Our clinical operations experts Erica Parks Murray and Laurie Stone recently attended MAGI 2024: The Clinical Research Conference in New Orleans, LA. The four-day event brought together upwards of 500 clinical research professionals worldwide, from the U.S., Spain, the Philippines, and more. These professionals are devoted to upholding the standards of quality, compliance, and efficiency in clinical research and are essential to driving advancements and transformations. Their work is helping to deliver much-needed new therapies that are positively changing patients’ lives. Below, Erica and Laurie share their key takeaways from MAGI 2024 and the conversations surrounding driving the future of clinical research within the clinical trial landscape. 

Driving the Future of Clinical Research

“We’re in the business of hope.” 

Sandy Smith, SVP of Clinical Solutions & Strategic Partnering for WCG, shared in her opening remarks that “we’re in the business of hope,” referring to the many clinical researchers, CRAs, CROs, clinical sites, sponsors, legal, and technology professionals in the pharmaceutical industry who were in attendance. This sentiment set the stage nicely for the conversations and topics that would follow for the rest of the conference – changes and advancement in technology, an increased and renewed focus on diversity, equity, and inclusion (DE+I) in clinical operations, and efforts to transform clinical research to meet the various health challenges patients continue to navigate. 

Advancing Health Equity – DE+I in Clinical Trials 

In clinical operations, fostering DE+I is pivotal for driving transformative change. Insights from the Tufts Center for the Study of Drug Development (CSDD) highlight key associations between DE+I practices and staff diversity at global investigative sites – shedding light that centralized clinical trial offices, unconscious bias Standard Operating Procedures (SOPs), and inclusive behavior SOPs were found to correlate with more diverse staff profiles. Additionally, the study found that the presence of technology in supporting DE+I goals (such as through Electronic Data Capture (EDC), clinical data management software, patient management systems, and other digital tools) was linked to increased staff diversity.  

To advance DE+I efforts, ongoing support and training for site staff in these technologies are essential, requiring continued investment from sponsors and professional associations. By prioritizing DE+I initiatives and leveraging technology effectively, clinical operations can drive meaningful transformation and create more inclusive environments for all stakeholders. 

Engagement is also key to these efforts, beginning right in the communities and neighborhoods to make a meaningful impact. Engaging locally can help patients more easily access what and how they need to participate in the trial — access to the site, medications, follow-ups, etc. – but this engagement must start sooner rather than later to build credibility and establish trust within the community. This means taking action early (at least nine months to one year ahead of the trial is advisable) and with sincerity – patients want to know the trials they’re participating in truly care about their needs and are acting in their best interest.  

From there, enrollment will just be the first step. Trial sponsors and stakeholders must stay connected to the participant throughout the trial and even afterward, following their journey and leaving room for open and honest conversations on room for improvement, how to better serve the community or patient moving forward, and more.  

Transforming Clinical Research to Meet Health Challenges  

Transforming clinical research to meet health challenges requires a shift toward continuous learning and collaboration. At MAGI 2024, stakeholders voiced frustrations with the complexities of the current clinical research landscape. Sponsors, clinical research organizations (CROs), and investigative sites expressed mutual discontent, highlighting real-world issues such as a lack of diversity, resource constraints, enrollment challenges, technology burdens, contracting and budgeting, and protocol complexity. For instance, as protocols become more intricate, site work effort increases, which affects recruitment, retention, and overall trial performance; data points have increased in Phase III Trials by three times over the past decade. 

Ultimately, clinical research has become an over-complicated process – from the collection of essential records to poor protocol design, resulting in burdensome reporting of deviations to physicians not knowing or sharing opportunities for their patients that could potentially be lifesaving. The “glaring disconnect” between visionary discourse and operational realities underscores the urgent need for change, as highlighted by the Journal for the Society of Clinical Trials (June 2023). 

To combat this disconnect, those involved must take a patient-centric approach. Start with the patient journey (through patient journey mapping) and identify where the challenges are in the design and how to mitigate them. The people writing the protocols for trials typically operate and write from a theory approach – e.g., sites are looking for site-driven solutions. Instead, this must be a collaborative partnership that puts a human face to the work completed. We must understand what each counterpart is trying to solve by identifying the common denominator(s). Every site wants to get things done promptly and correctly, and the CRO wants to deliver based on their commitment. In order to achieve our goals, we must identify a common metric to work toward together. 

State of Tech-Enabled Clinical Trials 

The landscape of clinical trials is undergoing a significant transformation with the increasing adoption of technology-enabled solutions. However, despite the potential benefits, barriers to investment persist, primarily driven by budget constraints and concerns over integration complexities. Stakeholders face critical decisions regarding which technologies to invest in, with considerations of whether to allocate resources toward site-level tools or sponsor-driven platforms. 

One notable trend that was discussed at MAGI 2024 is the delineation of responsibilities between sponsors and sites in acquiring technology. Sponsors typically procure essential tools such as Electronic Data Capture (EDC) systems, site selection and start-up tools, electronic Clinical Outcome Assessment (eCOA) solutions, and electronic Investigator Site Files (eISF).  

Recently, regulatory bodies such as the FDA have been signaling a decisive move toward digitalization to enhance trial efficiency and improve patient outcomes. With regulations no longer serving as a major roadblock, stakeholders must adapt swiftly to embrace technological advancements or risk being left behind in an increasingly digitized landscape.

As Catherine Gregor, Chief Clinical Trial Officer for Florence Healthcare, shared, “Change is coming faster, and sites and sponsors have to adapt or they will find themselves left behind.”  

Unlocking the FDA’s Guidance on Decentralized Trials 

The discussion on decentralized clinical trials (DCTs) centered around many of the themes we heard throughout the conference – how to enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility, among others. DCTs offer both advantages and disadvantages, which include access to technology and the complexity of principal investigator (PI) oversight.  

The FDA said, “We hear you,” and took additional steps to advance DCTs by releasing draft guidance in June 2023. The FDA defines DCTs the same as traditional site-based trials and confirms the PI is still accountable no matter where they take place. The three key points are clear: 

• Telehealth – as long as it’s outlined in the protocol – is still a point of contention because sponsors and sites need to talk about what needs to be designed in the protocol from the beginning. 
• Bringing your own device is endorsed; however, not every participant has access to a smartphone and 5G wifi, so there’s a need to create access to that technology for those that don’t have it.  
• PI oversight is still unclear, which creates risks for the physician and sponsor and reduces FEDORA adoption

Clinical Research Makes a Difference

As we reflect on the incredible conversations and discussions at this year’s MAGI Conference, we can’t help but think of the story of Katie Ortman Doble, reminding us that clinical research makes a difference. Ortman Doble is a stage 4, ocular melanoma survivor. In 2014, Katie was diagnosed with a rare form of cancer called ocular melanoma. Doctors gave her 16 months to live. Her father is a physician and was able to advocate for her by finding a clinical trial that could save her life. In the summer of 2023, Ortman Doble and her family celebrated her second anniversary of being cancer-free. Katie’s journey exemplifies resilience, determination, and the power of clinical trials in the face of challenging diagnoses. We are in the business of hope, but we also must bring persistence, tenacity, resilience, and humanity to the forefront of all that we do. 

Looking Ahead 

On this journey to truly transform and improve the clinical trial landscape – to make it a more inclusive, accessible one that can face the healthcare challenges of patients both today and in the years to come – we must embrace and act upon the change that’s coming now. Once again, we’re reminded of Catherine Gregor’s call to action: “Change is coming faster, and sites and sponsors have to adapt or they will find themselves left behind.” 

To chat more about these topics and themes from MAGI 2024 or the evolving clinical operations landscape, connect with our team today and visit our Clinical Research page here.