can’t adapt, you won’t survive. The way sponsors and CROs work together must change and, indeed, is already changing rapidly. Consider the rise of clinical research service outsourcing and how outsourcing almost seems too distant a word for the structure of many relationships. More and more, there is an inter-reliance between sponsors and their CROs. Trends present in one affect the other, and as both parties look to conduct more complex research to develop combination products, for example, sponsors and CROs are forming more tight-knit relationships. Sponsors are increasingly looking to leverage strategic alliances, both with CROs and their extended partners, to involve parties that can best address multifaceted research to add agility to the development process.
Furthermore, as sponsor/CRO relationships grow closer to meet the challenge of conducting multifaceted research, CROs must be willing to eliminate copied-and-pasted protocols and study designs. The value of this is demonstrated, for instance, by the risk mitigation and cost savings made possible by adaptive trial design. But even before work is underway, within the process of bidding and contracting, one way to assess a CRO’s flexibility (and willingness to adapt) is to discuss change management.
Change management is frequently marginalized in the bidding/contracting process as being nonessential to initiating study startup, and parties on both sides of the desk may be reluctant to admit they can’t always see the full road ahead. As research becomes increasingly complex, change orders are all but inevitable. Both sponsors and CROs should be adamant about addressing the liabilities involved with rapid changes in work, or what exactly constitutes a change order, so that crucial work isn’t impeded down the road. After all, when sponsors and CROs reach pivotal moments, the focus should remain on executing the trial, not transactions.
It’s also becoming apparent that inflexibility can derive from a CRO’s approach to maximizing the efficiency of trial conduct, through which standardized processes and services often stifle a CRO’s ability to accommodate unique and evolving needs. Moreover, as CRO efforts may go toward managing internal operations, highly bureaucratic organizational structures often get in the way when rapid change is necessary. Digging deeper, tailorable technology and truly experienced teams bring real flexibility that will be so critical to complex trials of the future.
Just as off-the-shelf processes won’t work, neither will off-the-shelf technology. Advanced technology has never been more accessible, which means it’s never been easier to deploy … and misapply. Technology only empowers users as far as their intuition can take them; technology is only a tool. Research progress is driven by subject matter experts who understand the criticality of the information at play. Moreover, the technology must be suited to the project it supports, the data it handles, and the users controlling it. Consider how reliant successful risk-based monitoring is on the technology’s ability to surveil therapeutically specific, yet globally fragmented data, as well as the technology’s interoperability with existing or coinciding trial management platforms. As we look to track individual patients, not just populations, and gain access to drastically more data (and more powerful analytics technology), technology must connect global research teams and strengthen communication in ways that accelerate trial processes.
As trials globalize, CROs must also have a valid presence in and understanding of the locations in which they work, especially if they are to operate remotely from those locations. There is a fine, yet true line of distinction between being global and actually having global reach. To offer the latter, a CRO must have the region-specific intelligence — cultural, regulatory, infrastructural, logistical, etc. — to plan and operationalize in project-specific ways and to assign teams with genuine experience.
Research is becoming more complex, and that’s a good thing. It’s inevitable that CROs must change with the coming tides in clinical research, but the speed, flexibility, and tenacity with which they do it will separate the CROs of today from the CROs of tomorrow.