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Elizabeth Rickenbacher, PhD, Director of Strategy for 4G Clinical discusses changes in the IRT and RTSM solutions.
Elizabeth Rickenbacher, PhD, Director of Strategy for 4G Clinical, has over 15 years of experience in the field of life sciences, and is an eClinical RTSM solutions subject matter expert. In this Q&A, she discusses changes in the IRT and RTSM solutions, their impact on trials during COVID, and the future need for these systems.
Applied Clinical Trials: RTSM (Randomization and Trial Supply Management) can be considered an evolution of traditional IRT (Interactive Response Technology). Is the distinction important?
Elizabeth Rickenbacher: Historically, IRT was used primarily for randomization and getting drugs to the site. Over the years, it became apparent that supply management was just as critical as randomization and the combined action of them together elevates the function of this system. They are synergistic and need to coexist. It also helps to bridge the silos between clinical and supply organizations.
The term RTSM has been around since the advent of IRT technologies, but it refers more to the function of the actual system vs. the modality of delivery (voice, web, mobile, etc).
In that way, RTSM is an evolution of traditional IRT as it more accurately reflects the functions of the technology, and recognizes the importance of the interaction between clinical operations and supply.
ACT: What can we expect of advancements in RTSMs in the next five years?
Rickenbacher: RTSM must continue to evolve to enable new clinical trial designs. Given what we see now, we can expect advancements in RTSMs to handle future iterations of decentralized trial designs, cell and gene therapy trials, digital supply chains as well as much more complexity in terms of adaptive designs, particularly in oncology trials.
From a technical and process point of view, there is a trend toward more self-service components to ease the administrative burden of adapting study parameters such as managing cohorts; enhanced flexibility to the patient level as patient advocacy for their own care continues to increase; as well as functionality to support the protocol designs of tomorrow’s trials.
ACT: How has the COVID-19 pandemic catalyzed a renewed need for RTSMs
Rickenbacher: RTSMs are a necessary technology for clinical trials which are too complex for manual trial management. COVID-19 has not changed that. Rather than catalyzing a renewed need for RTSMs, the pandemic has driven innovation in its functionality, for example, the ability to turn direct-to-patient capabilities on and off as needed within a live trial and enable decentralized trial designs with flexibility for patient choice.
RTSMs that have integrated forecasting capabilities also have helped navigate clinical supply challenges. While clinical supply chains were not disrupted as much as originally feared, agility in the supply chain became a necessity during the pandemic and will continue to be the case moving forward.
ACT: What future clinical trial trends will increase the need for RTSM?
Rickenbacher: While most Phase I trials are healthy volunteer studies that rarely need the support of an RTSM system, RTSMs are being used more frequently in Phase Ib oncology studies in patients. They have adaptive designs to allow the sponsor to follow different avenues of research–different dose levels, different dosing frequencies, different combination therapies, etc. These more intricate protocol designs and additional data and requirements are expected to move to the next phase.
Ultimately, these trials nearly equate to the completion of multiple early phase trials within a single trial. This complex management requires modern RTSM systems for the flexibility to adapt as these trials evolve.
Another example is handling program level supply management, such as ISTs (Investigator Sponsored Trials). The ability to handle these types of trials in an efficient and cost-effective manner has now become possible.
As for future clinical trial trends, as mentioned before, decentralized trials and increased cell and gene therapy trials, as well as anything that is trending towards therapies for personalized medicine, will require very sophisticated RTSMs to support the multi-faceted logistical requirements of manufacturing and complex supply chains, as well as resource planning