How the end-to-end approach of a full-service clinical research organization (CRO) addresses human clinical trial challenges
Drug discovery and development are crucial to introducing novel therapeutics in clinical practice, and the research in these fields is intensive. In 2020, the Center for Drug Evaluation and Research at the Food and Drug Administration approved 53 novel therapeutics, the second-highest number in its history. However, the drug development process remains time-consuming and complicated, and only a small proportion of identified drug leads are eventually approved for use in clinical practice.
The transition from preclinical to clinical studies is an essential step in the drug development process. Clinical trials are an integral part of drug development, and the number of ongoing clinical trials is high. In June 2021, there were 380,700 studies registered on ClinicalTrials.gov, with 58,695 of them actively recruiting.
However, the conduct of human clinical trials is accompanied by many challenges, spanning from the development of drug trial protocols, recruitment of participants, and study execution to obtaining study approvals and overcoming regulatory hurdles, all of which can significantly impede the drug development process. Full-service contract clinical research organizations (CRO), such as BioPharma, provide comprehensive services to streamline clinical studies and facilitate the drug development process.
Challenges of human clinical trials
Complexity in the development of drug trial protocols
The study designs of human clinical trials have become increasingly complex, which was identified as a significant challenge for drug development in a survey of clinical trial professionals. A variety of factors should be considered in the study design, such as inclusion and exclusion criteria; number of participants; study duration; selection of a control group; administration route and dose of the study drug; study assessments; and data collection, review, and analysis.
Moreover, the external validity of some human clinical trials may be limited because they may not reflect the variability of patient characteristics and other treatment-related factors in the clinical practice. BioPharma has nearly 20 years of experience in developing innovative clinical trial designs, which enables us, together with our clients, to map out an efficient strategy for clinical research.
Participant recruitment issues
The recruitment of study participants is another important challenge that human clinical trial professionals encounter. Participant retention can be difficult, as well, with high dropout rates for some trials. BioPharma Services has established a database of more than 18,000 active subject participants, including healthy volunteers and special populations, enabling us to perform efficient recruitment in a timely manner.
Challenges with human clinical trial execution
The efficient conduct of human clinical trials requires the presence of dedicated research infrastructure, personnel, and technology. Consequently, the absence of adequate research infrastructure, including insufficient financial and structural support, impedes the timely and efficient execution of clinical trials. Furthermore, clinical trial professionals have pointed out challenges in securing adequately trained personnel and technology that has the required capabilities and can gain acceptance among clinical researchers.
BioPharma Services has dedicated Phase I centers in Toronto, Canada, and St. Louis, Mo., which provide the necessary infrastructure to support our global clients’ early-phase drug development program needs. We are also experts in the conduct of bioequivalence and bioavailability studies, which can support generic and hybrid drug filings and 505(b)(2) New Drug Applications.
Navigating the path to study approval
The conduct of human clinical trials requires ethical review board approvals. This process is associated not only with extensive paperwork, possibly including multiple review cycles, but also with a relatively long timeline that may delay the initiation of a study. In addition, obtaining informed consent from participants also requires extensive paperwork.
Informed consent forms are developed to comply with legal requirements and may be perceived as confusing by some study participants. BioPharma Services has an experienced medical writing team that can support your submissions to the ethical review board and develop all clinical trial and program documentation.
Support from experts throughout the regulatory process
The complexity of regulatory requirements has been identified as one of the major challenges faced during human clinical trials. There may be variability among the regulations of different regulatory bodies, which can further complicate the execution of clinical trials. BioPharma’s expert medical writing team can assist you with the preparation of regulatory submission documents and more.
Benefits of the full-service Clinical Research Organization (CRO) approach
The complexity of human clinical trials necessitates a team of professionals with different backgrounds and the availability of dedicated infrastructure and resources. Identifying professionals to collaborate with on the execution of a human clinical trial can be a time- and energy-consuming process, as well as a drain on resources.
Alternatively, promptly drawing on already available resources streamlines the clinical trial process and facilitates clinical drug development. A full-service clinical research organization has at its disposal a team of qualified professionals and the necessary infrastructure to enable the conduct of human clinical trials.
End-to-end solutions offered by a full-service clinical research organization CRO
End-to-end solutions for Phase 1 clinical trial and II research trials translate into streamlined and efficient human clinical studies. BioPharma is a full-service clinical research organization specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide.
We add value for pharmaceutical companies and biotech companies running preclinical studies by delivering high-quality results in a timely manner. Our clinical research organization has embraced a culture and brand of excellence and developed into a global leader in medical research. We take pride in our client-focused approach, agility, and responsiveness.
BioPharma has established a robust database of both healthy subject volunteers and special populations for efficient and prompt recruitment. Our expertise spans across early-phase drug development programs, bioequivalence and bioavailability studies, as well as bioanalysis, biostatistics, clinical trial data management, medical writing, and regulatory affairs, and we have completed more than 2,000 clinical trials. Contact us to learn more or schedule a discovery call today.
BioPharma Services, Inc., a Think Research Corporation and clinical trial services company, is a full-service Contract Clinical Research Organization (CRO) based in Toronto, Canada, specializing in Phase 1 clinical trials I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with access to healthy volunteers and special populations.