The Clinical Research Crystal Ball: Looking At The Future

By Laurie Halloran, president and CEO, Halloran Consulting Group

In the life sciences industry, we are always hyper-vigilant about all of the risks involved in product development. Therefore, our “cuttingedge” approaches seem not quite as innovative as other high-tech industries. The time has come for a few key best practices that add efficiency and cost-effectiveness, something the clinical development world desperately needs. In order to confirm my theories, I queried a number of executivelevel professional colleagues in pharmaceutical and biotechnology companies, who shared their views off the record. I analyzed my queries and compiled the results into a cohesive discussion below. To add a note of practicality to each, I’ll suggest considerations for those who want to make it happen in the present and look toward the future.

Technology and Transparency that Facilitates Every Facet of Clinical Research
As in many other industries, the Internet has created entirely new business models whereby data and information sharing in public domains completely reverses the practices of the past. The day has finally come in life sciences where technology is changing the landscape in terms of realtime availability of data, on everything from patient- and physician-driven protocol design, to using tools online, and transparency in all financial aspects of clinical development, so that companies can conserve their limited resources available for R&D.

In the near future, clinical data will be collected via mobile apps held by patients, transmitted directly, and managed and monitored with significantly less burdensome and time-intensive direct contact in the process. This means that signal detection, safety surveillance, trend analysis, and potential fraud detection will all be completed in real time. Cloud technology and e-systems — with fewer opportunities for human error — will be the wave of the future, greatly speeding the time and increasing the quality of data collected. The company challenges of today are to ensure systems and tools are interoperable and secure. With all of these future advancements come a new set of skills required by our workforce and implementation of completely new methods, to define and manage quality and process.

One major change in the philosophy of companies that will speed up this process more than ever is collaboration between companies, with the ultimate goal of increasing efficiency and improving costs and quality simultaneously. Even the idea of a collaboration is unprecedented to date. In the past 10 years, there were enormous and relatively unsuccessful efforts to decrease direct costs associated with laborious manual processes. After this influx of exertion, technology is finally poised to make the core competencies of the past obsolete. In the near future, clinical research professionals will need to become better at both strategic and relationship management as the adoption of more efficient technology removes many of the onerous processes previously associated with monitoring and data management.

It is likely that the way clinical trials and programs are outsourced will change significantly because of these transformations. There will be an emphasis on partnering with vendors who are producing high-quality deliverables that meet or beat precompetitive cross-industry metrics with lower costs and who make their information available through shared quality data. The CROs that will be leaders are the ones that will invest in providing information and data that is robust, reliable, and available in real time on demand by industry sponsors. These CROs will also differentiate themselves on their ability to provide exemplary, proactive, relationship-based site management services. All of the processes, roles, and the mindsets within and between these relationships will need to evolve for clinical service providers to stay competitive.

Patient-Centric Focus will Be Key
No matter if sophisticated technology is able to transform the end-to-end production of data needed to demonstrate safety and efficacy, the necessity and presence of patients who produce that data will not change. Companies that are able to connect more directly with patients will have a competitive advantage, because there will be an emphasis on more than just treatment of disease.

In the future, there will also be a focus on the patient with respect to the molecular and genomic characteristics of their disease, and a more precise approach to detecting the basis of, and developing products for, devastating but underserved patient populations who need targeted therapies. While this is another use of Big Data, it ultimately benefits orphan patient populations that had received ineffective treatments in the past because of limitations in accurate diagnoses that are only now beginning to be addressed.

In my optimistic vision of the future, a patient in any part of the world would use their ubiquitous mobile technology to be diagnosed, treated, and selected for a clinical trial. And that trial design would be highly likely to result in a more rapid availability through the marketed product to benefit all who suffer from the illness. If we can envision it, we can create it. Let’s get there.