By the end of 2022, while the global COVID-19 pandemic seemed to be subsiding, the development of the biotech and healthcare industry has kept up its pace over the past three years. Rather, consolidation efforts have been accelerated in specific areas, especially the integration of healthcare and technology powered by data analytics, providing real-world evidence that makes smart healthcare more user-friendly.
Fast-growing Applications of Real-World Data
Real-world data (RWD) refers to the data relating to patient health status and routine delivery of healthcare. These types of data may come from a number of sources including electronic health records, medical claims and billing activities, and mobile devices that can inform on health status.
RWD has become increasingly important in healthcare decision-making. According to the U.S. Food and Drug Administration (FDA), the 21st Century Cures Act, passed in 2016, places additional focus on using these types of data to support regulatory decision making, including approval of new indications for approved drugs.
Real-world evidence (RWE) is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. The U.S. Congress defined RWE as data regarding a drug’s usage, or potential benefits or risks, derived from sources other than traditional clinical trials.
It has become increasingly common to collect and store huge amounts of health-related information using computers, mobile devices, wearables, and other biosensors. However, in the past, clinicians often felt lost when dealing with a sea of health data generated because the data was often unstructured and fragmented.
In clinical trials, randomization and blinding are the gold standards for determining treatment efficacy. Yet, with the strict definitions of eligible patients, the study populations are getting different from patients encountered in actual clinical practice, with a broader range of disease severity and age, a wider range of drug combinations, and more comorbidities. Besides, the representativeness of different patients in clinical trials has become another matter of concern. Therefore, RWD collected outside of randomized controlled trials, including patients’ health status and routine health care services, have gained greater importance.
Fast-growing Scale of Decentralized Clinical Trials
Large-scale clinical trials were once centralized and centrally managed for effectiveness and efficiency. As a result of the ongoing pandemic and the exclusivity and specificity of the study populations, the FDA has proposed strategies for decentralized clinical trials (DCTs). Unlike conventional trials, DCTs use remote medical and mobile or local healthcare providers, using processes and technologies that differ from conventional models.
DCTs are conducted remotely, with participants remaining at their homes for most or all of the study period. The aim of DCTs is to make it easier for patients to participate in clinical trials by reducing the need to travel to central trial sites. This approach has the potential to make clinical trials available to a wider demographic of participants and reduce drop-out rates. The global market for DCTs is projected to reach US$18.95 billion by 2028, up from US$7.135 billion in 2021, representing a compound annual growth rate of 14.8% from 2022 to 2028.
Since 2020, the FDA Oncology Center of Excellence has proposed collaborative initiatives to advocate for modernizing clinical trials, partnering with pharmaceutical companies to initiate the generalization of remote trial modifications and supporting evidence generation for approval of additional oncology indications of existing drugs or applications for new drugs or biologics.
Technology Development for Personalized Medical Needs
Major pharmaceutical companies are no longer focused on a single area. Instead, they are leveraging the power of new technologies to incorporate increasingly complex new modalities into their pipelines, such as cell therapies, mRNA, non-coding RNA (oligonucleotides and siRNA) and various gene therapies. These new therapies may bring significant progress for patients and, in some cases, hold the promise of a possible cure with a single dose.
A more personalized approach to healthcare has also been facilitated by multinational logistics companies and retailers entering the healthcare industry. In comparison to traditional healthcare providers, retail healthcare providers are generally more accessible and may not require prior appointments, and are less likely to be affected by shortages due to the high workload of clinical staff.
Furthermore, in light of the paradigm shift in healthcare, wearable medical devices will be increasingly used by individuals during 2023. These devices can track the users’ personal electronic health records and allow doctors to monitor patients remotely, thereby increasing connections between patients and clinical staff, improving data management efficiency, and achieving a balanced development of demand and supply.
