What’s in scope for future clinical trials? Learnings from the #SCOPEsummit

This year’s SCOPE was amazing and well attended with over 3100 people coming from around the globe representing sponsors, CROs, suppliers, consultants and most importantly patients. Coming off last year where there was a fraction of attendance compared to this year and many, including TrialX, found it successful on many fronts. We list some of the hot topics discussed below.

Decentralized clinical trials dominated the discussions 

Decentralized Clinical Trials was a major buzz throughout the conference as seen by the many mentions across the agenda and attendee list reinforcing that as an industry we will not be going back to pre pandemic practices. The discussion included the use of many digital technologies that would help support the continued shift from traditional clinical trials. 

While coming out of the COVID-19 pandemic many companies saw the wave of fully virtual and community based mobile sites trials recede, many others see a strong future of hybrid clinical trials, where patients will have an option to participate via traditional sites and academic research centers at the same time having the ability to complete some study tasks at home independently or with study nurse visits and televisits. This fact is validated with the number of new digital clinical solution companies popping up at an incredible rate. The amount of VC funding and engagement with these small companies was reflected by the sheer number of companies present at SCOPE 2023. Large companies like Science37, Medable and Thread continue to lead the way with significant marketing and sales presence. 

While we did not have a booth this year, next year will be different with increased presence with our innovative leaders, engineers and subject matter experts presenting on real world solutions. TrialX is pushing the envelope of decentralized clinical research with its TrialX xPAND platform. The xPAND database equips space researchers to reuse and integrate research data across different research studies and unlock innovative actionable insights. It is currently being used by the Translational Research Institute for Space Health (TRISH) for remote data collection during commercial space missions. The xPAND database now has the data of 9 commercial space astronauts across 3 space missions, with the next mission launching in April 2023.

Supporting clinical research in space missions provides an opportunity to build systems with multi-stakeholder collaboration and long term data reuse as key considerations. As highlighted at #scope2023, interoperability is a must in order to accelerate research and such models could potentially accelerate drug development here on earth by fostering data re-use across studies. TrialX was selected by The Translational Research Institute for Space Health (TRISH) after an exhaustive evaluation that included over two dozen small and large organizations and above mentioned companies. 

Diversity is a focus within and across the industry with regulators keeping a close look

Diversity, equity and inclusion in clinical trials was significantly emphasized in many discussions and presentations. With the new draft guidance issued by the FDA, regulators are requiring biopharmaceutical companies to address disparities within their clinical study protocol. According to this new draft guidance, sponsors of medical products are recommended to develop and submit a Race and Ethnicity Diversity Plan to the agency early in clinical development. Companies such as Pfizer, Moderna, Eli Lilly, J&J, Walgreens and the likes are also pushing for diversity, developing and building out departments and internal teams to ensure that this is not treated as just a feel good topic or a check the box type of initiative. Many DEI representatives are present across the cross functional teams involved in clinical trial planning and implementation process.

TrialX has been a leader pre-pandemic and today and has developed innovative patient recruitment technologies and patient-centric solutions to tackle the diversity challenges faced by the industry. With the launch of the DEI toolkit in iConnect – it’s award winning patient recruitment platform – TrialX is providing mechanisms for sponsors and sites to create an end to end multilingual experience for patients serving the information needs of diverse populations. In addition, with CureTalks – it’s social initiative, TrialX is helping raise clinical trials awareness through discussions educating about the importance of diversity and inclusion in clinical research.

Real world data, Real world evidence, Who owns the data? And no I am not a robot!!

The use of real world data (RWD) and real world evidence (RWE) was emphasized in many presentations, as critical to protocol development and trial design. Other hot topics included the tokenization of patient data as a way to get a complete picture of desired patient profiles to help increase direct access into clinical trial opportunities and fuel the areas of AI and Machine learning. This is a highly debated topic that has miles to go and regulators alike are keeping a keen eye on this from a patient privacy perspective. 

ChatGPT and BARD was also discussed throughout the conference and mentioned in several of the data management, patient engagement, patient recruitment, DCT and electronic health records presentations as a way to help increase efficiencies to increase participation and accelerate the drug development life cycle. It is our belief this momentum will continue and it will be front and center in many of the presentations at SCOPE 2024.  

Charles Speno, our Director of Account Management represented TrialX at SCOPE 2023 and had the opportunity to meet, share and learn from some knowledgeable industry experts and representatives yielding many introductions, quality discussions and valuable insights.

First day at #SCOPE2023
Connecting sharing and learning at #SCOPE2023

We look forward to potential opportunities to collaborate with large and small bio-pharmaceutical organizations and make our TrialX mission of connecting over a million patients to clinical research a reality. 

Drop us a line if you would like to know more about TrialX.

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Shweta Mishra

Shweta is senior marketing and content manager and also provides research and engagement support for Applied Informatics/TrialX products. She hosts women's health/infertility/reproductive medicine talk series driven by her personal experiences for TrialX CureTalks. A San Jose State University Graduate, she holds dual masters degree in Biochemistry and Nutrition Science, and is passionate about the science behind the diverse life phenomenon. She also holds certifications in Digital Marketing from Hubspot Academy, Protecting Human Research Participants from NIH and in Intellectual Property in Biotechnology from WIPO.