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mappings and submissions, can be reused. This facilitates better compliance, more consistent trials, and enhanced integration of data, leading to a greater understanding of drug efficacy and safety. Most organisations will see a return on CMDR investment within just six studies. Another huge benefit is automation. Electronic case report forms (eCRFs), database specifications, annotated CRFs, data transfer specifications and electronic data capture (EDC) systems can all be automatically created from trial metadata within a CMDR like ryze. Users can see and approve eCRF designs in native formats – such as Medidata Rave EDC – within the CMDR. And, with automated difference checking, user acceptance testing becomes more focused and streamlined.
Does clinical trial efficiency offer an opportunity to reduce drug development timescales? If so, how can organisations take advantage of this? The National Institutes of Health recently reported in cancer trials that if drug discovery- to-approval timescales fell to five years, then an additional 523,890 life years would be saved worldwide. We know that patient recruitment is a clear rate determiner in the duration of clinical trials. If we can reduce a 22-week trial set-up to six weeks, that translates to a huge head start for patient recruitment and significant reduction in overall trial duration. On average pre-2000, it took 68 studies to get a drug to market. With faster data insights driving adaptive trials, could this number be decreased? By deploying standards early and governing them within CMDRs, companies avoid potential costs of $1.5m during submission by saving conversion, data analysis, quality checking and pooling work.
We believe some CMDRs allow for visibility of data insights earlier in the trial process. How do they do this and what is the impact? Our CMDR ryze delivers study data tabulation model (SDTM) automation through metadata- driven conversions, producing human-readable specifications and machine-executable mappings which transform data to CDISC formats. This metadata-powered process eliminates
traditional manual specification processes in Excel and double programming of these conversions. Now, SDTM data delivery timelines can be reduced to gain insights faster.
50 | Outsourcing in Clinical Trials Handbook
“By deploying standards early and governing them within CMDRs, companies avoid potential costs of $1.5m during submission.”
We all know when we receive data it will throw up unexpected issues. With a metadata- powered conversion process, daily conversion runs are possible and data anomalies are recognised early on. Mappings can be proactively changed, saving considerable time at submission. A typical study might require 70 mapping changes in a month, yet some of the COVID-19 studies we worked on required 280. Without the automation delivered by ryze, it wouldn’t have been possible to implement these mapping changes, meet tight timescales and deliver vital insights into the efficacy and safety of these vaccines.
Has COVID-19 affected the clinical trial process and do you expect these effects to persist? COVID-19 pushed our industry to accelerate the delivery of life-saving medicines to market. The fastest any vaccine had previously been developed, from viral sampling to approval, was four years, for mumps in the 1960s. From seeking a COVID vaccine in early 2020 to approval in December 2020, the pressure exerted by the pandemic refined clinical trials and slashed the previous best four-year time frame to get an injectable to market in under 12 months. ryze enabled sponsors to develop and visualise data collection forms, set up studies quicker and transform data to CDISC formats at record-breaking speeds. We have shown advanced CMDRs deliver real and lasting benefits for patients, and we can’t go back to the way things were. COVID-19 will have a lasting effect since research and development budgets for the pandemic were inevitably borrowed from elsewhere. What will the impact on clinical trial spend for key therapeutic areas such as oncology, neurology and cardiology be? Clinical research in all therapeutic areas must continue. It will still be possible to do this with reduced funds by running faster, more efficient and cost-effective trials. The technology used in COVID-19 trials will fuel this.
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