As most medications are primarily excreted through the kidneys or liver, most drugs in development will require a renal and/or hepatic insufficiency trial to assess the impact of organ impairment on the pharmacokinetic (PK) parameters of the investigational product. The data obtained from these trials will support the development of safe and effective dosing regimens for the affected patient populations. However, due to patient recruitment-related challenges, these trials present a unique challenge not typically found in standard clinical pharmacology studies.
To successfully manage organ impairment studies, clinical research organizations (CROs) must implement a model for study management that promotes communication, transparency and the alignment of overall objectives with sites and subject matter experts who have direct access to the patient population. When the CRO shows flexibility and adaptability to the real-world challenges of these studies, sites feel supported.
Therefore, the CRO should do all they can to remove unnecessary burdens on the sites and should be willing to leverage sites’ medical and operational expertise early and often. Organ impairment studies require this expertise; sites’ contributions to trial design, inclusion and exclusion criteria and patient care should be routine and welcomed.
A deep understanding of this special population is pivotal to developing a protocol that addresses the reality of the patient’s disease state (baseline), laboratory values, co-morbidities and medications. Once the study begins enrolling, investigators may encounter significant laboratory abnormalities, especially when impairment levels increase across the patient arms. Monitoring for significant parameter changes is a critical task across study management and patient oversight. Therefore, assigning investigators who can effectively interpret the laboratory values is crucial to ensure the appropriate patient management in the trial and accurate data reporting.
Lastly, when designing these trials, sponsors and CROs should consider how they can utilize clinical pharmacology tools such as population pharmacokinetic (PopPK) modeling and/or physiologically based PK (PBPK) modeling can in combination with adaptive trial design to decrease the burden on patients with renal and/or hepatic impairment. Furthermore, by using PopPK modeling of data from Phase II and III studies, it may be possible to gain insight into the impact of other impairment levels, potentially reducing the number of patients required for these clinical trials.
Register for this webinar today to learn how to effectively manage renal and hepatic impairment trials by leveraging site expertise, enhancing communication and utilizing advanced clinical pharmacology tools.
Speakers
Korey Nevitt, Executive Director of Site Partnerships, Dr. Vince Clinical Research
Korey Nevitt, Executive Director of Site Partnerships, has been in clinical research for over two decades with robust experience in operations, commercial strategy and planning and global site partnerships. Korey is responsible for the growth and expansion of our strategically aligned site partners and ensuring that the multi-site studies are conducted by the most capable investigators, that they are aligned with DVCR’s commitment to speed and customer service and that they deliver the highest quality data possible to biopharmaceutical clients.
Message Presenter
Harry Alcorn, PharmD, Chief Scientific Officer, Elixia
Harry Alcorn, PharmD, has over 30 years of clinical research experience working with public and private biotech and pharmaceutical companies in studies of kidney diseases, diabetic, hepatic and cardiovascular patients. He has designed / authored protocols and been a consultant to a multitude of companies in the industry on protocol development, clinical execution in specialty populations and regulatory guidance.
He has served as Principal Investigator or Sub Investigator in over 300 clinical studies and has assisted many biotech and pharmaceutical companies in negotiating protocols and presenting to the FDA. He has also presented at numerous international meetings and industry seminars discussing the critical challenges in conducting renal and hepatic studies.
Dr. George Atiee, MD, Principal Investigator, Dr. Vince Clinical Research
Dr. George Atiee has over 35 years of experience in clinical research and has participated as an investigator in well over 300 clinical studies. Before his role with DVCR, Dr. Atiee served in various leadership roles such as Vice President, Medical Director, Site Director and Lab Director for multiple CROs.
Dr. Atiee brings a unique perspective to our organization with his ability to assess critical study paths and provide operations teams with efficient strategies for enrollment, data collection and biomedical interventions.
Message Presenter
Toni Grant, PhD, Associate Director, Pharmacokinetics, Dr. Vince Clinical Research
Toni Grant, PhD, is the Associate Director of Pharmacokinetics at Dr. Vince Clinical Research. In her over 17 years in the industry, she has worked across all study phases and has extensive experience in early-phase clinical research. Her approach is grounded on collaboration with internal and external study team members to ensure clinical pharmacology objectives are appropriately assessed and the findings are clearly communicated.
Toni is also responsible for driving process improvements to increase efficiency in analyzing and reporting results. She ensures her team members maintain their commitments to high quality, scientific and ethical standards.
Message PresenterWho Should Attend?
This webinar is designed for mid- and senior-level professionals responsible for the clinical development and regulatory submissions of investigational medicines across a broad range of therapeutic areas. Relevant areas of expertise include:
- Clinical Pharmacology
- Translational Medicine
- Early Clinical Development
- Research & Development (R&D)
- Clinical Research/Drug Development
- Clinical Operations/Clinical Development
- Clinical Outsourcing/Clinical Contracts
- Strategic Outsourcing & Vendor Management
- Site Selection/Site Engagement & Management
- Clinical Program Management
- Clinical Project Management
- Clinical Affairs
- Medical Affairs
- Medical Director
- Regulatory Affairs
- Pharmacokinetics/Pharmacodynamics
What You Will Learn
By attending this webinar, attendees can expect to learn:
- How to successfully facilitate relationships with clinical sites who specialize in renal and hepatic impairment studies
- How to effectively leverage the expertise of sites to improve trial outcomes
- How investigators can understand and interpret laboratory values from this patient population to ensure appropriate patient management and accurate data reporting
- How clinical pharmacology tools can be leveraged to potentially reduce patient burden and the number of patients required for these clinical trials
Xtalks Partner
Dr. Vince Clinical Research (DVCR)
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas such as neuroscience, substance abuse, pain, cardiometabolic disorders, infectious diseases and many others. CRO services include project management, data management, biostatistics, statistical programming, PK/PD analysis, medical writing, monitoring as well as site feasibility and management for multi-site trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
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