Emerging biopharma companies, which are relatively smaller than large global players, are comparatively more focused on oncology, infectious disease, and vaccines. According to a 2022 report by IQVIA, oncology represents 39% of the emerging biopharma pipeline. These smaller biopharma companies are also responsible for a significant portion of all oncology drug development in the industry, with more than 1,500 oncology products in development. In turn, this has fueled the need for clinical trial infrastructure that enables the fast execution of high-quality clinical trials and is tailored to the unique needs of small oncology sponsors.
Precision Medicine and Oncology Clinical Trials
Precision medicine, also known as personalized medicine, is an innovative omics-based approach to identify, prevent and treat disease using DNA, RNA, and protein analyses. The shift towards precision medicine in oncology requires a parallel change in oncology clinical trials from tumor type-centered trials to precision trials or genetics-driven trials. For the latter, the core principle is to customize treatment or prevention strategies to match specific treatments with specific genetic mutations. In response, contract research organizations (CROs) introduce innovations in oncology clinical trial design and improve operational efficiency through genetics-directed and adaptive trials. For oncology sponsors, adaptive trials can offer a seamless transition to confirmatory trials if early results are positive.
Benefits of working with a small Oncology CRO
To bring new therapies to market, biopharma companies engage CROs for their expertise in navigating the complex landscape of drug development and regulatory pathways.
Oncology sponsors need to be aware of and adapt to potential changes in the drug approval process by regulatory authorities, who are working to overcome technological, ethical, and legal barriers in providing precision medicine to their patient population.
The selection of a CRO depends on the experience, areas of expertise, geographical reach, and, importantly, the ability of the CRO to meet the sponsor’s clinical objectives. The benefits of working with a small oncology CRO include the following:
Expertise: Small oncology CROs offer a high degree of specialization in oncology. The Vial Oncology CRO focuses resources and energies on developing in-depth expertise to deliver a streamlined oncology clinical trial start-up, more predictable patient recruitment, and high-quality data. To remain competitive and offer clients a full range of value-added solutions, small oncology CROs keep up to date on the latest technologies, techniques, and tools in oncology clinical research. As Vial has invested heavily in technology products and managed best-in-class research sites, it has a breadth of experience that matches or exceeds that of sponsors while having in-depth oncology experience and expertise.
Therapy Experience: Sponsors prefer CROs that have therapy experience and understand the challenges they will encounter on the path to regulatory approval. Smaller biopharma companies embarking on oncology drug development for the first time may rely on CRO partners like Vial and its oncology expertise, to supplement their capabilities, and to provide tactical and strategic support. The Vial Oncology CRO has built its scientific advisory board to include experienced research oncologists who understand how to harness the power of precision medicine and clinical data to combat the growing complexity of oncology clinical trials.
Trial design: Given that researchers have access to lifestyle, environmental and health data, precision oncology trials can be designed to include patients who are most likely to respond to the targeted treatment. This benefits both the patient and the sponsor. As a small Oncology CRO, Vial offers oncology sponsors a CRO built to match their unique needs for the execution and successful completion of clinical trials.
Technology: To support the data-demanding analyses needed for precision medicine, high-throughput-omics technologies enable the retrieval of comprehensive and holistic biological information, while advanced data processing capabilities enable the data modeling required.
Small Oncology CROs, like the Vial CRO, are poised to adopt the latest technologies, identify opportunities for application, and provide insights on how the tech may be deployed to improve oncology clinical trial performance. To this end, some CROs have developed their own unique technology products and services. The Vial Technology Platform is one example of tech-enabled clinical trials supported by a small CRO. Vial’s seamless operating system ensures that trials are run with maximum efficiency. For more information on the tech-enabled capabilities developed by Vial, click on the links below:
VialConnect is an intuitive clinical trials management system (CTMS) built for coordinators and investigators whereby all investigator site files, electronic logs, and participant binders can be created, edited, distributed, collected, signed, and reviewed electronically. Digital from start-up to close-out, VialConnect allows cross-organizational efficiencies between the sponsor, CRO, and sites.
Vial eSource is a digital system that allows for initial data capture in an electronic source which can be in the form of electronic consent forms, electronic patient diaries, electronic case report forms (eCRF), and clinical outcomes. Built hand-in-hand with world-class data management teams, eSource has automated data validation and rigorous query workflows built directly into the platform to ensure the highest quality clinical data.
Vial eTMF is a seamless file management system with an intuitive workflow for clinical operations teams. eTMF is an electronic Trial Master File that enables structured clinical trial document collection. TMFs are required for good clinical practice.
Vial Electronic Data Capture (EDC) is an electronic system used to record and maintain subject data in clinical trials. It includes a data entry system, validation process, and reporting tools for data analysis. The Vial EDC integrates builds and protocol amendment management as well as end-to-end data security.
Vial electronic patient-reported outcome (ePRO) is a consumer-grade, mobile patient experience that is compliant and customizable for patients in a trial. It is an electronic system that allows patients to directly report the status of their health condition through computers or mobile devices and may be in the form of electronic diaries or questionnaires.
People: Oncology sponsors need a CRO team with expertise at all levels and who pay enough attention to detail. Small Oncology CROs like Vial invest in developing the expertise and abilities of in-house oncologists and clinical delivery experts to run complex oncology clinical trials. The Vial Oncology CRO is also supported by a team of highly experienced scientific advisors.
Sponsors prefer working with the same people from start-up to completion. Changes in project manager and clinical research associate (CRA) may result in unanticipated disruption, dissatisfaction at research sites, and extended timelines. Smaller CROs tend to have significantly lower turnover than large ones, providing the stability and continuity sponsors need.
Culture: In choosing a CRO, sponsors seek CRO partners with a similar corporate culture and value intangibles such as trust, reliability, and being proactive in solving issues. Emerging biopharma companies may not prefer having to fit into a large CRO’s system and existing working culture .
Customization: Sponsors express the need for transparency, flexibility, and problem-solving skills from a CRO. Smaller CROs offer more flexibility for customization and can propose and jointly execute out-of-the-box solutions and approaches for projects. Precision medicine trials can be smaller than traditional trials and yet produce better results as they allow researchers to target specific aspects of a disease, e.g., a genetic mutation. Innovative trial designs can therefore be conducted more efficiently and within shorter timeframes. For the sponsor, this could potentially reduce the time to market.
Undivided Attention: For sponsors seeking a high-touch relationship with a CRO, small CROs can offer close contact, good oversight, and a more personal experience. In a partner-like model, small CROs are responsive and mindful of their emerging biopharma client needs.
Small Oncology CROs are flexible, adopt the latest in technology, and can customize solutions to meet the needs of sponsors, regardless of their size. In response to the shift to precision medicine in oncology by emerging biopharma companies, small niche CROs also offer a high degree of specialization in oncology with the experience, expertise, and undivided attention to be valued partners in the drug development journey.