Pat Barrett Vice President Life Sciences, IntegicOne of the most widely discussed and closely examined topics in the pharmaceutical industry today is the growing time and cost required to successfully complete clinical trials with the impact of this trend being most evident in the shortage of new drugs being submitted and approved for distribution. With clinical trials representing typically half of drug development costs as well as the lion’s share of time needed to commercialize new treatments, streamlining the clinical trials process is obviously a major priority for the pharmaceutical industry as every day of delay in bringing new products to market can cost a pharmaceutical firm millions in lost revenue. But, where does a firm start this process?
Having led one of the largest US Contract Research Organizations (CROs) for clinical trials, I can tell you that the first place that we need to look is in the field where the trials are actually being undertaken. There you’ll find an often manual, stovepiped process that has failed to keep pace with the growing size, scope and complexity of today’s clinical trials. With the results of this approach speaking for itself, it is now time for the industry as a whole to overcome its traditional biases and enhance its strategic adoption of technology to streamline, automate and optimize these core business processes.For example, here are some of the everyday issues that trial monitors and project directors face in the field that can be improved upon through the more consistent use of a common platform for managing clinical data throughout the organization:
• Study start-up – do you use a templated approach for initiating a clinical trial that reduces errors while speeding development or must this work be customized to each trial?
• Sites – do you maintain a database on each available site and the success with previous trials in order to better anticipate and avoid challenges?
• Patient enrollment – do you maintain a database on patient enrollment by site and protocol for previous studies?
• Patient management
• CRFs (Case Report Forms) – does your current process prevent unnecessary rework and lost pages by maintaining standardized reporting formats?
• Drug supply/control – does your current process ensure on-time delivery of clinical supplies?• Submissions – will your current process stand up to an audit of previous submissions by the FDA?
The cumulative result of all of these issues is the higher costs and frequent time delays too often associated with clinical trials. Further complicating this situation is the common need to rework data and recruit new participants due to additional breakdowns in the system. Worse yet, you’ll never know it as this situation also prevents information from reaching you that would provide you with the visibility needed to monitor and manage the overall process. The impact of these issues on the pharmaceutical industry’s bottom line is only going to grow over the coming years as the industry changes in a number of ways. The lack of sufficient blockbuster drugs on the horizon and the move toward more targeted drugs will both result in an increased number of trials from the 80,000 annual trials that we see today in the US alone. In addition, the trial process will undergo equally significant changes as we more frequently see treatments showing particular promise during late stage development being aggressively moved into human trials and also brought to market sooner.
As such, we’re faced with a situation where the number and complexity of trials is slated to grow dramatically as is the scrutiny that they are under, which means that it’s time for the industry to adopt new approaches towards the management of clinical trials. For example, more aggressive approaches to clinical trials raises the already high patient safety bar even higher with more comprehensive patient monitoring capabilities now needed to provide an elevated level of checks & balances. Likewise, our deepening dependence on a limited number of trial sites, expanded uses of CROs and growing pursuit of jointly developed treatments means that clear communications, consistent processes, and end-to-end visibility are more difficult to achieve, but more important than ever.Greater and more effective use of technology is crucial to addressing these issues, but more specifically, it’s the appropriate and targeted use of technology that promises to pay big dividends. Historically, the pharmaceutical industry has been somewhat wary of technology with the importance of its work placing an unfettered confidence in paper. However, we’re now in a technological age in which the benefits of its expanded use far outweigh its costs and risks. As organizations like the National Institutes of Health have argued, we’ve taken the current model as far as we can, evidenced by its diminishing returns, and must embrace new approaches to achieve new breakthroughs.
Among the attributes that these new approaches and technologies must encompass are the following:
1. Thorough knowledge of the business process.CROs and pharmaceutical companies are large and dispersed over a wide geographic area. Each individual needs an understanding of where they fit into a business process and the impact that their work has on others in the process. Currently, this is often lacking. However, if a trial management system increases visibility at all levels and can be modified to address current business issues, each individual or department can see the status of current trials and can, therefore, identify issues in a more timely manner.
2. Automated business process management that can be rapidly adapted.Sharing information is key to the success of clinical research. As such, routing appropriate documentation to the right people is imperative, and incorporating the dynamic nature of trial management into the platform provides organizational stability. A system that automates the information sharing process by notifying managers of available reports and metrics eliminates the confusion about “what’s next”.
3. Reports of key metrics.Staff at each level of a clinical trial, from the site coordinators to the trial managers to the senior-level global executives, needs data collected at some stage of a trial. However, as more demands are made on employees’ time, they have less time to sift through information to find what’s relevant to their immediate goals. A global trial management system has the ability to customize reports by user so that individuals can select what information is relevant and receive it via email at predetermined intervals.
4. Automated alerts of key milestones.Today’s offerings in technology for clinical trials should provide a system of automated alerts for every level of management. Whether via email or on a personal “homepage” within the application, busy pharmaceutical executives should have access to easy reminders of upcoming deadlines. We’re currently working with one of the world’s top CROs to develop an end-to-end system encompassing all of these attributes within a single platform that automates daily operations while centralizing control and visibility. Among the significant benefits that they expect to realize are as follows:
• Automating key processes will speed trials and, therefore, time to market.
• Reduced errors, improved data quality and the ability to cross reference findings across studies will increase patient safety.
• Applicable regulations and standards can be incorporated into the software and ensure compliance.
• Approaches to clinical trials management can become more dynamic, so that geographic diversity doesn’t impact the ability to conduct comprehensive trials.
Ultimately, we’re also looking ahead and anticipating additional changes in the marketplace, such as the need to more regularly poll trial data over a longer time period or to source trial participation on a more global basis. In this environment, we both believe that the ability to instantly access a “single version of the truth” from anywhere within the organization is fundamental to the company’s continued growth.
The growing challenges facing the pharmaceutical industry are best understood by those who face them directly and are most able to mitigate them. By more effectively leveraging today’s technology, we can empower these individuals to overcome these seemingly insignificant challenges encountered on a daily basis with the understanding that when multiplied by the 80,000 clinical trials currently underway, these challenges represent the crux of the pharmaceutical industry’s current predicament. However, by streamlining, automating and standardizing the clinical trial process through the more effective, end-to-end use of technology, we can eliminate much of the unnecessary cost and time delays that are slowing and preventing new drugs from reaching the market.