Dear SCDM Friends,

SCDM has had a very busy last few months. The SCDM Annual Conference in Boston brought together our global community to share knowledge not only on vital themes of our industry like RBQM, AI, Regulations, DEI, and the skills and insights from our clinical data professionals, but also brought to center stage the voice of the site and the patients for an opportunity to engage directly and reflect on how we may enhance their journeys in clinical trials through the lens of data.  We also shared our poster, innovation and volunteer awards as well as launching our CCDA exam. I will share further on each of these but first, a special highlight on our half-day academia event at Northeastern University. 

You may not have been aware, but a year ago, in preparation for the SCDM Annual Conference in Boston, Hong Yu, the MS Director of Data Management at Sean M Healey & AMG Center for ALS Neurological Clinical Research Institute, had the brilliant idea to reach out to her colleagues at Northeastern University to see if they would be interested in having some SCDM Board members come to their campus for a spotlight on the Society, careers in clinical data management and the launch of our  Clinical Data Associate certification program. With many disciplines like life sciences, health informatics and computer science commonly feeding into clinical data professional positions, it seemed like an excellent networking fit and Northeastern University agreed. The event was a success with many students in attendance and further participation by students at the conference as well.  You may have spotted their smiling faces as they actively immersed themselves in our content and engaged in conversations! We will be looking to continue this model in future conferences, so watch this space.

Board of Trustees meeting updates 

The September Board meeting was engaging with our new Educational Director, Eva Martin. She joined our SCDM team earlier this year and comes with an amazing background on educational content coordination and deployment. She will be helping to drive forward SCDM’s key educational stream, including roll-out of our new learning experience platform (LXP).

What is LXP?

This will be an AI-driven platform not only to provide a personalized learning journey for the individual but also can be tailored to an employer’s level (assign a curriculum) and as a facilitator of new content support through generative automation.  It sounds good because it is, and I can’t wait to see it rolling out in the year ahead! For now, our Learning Hub continues to evolve as new materials like CDA 101 get mapped onto our competency framework for continued learning content.

We closed with a highlight that the Executive Committee will be meeting in Q1, 2025 to discuss our next three-year focus as we are approaching the end of our latest cycle and welcome: 

• Carol Schaffer into her role as Chair of SCDM in 2025. 
• We also had some Board of Trustee election results, also mentioned at the business meeting at the conference. I am proud to have been re-elected as your SCDM Executive Secretary for 2025. 
• Ward Lemaire will also be joining the Executive Committee as Vice Chair of SCDM.   
• For Board members, Dawn Kaminski has been re-elected for a three-year term, along with Manny Vazquez and Ram Mudaliar.   
• Jonathan Andrus will continue as SCDM’s Treasurer. 
• We wished Arshad a thank you as he moves through his final months of past-chair through the end of 2024. I am sure there will be lots of celebrations of his SCDM tenure at the India event in December, which he plans to attend. Please join me in welcoming our new members to the Board and Executive Committee.   

Thank you to all nominees and Board members for your efforts throughout the year and a special thank you to Patrick Nadolny for chairing SCDM throughout an amazing 2024! 

SCDM Annual Conference

For the SCDM Annual Conference, over 1200 participants were in attendance, and the conference revolved around the patient and site perspectives. A few highlights for me were the Leadership Forum where we broke into pods to discuss site and patient experience topics. There will be an SCDM paper coming on the discussion points in the coming year. When leadership was asked what they thought were the top three participant challenges that should be addressed to enhance the participant experience in clinical trials, number one was Difficulty Finding Clinical Trials to join! This was followed by Participant Burden (e.g. Travel, dependent care, financial) of participating in clinical trials and then lack of trust in the healthcare system. On a positive note, there are new free-access platforms emerging that are working to help solve the first gap on easing the patient’s burden to find clinical trials. Another point that really struck home was Dr. Marilyn Neault’s personal insights on data collection considerations for a Parkinson’s trial. One study she participated on required her to fill out a table with very small fields and no reference markers. You can imagine, for a patient that has tremors as a part of the symptoms of their disease, how this could be a challenging ask. Then to fold on top of that the form was asked to be filled out every thirty minutes how difficult that must have been. Perhaps it was ultimately necessary for that trial’s insights but take a moment during design to consider how it may impact the patient experience. 

Better yet, invite a patient or advocate to key early trial design meetings and offer to receive feedback at trial end. You may find that their measures of success differs from your initial hypothesis and something as simple as knowing when their cycle of symptoms will surface on a daily basis may lead to better quality of life if it means they can plan activities around them. We also had two tremendous keynotes this year. 

Our opening keynote was Kathryn Godburn Schubert, President & CEO for Society for Women’s Health Research. In recent years, we have been gaining greater visibility and traction with respect to Diversity Equity and Inclusion on clinical trials, but it is staggering to think that we still have substantial progress to make in this area as well. For example, did you know that women were completely excluded in clinical trials in the US until the 1990’s? This has resulted in the underpinnings of signs and symptoms of some indications to be biased towards male anatomy and one of the reasons thought to be the root of cardiovascular disease being the leading cause of death worldwide in females (1 in 5). Simply put, their symptoms present differently from males as does their physiology, but the research and socialization has lagged that of males. If this is a surprise to you, I encourage you to investigate further.   

Our closing keynote was a heartfelt story by Mark Dant, Executive Director from the Ryan Foundation, who told of his son’s battle with Mucopolysaccharidosis Type 1 (MPS-1). A genetic mutation which causes deficiency of the enzyme alpha-L-iduronidase (IDUA), key to the break down of glycosaminoglycans (GAGs). These long chains of sugar molecules build up in cells and damage cells if not broken down, eventually leading to death within 15 years. When Mark’s son was diagnosed, he was already quite a few years old, and Mark was told there was no treatment available and research was very limited due to the rareness of the disease. As a police officer, Mark was not versed in medical terminology, let alone clinical trials, and headed to the library (those things with books and papers) to self-educate. He discovered clinical trials were very expensive and his son’s best hope was to raise funds so when a researcher was found with a promising candidate, the clinical trial could proceed as rare diseases typically are hard to sponsor due to their limited return on investment given the limited patient population. He started with a bake sale and over years built a fund of 1 million dollars in the hope of connecting with a researcher with a promising solution. He found that with Dr Emil Kakkis and together they backed an enzyme replacement therapy that led to FDA approval and now global approval as a treatment option. It was a very long journey, but Mark’s son received treatment in time and is thriving and successful today. It was made all the more moving by Mark’s connection with all of us in his closing note. “You work with data, and this brings hope. Please remember to look beyond and see the patients waiting for something to change.” A well-deserved standing ovation and well worth watching both keynotes and the many other sessions of excellence throughout the conference. All of these are now available online through the app for those registered! Oh yes, the Formula 1 social event was also huge fun!   

We had some special awards at this year’s conference as well. Volunteer of the Year was awarded to Claudine Moore, Chief Editor of JSCDM for her work expanding accessibility to the Journal. An amazing 160 countries are now accessing the journal as of this year! For the Volunteer Project of the Year, this is awarded to Deepak Kallubundi, Head of Clinical Data Management Operations, FSPx, Fortrea and Kelly Chelnik, Manager, Clinical Data Management, Abiomed for their leadership on the Certified Clinical Data Associate project and CCDA launch. For the Innovations awards, there were three categories. The Clinical Data Science implementation excellence goes Clinion for their EDC with AI, multilingual chat bot,  AI-enabled medical coding platform offering. The innovation in health technology solutions award goes to Crucial Data Solutions for their TrialKit AI’s intuitive AI analytics engine facilitating accessible, prompt-based trend analysis, charting, and dashboards. Finally, the innovative startup of the year award goes to Readout AI for their automated blinded analysis, AI-based stats and medical writing, smart edit checks and machine learning-based outlier detection solution. The Board have also chosen to include a new category – Adding Site and Patient Centricity award for next year’s awards and we look forward to seeing your submissions! 

We also had six posters showcased at this year’s event.   

1. First place went to Jayasmita Dutta, MS, Associate VP, Capability Development, Accenture. Her poster on “Reimagining” DM Trainings provided clear visualizations and two key skill development facets – that of Recall (information readily retrievable by learners) and Refer (Information that necessitates checking when needed). We need to adjust learning to also allow for career aspirations and job rotations to keep learners inspired and foster a continuous “culture of learning.” Gamification of learning was my favourite for recallability!   
2. Second went to Mehdi NajafZedeh, PhD, Senior Director, Science Lead, Medidata Solutions, Sevtap Demirci, Saira Niamathullah, Ben McConnochie, Jimmy Polowaczyc and Ayushi Tyagi, Amir Ahmed and Dr. Ana Oromendia.  Their poster on Experience in Implementing Clinical Trial to Real World Data (RWD) Linkage showed there was an acceptable level of effort required across different trails/sponsors for implementing trial linkage sub-studies and efficacy gains from scaling data linkage across trials. Integration was easily adopted by clinical site staff with a note that early planning and inclusion in informed consent is key to deployment.   
3. Third place went to, Munenori Takata, Sawana, MD, PhD, Project Lecturer, Tohoku University Hospital, Narita, Yukikazu Hayashi, Yasuharu Shibata, Kazuna Higuchi and Komehei Nakashima for their poster on Query Journey – Analysis for Resolving Queries at the Root from Surveys in Japan, highlighting challenges related to queries that Japanese clinical trial professionals encounter as a result of quality by design deployment in their region. 

Upcoming Events:

SCDM India Annual Conference, Hyderabad, Dec 5-7. This year will have something special added, as the inaugural pre-conference workshop for Certified Clinical Data Associates will be launched. Mayank Anand, GSK VP and former chair of SCDM, will be providing a keynote on the Future of Clinical Data Work: Adapting to a Changing Data Landscape and other topics will range from Risk-Based Data Management, data security, privacy, and regulatory compliance. You’ll get the chance to grow your expertise, discover industry best practices and be the first to learn about innovative methodologies and technologies essential for maintaining data integrity and reliability. Check out the program for more information. 

SCDM EMEA Conference in Brussels, Belgium, April 9-11, 2025. Registrations opening soon – stay tuned!

Education and Certification

We are excited to launch the Clinical Data Associate (CCDA) Certification Program as of October! If you are new to Clinical Data Management (0-2 years) or know someone interested, this is a terrific certification to pursue as it will differentiate you from others entering this field. Additionally, a new and free on-demand webinar, Clinical Data Associate 101 is now available.  For those interested in advancing their certification, CCDM is the next level and this quick link can get you started. If you are looking for content on Clinical Data Science, CDS 101 is a terrific overview.  Where’s CDM 101 to complete the trilogy, you ask! Fear not, the Global Academic Council is working on that for you and will look to launch it in the middle of 2025! The SCDM community is expanding educational materials around Clinical Data Science, and CCDS development is well underway. 

We also have had a dozen webinars launched in September through the end of the year. Many will be on demand if you missed them but keep your eyes out for announcement emails for those coming in December on RBQM, Strategic Thinking, and eCOA topics! 

Education and Certification

As always, we can’t continue to thrive and advance as a society without the support offered by each of the many volunteers within our society. A tremendous thank you to our many volunteers across all stakeholders and levels of Clinical Data Management. Your continued collaborative spirit to drive our industry forward in the pursuit of clinical research and the development of safe and effective medical treatments for a healthier world is no small feat and well worth a standing ovation. It is perhaps embarrassing to stand and clap in an office while writing this final note, but if it brings just a little bit of joy to your next volunteer session with SCDM, it is time well spent!  Looking forward to shaking your hand in person or waving a hello online the next time our volunteer paths cross! 

Cheers, Stephen

Stephen Cameron

Secretary, SCDM Board of Trustees