The growth of the global biotech industry has increased the need for a clinical trial infrastructure that can facilitate the efficient and high-quality execution of research studies. According to a recent study, the growth of the international clinical trials market is projected to grow at a compound annual growth rate (CAGR) of 9.1% to reach US$54.3 billion in 2027. In the pursuit of bringing innovative therapies to market, both large and small sponsors are increasingly turning to contract research organizations (CROs) for research services on a contract basis and to help navigate the complex landscape of drug development. CROs support the biotech industry with their experience and expertise in running clinical trials, streamlining the process, and increasing the speed at which new medications, devices, and technology are brought to market.
The Role of CROs
CROs are third-party organizations that provide services and resources to support pharma, biotech, or medical device companies, as well as research institutions, universities, and government organizations in their research. Sponsors may outsource clinical trials’ oversight and day-to-day management to a CRO. The services provided may be niche, limited to biostatistical advice, management of regulatory affairs, or pharmacovigilance. Some CROs also offer a full range of services for clinical trial management, from selecting clinical sites and investigators to supporting patient recruitment, safety surveillance, clinical monitoring, site audits, project management, data management, and biostatistics.
CROs and The Clinical Trial Landscape
Traditional clinical trial systems‘ ineffectiveness affects sponsors, CROs, clinical research associates (CRAs), site staff, and patients. These include poor recruitment and retention, inefficient data management processes, selecting and maintaining good sites, lack of high-quality data collection tools, the financial, physical, and time pressure on patients of on-site visits, operational complexity and expense, extended timelines, and clinical research workforce gaps, amongst others. CROs can help solve biotech sponsors’ challenges in several ways.
Emerging biopharma companies are increasingly responsible for a larger share of the research and development (R&D) pipeline – a record 65%, up from 34% in 2001. In 2021, emerging companies sponsored 3,386 clinical trials, an increase of nearly threefold in a decade. R&D spending in smaller biotech is forecasted to grow twice as fast as their larger counterparts. This shift towards outsourced clinical trial oversight emphasizes the importance for smaller biotech sponsors to consider essential elements when choosing a CRO.
Emerging Trends and Observations. To learn more about the future of the clinical trials industry, Alsumidaie (2022) interviewed DIA, a global member-driven association of life science professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotech, medical devices, and related healthcare products.
- Diverse patient populations and patient focus. The pandemic helped integrate communities that previously faced barriers to entry, e.g., not feeling welcome or knowing how to participate. Further, there has been growing patient engagement and patient-centric drug development.
- Expanded collaboration. Reimbursement, health technology assessment (HTA), and other experts engage earlier in the drug development lifecycle to improve patient access.
- Shift to Decentralized Clinical Trials (DCT). Center for the Study of Drug Development of Tufts University found that decentralized processes increase the efficiency of drug development.
- Patient-centricity and regulatory changes. The U.S. FDA published guidance on patient-focused drug development, including collecting patient input and identifying patient priorities.
- Patient privacy, data ownership, and data integration. Stakeholders realize that new data collection and analysis methods may challenge drug development.
The Impact of COVID-19 on Clinical Research
The COVID-19 pandemic has significantly impacted the landscape of clinical research, prompting a rapid shift towards innovative approaches and decentralized trial models. As the industry adapted to the challenges posed by the pandemic, new methods such as remote monitoring, video visits, and electronic consent emerged, leading to improved flexibility, increased speed, and more timely data collection.
A survey of the life sciences industry conducted in 2020 (Oracle, 2021) identified similar trends: a rapid shift to DCT and balancing data quality concerns with regulatory compliance. Below we list key findings of a follow-up survey in 2021 of professionals in biopharma companies, medical device companies, and CROs around the world.
1. New methods adopted during the pandemic
The majority of respondents (82%) who implemented new clinical trial approaches reported that they positively impacted clinical trials overall. The most common approaches were remote monitoring, video visits, phone visits, eConsent, and electronic health records (EHR). At the same time, the top three positive outcomes of adopting new methods were more timely data, improved flexibility for patients, and increased speed.
2. Confidence in data generated from newly adopted approaches
The vast majority (92%) of respondents who adopted new clinical trial approaches during the pandemic were equally or more confident in the data collected than those collected using pre-pandemic methods.
3. Embracing change: adoption of new clinical trial methods
Almost all (97%) of respondents who adopted new clinical trial methods reported that they would continue using at least one of these new methods.
The Evolving Role of CROs
Due to the emerging trends and impact of the pandemic on clinical research, CROs have needed to adapt and better serve sponsors across the board. The Vial CRO is reimagining clinical trials by working with sponsors, CRAs, site staff, and patients to conduct tech-enabled trials which are cost-effective, timesaving, patient-centric, and of higher quality to bring new therapies to market. As a small CRO, Vial can also offer emerging biopharma and biotech companies the speed, agility, and undivided attention of a true partner.
Tech-Powered Clinical Trials
Majority of the surveyed companies who had introduced decentralized approaches planned to continue at least one. DCT adoption requires appropriate training and delivery across sites and improved data collection and management. Moving forward, the organizations surveyed also plan to give patients the option to choose how they participate in clinical trials.
CROs like Vial adopt the latest technologies, identify opportunities for application, and provide insights on how tech may be deployed to derive benefits of tech-enabled clinical trials and to improve clinical trial performance.
Addressing the inefficiencies of traditional clinical trial systems:
- Vial eSource replaces paper, driving clinical trials into modern practices — radically streamlining trial workflows.
- Vial EDC (electronic data capture) is a modern, intuitive, and hyper-responsive EDC platform.
- Vial ePRO (electronic patient-reported outcome) is a consumer-grade, mobile patient experience that is compliant and customizable for patients.
For more information on Vial, visit us here and explore our therapeutic areas: Dermatology CRO, Ophthalmology CRO, Oncology CRO, Gastroenterology CRO, Neurology CRO, Cardiology CRO, Medical Device CRO, Rare Disease CRO, and Digital Therapeutics CRO.
