Guest Column | May 21, 2024

Unlocking Next Generation Clinical Trials Through Data Sharing & Tech-Driven Approaches

By Kieran Reals and Charlie Paterson, PA Consulting

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Clinical trials haven’t always enjoyed the best reputation, but sentiments are shifting. To understand public perceptions of clinical trials, we spoke to 2,000 U.S. respondents. Our results reveal a surprising reality: despite traditional concerns around cost, safety, and convenience, views are largely positive. More than three-quarters (77 percent) say trials are essential for bringing lifesaving therapies to market, and 64 percent are willing to share their clinical data with researchers to aid the development of treatments or cures. Crucially, 65 percent are happy for this data to be shared across studies, especially if it could drive down the cost of treatment.

This stark shift represents an opportunity for biopharma companies to reimagine clinical research, to enhance stakeholder experience, and to connect data sources in novel ways to accelerate the development and delivery of new therapies.

Key Focus Areas: Trust, Transparency, And Diversity

While the picture is broadly positive, there are a number of key challenges to address. Our survey reveals that public trust in biopharma companies as leading entities operating trials is generally low. This is due to a perception that organizations lack transparency. Respondents also expressed concerns over the negative side effects and potential long-term impacts of trial participation, and three-quarters flagged the need for more diversity and inclusion in clinical trial recruitment to ensure the effectiveness and suitability of drugs for a broader population. Each aspect here points to a significant need to engage the public more effectively to educate and a potential opportunity to rethink how new channels and brands can be used to build public trust and reach new communities.

Making The Most Of Crucial Health Data

Despite a general skepticism toward biopharma companies conducting clinical trials, a significant number of participants are eager to have their data utilized by researchers. Data amalgamated from diverse clinical trials is instrumental in training artificial intelligence (AI) and machine learning models, uncovering new applications for therapies, or broadening existing drug labels. AI automation and natural language processing can be used to integrate data from varied sources and to decipher unstructured inputs to identify new insights. From patient consents to medical and laboratory records, this can reduce the need to find new patients or arrange for new data collection. This approach not only expedites research and enables operational efficiency but also enhances trial designs for the future.

In addition to their willingness to contribute data, participants are also advocating for investments in AI to bolster diagnostic and therapeutic research. The efficacy of AI is inherently tied to the caliber of data it processes, suggesting that expanded access to high-quality trial data could be a game changer for the industry. This advance is particularly timely as new development methodologies enable dramatically accelerated release timelines with sophisticated, secure, and compliant custom solutions being built at a fraction of the costs seen just a few years ago. Leading trial organizations are taking advantage of the ability to create new workflows that augment and, in some cases, replace legacy workflows — enabling significantly increased capacity to expand development and bring therapies to market faster than ever before.

Delivering More For Patients

Human-centered design is right at the core of successful clinical research, encouraged by increased industry focus and directives such as Patient-Focused Drug Development.

With firm evidence of peoples’ willingness to share their health data, it’s up to biopharma companies to respond, implementing new technologies to develop insights that enhance clinical research. This means making it as easy as possible for people to participate in trials and providing all the necessary support to guide them through the process. It is essential that this supports continuous post-participation, as information is used across studies. It’s also about seeing the value in collaboration — sharing data through opt-in structures will reduce data collection efforts and avoid overwhelming patients, caregivers, and patient advocacy groups with requests.

Using data to feed well-governed, AI-enabled systems can increase the value of clinical research for patients by generating insights for more effective, targeted treatments. By sharing results across a range of channels, biopharma companies can improve engagement and commitment from participants and patients while boosting levels of trust.

Key Actions For Biopharma Companies

Based on our findings, there are several actions biopharma companies can take to increase the speed and success of clinical trials:

  • Adopt a joined-up approach to trial design and development to increase the pace of R&D and deliver faster, more cost-effective clinical research — over two-thirds of respondents call for more collaboration on global health initiatives and medical research.
  • Focus on cybersecurity and regulatory compliance, not only to mitigate constantly evolving threats and improve resilience but to unlock the growth digital trust enables by giving participants and researchers confidence in your ability to safeguard their data.
  • Provide comprehensive and transparent information to potential study participants by meeting them where they are and adopting new channels of engagement. This can be done by using real-world evidence to identify likely sources of potential participants and sharing relevant trials with target demographics through tailored outreach channels, including social media, local physicians, brochures, and advertisements.
  • Improve the participant and site experience through taking a user-led approach to designing accessible onboarding and communication mechanisms and offering post-trial support, as well as involving patients and advocacy groups in protocol design. Explore opportunities to rapidly build and deploy new digital experiences that remove redundancy from legacy ClinOps enterprises.

The evolution of clinical trials will be driven by meaningful data insights, integrated technology platforms, and a bold, collaborative approach. Biopharma companies have a clear opportunity to build on positive sentiment, leveraging data and technology for more human-centered, impactful, and accessible trials. Through a patient-centric, data-first, and collaborative approach, biopharma companies can meet growing demand, navigate complexity, and deliver value across the healthcare ecosystem.

About The Authors:

Kieran Reals is a healthcare and life sciences expert at PA Consulting. He leads organizations in transformations of their operational approach to fully utilize the potential of interconnected digital processes. He operates across the life sciences value chain but specializes in radically transforming clinical trial development.

Charlie Paterson is a clinical development expert and associate partner at PA Consulting. He has a background in physics and extensive knowledge of lab technology, clinical trials design and execution, and provider operations. He drives the development and adoption of breakthrough technologies with leading organizations across the clinical trials continuum using data-driven approaches.