Clinical trials are crucial for swiftly determining the viability of new therapeutic candidates through rigorous data analyses. Collaborating with seasoned clinical research organizations (CROs) is pivotal for achieving these outcomes, particularly in the intricate realms of oncology and rare diseases. Specialized CROs bring a deep understanding of both investigator and patient needs, bolstered by a wealth of experience in guiding successful trials. With established operations across North America and Europe and expanding influence in Asia, Ergomed Clinical Research continuously enhances our expertise in meeting global care standards and understanding diverse patient populations, reinforcing our leadership as a therapeutic specialist poised to support sponsors at any scale.
Minimizing Costs and Time While Ensuring Patient-Centric Outcomes
The fundamental objective of any clinical trial is to assess the safety and effectiveness of a drug candidate. Achieving this goal necessitates conducting studies that are as compact as possible, with the smallest possible study size and using efficient endpoints to minimize costs and accelerate decision-making. Designing such studies requires careful consideration of these factors alongside the specific needs of the patient population involved.
Engagement with advocacy groups is particularly invaluable, especially for rare diseases and specific oncology indications, as it enriches the study design with patient-centered insights. Additionally, the choice of trial sites is pivotal and often influenced by patient availability and the interest of investors in certain markets, with the United States frequently being a preferred location. Even in the recent release of the U.S. Food and Drug Administration (FDA) Guidance for Industry from Project Optimus, patient advocacy engagement is encouraged as part of the drug development process: ““Engaging with patients and other key stakeholders, such as advocacy groups in a given disease area, can provide valuable input on important considerations regarding safety, tolerability, and dosage convenience (e.g., schedule, pill burden) when selecting an optimized dosage(s).”
Involving a diverse array of experts is essential for successful clinical trials, especially in oncology, where the complexity of trial design demands input beyond the expertise of a single individual, even for narrowly defined disease indications. This multidisciplinary approach ensures that all aspects of the trial, from protocol development to patient recruitment, are thoroughly considered. Once a robust trial design is established, seeking feedback from regulatory agencies becomes a critical step. Securing early advice from prominent regulators like the FDA and the European Medicines Agency (EMA) ensures that the trial has feedback from vital stakeholders and is optimally configured.
To verify the feasibility of these designs, a formal “feasibility” study is conducted to confirm that enough patients can be recruited swiftly, ensuring that the trial proceeds efficiently and effectively. The most informed feasibility assessments go beyond the standard pro forma by engaging in clinician-to-clinician expert discussions across various medical and scientific disciplines. For example, in oncology trials, input from oncologists, radiologists, pathologists, and pharmacologists may be required to address the full range of considerations — from patient diagnosis and treatment regimens to drug metabolism and imaging requirements. This interdisciplinary collaboration helps ensure that the study design is not only scientifically sound but also practical for implementation in diverse clinical settings.
Clinical trials are fundamentally designed to facilitate swift go/no-go decisions for new drug candidates, leveraging robust data to guide these outcomes. Effective partnerships between study sponsors and seasoned CROs are integral to achieving this objective. CROs must deeply understand the sponsor’s background, patient experience, and the study dynamics to anticipate the required level of investment. By integrating this understanding with insights drawn from previous experiences along with real-time robust feasibility, CROs can craft more creative and yet resilient study designs that employ the most suitable endpoints. This tailored approach ensures that each study is optimally and efficiently designed while avoiding undue complexity and unnecessary costs.
Essential Collaboration and In-depth Understanding
Today’s clinical trials necessitate the involvement of medical professionals from varied specialties. For a CRO to operate effectively, it must possess a comprehensive understanding of the disease under study, including rare diseases, as well as the study protocol, to determine the necessary expertise required for the trial.
Take prostate cancer research as an example: it requires the collaborative efforts of oncologists and urologists, tailored to the clinician who is treating the patient and the specifics of the therapy being administered. When treatments involve radiopharmaceuticals, this collaboration extends to include nuclear medicine specialists and diagnostic experts, not to mention the complexities of the supply chain. Establishing these foundtational internal collaborations before commencing the study is crucial, as a cohesive interdepartmental relationship significantly contributes to the success of complex trials by ensuring smooth participant recruitment and minimizing treatment-related complications.
Furthermore, a deep understanding of both patient and protocol needs is vital for determining the most effective format for clinical trials. While wholly decentralized trials offer significant benefits in certain scenarios, oncology trials often benefit from a hybrid model. This model is designed to reduce patient travel to essential visits only, such as for necessary imaging or procedures that cannot be conducted remotely, thereby lessening patient burden, simplifying processes for patients and investigators alike, and enhancing overall study efficiency.
Evaluating Investigator Site Performance
A critical component in the setup of clinical trials is the selection of investigator sites, which requires careful consideration of a multitude of factors. Recruitment history is a key consideration, but other elements are equally relevant. For instance, sites that have established relationships with a CRO are often able to accelerate the start-up phase, as contracts and terms are already negotiated.
However, a site's past success does not guarantee future results. Changes in site personnel can impact performance. Conducting thorough site visits and engaging directly with investigators and their teams are key to accurately assess the suitability for the study. Additionally, collecting detailed information about potential sites and their staff helps in making informed decisions that optimize the conditions for conducting the trial, ensuring smoother operations and a better overall experience for both patients and sponsors. Additionally, particularly for rare cancers, it is imperative to assess the history of the site in conducting clinical trials for the disease under investigation to avoid possible saturation and depletion of possible local participants.
The Increasing Demands of Novel Oncology Therapies
In the field of oncology, the development of novel therapies such as chimeric antigen receptor T (CAR-T) cell therapies, bispecific and trispecific antibodies, and radiopharmaceuticals is advancing rapidly, each showing significant promise. These therapies introduce complex requirements for clinical trials, particularly concerning the need for heightened monitoring due to their potential and often unique side effects. It is imperative that patients are informed about the increased level of commitment these treatments entail.
Selecting the right investigators is equally paramount; only those with a profound understanding of how to administer these treatments and manage potential toxicity should be involved. For instance, radiopharmaceuticals necessitate specific radiation protection measures for patients, their visitors, and hospital staff, dependent on the isotope used. These drugs often require delivery through designated entrances, and special procedures may be needed if a patient experiences adverse effects such as vomiting post-administration, potentially leading to temporary closure of treatment rooms.
Furthermore, dose escalation protocols for these drugs differ significantly from traditional medications. In the case of CAR-T cell therapies, for example, managing cytokine release syndrome is a significant challenge, and trial sites must be adept at recognizing and treating this condition. Additionally, the location of trial sites is crucial; they must be situated within a specific proximity to the manufacturing facility to prevent degradation of the therapies during transport, and specialized packaging is necessary to minimize degradation, protect individuals involved in transportation from exposure, and to properly communicate the contents and associated risks.
Ergomed's Distinctive Advantages
Ergomed Clinical Research, a midsize, full-service CRO, excels in advancing oncology and rare disease programs from initial stages through post-marketing research across North America, Europe, and Asia. Our extensive scientific expertise and deep knowledge enable us to adopt a consultative approach, tailoring our services to meet specific client needs. Our unique historical experience as part owners of the drugs we've helped develop, has ingrained a profound understanding of the importance of adhering to timelines, crafting protocols that meet care standards, and collecting robust outcomes data that withstand scrutiny from regulatory bodies and payors.
This co-development experience is a cornerstone of our distinctiveness. Having previously served as investigators, we bring a unique perspective that ensures our study designs are feasible for both sites and patients. We engage deeply with sites to grasp their challenges and devise effective solutions. Consequently, Ergomed's study designs are streamlined, pragmatic to implement, and efficient, fostering seamless recruitment and strong relationships with physician investigators.
Moreover, Ergomed boasts a dedicated Strategic Solutions and Patient Centricity group focused on patients, investigators, and data, led by directors specializing in Patient Engagement, Clinician Engagement, and Data Intelligence. The Patient Engagement Director collaborates closely with patient advocacy groups to understand the patients' experiences and ensure that our trials are patient-centric, enhancing the quality of life for participants. The Clinician Engagement Director views trials through the lens of the clinicians, addressing their practical challenges and ensuring that our trials align with standard care practices. Our Data Intelligence Director leverages diverse data sources to optimize trial planning in terms of site selection and recruitment timelines, while also monitoring trial progress in real time.
Ergomed’s Site Management and Study Physician teams offer personalized support to investigator sites, providing a responsive support system that caters specifically to the needs of coordinators and investigators, distinguishing Ergomed from traditional CROs that lack this focus.
Additionally, our growing expertise in novel therapies within the rare disease and immuno-oncology sectors, including checkpoint inhibitors, bi- and trispecific antibody drugs, and CAR-T cell therapies, positions us very favorably. These therapies, which interact with both tumors and the immune system, require complex study designs and numerous procedures. Our proactive presence at trial sites to understand their unique challenges ensures that these complexities are effectively managed, ensuring coordinated and properly implemented activities.
Ergomed’s Footprint in the United States
Following the acquisition of the Texas-based oncology and rare disease CRO, MS Clinical Services, LLC (“MedSource”) in December 2020, Ergomed significantly expanded its client base in the United States, adding over 20 new clients and solidifying its presence in this pivotal market. Our extensive track record in oncology and rare disease drug development spans the gamut of product types, clinical trial phases, and study designs. We have successfully completed major studies in prostate, breast, endometrial, ovarian, head and neck, gastric, lung, pancreatic, and ovarian cancers and other rare indications, and diverse treatment modalities including stem cell, cellular and gene, and oncolytic virus therapies, fostering both informal and formal partnerships across our expansive investigator network to meet client timelines and regulatory demands.
Looking ahead, Ergomed is dedicated to maintaining a high standard of medical science expertise, especially in the intricate domains of oncology and rare diseases. We continue to deepen our knowledge and enhance our operational presence, not only in North America and Europe but also expanding into East and South Asian markets, with a strong focus on China. By leveraging our understanding of investigators, care standards, and patient populations, we are poised to further cement our status as a leading therapeutically specialized CRO, equipped to support sponsors at local, regional, and global levels.
