Declining R&D productivity, soaring product development costs, growing complexity of trial protocols, and rising regulatory submissions are prompting pharmaceutical, biotechnology and medical device companies to outsource research services.
In fact, a study by Frost & Sullivan forecasts that the size of the global CRO market will expand at a compound annual growth rate (CAGR) of 12.4%, to $57bn, by 2020. The future of contract research organizations (CROs) thus certainly look promising. To capitalize on this business opportunity and deliver enhanced value to your sponsors, CROs need to incorporate certain ongoing changes in the research studies.
First, the number of end points, eligibility criteria and procedures concerning Phase II/III studies has increased notably since 2002. Second, trials today involve a growing number of countries and investigative sites, and hence must incorporate changes in protocol design to capture data pertaining to health technology assessment. Third, the scope of research studies is expanding, with most new drugs being approved linked to speciality or complex indications such as autoimmune diseases that entail in-depth knowledge of sites and investigators.
Delivering more value for sponsors
All these dynamics require CROs to reimagine their trial execution approaches, considering that the average per-drug product lifecycle costs, including trial expenses, has now raised to a whopping $2.9bn. And, the need to innovate around trial design and execution will only grow as sponsors place more emphasis on collaborative studies, personalization, real-world evidences, and new technologies like wearables and social media.
Here are three ways you can improve the effectiveness and efficiency of clinical trials, and thereby help your clients realize increased return on investment (ROI):
1. Explore innovative trial designs: Experiment with adaptive and enrichment designs such as sequential parallel comparison design (SPCD) to substantially reduce the impact of the placebo effect in trials, for example, in neuroscience indications.
You could also look at trying out a model-based drug development approach, which will provide a quantitative rationale for trial design, dose selection and decisions during study execution, thus improving the efficiency of clinical development. Some CROs have already set up in-house quantitative clinical development groups to harness mathematical models for analyzing the relationship between drugs, diseases and patients.
Pursuing new design formats will also eventually help your development teams capture the requisite information for securing regulatory approvals.
2. Embrace risk-based monitoring: Adopt risk-based monitoring (RBM) techniques to proactively identify and define study risks, and take appropriate mitigating steps to improve patient safety and data quality. For instance, you could adopt remote data capture technology and clinical trial monitoring systems to track specific data sets for source document verification (SDV). RBM can also come in handy for targeted monitoring to reduce the need for SDV, based on risk evaluation.
By using RBM, you will be able to realize greater trial efficiencies as compared to conventional monitoring strategies, both in terms of cost savings and effective deployment of resources. This could emerge as a critical source of competitive advantage, considering on-site monitoring, which on an average accounts for 25% to 30% of the overall cost of clinical trials.
3. Implement eClinical Suite for Big Data management: Roll out next-generation, cloud-based clinical trial management systems for robust integration of data from diverse internal and external sources, and provisioning of on-demand, real-time access to relevant data. In conjunction, deliver web-based, device-agnostic tools that sponsors can use to swiftly extract vital trial information from mass data sets, and take timely, informed decisions to reduce costs and cycle time.
Implementing such eClinical technologies will also foster greater collaboration across the value chain, improve regulatory compliance, and cost-effective, real-time data management.
Another major benefit will accrue in the form of using these tools to enable in-stream data review and analytics during the course of a trial. As a result, you will be able to better manage the trial lifecycle, resulting in increased operational efficiency, continuous process improvement, and therapeutic advancement.
Contract research is here to stay, and your role in shaping the future prospects of your sponsors will only grow in importance going forward. As drug makers seek to shorten product development lifecycles, satisfy regulatory demands, and contain costs, you can position yourself as a strategic partner by using data-driven insights to make clinical trials more efficient and effective.
In any clinical trial, data is a critical component that can significantly impact the entire project in terms of end-to-end turnaround time, costs, and efficiency. Today, with technological advancements powering clinical data management, it may in fact even have a role in determining the overall success of a project.
For clinical research organizations (CROs) and the broader pharmaceutical industry around the world, drug development remains a complex and costly process spread across multiple sites. Clinical trials form an essential part of this process, lasting many years and costing millions of dollars.
Leading pharma regulators such as the U.S. FDA continue to impose, and enforce, strict compliance standards with regard to approval of new drugs. The U.S. watchdog’s strict vigil means that for every new medical device or drug securing market release, thousands get rejected – cumulatively representing billions of dollars, and years of research.
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