Recent decades have brought about important innovations in drug development, including novel clinical trial designs, digital endpoints, and regulatory changes. These factors have contributed to the increased complexity of clinical trials. However, the wide range of therapeutic areas in clinical trials also contributes to their complexity. Moreover, different therapeutic areas may pose specific challenges regarding volunteer recruitment, clinical trial design, adherence to regulatory guidelines, required medical procedures, and data analysis.
To address the complexity of clinical trials across diverse therapeutic areas, it can be very beneficial to collaborate with an experienced clinical research organization (CRO) that has the know-how of a multidisciplinary team of experts.
Therapeutic areas are fields of research and therapeutic development for groups of similar medical conditions. Globally, oncology is the therapeutic area with the highest clinical trial volume. It is followed by mental health and behavioral disorders, endocrinology and metabolic diseases, cardiovascular and circulatory diseases, and nervous system diseases.
As a full-service Phase 1 CRO, BioPharma Services is involved in drug development programs across a variety of therapeutic areas, including cardiovascular diseases, oncology, neurology, psychiatry, pain, infections, digestive system diseases, metabolic disorders, reproductive diseases, blood disorders, urological diseases, and respiratory disorders.
Innovative research and clinical tools, such as the use of engineered human cells, preclinical modeling, real-world data, and artificial intelligence, continue to find applications in drug development.
During the preclinical stage of drug development, animal models have long been established as the gold standard to characterize the safety and pharmacological effects of NCEs. However, challenges in extrapolating animal-derived data to humans and concerns about animal welfare have emerged. To address these concerns, there has been a trend toward decreased use of animal studies and greater implementation of engineered human cell lines and preclinical modeling in drug development programs. Human disease models with the potential to provide insight into the pharmacological and safety characteristics of NCEs include 2D-cell cultures, organoids, bioengineered tissue models, and one-organ and multi-organ models.
As clinical trials are limited in their duration, they can deliver safety and efficacy data concerning a fixed period. Real-world evidence (RWE), that is generated during routine clinical practice, can provide additional data regarding the use, safety, and efficacy of a drug. Sources of RWE may include patient health records, registries, pharmacy claims, and social media. Even though the broadest application of RWE has been in collecting safety data about a drug, it can also help instruct the design of future clinical trials.
In addition, there is a tendency towards the adoption of artificial intelligence and new technological platforms in clinical drug development programs. The implementation of artificial intelligence can help to improve testing efficiency and accuracy and promote the fast delivery of reliable data. More specifically, artificial intelligence may optimize clinical trial design, helping to transition clinical trials faster from the planning to the delivery stage. In addition, artificial intelligence tools may aid in the practical aspects of clinical trial delivery and provide novel simulation tools.
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