SCDM 2023 – patient-centricity in clinical data management
By Bruce Hellman
Chief Patient Officer and Co-Founder of uMotif
San Diego played host to 2023’s Society of Clinical Data Managers (SDCM) 25th anniversary conference. Billed as a Festival of Data Science, I was delighted to attend with over 1,000 professionals from across the world and to take part in two panel discussions.
The conference always generates interesting debate and insightful meetings, and this year was no exception I was particularly excited to catch up with clients and partners, all of whom are focused on and committed to a bright future for global clinical trials.
So what did I learn from SCDM 2023?
Quite rightly, patients are at the centre
It was wonderful to experience so many sessions and conversations that focused on patient centricity. It would be all too easy for a conference on clinical data to focus only on the data itself. Instead, the need for greater patient centricity and a desire to deliver a better experience for trial participants resonated strongly.
I was honored to take part in two panel discussions. One session focused on Decentralised Clinical Trials, chaired by Garun Yadav (Syneos) along with Brooks Fowler (Abbvie), Shobit Shrotriya (Accenture). The panel highlighted some practical ways to design tech around patients, sharing a mix of personal stories and learning from across the industry. The other, led by Debu Baruah and Arshad Mohammed (GSK), involved Zabir Macci (IQVIA), Joby John (Sitero) and myself to discuss the potential for a ‘super app’ to bring together a wide range of services and solutions for a clinical trial. With some great questions from the audience, I was again really pleased to hear the importance of patient centricity in driving the future, along with the need for data quality and validity.
AI approaches, but cautiously
There was also a lot of discussion about artificial intelligence (AI) and how it can best be leveraged to help deliver better, faster and more cost-effective data trials. There are some exciting use-cases in our industry with near-term application, such as speeding up medical coding. There was also understandable caution related to the ‘black box’ nature of AI’s decisions and processes, and concern that training data sets could be too limited in their breadth and depth – the factors continue to present challenges around the strict validation and GCP requirements for clinical trials.
This is an exciting area, and one where the pace of change will likely continue to increase – with the next three-to-five years likely to bring rapid development and change.
Site burden is high, and tech integrations are required
A number of sessions discussed the significant burden on sites, related to juggling multiple technology platforms to support trials. Most sites are leveraging and managing upwards of a dozen technology systems on each study. This reality makes life very difficult for site professionals who often work across multiple studies. In addition to system proliferation, there’s an increasing drive to capture data directly into systems (Direct Data Capture, or eSource), rather than traditional paper source data being transcribed into an EDC (Electronic Data Capture) system. While 60% – 70% of trial data comes from outside the EDC, that sites’ processes and systems are still largely based on paper-based sources, which may limit some uptake of eSource.
A resounding message emerging from the sessions was that sites’ lives need to be made easier. I’m excited about how technical integrations and Single Sign On approaches could reduce site burden – for example, through our work with Syneos and StudyKIK.
After a few great days in San Diego I’m very much looking forward to next year’s conference in Boston!