Our Niche: How Early-Stage Clinical Trial Expertise Delivers Better Client Solutions
The process of clinical drug development is complex and associated with high costs and risks. A recent report on drug development found that the overall likelihood for approval of Phase 1 developmental candidates was 7.9% for the time period between 2011 and 2020, and the process lasted on average 10.5 years.
Each stage of clinical drug development presents its own set of challenges. However, the early stages – Phase 1 and Phase 2a – are critical because, without their successful completion, the development of the investigational therapeutic cannot proceed.
Studies encompassed by Phase 1 and Phase 2a clinical trials
Phase 1 clinical trials investigate the safety and tolerability of novel therapeutic interventions in humans, following up on the results of preclinical studies. Moreover, they provide information on the pharmacokinetic (PK) properties of investigational drugs and may include drug-drug interactions and food effect studies.
In most cases, Phase 1 studies are performed on healthy volunteers. However, in certain instances, such as in the field of oncology, patients will most likely be participating. Phase 2a clinical trials build on the findings of Phase 1 studies to demonstrate the biological activity of the investigated therapeutic.
Challenges with early-phase clinical trials
The significance of early-phase clinical trials in drug development underscores the need for adaptive and comprehensive study designs and efficient recruitment. Some of the challenges that early-phase clinical trials frequently face include:
Complexity of the study design of early-phase clinical trials
A recent study found that the complexity of clinical trials conducted during 2011–2015 had increased compared to those performed during 2001–2005. Changes included a higher number of performed procedures, more frequent procedures overall and per visit, an increased number of planned visits per study subject, and a heavier burden associated with study participation.
Phase 1 clinical trials designs are especially complex and characterized by extensive safety monitoring and correlative testing. BioPharma Services has an expert North American-based medical team and dedicated Phase 1 clinical trial centers that enable us to conduct early clinical development studies efficiently. Our scientists work closely with the principal investigator and clinical staff throughout the entire trial to ensure each study is run as designed and to help identify solutions to any unexpected problems that might arise.
Selection and recruitment of study participants
The selection of study subjects and their recruitment are key aspects of the conduct of early-phase clinical trials. However, the failure to recruit and retain sufficient study participants has emerged as a significant challenge in many clinical trials. BioPharma has established an extensive database of potential study participants to address this problem, which includes both healthy volunteers and special populations.
Initial dose selection and dose escalation
The initial dose selection of investigational drugs for Phase 1 clinical trials may be based on the findings of preclinical studies. However, the translation of preclinical results into clinical studies and the establishment of a suitable dose-escalation scheme are complex and challenging. Led by Dr. John Oldenholf, MSc, PhD, BioPharma’s Clinical Pharmacology team’s expert scientists work to provide reliable and data-driven solutions to clinical trials so that appropriate dosing schemes and selections — all with patient safety as a top priority in the decision-making process.
Selection of relevant endpoints and addressing multiple study objectives
The selection of suitable endpoints to assess the safety and tolerability of investigational therapeutics in Phase 1 trials and their biological activity in Phase 2a trials is a key factor in clinical trial design. Commonly, in addition to the primary safety endpoint, other safety-related and clinical pharmacological parameters are selected as secondary endpoints in Phase 1 clinical studies, a decision that requires the expertise of physicians and clinical pharmacologists.
The importance of statistical design and regulatory oversight
In light of their complex design, an appropriate statistical analysis plan is critical for successfully completing early-phase clinical trials. Further, regulatory professionals should be involved throughout the process to ensure that all aspects of the study comply with regulatory bodies’ requirements. The biostatisticians and regulatory writers at BioPharma Services have extensive experience in the support of early-stage clinical trials.
BioPharma’s end-to-end Phase 1 & 2 expertise helps clients accomplish their early development program goals
BioPharma Services has an experienced medical team that is dedicated to developing innovative medical therapies and healthcare solutions. Our personalized and comprehensive approach to clinical trial design and execution makes us a trusted partner in conducting even the most challenging early-phase clinical studies.
In addition, we have established a large volunteer database of more than 18,000 active subject participants that enables us to seamlessly execute a variety of Phase 1 trials. Our volunteer database includes healthy males and females, post-menopausal and/or surgically sterile females, hypogonadal and vasectomized males, and recreational drug users.
The extensive expertise of our team and the infrastructure of our Phase 1 centers – located in Toronto, Canada, and St. Louis, Missouri – also have been integral to the successful completion of more than 2,000 early-stage clinical trials.
The wide range of clinical studies that we conduct includes first-in-human clinical trials and single-ascending-dose and multiple-ascending-dose designs. Furthermore, we have expertise in food-effect, pharmacokinetics, pharmacodynamics, bioavailability, and bioequivalence studies. In addition, our considerable experience in the field of drug abuse research enables us to conduct drug-drug and alcohol interaction studies, human abuse potential/abuse deterrent assessments, and medical cannabis studies.
Overall, BioPharma’s comprehensive niche expertise in early-phase clinical drug development puts us in a unique position to provide innovative and reliable solutions for a variety of Phase I & IIA clinical trials.
Our team is dedicated to improving healthcare and providing innovative medical solutions to our communities. This unique network of experts, along with our flexible approach, allows us to take on even the most challenging studies and be your trusted partner in the creation of leading-edge healthcare solutions and medical therapies.
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 1/2a clinical trials 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.