In response to tighter margins, globalization and increasing regulatory complexity, sponsors have been embracing an outsourcing model using Contract Research Organizations (CROs) to conduct scientific services for all phases of clinical research.
A primary motivator driving this trend is the expected benefits to be gained from external specialization, allowing drug makers to focus on core competencies and a value focused workflow. The pace of scientific discovery requires drug companies to utilize cutting-edge techniques and subject expertise across a vast breadth of therapeutic specialties. Outsourcing provides access to these technologies with none of the costly in-house investment. Beyond offering market agility and introducing fair market price efficiencies to many aspects of the drug development pipeline, strategic outsourcing also aims to shorten end-to-end launch time, allowing sponsors to recoup R&D expenditure quicker. With most sponsors utilizing an outsourcing model of some kind, the biggest opportunity might still lie ahead. As the industry adapts to be more budget minded and efficient, the quest for innovation remains. So, what does meaningful innovation look like for the clinical trial industry?
Technology as Opportunity
CROs are poised to transition from a pay-per-service provider to a long-term strategic partner within the industry. The benefits of this approach will not come from simply increasing relationships with CROs, but in how sponsors leverage those relationships to introduce innovation into their workflows. Both see optimized outsourcing models as the key to sustained mutual growth, but until recently, it was still unclear how industry innovation would take shape. Cue the rise of cloud-based technology solutions.
The benefits of cloud solutions can be seen in another industry charged with managing complex global supply chains, strict international regulatory guidelines, consumer safety monitoring, exorbitant delay costs, and huge data management needs - the food manufacturing industry. As food companies implemented cloud solutions, they reported improvements in operating processes, cost savings, and an increase in product quality resulting from data-driven decisions. Those insights were possible due to enhancements in data integration, automation, and improved predictive analytics. Like so many other industries, the drug development industry is ripe for adaptation and process optimization from cloud-based software.
Clinical trials, the costliest stage in drug development, have much to benefit from leveraging the cloud to collaborate with partners and share views of key data trends and process metrics. The precisionFDA online research portal offers a good example how cloud computing can be used across a complex partner ecosystem drive innovation. A product of President Obama's Precision Medicine Initiative (PMI), the precisionFDA portal aims to translate next-generation sequencing (NGS) genomics data and knowledge into clinical care. To achieve this goal, precisionFDA is relying on the latest cloud computing and storage infrastructures to offer an open, cloud community where scientists can share data, insights, and methods. To achieve that goal, precisionFDA is drawing upon the latest computing and storage technologies to provide an open source cloud-based space where experts can share data, results, ideas, and methodologies. According to the FDA, as of October 2016, it had more than 1,600 participants, from academic researchers to statisticians and clinicians.
Cloud-computing and next-generation services are now not only in demand from sponsor companies, but may be the solution to the data infrastructure bottlenecks that plague clinical trials. With the advent of cloud-based software, collaboration and analytics have the potential to revolutionize the traditional clinical trial workflow. Data is no longer locked into physical devices and infrastructure, it becomes easier to work with partners. Sharing documents, workflows and common metrics across organizational boundaries increases communication efficiency and reduces cycle times. As a result, technology adoption is quickly becoming a key differentiator for CROs, as sponsors increasingly look for partners who have the infrastructure in place to minimize costs and streamline collaboration. CROs are, in turn, striving to position themselves as technology innovators, but the challenge of disconnected, antiquated systems and lack of standardization continues to plague the industry. According to David Blackman, PPD's Business Innovation Director, "The trend of biopharma companies and CROs developing their technology strategies and roadmaps independently has resulted in an enterprise information portfolio that is made up of various disparate data warehouse and storage areas. This disconnected approach is magnified when clients that work with multiple CROs receive both patient and operation data/reports in each of their partners' formats, causing clients to manage their studies or programs through these non-standardized processes." The time is right for the adoption of cloud-based technology solutions that, not only streamline collaboration between CROs and sponsors, but also standardize the data views and workflows from study to study. This will save time and promote efficiencies across the clinical research value chain.
An Innovative Partnership
Beyond just technology, this new opportunity for innovation is borne out of the realization that leading CROs are sitting on a wealth of actionable data and expertise which can be leveraged into data driven decision making on a large scale, from starting clinical trials through to execution. CROs have the benefit of years of cross sectional data which could enable meaningful predictive analytics designed to mitigate risk and predict success. Data on historical trends, trial cost effectiveness, patient enrollment and retention, screen failure rates, and site performance, are invaluable in framing out the early stages of study startup, for example. Comparative data on total principal investigator cost per patient and the total site cost per patient are key metrics in evaluating cost performance of a study and projecting financial risks in future trials. This benchmarking analysis has traditionally been a painstaking and inexact task with many moving parts, causing costly delays before the actual clinical trial can even begin. The Tufts Center for the Study of Drug Development estimates that it takes an average of eight months to reach the site initiation phase in clinical development. Expediting or improving this workflow is possible with aggregated insights and data analysis provided by a partner who specializes in site identification.
Experienced CROs have weathered steep competition for trial sites and within certain therapeutic areas. They have adapted to work in the constantly changing global regulatory landscape, and offer subject expertise to sponsors who work with them. The data, technology, and scientific knowledge offered by leading CROs makes them primed to step into a new role as strategic partner. They have deep experienced having interacted with more investigative sites (and investigators) and can translate that first-hand knowledge into evaluating their fitness for a specific study. These relationships provide tangible gains during the crucial phase of designing and launching clinical trials.
A Strategy for Strategic Partners
With so much at stake, where do you start when considering the right long-term, strategic CRO partner? With technology and the market both priming CROs to step in as industry innovators, there are certain attributes to look for in 'best-in-class' strategic partners:
- Early Adoption of Cloud Systems and eClinical Tools: CROs who embraced new technology early are best poised to benefit from the transition. This is most valuable in streamlining manual processes to uncover hidden bottlenecks. As a strategic partner, they will not only have mastered the benefits of eClinical tools and cloud-based systems to optimize process efficiency, they will be open to innovative approaches going forward.
- Optimized Analytics: CROs making the most of data by looking for actionable trends in enrollment, site performance, trial data, cycle time, monitoring, cost ratio, and screening can offer more accurate predictive modeling. This is particularly valuable in conducting adaptive trials and during site identification. CROs who specialize in global site identification analysis provide a significant advantage for sponsors.
- Integrated Data Management: Cloud-based technology platforms should make accessing data easier. Avoid CROs who can only provide raw trial data in a single form or after a specific request, this may translate into costly delays. Best-in-class cloud technologies should offer multiple ways to access data in real-time with build-in reporting functions. CROs who specialize in data management services often perform better by regulatory and efficiency standards.
- Subject Expertise: Utilizing CROs expertise for therapies allows sponsors to benefit from the learnings, successes, and failures of others. Additionally, leading CROs will offer highly trained staff at all levels of trial administration, including monitors and site managers. This is particularly valuable in navigating the increasing complexity of global regulatory guidelines. Successful CROs have conducted many global trials, and proactively incorporate new regulatory policy into their workflow.
- Relationships: Many leading CROs have strong relationships with sites, investigators, and local regulatory agencies. CROs with regional offices offer increased access to local patient populations and cultural knowledge. These make them a valuable ally in shortening the study startup phase and help ensure trial success. By leveraging locally based knowledge through CRO employees, sponsors can improve enrollment and site activation time.
- Experts in Risk Based Monitoring (RBM): If implemented correctly, RBM is a way to reduce the costs of traditional, entirely on-site monitoring program. Experienced CROs who specialize in RBM can offer cost savings and innovation by developing an appropriate risk-management strategy for each study in question. RBM consultants should be skilled in identifying the risks associated with specific trials and provide tailored risk management plans accordingly.
The cloud has changed the way we collaborate and share information. For most industries, it has changed the way they do business. Even though adoption lags other industries, we can expect to see changes coming as cloud computing becomes the next frontier in driving down the cost of clinical research. Sponsors and CROs alike suffer from using disparate tools installed on-premise that require data and knowledge sharing via file exchange or other costly, error-prone means. While subject matter expertise, relationships, and qualifications will always be critical for CRO selection, they are simply not sufficient criteria for sponsors who need to make a step change in efficiency. The next competitive battleground for CROs is technology maturity and infrastructure. Embracing this approach will require collaboration between regulatory agencies, sponsors, CROs, academic institutions, and technology companies alike. Such collaborative models will breakdown the traditional boundaries amongst organizations and functional silos, empowering stakeholders, driving process efficiencies and ultimately accelerating the delivery of approved therapies to patients in need.
Article published in Clinical Informatics News, August 2017