Partnering for Performance

A survey produced by Health Industry Insights, an IDC company, and sponsored by Parexel, reported that the top three most important performance metrics for biopharmaceutical companies in working with clinical research organizations (CROs) on clinical studies are meeting milestones, keeping the project on time, and keeping the project on budget.

Joshua Schultz

These conclusions are reinforced in a Tufts Center for the Study of Drug Development survey conducted for the Association of Clinical Research Organizations (ACRO): High CRO usage projects are submitted more than 30 days closer to their projected submission date than are low CRO usage projects. The study found that in addition to completing projects faster with extensive use of CROs, sponsors maintained a comparable level of quality.

This ability of global contract service providers to provide efficiencies is not a new concept. Parexel, for example, broke new ground in the early 1980s by conceiving of a highly complex, multidisciplinary, and systems-oriented approach to outsourced clinical development, bringing efficiencies, speed, scalability, and standardization to the process. It is now widely recognized that global service providers can provide a full range of services to efficiently and cost-effectively manage the clinical development process.

There are myriad examples of how CROs have made the biopharmaceutical product development process more efficient and effective for clients, helping to successfully develop and commercialize products for international markets. For instance, Parexel's experts recruited patients 10 months ahead of plan by rapidly initiating a Phase III oncology study in 22 countries, which was supported by an interactive voice response system (IVRS) in multiple languages. In another project, the Company's late-phase study team managed an expanded access program for a global pharmaceutical company involving centralized management of more than 3000 investigator sites across 75 countries, enabling 32,000 patients to receive a beneficial new cancer treatment quickly.

Extending global reach

As clinical trials have expanded in number and complexity, more patients are required. Biopharmaceutical companies are developing and commercializing products for more international markets, further driving the need to conduct clinical trials throughout the world. China, India, and Latin America continue to be high priority locations to conduct studies.

Companies must look to service providers to provide an essential set of capabilities, including a global platform. The partner must operate on a truly integrated and global scale, streamlining management of projects for clients around the world, and provide a wide array of geographic locations in which to conduct projects. The service provider must have the local and global expertise required. With established global procedures and a dedication to highest quality standards, combined with therapeutic expertise, regulatory knowledge, and services that are integrated worldwide, companies benefit from a partner's access to patients across geographies and from accelerated study timelines.

Harnessing technology assets

Biopharmaceutical companies can improve the performance of clinical development programs with leading-edge technologies and the clinical knowledge that some service providers bring to bear. These technologies can decrease the time and cost of clinical development while bringing increased quality and efficiencies to clinical trial management.

Data-driven patient recruitment is one key area of technology advancement. The challenge of finding enough patients has continued to grow and now impacts the majority of clinical trials. The ability to utilize tools for more accurate last-patient-in (LPI) predictions is becoming a critical component to any successful program. When incorporated early enough, predictive tools can relieve the patient recruitment bottleneck, helping sponsors reduce costs involved in bringing new products to market faster.

Biopharmaceutical companies should look to service providers for the right combination of expertise and technology along with the global recruitment capabilities to help them make substantial improvements in the speed and predictability of their recruitment milestones. Outside experts can leverage technology and data assets based on experience conducting studies across a wide range of countries and indications.

The industry can take advantage of data-driven patient recruitment capabilities to identify potential high-performing investigators, use tools to better plan for recruitment based upon known factors, and to incorporate contingency-based escalation into recruitment planning. It is important that with the use of such technologies companies establish organizationally integrated groups that drive recruitment.

Patient recruitment estimates can be refined through the use of modeling tools, investigator-specific performance data, and site-level patient data. The use of sophisticated recruitment modeling tools is replacing reliance upon straight-line estimates of recruitment that have been traditionally used. Combining more precise modeling, enabled by widely available technologies, with improved recruitment rate estimates allows for further improvements.

Overall, sponsors can benefit by partnering with contract service providers to take a strategic approach to patient recruitment execution to reduce costs and bring new products to market faster.

Electronic advances

As biopharmaceutical companies face further globalization of clinical trials and manage increasingly complex studies, they must be able to access more comprehensive and integrated information throughout the clinical development process. The use of Electronic Data Capture (EDC) and standards, another area of technology advancement, can enable more effective information flow across various functions and organizations involved in executing clinical studies and development medical products. Ultimately this will encourage new models for designing and running clinical studies. Companies that are facile in deploying and using EDC globally will increasingly have an edge.

While the industry continues to focus on EDC implementation, EDC must be viewed as more than just a different way of capturing patient data and instead as one component of a total eClinical solution to help companies realize significant improvements in efficiency and data quality in clinical trials.

A goal is to reap the tremendous benefits that can be derived from an eClinical solution, which is critical knowledge management for biopharmaceutical drug development. Companies will need to focus on an overall eClinical solution, allowing for interchangeability and interconnectivity of data among standard components, such as Clinical Trial Management Systems (CTMS), IVRS, medical imaging, and EDC.

Biopharmaceutical companies should look to outside technology providers to integrate new and existing systems and other core eClinical technologies into their infrastructure. Bringing data together will create a broader picture of the trial and result in improving quality, safety, and decision-making.

Tapping into expertise

The Health Industry Insights survey results indicate that companies are confident in the talent resident in their service providers. As many biopharmaceutical companies continue to focus their core efforts on discovery, it is expected that the industry will develop even stronger and more strategic relationships with their outsourced partners to provide even greater efficiencies, a deeper portfolio of offerings, and extensive levels of expertise. According to the 2005 Thomson CenterWatch Vendor & Outsourcing Survey, 63% of companies outsource at least part of their clinical research to access expertise that is not a core competency.

It is apparent that study sponsors have increasingly relied on the expertise of their service providers. For example, member companies of ACRO, representing approximately 70% of the total contract services market, contributed 30,000 clinical research personnel to biopharmaceutical industry clinical development in 2004—that's up from 25,439 in 2001, a 5.5% average annual growth rate.

Clinical monitoring, project management, site management, patient and investigator recruitment, data management, biostatistics, bioanalysis, medical affairs, and medical writing should be part of the main stable of clinical research capabilities provided, and study sponsors should look to a partner to provide a full spectrum of capabilities from Phase I to Phase IV. However, in the face of global regulatory and public health mandates that are making drug safety a top priority, sponsors need specialized expertise in taking a proactive approach to pharmacovigilance. This means incorporating safety and risk management at the earliest stages of product development, where it can provide the most benefit, and continuing across all phases of clinical development. Additionally, companies need expertise in anticipating postmarketing commitments and preparing to meet them.

To implement an effective pharmacovigilance program, a foundation of safety risk must be established early on and managed closely throughout the entire drug lifecycle. Sponsors should work with partners to evolve their business models and take a strategic approach to pharmacovigilance. This includes assessing pharmacovigilance efforts, creating a lifecycle pharmacovigilance strategy, defining a company's risk profile and developing a risk management plan, and conducting due diligence. With the need for this specialized expertise and capabilities, many companies are choosing to outsource the implementation of their pharmacovigilance systems and operations, ranging from a project to a function or even an entire department.

This type of outsourcing, tapping more deeply into expertise provided by contract service partners, is expected to grow. Some analysts believe clinical drug development outsourcing is approximately a $15 billion industry that is growing about 12% per year. That rate could be driven higher as service providers provide more solutions to the challenges facing biopharmaceutical companies.

As more significant therapeutic and life-saving advancements are generated, the global service provider role will become more critical in assisting biopharmaceutical companies with development of safe and effective treatments for patients worldwide. The contract services sector will bring more expertise and innovation, continuing to benefit the biopharmaceutical industry in driving clinical development performance.

Joshua Schultz is vice president of clinical research services at Parexel, 200 West Street, Waltham, MA 02451-1163, email: Joshua.Schultz@PAREXEL.com