How—and Why—the Role of Clinical Data Manager is Changing
Clinical trials are becoming increasingly complex. New data collection technologies, data visualization tools, and the COVID-19 pandemic have all impacted the way trials are conducted. As these changes disrupt the industry, the data management profession continues to evolve.
We spoke to Monica Pimazzoni, Director of Clinical Data Management of CROS NT, an Alira Health company, about what the future holds for data managers.
How has the COVID-19 pandemic changed data collection in clinical trials and the life of data managers?
The COVID-19 pandemic changed the way we were running clinical trials, notably: no or very few contacts with the sites and no possibility for CRAs to have onsite visits. As a result, we realized we did not have processes or tools in place to allow us to do a proper data oversight remotely.
We had to quickly implement changes to the eCRF to allow telephone visits, adjust validation checks to allow wider time windows, capture additional data to justify missing visits or missing examinations when the patient had a telephone interview instead of an on-site visit, and re-think protocol deviations possibly caused by the pandemic. And we had to be flexible and fast in implementing all these changes!
At the same time, we also had to investigate the recommendations and guidance from different regulatory bodies, like EMA and FDA, and implement their recommendations on how to manage pandemic challenges for clinical trials.
What are the biggest challenges that data managers currently face?
The biggest challenges data managers face is the evolution of technology and being involved in studies that do not fall under the traditional classification of clinical trials.
Today there are more and more decentralized trials that require new technology, such as tools based on artificial intelligence and tools to support to Real World Evidence.
A data manager is now exposed a variety of different scenarios, and this requires a broader range of competencies, and understanding different needs and requirements in terms of data collection or data retrieval. It is a cultural change within the industry and data managers will have to adapt and evolve to stay up to date with the new generation of data collection methodologies.
How is the relationship between data managers and technology evolving?
I would define data managers as ambassadors of technology. We need to be up to date with the new ways to run studies—we need the right knowledge and competencies to drive study teams in implementing new technologies. Sometimes this means taking a risk to adopt innovative, but not yet well-known solutions that could bring about new opportunities.
What are the main technologies shaping data manager work?
In addition to EDC technology that is a standard for most studies, there is increasingly more need for integration with different tools like RTMS, eCOA/ePRO patient apps, and smartphones to communicate with patients and collect data, as well as data visualization with advanced analytics.
A data manager is exposed to all of that technology daily. We need to understand the requirements for electronic randomization, triggers for drug re-supplies, drug thresholds, and, when dealing with questionnaires, all the implications with licenses, translations, and requirements for Full Linguistic Validation. This is above and beyond the traditional data manager skills of dealing with clinical data, queries, and coding.
How does the new trend of decentralized clinical trials impact data managers?
The COVID-19 pandemic has significantly increased the implementation of decentralized clinical trials, with more activities conducted remotely and in the homes of participants. This has dramatically changed the way data managers operate, moving from traditional EDC data management processes and collection tools to more innovative, technology-driven solutions that better respond to the decentralized needs of clinical studies.
Now, whether decentralized clinical studies will become the new normal is difficult to say. The interpersonal contact and interactions of patients with the site is an important aspect and that can be the reason the patient stays engaged and committed to the clinical trial. There are many other aspects of decentralized clinical trials to consider as well, like required changes in regulations, in hospital procedures, in company organizations, to name just a few. They will all be impacted and will have to be resilient as the industry evolves.
What are the main skills data managers need to adapt to this new reality?
- Overall investment in understanding leading-edge technology and ability to identify, propose, and adopt new tools and solutions to better support research and trials
- Flexibility to adapt to a rapidly evolving environment
- Open-mindedness that embraces new ways of working
How do you think the role of data managers will evolve in the next 2–5 years?
I believe data managers will acquire a very different skillset. We will become more technology driven, with more exposure to innovative solutions that can capture patient’s data like wearable devices and electronic health records. And, thanks to advanced analytics and data visualizations, there will also be new ways to look at this data. A data manager will need a scientific background combined with technology and informatics—even more so than today. This will allow them to connect clinical and research environments and requirements with technology solutions to meet the needs of sponsors—and most importantly—patients.
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