The post Beyond the Hype: Innovating Obesity Treatments for Real-World Impact  appeared first on Premier Research.

The post COG NE appeared first on Premier Research.

The post Breaking Free from SDR and SDV: The Case for Centralized Monitoring appeared first on Premier Research.

In this debrief, we’ll explore key takeaways from SCOPE, showcasing how emerging technologies are driving the future of clinical trials. 

The rise of site consolidation 

A notable and recurrent theme from SCOPE surrounded the consolidation of sites into larger site networks. This movement is generally driven by private equity and venture capital investments, which aim to streamline administrative burdens and enhance operational efficiency. By forming site networks, independent research sites join forces under a centralized structure, allowing for streamlined operations, standardized procedures, and enhanced access to resources like advanced technology and dedicated staff. 

• Centralized administrative processes: Shared resources improve site performance and reduce administrative burden. 

• Enhanced technology and tools for site operations: Many site networks invest in advanced clinical trial management systems (CTMS), electronic health records (EHR) integration, and AI-driven patient matching to optimize trial execution. 

• Focused patient care and protocol adherence: Standardized training, centralized oversight, advanced technology integration, and dedicated patient support ensure higher quality trials for patients while increasing compliance. 

• Cost efficiency through resource sharing: Consolidation can enhance financial viability by ensuring consistent trial opportunities, reducing overhead costs, and attracting investment from sponsors and CROs. 

“Private equity can really provide that level of support to sites, there is an opportunity for sites to have even more improved tools and technology.” 

Site network consolidation not only promises operational efficiency but also shifts the focus back to patient care, allowing site staff to dedicate more time to medical and protocol procedures. 

AI’s role in patient recruitment 

AI’s impact on patient recruitment is undeniable. With a significant percentage of solutions presented at SCOPE focused on patient recruitment support, it’s clear that AI is revolutionizing how clinical trials attract participants. 

• Improved targeting of potential participants: AI analyzes EHR, genetic data, and real-world evidence to quickly find eligible patients, and machine learning models ensure precise selection based on trial criteria. 

• Enhanced patient engagement: AI-driven chatbots and digital tools provide personalized communication and support. 

• Faster recruitment timelines: Streamlined processes accelerate recruitment and study startup. 

As AI technologies advance, they provide more sophisticated tools for patient recruitment, ensuring that trials are populated with suitable participants more efficiently than ever before. 

Modernizing biospecimen collection  

A very well-attended session at SCOPE focused on the critical need for improving sample management, particularly in how informed consent is handled when a participant withdraws from a study. As trials increasingly rely on biobanking, genetic analysis, and AI-driven insights, ensuring proper handling of biospecimens—especially in cases of patient withdrawal—is critical. 

This trend underscores the need for modernization in biospecimen management. AI insights are being leveraged to address these challenges, offering a more comprehensive approach to consent management and specimen tracking. Some considerations for improving this process include:  

• Clear and granular consent: Modern consent forms should outline specific uses of biospecimens, including future research, secondary analyses, and data sharing, allowing patients to make informed decisions. 

• Withdrawal protocols: When a patient withdraws, sponsors must define whether samples are destroyed, de-identified for continued use, or retained for specific purposes based on consent parameters. 

• Enhancing transparency and patient trust: Clearly communicating how biospecimens will be used—even post-withdrawal—enhances trust, supporting long-term engagement in clinical research. 

Challenges of AI and tech adaptation 

While AI offers numerous benefits, its adoption in clinical trials is not without challenges. The integration of AI technologies into existing processes is often hindered by regulatory complexities and data access issues. 

• Navigating data privacy regulations: Evolving global regulations on AI, data privacy (e.g., HIPAA, GDPR), and GCP compliance create challenges for widespread adoption.  

• Data quality and integration: AI relies on vast datasets, but inconsistencies, incomplete records, and siloed systems can hinder accurate analysis and patient matching. 

• Ensuring compliance with AI-generated data: Protecting patient data from breaches and safeguarding secure AI-driven decision-making is critical for maintaining trust. 

• Adapting existing processes to leverage AI: Sites, sponsors, and CROs must invest in training and change management to ensure seamless integration and effective use of AI tools. High upfront costs, infrastructure needs, and ongoing maintenance can also make AI adoption challenging for smaller research organizations. 

“We aren’t adapting our process and expectations to live in an electronic world as fast as the electronic world is creating capabilities for us.” 

Addressing these challenges requires a concerted effort to align technological advancements with regulatory frameworks, ensuring that AI can be seamlessly integrated into the clinical trial landscape. 

Looking ahead: A preview of SCOPE 2030 

The future of clinical trials is poised for transformation by 2030. The integration of AI into all facets of clinical processes is expected to be a game-changer, driving efficiency and innovation. Some expectations for trends we’ll be discussing at SCOPE 2030 include:  

• AI embedded in all clinical processes 

• Increased use of synthetic control arms 

• Consolidation of tech vendors for streamlined operations 

“AI should be layered on top of every process, even if in the smallest way, as a starting place for the human to then begin interacting with it.” 

As clinical trials continue to evolve, AI integration and site network consolidation mark significant advancements toward greater efficiency and patient-centric operations. Adapting to these shifts will be essential for companies aiming to stay competitive in a rapidly changing landscape. By 2030, AI will be a driving force behind industry transformation, unveiling new levels of innovation and operational excellence. 

To hear more about Premier’s perspectives for embracing AI and other emerging trends, contact us. 

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit prmresearch.com.  

The post Embracing AI: Emerging Trends and Key Insights from SCOPE 2025 appeared first on Premier Research.

The post Mastering CRO Oversight: <br>8 Steps to Guide Your Approach appeared first on Premier Research.

The post Mastering CRO Oversight: <br>8 Steps to Guide Your Approach appeared first on Premier Research.

This guidance not only underscores the FDA’s commitment to modernizing clinical research but also highlights the potential of DCTs to expand trial access, improve diversity, and reduce burdens for participants—all while maintaining the rigor of traditional clinical trials. This blog explores the benefits of decentralized trials, highlights key attributes of the new guidance, and outlines strategies for implementing DCTs. 

Overcoming challenges of brick-and-mortar trials  

As clinical research evolves, the limitations of traditional brick-and-mortar clinical trials have become increasingly apparent. These challenges can create barriers for both patients and sponsors, including:  

• Accessibility issues: Patients often need to travel long distances to centralized trial sites, creating a burden for those in rural or underserved areas. 

• Enrollment and diversity challenges: Logistical challenges reduce participation rates and limit the diversity of study populations, affecting the generalizability of results. 

• High costs and rigid scheduling: Fixed site visits can create barriers for patients with demanding schedules, while sponsors face significant costs for maintaining trial sites and managing logistics. 

DCTs offer a promising alternative, bringing greater flexibility and accessibility to the process. By leveraging technology and community-based approaches, DCTs are transforming how trials are conducted, offering:  

• Greater access: Telehealth visits, remote monitoring, and local provider partnerships reduce the need for travel and make trials more convenient. 

• Enhanced diversity and retention: Flexible trial models attract patients from underrepresented populations and improve retention by minimizing logistical burdens. 

• Cost and time efficiencies: DCTs can streamline operations to maintain or even improve study timelines. 

Even if there’s only one of four visits that can be done at home, that’s still appreciated. 

Driving clarity with guidance 

The FDA’s regulatory guidance for DCTs provides essential clarity for sponsors and researchers, ensuring trials maintain rigor and compliance even when conducted outside traditional settings. This guidance addresses key challenges, such as data variability and the integration of local healthcare providers, while accommodating various operational models, from fully decentralized to hybrid trials. By setting clear standards, it ensures all models uphold data integrity and meet regulatory requirements. 

The regulations are the regulations, whether your operational model is in a decentralized model or not. 

Key topics of the guidance include obtaining informed consent remotely, verifying participant identity, ensuring proper training for personnel conducting assessments, and addressing logistical challenges, such as the shipment of investigational products to participants’ homes. Additionally, the guidance clarifies the responsibilities of sponsors, investigators, and Contract Research Organizations (CROs) in DCT operations while highlighting strategies to enhance trial access, diversity, and retention.  

The role of local healthcare providers 

A critical focus of the guidance is the role of local healthcare providers not directly affiliated with the trial. By incorporating these familiar professionals into the trial process, sponsors can reduce the burden on patients, enhance their comfort, and improve engagement. This approach not only helps to streamline trial operations but also fosters stronger patient retention and diversity by making trials more accessible to those in rural or underserved areas. Additionally, empowering trained caregivers or local providers to conduct specific assessments ensures consistency in data collection, even in decentralized settings. 

Considerations for implementing DCTs 

While DCTs mitigate many obstacles of traditional trials, they introduce their own complexities and require careful planning and execution to ensure success. The following tips are essential for operationalizing a DCT more effectively.  

Leverage the reach of digital advertising  

Using social media platforms like Facebook and Instagram for advertisements can help DCTs reach a diverse range of demographics. To achieve a varied participant base, sponsors should tailor their advertising to different groups, incorporating culturally sensitive messaging that resonates with various cultural backgrounds, ensuring broad demographic reach across age ranges and ethnicities, and collaborating with Institutional Review Boards (IRBs) to ensure that all communications are appropriate and effective. 

Engage with regulators early  

When considering DCTs, early engagement with regulatory bodies is vital. The operational models of DCTs differ significantly from traditional trials, necessitating detailed planning and consultation. Engaging with experts and regulatory bodies early in the process can help navigate the complexities and ensure compliance with all necessary guidelines. 

Choose the right technology platforms 

Technology is the backbone of decentralized trials. To facilitate remote monitoring, telehealth visits, and data collection, a robust, user-friendly platform is critical. Sponsors should look for solutions that support real-time data capture, secure communication, and easy participant access, while complying with regulatory standards like HIPAA and GxP to ensure data privacy and security. 

Design flexible, patient-centered protocols 

One of the key advantages of DCTs is flexibility. Trial protocols should be tailored to meet the needs of patients, whether through flexible scheduling for telehealth visits or remote monitoring options. Reducing the need for travel and providing personalized support will improve enrollment, retention, and overall patient satisfaction. 

Support patients every step of the way 

Dedicated help desks or hotlines play a crucial role in ensuring participants feel supported and informed throughout a decentralized clinical trial. These teams provide ongoing communication, addressing any concerns participants may have and fostering a sense of connection during the trial process. By offering consistent support, participants have a reliable point of contact to assist with any issues or questions, enhancing their overall experience. Additionally, this personalized approach helps build rapport, making participants feel valued and informed. Not only does this strategy improve patient retention, but it also ensures that data collection remains comprehensive and uninterrupted. 

Our Patient Engagement and Retention Team is our call center… they form those relationships from the minute a person responds to an ad. 

Long-term follow-up studies: A prime use-case for DCTs 

Long-term follow-up is a critical component of many clinical studies, especially those involving treatments like cell and gene therapy. These studies require monitoring over extended periods, sometimes spanning several decades, to assess the long-term efficacy and safety of treatments. 

DCTs offer a viable solution for managing these long-term follow-ups. By utilizing decentralized approaches, such as patient call centers, researchers can maintain ongoing communication with patients without overwhelming brick-and-mortar sites. These centers facilitate regular check-ins, ensuring that any adverse events or changes in health status are promptly reported and managed. 

This approach not only alleviates the logistical burden on research sites but also supports patient retention by maintaining engagement and ensuring they feel connected to the study. 

Reshaping clinical trial conduct 

DCTs represent a significant advancement in clinical research methodologies. By broadening patient demographics, enhancing trial diversity, and simplifying long-term follow-up, DCTs offer a more inclusive and efficient approach to clinical research. As regulatory guidelines continue to evolve, the integration of DCTs into mainstream research is likely to expand, offering new opportunities for innovation and improvement in the field.  

For support with implementing your DCT, contact us. 

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit prmresearch.com.  

The post Navigating the New Era of Decentralized Clinical Trials  appeared first on Premier Research.

We sat down with Premier’s leading oncology experts to discuss the deeply personal impact that cancer has on millions of people worldwide. Today, we acknowledge that everyone’s journey with cancer is unique and celebrate the contributions of individuals—from patients and caregivers to researchers and advocates—in building a united front against cancer. 

Elaina: As this year’s theme alludes, every individual impacted by cancer has unique perspectives and needs but are all united in a shared ambition to lower the cancer burden and see cancer treated successfully. What role(s) do CRO’s play in supporting these ambitions and how can we become better partners for progress with other stakeholders in the life science industry? 

CROs are committed to working with stakeholders across the life science industry to deliver treatments to patients in the most efficient and effective way possible. By the nature of their business, CROs are incentivized to remain on the cutting edge of technology, such as data analytics, artificial intelligence, and digital platforms, offering life science companies ways to streamline clinical trial processes, improve data accuracy, and enhance patient recruitment and retention.

CROs are uniquely positioned to implement patient-focused solutions like wearable sensors, telemedicine, and mobile applications, These advancements help reduce the burden of participating in clinical trials, making them more accessible and inclusive. As a result, trials can better represent diverse populations and lead to more effective treatments.

In addition to their commitment to fostering inclusion, CROs also actively build relationships with community and patient advocacy groups, and work to strengthen relationships with community sites and networks to broaden the pool of patients invited to participate in clinical trials.   

Ultimately, CROs want to work with life science companies to improve the clinical trial experience for cancer patients, enhance patient outcomes, and ensure a positive experience for all. 

Sandy: With the rise of precision medicine, therapies are becoming more individualized and targeted to meet the unique characteristics of specific tumors and cancer genotypes. What new targeted therapies are you most excited about and where do you see room for growth and future development? 

The field of oncology continues to shift toward personalized medicine, with new therapies designed to target the unique molecular and genetic characteristics of specific tumors. RNA-based therapies, such as those that target specific oncogenic drivers or introduce tumor-suppressive factors, are being developed to elicit immune responses against cancer-specific mutations. We’re seeing similar responses with small molecule inhibitors that also specifically target oncogenic mutations. 

Further, antibody drug conjugates (ADC) are powerful therapies that can link a cytotoxic payload to a monoclonal antibody, allowing for precise delivery to cancer cells expressing specific targets. 

As we look ahead, I’m excited to see continued investigation of liquid biopsies and companion diagnostics to enhance early disease detection, monitor tumor evolution, and guide therapy changes based on the latest molecular profiles. We’re also on the brink of a technological evolution where AI and machine learning will become an integral part in discovering new cancer treatments, further propelling precision oncology to a more sophisticated state. 

Ashley: You’ve talked about the importance of engaging clinical sites in the community, not only large hospitals or academic institutions, to support recruitment efforts in oncology clinical trials. How do community sites differ in their ability to meet the unique needs of individual cancer patients? 

Community oncology practices often provide more personalized care. Patients typically see the same oncologist and care team throughout their treatment, fostering strong patient-provider relationships. They also reduce the burden of clinical trial participation on patients by offering convenience and accessibility. These sites are usually located closer to patients’ homes, reducing travel time and related expenses, and this proximity can improve adherence to treatment regimens and the quality of the data.

Lastly, because many community oncology practices collaborate with larger hospitals and academic centers, they can leverage shared expertise and resources to provide access to the same great treatment options available at large academic institutions while taking advantage of the smaller community setting to optimize patient outcomes.   

Meera: We’ve heard a lot about the need for increasing patient centricity in clinical trials, which emphasizes the importance of treating patients as partners and can involve shared decision-making. In what ways is the oncology clinical trial landscape evolving to become more people-centric, which the World Cancer Day campaign is differentiating from patient-centric as having a broader context within the larger community to address the health of entire populations. And what challenges remain in delivering this approach? 

The oncology clinical trials landscape is increasingly adopting people-centric approaches by integrating community engagement, including diverse population representation, addressing social determinants of health, leveraging real-world evidence and decentralized trial designs, and integrating initiatives like Project Optimus, which prioritizes dose optimization and patient safety. These efforts involve caregivers, advocacy groups, and local communities to improve access, awareness, and equity.  

Broader initiatives, such as tailoring trial designs to diverse populations and utilizing real-world evidence, reflect a shift toward holistic health improvement. However, challenges remain, including recruiting and retaining diverse participants, addressing systemic disparities in access, building trust within underrepresented communities, and ensuring the scalability of inclusive trial methodologies without compromising scientific rigor.  

These obstacles require implementing strategies to improve sustained collaboration across stakeholders to create innovative policy frameworks. I look forward to seeing the strides that the life science industry makes in becoming more people-centric in the years to come.

Moving Forward Together 

As we celebrate World Cancer Day 2025, join us in taking a moment to pause and reflect on the unique story of cancer, acknowledging the amazing work of sponsors, advocacy groups, and, most importantly, the patients who dedicate their time to participating in clinical research to advance new life-saving therapies. Together, we can unite to create a powerful future filled with hope, determination, and action. 

To hear more perspectives from our oncology experts, book a meeting with them here. 

ABOUT PREMIER RESEARCH:  

Premier Research, a global clinical research, product development, and consulting company, is dedicated to helping innovators transform life-changing ideas and breakthrough science into new medical treatments. We offer strategic solutions across the entire development lifecycle, from pre-clinical through commercialization, specializing in smart study design and full-service clinical trial management.    

Leveraging technology and therapeutic expertise, we deliver clean, conclusive data with a focus on reducing development timelines, securing access to the right patients, and effectively navigating global regulations to ensure submission-ready results.    

As an organization that puts patients first, we pride ourselves on helping customers answer the unmet needs of patients across a broad range of medical conditions. Visit prmresearch.com. 

The post Celebrating World Cancer Day: An Interview with Leading Oncology Experts appeared first on Premier Research.

The post American Diabetes Association Annual Meeting appeared first on Premier Research.

The post BIO International appeared first on Premier Research.