The ever-increasing demand for new and innovative pharmaceuticals is an ongoing, worldwide challenge for researchers and pharmaceutical companies. At the heart of this endeavor lies the crucial clinical trial phases II and III where major decisions about the viability of new drugs are made and their safety and efficacy are rigorously tested before reaching patients.
Critical to the success of these phases is the initial site selection process, when pharmaceutical companies determine where clinical trials will be facilitated. Clinical Research Organizations (CROs) and other specialized recruitment companies have historically provided the expertise and resources for site identification and management needs. Depending on the pharmaceutical company size and available resources, CROs and clinical site selection companies may be better equipped to navigate the complex landscape of regulatory requirements and streamline trial processes.
But pharmaceutical companies know all too well that the site selection process, while well established, is often fraught with challenges, leading to significant delays and increased costs.
Challenges with the Current Site Selection Model
In the traditional paradigm of clinical trial site selection, pharmaceutical companies often grapple with fragmented data sources, limiting their ability to make informed decisions. The data generated from previous trials, electronic health records, and real-time patient information often resides in silos. This makes it increasingly difficult to gain a comprehensive understanding of potential site performance and medical or patient management issues.
Despite the potential benefits of CRO and specialized recruitment company partnerships, these relationships also come at a cost. Conflicts of interest may arise when CROs are involved in both site selection and trial management. This has led to biased site selection or management decisions that favor the CRO’s interests over those of the pharmaceutical company. Initial cost implications of partnering with CROs can also be quite significant.
The Future of Site Selection
Pharma companies must have access to the right data and strategic partnerships to make more informed and timely business, medical, and pharmaceutical decisions.
To overcome the limitations of the current process, we partner with clients to develop a site selection model that champions a data-driven, technology-rich, and patient-centric approach.
Data-driven Decision-making
Thanks to the availability of large datasets and other predictive analytics tools—as well as the quickly evolving technologies of AI/LLM—pharma companies can now achieve a much more holistic view of site performance and trial progress.
The ability to access large data sets pulled from disparate sources, from electronic health records to previous trial data and real-time patient information, will broaden the size and scope of knowledge capture. By centralizing and analyzing this wealth of information, pharmaceutical companies can leverage predictive analytics for real-time decision making. These techniques will allow companies to:
- Expedite site identification
- Accurately forecast site performance
- Reduce time between protocol approval and site activation
- Improve patient recruitment and engagement
- Achieve DEI objectives
- Identify risks and issues early
- Eliminate costly trial delays
Alternatives to Traditional CRO Involvement
Pharmaceutical companies have long benefited from their collaborations with CROs and, more recently, with newer specialized recruitment companies. But the question still stands: Should pharmaceutical companies remove CROs from the site selection process?
While each pharmaceutical company and clinical trial has unique needs, alternatives to traditional CRO involvement are certainly worth exploring. In-house site selection and management capabilities may allow companies to gain greater control over the entire clinical trial process from site selection to patient recruitment and data management. In-house management may lead to certain efficiencies and economies of scale, but the start-up costs and learning curves associated with this approach can be considerable.
Another alternative approach pharma companies might consider is partnership with a technology company that specializes in data-driven site selection and patient engagement solutions. These companies often bring new or advanced skills in data analytics, artificial intelligence, and machine learning to the trial process, enabling pharmaceutical companies to better leverage their people.
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New Model, New Considerations
As with any new strategy, change can feel daunting. While the long-term benefits of modernizing your clinical trial site selection process may outweigh any potential costs associated with transformation, there are some important considerations for any pharma companies looking to pivot to a more data-driven approach.
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Training and Adoption Challenges
Training staff in new technologies and related analytic tools can be a challenging endeavor, but it will be critical to the success of this new model. Pharmaceutical companies will need to invest in extensive and comprehensive training programs to ensure their people will be effective and proficient when using new tools.
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Overcoming Institutional Inertia
Admittedly, the Pharma industry does not typically accept change all that readily. Institutional inertia (both corporate and CROs) remains a significant barrier to change. Pharmaceutical companies must implement robust change management strategies that encourage early adoption if they want to modernize their site selection model.
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Regulatory Considerations
Being in compliance with all regulatory guidelines is still paramount to maintaining the integrity of clinical trials. The acceptance of data-driven site selections by senior, in-house regulators and data scientists is not yet common, but it seems to be gaining some level of acceptance.
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Ensuring Data Privacy and Security
The ability to continually ensure the privacy and security of all patient data is crucial to the success of any clinical trial. With the increased use of electronic data and patient health records, pharmaceutical companies must continue to implement robust data security measures and initiatives.
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Adhering to Good Clinical Practice (GCP)
All site selection and patient recruitment processes must align with GCP principles. Regular audits and monitoring ongoing clinical sites are vital to ensuring regulatory compliance throughout the trial.
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Ethics and Patient Protection
For patients involved in remote trials, the need for informed consent remains an absolute priority—especially when developing remote trials. When leveraging decision-making algorithms, transparency and fairness must be maintained to protect patient rights.
In the unending quest to accelerate pharmaceutical development and bring effective and innovative treatments to patients, the traditional approach of clinical trial site selection is clearly ripe for major change and transformation.
We work with clients to develop a data-driven site selection model that brings together the best that new and innovative technologies have to offer pharma companies and patients. Pivoting away from traditional CRO and specialized recruitment company partnerships to leverage technology expertise may contribute to the reduced trial duration, improved patient recruitment, and major cost-saving outcomes that pharma companies are eager to achieve.
Even as customers navigate the challenges that come along with adopting this revolutionary approach—from regulatory blockers to institutional barriers—we are confident that the future of clinical trial site selection can be data-driven, patient-centered, and transformative.
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