Clinical Trials the IT Way

Clinical trials often get delayed by as long as six months, and these delays can impact new product introduction and potentially hamper overall profitability. Each year, drug companies sponsor hundreds of clinical trials. While the cost of a new approved drug can easily exceed $800 million, the number of new drug approvals over the years does not commensurate with research and development (R&D) spending. Such declining R&D efficiency and expenditures could have been mitigated sooner through early termination of any trial that will eventually fail. Therefore, drug makers are determined to find new ways to improve their odds for success, including identifying potential "failures" earlier in the clinical trial process while maximizing opportunities for more promising drug candidates. In addition, research has also shown that significant costs savings could be achieved with shortened development cycles.

Managing Clinical Trials in Asia

With Asia fast becoming a favored destination for clinical trials, recruiting patients within tight timelines often poses a sizable challenge due to the added complexity of dealing with multiple countries, languages and regulatory compliance requirements; larger population bases of investigators and subjects across multiple sites; and lax enforcement of intellectual property (IP) laws. To illustrate, while confidentiality agreements are binding in the West, a global pharmaceutical company engaging trials through its clinical research organization (CRO) in Asian cities might find it difficult to enforce strict confidentiality with respect to its new drug formula. IP rights enforcement is simply inconsistent across Asia today.

On a day-to-day basis, clinical trials are still laden with manual processes and inefficiencies. In Asia, although there are benefits from relatively low cost of administering clinical trials and data analysis, much valuable time is wasted on labor-intensive tasks such as tracking study documents and maintaining contact interaction records, thus causing version control problems with repetitive data entry of the same information into multiple systems. These factors adversely impact the quality of research and data derived from each clinical trial, reinforcing the importance of releasing clinical trial information to the right people, at the right time and with the right level of detail.

Without the right decision support systems and key performance indicators in place, the overall costs for managing clinical trials rise when clinical users and administrators are unable to spot problems early and take corrective actions sooner. This is exacerbated by an increasing need for real-time information over multiple channels to different parties.

Effective Clinical Trial Management

Information technology (IT) plays a crucial role in managing clinical trials. To improve clinical R&D efficiency, life sciences companies can use IT to effectively tackle project management, document tracking, budget tracking, payment management, patient monitoring, contract management and forecasting and reporting systems. Essentially, IT can enable effective clinical trial management by streamlining the entire clinical trial process and addressing delays in clinical trials. Key features needed for an effective clinical trial management system include:

• Project and resource management tools that drive resource optimization and facilitate planning, budgeting and tracking of all trial-related tasks and activities, including tracking of actual versus planned progress.
• Study management tools that support site visit scheduling, protocol updating and version tracking, and that also enforce adherence to established protocols.
• Trial status reporting tools that provide real-time trial status tracking and reporting, subject status tracking and analysis of subject enrollment rate.
• Investigator and site management tools that provide site and investigator profiling, site personnel tracking and document tracking. That also enables investigators to maintain both private and shared notes.
• Investigator and subject recruitment tools that track investigator qualifications and specialties; support investigator and subject recruitment campaigns through the Web, email and mail; and maintain investigator and subject qualification scripts.
• Payment generation and management tools that create, monitor and track trialrelated payment activities and allow investigators to determine payment status, and that also integrate easily with existing back-office payment systems.
• Clinical research associate (CRA) productivity tools that automate and simplify CRA activities such as site initiation, monitoring, evaluation and closeout visits; entering and tracking open issues and follow-up items; and communication with tools such as autocorrespondence, mail merge, email blast and quick search.

Improving Outcomes in Clinical Trials

In Asia, market heterogeneity gives rise to challenges and compliance needs that are unique to certain markets. Given the genetically diverse population, many have not received medication to treat their ailments, including chronic conditions. This presents a large potential patient base that pharmaceutical companies can leverage on to assess the potential success of new drugs. More Asians are open to participating in clinical trials since the trials provide access to medication and care that would otherwise be beyond their financial reach. In addition, an effective clinical trial management system should also provide a multi-channel, investigator focused support for global trials and support for diverse regulatory compliance needs.

• Multi-channel, investigator-focused interaction Creating and maintaining close relationships with investigators is critical to success. Regardless of the communication channels, effective interaction between investigators and the trial sponsor or CRO can increase successful patient/subject recruitment and patient management, thereby resulting in improved investigator and patient satisfaction.
• Support global trials Due to their rapidly increasing appetite for trial subjects, companies can no longer limit trials to subjects in their own countries. They need to conduct global trials in multiple countries simultaneously. As a result, the clinical trial management solution should support multiple languages, multiple currencies and multiple time zones as well as coordination of trials at various levels, including global, regional, national and site.
• Support regulatory compliance A major requirement for successful trial outcome is rigid compliance with government regulations, such as 21 CFR 11. The solution should permit tracking and auditing of all trial information relevant to regulations to ensure and demonstrate compliance. The solution should permit access to auditing information by independent parties. All regulatory information must be secured so that only authorized people can access it.

Reaping Benefits from a Clinical Trial Management System

Some of the acknowledged results of IT enabled trial management include:

• Reduced site initiation time from 12 to 10 weeks. With the accessibility of past performance data of the site and site personnel, and by streamlining the initiation activities, project managers can achieve accelerated site initiation.
• Reduced subject enrollment time from 25 to 30, to 16 weeks. Multi-channel campaigning creates awareness across the patient population and helps enhance trial perception and image. Site monitors gain critical visibility to effectively gauge and make proactive decisions, and address delays in patient recruitment.
• Reduced CRA monitoring effort by 30%, monitoring visits by 10 to 20% and travel expenses by 15% from the sponsor location. The CRA has a comprehensive view of site activities, compliance and enrollment. This reduces the CRA's presence at the site and eventually minimizes trial travel expenditures.
• Reduced man-hours required for investigator payment processing resulting in annual cost savings of at least $500,000. Implementing an automated investigator payment process not only reduces site payment monitoring efforts but also increases investigator satisfaction by providing timely and accurate payments.
• Eliminated payments for missed visits and streamlined payment processes based on completed visits or activities.
• Consolidated real-time view of trial status is reduced from weeks to days and allows for early recognition of progress/quality issues at sites.
• Globally standardized processes and enhanced compliance increase the speed and accuracy of data entry and exchange through Web-based data collection, helping to generate more consistent regulatory reports with the use of templates from reusable library.
• Enables better and timelier decisions based on qualitative estimates.
• Supports improved customer experience for investigators and sites with online access to sponsor and CRO information, study documents, templates, protocol synopsis, agreements and Frequently Asked Questions (FAQs).

Conclusion

Clinical trials consume a considerable portion of R&D time, effort and money. With its varied mix of demographic and ethnic compositions plus wider availability of advanced infrastructure and technology in some locations, Asia represents an ideal clinical trials test-bed. Accordingly, it is attracting a growing concentration of clinical trials. With the large available pool of qualified investigators and subjects, the time is especially right to reap the benefits of IT-enabled clinical trial management in Asia.

The use of IT in the trial management process will ensure efficient utilization of these resources, effective campaigns to drive the right subjects for specific clinical trials, as well as organized and objective measurement of outcomes from engaging the investigators and subjects. In the long run, drug trial sponsors and CROs can experience improved operational R&D efficiencies and clinical trial outcomes, leading to immense returns via better products and boosted profitability for drug makers.