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Applied Clinical Trials
It’s clear that the value clinical trials bring to the health and well being of our existence is being recognized and expectations from the public are high.
The current pressure on sponsors and contract research organizations (CROs) to execute clinical trials quickly and effectively is on the increase, as evidenced by the reaction of the public when the government halted new enrollment and grant acceptance during the government shutdown to the ongoing discussion that Ebola has raised with the Food and Drug Administration incentivizing biopharma companies to invest in treatments. It’s clear that the value clinical trials bring to the health and well being of our existence is being recognized and expectations from the public are high.
Here are my predictions on how these trends and others will impact clinical trial processes in 2015.
Environmental factors and cost surrounding the creation and storage of paper has raised awareness around lessening our reliance on paper, although there is still some level of resistance. The DIA reference model and ETMF framework will give many organizations a place from which to start moving toward fully electronic trials. Furthermore, CROs, pharma companies, and sites are increasingly adopting portals and cloud-based applications to exchange documents in a secure environment, continuing to drive the paperless approach.
Savings from electronic storage
In our study site research, we have found that some larger sites are doing as many as 20 studies simultaneously, but have to pay for storage just to retain study documents in accordance with record retention regulations. These costs can run as high as $1,000 per month. There are some “old school” regulatory departments that maintain that documents should be readily available in a file room, but as these individuals retire, many organizations will begin the transition and go electronic.
Furthermore, guidance from the DIA and the FDA will be critical in facilitating this transition. The FDA has started requiring fully electronic submissions, but this hasn’t yet filtered down to the site level. As documents become managed and stored electronically, sponsors will start to realize average savings of $100k+ per study, and sites will start to reduce expenses related to storing paper documents.
The year for eSignatures
In response to FDA advisories and the increasing use of mobile devices by investigators, the industry will make significant moves to adopt eSignatures. The speed of adoption will depend largely on pharmaceutical companies allowing eSignatures and building them within their processes.
The other key aspect will be training internal staff and sites on how to manage electronic signatures. It won’t just be a matter of implementing the technology, there will be a learning curve as a number of different vendors support this technology and they all look slightly different. As the industry works to identify a solution that will be compliant and universally accepted, this will be widely adopted.
Clinical IT, which increased IT spending for analytics by 51% in 2014 according to Gartner, will continue the trend. This will support the industry's desire to better identify patterns and deviations to improve performance in clinical operations. Organizations have a lot of data, but it’s not in the right places-they don’t have the platforms to garner actionable information out of their data.
Clinical IT will be particularly helpful as organizations utilize analytics in study startup processes. This type of insight will provide current and actionable data on things like document and submissions status, milestone status, country, site, phase, etc. As team members and partners have better data visualizations across multiple trials, they will be better able to quickly identify risk areas.
Sponsors and CROs will follow the software industry and leverage Lean Startup principals to monitor operational performance and make incremental improvements. This will result in reduced costs and improved efficiencies. Sponsors and CROs are actively employing staff with expertise and looking to evaluate and improve the existing processes and incorporating change management principles to effectively roll out streamlined, measurable processes to drive the business of clinical trial start up and execution.
As we move into 2015, it will be critical for CROs and pharmaceutical companies to begin leveraging innovative technologies to aid in their goals to streamline critical trials, and ultimately get life saving drugs to market more quickly.
Sandra Freeman, RN, BSN, is Senior Director of Customer Success at goBalto.