The norms and mandates governing clinical trials are highly convoluted. After passing through multiple radars, a successful trial vouches the efficacy of medical devices or drugs that detect, diagnose, nourish, and treat. Strict mandates, geopolitical regulations etc. are therefore, obligatory across the trial process. To complicate it further, each organization follows its own standards while conducting the study. So, to simplify the diversity, stakeholders involved in the trial process formed industry consortiums that establish common standards for clinical trials. Standards alone, however, do not yield effort optimization. It requires a fully functional metadata repository (MDR) to connect all sources of truth across systems and enable reusability to make the standardization efforts a success. In this blog article, we will learn about the two broad challenges faced by the industry, and how a well-constructed MDR can tackle those.
Standards and version updates
Multiple initiatives by enterprises have resulted in the creation of various standards which are siloed and incoherent. They are maintained and published separately, for instance, Clinical Data Acquisition Standards Harmonization (CDASH) for source collection, Study Data Tabulation Model (SDTM) for submission data, Analysis Data Model (ADaM) for data analysis and so on. The versioning of each of these standards is unsynchronized which is worrisome since they are interlinked. For example, a new version of CDASH potentially may have a significant impact on SDTM. Analyzing updates at study level is tedious and time-consuming, therefore detrimental when the objective is timely delivery. With every new release, variations in standards complicate matters where decisions about inclusion or exclusion of items in the new release are to be taken. Version upgrading is a time-consuming and labor-intensive process which involves a lot of cross-functional stakeholders. In such cases, technology can help reduce the effort by providing user-friendly comparison reports and quickly resolve the versioning issues.
Reusability and Governance
The second key challenge faced in standardization is its reusability and governance aspect. Two drivers that would sustain and prolong the usage of standards are the scope of automation in reusing the standards and setting up studies faster and deploying a robust governance framework.
Standards implementation requires equal support from all users. Users typically exhibit reluctance or are complacent in using standards due to not paying attention to the frequent updates. Consequently, if the workflow and governance processes are not streamlined, maintaining standards would be cumbersome with every user deviating and carrying out their own activities.
So how does MDR help?
Let us look at a few ways how MDR helps in overcoming the standardization challenges:
A robust governance mechanism makes available all the necessary data points to the applicable owners for them to take informed decisions on whether to accept or reject a change.
Metadata standardization is one of the most required, in-demand, and popular initiatives to be undertaken, but it would lose its transformational impact if we are unable to realize its optimal value, something that the MDR can help us with. A well-designed functional MDR can overcome the existing challenges by not only centralizing metadata management but also facilitating automation and impact analysis. This foundation will enable the implementation of advanced techniques, like artificial intelligence, to identify related processes and enable rapid study setup.