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The Next Generation Of Clinical Development

Cyndi Verst, president of clinical operations for QuintilesIMS, invites you to imagine a different kind of clinical trial, where there are limited unknowns and precision and predictability is within reach.

Imagine a new type of clinical trial. One where you start with a clear picture of the relevant patients, physicians, unmet needs, and treat-ment approaches. Know how many patients with a specific condi-tion exist and where to find them. You see what improvements are needed to matter to patients, physicians, regulators and payers. This precision and predictability is within reach – and arriving at a crucial time for a biopharmaceutical industry facing a tipping point.

The current challenges are well-known. The cost to develop a new drug now exceeds $2.5bn, and two-thirds of drugs launched fail to meet pre-launch expectations their first year in the market. Almost 80% of trials are delayed, mainly due to slow enrollment, and a month’s delay can result in potential lost sales in the millions of dollars. And the demand for patients and trial sites is increasing as the number of global trials grows.

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As a partner to life science companies, we have been working with our clients to develop solutions to address these challeng-es. However, in order to truly transform clinical development, a different approach is required.

This new approach requires reframing how we think about evi-dence development. It starts with a foundation of real-world data to understand the unknowns that often derail clinical trial efficiency. By successfully integrating this data with detailed, fit-for-purpose analytics, technology, and scientific and therapeutic expertise, researchers can address these unknowns as they emerge during development. Biopharmaceutical companies can then better predict and position a product from discovery to commercialization.

CONVERTING DATA TO INSIGHTS TO ENABLE SMARTER DECISIONSThis clinical development transformation is not about ‘big data’ but instead ‘smart data’ resulting in meaningful insights. QuintilesIMS distinctly creates those data linkages and relationships to help our clients make the right decisions for their research program. We leverage and integrate disparate sources of data with our deep therapeutic and scientific expertise, proprietary technol-ogy tools and more than 30 years of clinical trial experience to help our clients advance their clinical outcomes and commercial performance.

We start by working with our clients to determine what evidence can best inform their decision-making and whether data are avail-able or need to be created. To truly understand what is happening to patients across care settings, clients often need insights that re-quire thoughtful integration of information from multiple sources, including prospective studies.

We can analyze data from numerous types of data across the healthcare continuum including patient registries, clinical out-comes assessments, pharmacy and medical claims, hospital data, prospective studies, consumer data, social media and wearable devices. By looking at broad cohorts of patients or selected patient groups or settings, clients have both a macro perspec-tive of trends complemented by micro-level detail to make more informed decisions. And the applications are broad. Optimize protocol design. Select sites with eligible patients. Recruit targeted patients quickly.

When these disparate data assets are brought together to sup-port clinical development and commercialization, a new con-struct for more precise and predictable development becomes clearer. Most, if not all, of the tools and data exist. When used effectively they can provide greater predictability, accelerate timelines and speed drugs to market to maximize the value of the treatment asset.

CASE STUDY: FINDING THE RIGHT SITES WITH THE RIGHT PATIENTSAccording to a recent Tufts CSDD report, about 50% of sites miss recruitment targets and many fail to recruit a single patient. If the goal is to reduce these failure rates in clinical trials, how should biopharma companies proceed? By harnessing a range of clinical

and real-world data sources as well as using predictive analytics and machine learning to analyze trends. Leveraging these data sources and capabilities will allow companies to proactively iden-tify the sites and locations that are most likely to succeed in their recruiting efforts, based on past performance and patient access.

We recently helped a client improve their recruitment rates by build-ing an investigator “heat map,” using prescription and diagnosis data as well as detailed analytics that uncovered research naïve physicians. We then deployed clinical research associates to work with the investiga-tors to engage these research naïve physicians through the use of referral networks. Creating this map of investigators and referral networks helped our client take advantage of untapped patient populations and clinical experts in a crowded and competitive research marketplace.

BETTER, FASTER, MORE EFFECTIVEThe past decades have proven the utility of appropriately curated data in improving efficiency and efficacy in clinical development and market access. When companies have the access and capabil-ity to analyze big data or work with partners who can provide this expertise, they can gain efficiencies, enhance research efforts and develop more targeted endpoint strategies. These steps can trans-late to better, faster and more effective trials.

We are passionate about sharing our capabilities to help our clients in this pursuit and create the solutions that can help them drive healthcare forward for the patients they ultimately serve.

Cyndi Verst

We start by working with our clients to determine what evidence can best inform their decision-making and whether needed data are available or need to be created.