Clinical research in respiratory diseases plays a pivotal role in advancing our understanding of various conditions, developing new treatments, and ultimately improving patient outcomes. However, conducting high-quality clinical research in this field is not without its challenges. At the recent European Respiratory Society (ERS) Congress, there were many presentations exemplifying the impressive steps forward in treating patients and bringing the right drugs to the right patients. At the same time, various issues were brought to the forefront through discussions with existing and potential clients and partners of hVIVO. This blog aims to highlight some of the key challenges faced by the sponsors conducting respiratory disease clinical trials, and explores how specialised private sites like hVIVO may be able to help support sponsors in delivering, despite these hurdles.
1. Recruitment Challenges and Competitive Enrolment
One of the most pressing challenges in respiratory clinical research is the ability to deliver the number of patients needed. Clinical trials often hinge on the timely enrolment of participants with very specific characteristics (phenotypes) that are sometimes like needles in haystacks. The difficulty in finding those patients, engaging them, screening and enrolling them, and the subsequent delays that may ensue can significantly impact the overall timeline and cost of a study. Despite best efforts, sites may struggle to identify the specific patients to participate in these trials, leading to recruitment targets that are difficult to achieve.
Difficulties in accessing these patients can result in prolonged enrolment periods, increased costs, and delayed study completion, affecting the overall success of the trial. Factors contributing to this include limited site access to large numbers of engaged patients with the right phenotype that are willing to be part of a trial. Addressing this issue requires building good relationships between sites, CROs, and sponsors; building and maintaining engaged cohorts of patients; data-driven approaches to better predict feasibility; and robust enrolment strategies that allow for over-delivery based on competitive enrolment between sites.
2. Limited Capacity for Overnight Stays
Another challenge for clinical studies is the availability of sites with capabilities for overnight stays with clinical oversight. Many studies in respiratory diseases require extended monitoring of patients, including overnight stays to ensure safety and comprehensive assessments, sampling and data collection. However, not all sites are set up for this. While some sites do have the infrastructure to support overnight stays, it may be difficult to ensure the availability of the necessary medical staff around the clock, 365 days a year.
This limitation can hinder the ability to conduct studies that require continuous patient monitoring. To overcome this challenge, there is a role for sites that have robust staffing models that can support 24/7 operations and ensure patient safety and data integrity during overnight stays.
3. Enrolment Limitations During Weekends
The operational hours of some sites present another obstacle in clinical research. Many sites operate primarily during regular weekday hours, with minimal activity over weekends. This operational limitation may contribute to slowing down the pace of patient enrolment and prevent performing study procedures such as IMP dosing over the weekend.
Weekend enrolment capabilities provide a useful boost to help maintain momentum and meet targets in a timely manner. Providing clinics on weekends and evenings can also ensure minimal delays to patients arriving for triggered clinic visits, getting treatments into patients more quickly. Increasing site flexibility and exploring alternative enrolment strategies, such as mobile health units or utilising telemedicine, may also help address these challenges and keep studies on track.
4. Variability in Lung Function Quality
Spirometry is one of a range of important tools in respiratory research, providing key data on lung function that informs both the inclusion of participants and the evaluation of treatment efficacy. However, if not addressed from the start, the quality of spirometry performance can vary across sites. This inconsistency can often be due to differences in staff experience and training, the availability of skilled technicians, and variability in equipment quality.
High-quality spirometry is essential for generating reliable data, while “noisy” data can compromise the ability to measure the effect of a treatment accurately. Concerted efforts to standardise equipment and training as well as implementation of rigorous quality control measures can help maintain high quality standards of spirometry across sites.
5. Challenges in Imaging Availability and Timeliness
Imaging can play an important role in respiratory clinical research, providing vital information on disease progression and treatment effects. However, the availability and timely performance of imaging procedures can be challenging, particularly in public hospital settings. Factors such as limited access to advanced imaging technologies, competition for equipment use, and staffing shortages can delay imaging, affecting the overall study timeline.
Addressing these imaging challenges requires strategic planning and collaboration between sites and sponsors. Supporting hospitals to increase capacity to allow additional imaging slots to be open for clinical trial patients, increasing access to private imaging facilities, and exploring partnerships with specialised imaging providers can help ensure that this critical component of respiratory research is conducted efficiently and on schedule.
6. Lengthy and Complex Contracting Processes
The initiation of clinical research sites often encounters delays due to complex and lengthy contracting processes. Negotiating site contracts can be a time-consuming aspect of trial setup, as legal, financial, and operational terms must be carefully aligned between sponsors and sites. These delays can be especially pronounced where additional layers of bureaucracy are involved.
To expedite site initiation, sponsors, contract research organisations (CROs), and private sites benefit from streamlined contracting processes. This may be achieved through use of standardised contract templates, early engagement with legal and financial teams, and proactive identification of potential bottlenecks. Reducing the administrative burden of contracting can help accelerate study start-up times and enable clinical research to commence without unnecessary delays.
How Specialised Sites, Like hVIVO, Endeavour To Address These Challenges
As a private site specialising in respiratory and infectious diseases, hVIVO is well positioned to address many of the challenges outlined above. By strategically focusing on these therapeutic areas, hVIVO can offer tailored solutions that alleviate common pain points in respiratory clinical research:
The challenges in conducting clinical research in respiratory diseases are multifaceted and often stem from site access to engaged patients, operational constraints, and administrative hurdles. Sponsors experiencing these challenges may benefit from further collaboration, leveraging the expertise of specialised sites, like hVIVO, that access engaged patients and are equipped to handle a range of specific needs of respiratory clinical trials. By focusing on solutions that enhance patient engagement and enrolment, operational flexibility, and data quality, it may allow for enrolment of patients onto trials more effectively.
