Nothing derails a clinical study timeline more than poor planning and not anticipating and preparing for potential roadblocks. While you may not be able to anticipate everything, many of the risks and challenges can be averted if you understand the landscape and prepare accordingly.
In a new whitepaper, Medpace medical and operational experts highlight some of the challenges they’ve experienced in Infectious Diseases clinical development and offer strategies for overcoming them. Below we highlight some of the challenges – access the full paper here to learn more about best practices.
Potential Challenges Facing Clinical Researchers in Infectious Diseases
Regulators, Institutional Review Boards, and Ethics Committees – The clinical development of biologics, phages, microbiome-related products, as well as other newer technologies can encounter numerous questions from country regulators and local ethics committees needing to become familiar with the technology. These questions can significantly impact timelines, especially among groups or indications that have mainly been accustomed to small molecule drug development.
Asia-Pac: The regulatory environments in the Asia-Pacific region have become more favorable and are attracting an increasing number of sponsors developing anti-infectives—especially those looking at the region for indications with a high incidence of specific Multi-drug Resistant Organisms and viral indications. In India and China in particular, there are certain restrictions on getting samples (including microbiology samples) out of the country. Without certain capabilities, studies in these regions will face certain roadblocks.
Site Relationships and Logistics – Especially for inpatient studies (regardless of geography), start-up timelines can be delayed if the site-specific logistical issues and the number of internal hospital committees are not fully appreciated. Some of the challenges include:
- More and more, academic centers and institutions require review by several different committees, especially if the technology is novel. This has to be fully elucidated during the feasibility process.
- Sites will generally rely on the sponsor to provide ancillary supplies and equipment (i.e., refrigerators, IV pumps, centrifuges, etc). Many times, the site will not identify needs until the site initiation visit, so it is extremely important to understand the equipment and logistics required and identify these needs early during the qualification of sites.
- Multi-departmental collaborations may require multiple contracts (lab, pharmacy, hospital, PIs, and sub-investigators). If the sponsor is not prepared for the start-up costs that will be coming through or do not delegate this out to the CRO with a dedicated start-up team, then a bottleneck can occur and start-up will be delayed.
Read the Full Whitepaper
Brian Murphy, MD, MPH Vice President, Medical Department, Infectious Diseases and Vaccines and Lorie Nugent, Sr. Director, Clinical Trial Management discuss more potential challenges and offer solutions for researchers wanting to overcome these potential delays in their whitepaper. You can access it in its entirety here.
Medpace is a global full-service clinical research organization providing Phase I-IV core development services for drug, biologic, and device programs. With medical and regulatory expertise in multiple therapeutic specialties including infectious disease, Medpace has assembled experienced and therapeutically focused teams to execute at every level of the company’s operations, providing complete and seamless drug development services.
To learn more about Medpace and how we can support your next clinical trial, contact us here.