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Collaboration and Outsourcing: Easing Clinical Trials

By Rishi Kakar, MD, Chief Scientific Officer, Segal Trials

Rishi Kakar, MD, Chief Scientific Officer, Segal Trials

The pharmaceutical industry continues to experience a paradigm shift with the growing trend of outsourcing and building strategic partnerships. Contract research organizations (CRO) which are an integral part of the pharmaceutical industry, respond to this change with headway toward collaboration. As the size, complexity, duration, and cost of clinical trials continue to escalate, additional factors such as technical expertise, improved operational efficiency, and access to innovation also serve as primary drivers for outsourcing and collaboration. In the light of this, a significant development that I have observed is the consolidation of small/mid-size CROs with large CROs. Some of the recent noteworthy partnerships include INC Research Holdings merging with inVentiv Health to form Syneos Health, and Quintiles with IMS Health to become IQVIA. This consolidation between the pharma companies and the CROs is primarily driven by the need to minimize clinical trial delays and costs and improve operational efficiencies. Additionally, the transformation is also urging many CROs to become keenly involved in developing a network of high-quality clinical research sites that can be activated rapidly when a sponsor provides them with a trial.

Collaboration and Outsourcing are Key

The key to a CRO’s success lies in its ability to understand the issues encountered by clinical research sites when conducting a study. CROs need to be responsive to sponsor timelines and cost. To ensure this, organizations must come up with an approach that minimizes the study initiation and execution time and provides regular feedback and analytics, enabling researchers to make any necessary changes while the study is being conducted. I believe collaboration between sites, CRO’s and sponsors is the solution to that. In the increasingly complex clinical trial landscape, this close collaboration is key to defining and implementing standard approaches that promotes efficiency in a trial. A framework that standardizes trial processes will eliminate the rework and redundancies and reduce the time taken for full study optimization. Collaborations are becoming a strategic priority for organizations hoping to create greater efficiencies in the race to deliver innovative therapies, drugs, and medicines.

"The key to a CRO’s success lies in its ability to understand the issues faced by clinical research sites when conducting a study"

Similarly, outsourcing continues to be a clinical trial mainstay, strengthening the partnership between sponsors and CROs. Strategic outsourcing is a viable approach for collaborative drug development by aligning objectives and business processes of sponsors and CROs. It provides the complete advantage of the expertise and operating efficiency that both the CROs and sponsors bring to the table, increases patient recruitment, lowers cost, reduces the timeline of the trial, and enables to better leverage internal operating resources.

Enhancing Research Studies

From the beginning of a trial, it is essential for a CRO to have a specific template that comprises a list of potential vendors whose products can be utilized for the study. This template specifies what kind of training a vendor needs, when and how they can help during specific trails. It is not uncommon for many vendors to change or add trainings mid-way through a clinical trial, or at times change their approach. This tends to contribute to the increase time burden of the trial, which sponsors may view as increased cost and time delay causing hardship both to the CRO and the research site. Hence, while collaborating with a particular pharma company, it is imperative for CROs to understand the aim of the clinical trial, identify the approximate time it would take, predict the redundant, exploratory measures that may impair the trial, and the vendors that can help.

The next important thing is to look at the technology from the perspective of the patient. In this aspect, CROs must interpret the main question: “Will this technology produce certain amount of burden on the patients and deter them from being in the trial or will it help?” A patient-centric approach enhances the understanding and knowledge among patients regarding their own health, wellbeing, and healthcare choices, leading to improved care. Collaborating and engaging with patients in the decision-making process enables healthcare providers to make better decisions concerning a patient’s health.

So, CROs must take all of these into consideration during the initial feasibility analysis and discuss with the sponsors regarding the same in order to conduct clinical trials more efficiently.

The Future of the CRO Landscape

The emergence of disruptive technologies combined with patient-centricity is forcing research organizations to consider new radical models. One such approach is site-less clinical trials, which will see increased adoption by some CROs. Patient participation is essential component of a clinical study; however visit requirements can contribute to a burden on the patient who has to visit the research center numerous times throughout the trial. A site-less trial minimizes the visit burden that patients experience to just two times—once at the beginning of the study for authorization and once at the end, when the primary endpoint is measured. This process may also be attractive to sponsors due to savings in time and money. This approach, however, shifts burden of assessments to patients and relies on their motivation to engage with the study team. The complexity of the clinical trials has also led to a shift at the site level. More and more trials are being conducted by mid-size to large-size clinical research sites that have the resources to manage such complexity and have build in diversification to mitigate against any financial risks.

The biggest predicament the CRO industry faces as it goes through this evolution is they are sandwiched between the sponsors’ specific needs, timelines, and cost, and needs of research sites. Retaining both sites and patients lies in a CRO’s ability to treat them as valued partners, and one way to accomplish this is to understand and address the various hurdles that both trial sites and patients face, ultimately developing trust and loyalty for long-lasting partnerships.

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