Getting a new product to market is expensive. There are a variety of studies and research that point to a wide array of costs, but generally speaking, it costs nearly $3 billion dollars to bring a new drug to market. Yes, you read that correctly. Beyond this, the success rate of a new compound to make it all the way through the development process and to approval is only 12%. The current model is fraught with inefficiency and unnecessary administrative burdens.
Embracing a model that reimagines clinical trials is critical to drive cost savings. To direct true savings, this model needs to rethink many current practices from the bottom up. In particular, sponsors need to stop perpetuating outdated practices and redesign processes around modern technologies and approaches.
- Safety issues
- A lack of efficacy
- No further funding
- Failure to follow FDA guidelines
- Problems with study groups
With this in mind, what can sponsors do to be smarter with spending their finite research and development dollars?
Stop Forcing Unnecessary and Expensive Technology on Sites
Many research sites have already embraced technology to run studies and collect data. Sponsors can use this technology to review and monitor the data that is already being collected. However, many sponsors spend countless hours and massive amounts of money on third-party tools that require sites to re-enter data they’ve already collected. In fact, site users are the only users in the entire research process that have no say on the technology they use in their day to day job.
Stop Applying Outdated and Redundant Processes
Today, processes that have been in place for nearly 30 years are still being applied in trials. However, many sites already have solutions in place that make these processes completely unnecessary. Electronic data capture (EDC) systems are traditionally developed and programmed by data managers. However, they tend to be disconnected from the clinical needs of the sites. Data managers are primarily focused on the needs of backend data submission requirements. As a result, tools and technologies, which are not natively known and understood, are forced upon sites. Most sites, who often work on dozens of research studies at a time, now have to learn and manage countless sponsor-provided third-party data collection tools.
What Does this Antiquated Approach Mean for Sites?
- Initial collection of protocol required data is done on paper or other site based systems/solutions
- Transcription into sponsor mandated systems is required of the sites. Sites typically employ resources who simply enter this data into EDC systems weeks after the patient interaction
- Reviewing and responding to queries which are generally related to transcription and avoidable data entry issues
- Hosting and managing sponsor/CRO trial monitors who largely focus on carrying out Source Data Verification (SDV) as a large part of their visit, as opposed to being focused on meaningful aspects of protocol compliance.
How Can You be Smarter with your R&D Dollars?
What if you could tap into a network of nearly 2,000 research sites that are already technology enabled, patient-driven, quality minded, and leaders in diversity, equity and inclusion? And, better yet, what if you could harness the data that these sites are already collecting without requiring an additional data collection tool?
Using CRIO, sponsors and CROs can define the study-specific eSource templates that are derived directly from the protocol and ordered in accordance with the schedule of assessments. These CRIO eSource templates form the basis of what is then pushed out to sites (both pre-existing and new CRIO users) for use in collecting protocol compliant data. Beyond this, sites are still able to create and include their OWN site specific procedures in addition to what is being provided by the sponsor.
This approach ensures a protocol compliant collection of data at the time of the patient encounter. In-form validation checks interrogate the data at the time of entry. This leads to better quality, fewer post entry queries, enhanced protocol compliance and a host of process efficiencies. Now sites can focus on the critical aspects of the trial such as recruitment, retention, patient follow up, and study drug accountability.
CRIO Sites Perform Better
With 2,000 sites using CRIO eSource across 4,500 active protocols, there is a large database to quantify the impact of CRIO on site performance. Our case studies and quantitative research prove that sites can reduce protocol deviations by 40% and lower the risk of a negative FDA audit finding by 70% when using CRIO. In addition, we have demonstrated that sites that use CRIO outperform non-CRIO sites in enrollment in 2 out of 3 trials, with a median outperformance of 40%. And finally, across the entire CRIO site network, we are observing racial diversity that is twice the industry average.’
Data Review and Management
CRIO’s system automatically sends site eSource data directly into a sponsor-facing application called CRIO Reviewer EDC. This enables the clinical team to review data remotely. With built-in edit checks at time of capture, the data is more likely to enter the system accurately and completely. Because the eSource is now effectively the same as the eCRF data, traditional onsite monitoring or source data verification is eliminated.
Within this framework, sponsors and CROs should embrace a centralized clinical data monitoring approach. This provides for a single primary workflow for clinical oversight and review of data as it comes in. In this workflow, monitoring teams can:
- review data
- issue and close queries
- track source data changes
- lock data
- and medically code verbatim terms
A streamlined approach for data review and management eliminates the need for further redundant data review. The figure below depicts how the traditional five workflows can be reimagined into only two.
In summary, applying a reimagined approach to managing clinical trials should be a core part of your overall R&D strategy. Take advantage of systems and tools that are already in place within your research sites. This is often the simplest and most efficient path to success. It is counterproductive to force redundant tools onto sites simply “because it’s always been done that way.” It is also expensive, both in terms of direct billing from your CRO and lost productivity of your sites. CRIO’s dual approach to addressing the needs of sites and sponsors creates value for both stakeholders. It reduces the number of redundant and administratively burdensome systems forced on sites. This ultimately drives cost and time efficiencies for sponsors.