Leveraging Clinical Trial Technology: Critical to the Initiative's Success

Those companies involved in eClinical technologies will continue to play an important role in the FDA's Critical Path Initiative. With the safety and efficacy of new medical products being paramount, the technologies available in the clinical space offer faster access to cleaner, more reliable data. These data are crucial as they enable valuable products to more quickly progress from development to the public. They also enable regulatory bodies to make the most informed decisions about new products.

John Cline

In order to spur this initiative, which has the potential to have a great impact on the development and availability of new medical products, many challenges must be met. According to the FDA, the "critical path" to product development contains three key dimensions: assessment of safety, proof of efficacy, and industrialization. Key to driving quicker access to higher quality data to assess safety and efficacy is the adoption of eClinical technologies that streamline the collection and review of data. These include, but are not limited to, electronic data capture, electronic patient reported outcomes (ePRO) tools, interactive voice response, and analytics and reporting tools.

One of the principals guiding the FDA's initiative is collaboration among government, academia, industry, and others. In recent years, collaboration in the industry has swelled with partnerships between organizations like CROs, eClinical vendors, and consulting firms. These partnerships enable the industry to develop the infrastructure required to modernize clinical trial research and create tested methods for collecting, reviewing, and reporting clinical data. To best facilitate this initiative, industry needs to seek out and take advantage of these collaborative opportunities.

The important role of standards

The FDA has also indicated that development of standards will play an important role in the Critical Path Initiative. This is immediately apparent in the submission of trial data to the FDA where standards, like STDM, will be increasingly important. Industry organizations, like CDISC, are collaborating with industry to develop data standards to facilitate the interoperability and submission of clinical data. It is beneficial for technology vendors and others involved in research to work with, not against, standards as they have the powerful ability to unify and create opportunities for better data and safer products.

Technology now available for clinical trial research needs to be better leveraged to reach the goals of the Critical Path Initiative. For example, modeling and simulation tools such as dynamic randomization testing, which researchers can use to quantify the patterns of enrollment to various strata in a clinical trial, can play an important part in accelerating and planning a study population. This is an asset to researchers who seek highly statistically relevant data at the end of a study. These and other tools will help researchers improve the quality of the data they collect.

The Critical Path Initiative calls for trend analysis across trials as well as adaptation of trial design based on gaps in data endpoints and the projection of required information. With the use of data and CRF standards, the application of adaptive trial design becomes possible. Data can be scrutinized as it is collected to identify potential safety issues and correct the situation. The immediate availability of data can also be used as a guide for future trial development. Protocols can be crafted to help researchers collect data to address specific efficacy and safety questions about a product. The clinical trial industry can thrive by offering easy-to-use technology to make data available earlier in the process and in standard formats to enable trend analysis.

Streamlining the process

etrials has focused its efforts on making data collection, review, and reporting easy for sponsors, investigators, monitors, the FDA, and any other organizations that need access to critical data. We work to create fully etrials has focused its efforts on making data collection, review, and reporting easy for sponsors, investigators, integrated technologies that will make it simple to apply any standards that the industry adopts. With the cost of drug and device development skyrocketing, it has become important to seek new methods and technology that will streamline the entire process, from R&D to approval. It is without question that there is a long road ahead to meet the goals of the FDA's initiative. The clinical trial industry has the opportunity to assist in this effort by making it a priority to streamline access to higher quality data resulting in better patient safety and product efficacy.

John Cline, Chief Executive Officer, etrials