As the global COVID-19 pandemic continues on, the search for a viable treatment is well underway. The efficiency of this research will ultimately determine when and how the world can return to a sense of normalcy.
A crucial part of running efficient clinical trials is the ability to recruit enough patient participants, which is essential to obtaining reliable and meaningful results. Choosing the right CRO with infectious disease experience, as well as robust patient enrollment and patient engagement solutions, allows for effective clinical study management for COVID-19 and other infectious disease research.
Infectious Disease Trial Recruitment Challenges
As evidenced by the COVID-19 crisis, recruiting and enrolling patients for infectious disease trials is a complex endeavor. In late June, there were 140 COVID-19 vaccines in development with 13 in human clinical trials. The later-phase studies have enrollment targets in the tens of thousands.
Investigators face the challenge of enrolling enough patients to test therapies on those who progress to a more serious stage of the disease. About 80% of COVID-19 patients recover before their condition becomes serious. Thus, a large patient pool is required to obtain statistically relevant results — and enrolling the target number can be a challenging task, especially when project timelines are strict.
Though recruitment can pose difficulties, it doesn’t mean there is not a team prepared to take them on. To cite an example from our own clinical study management portfolio, OCT Clinical overcame seasonal challenges in a recent influenza study with Dr. Reddy’s Laboratories, meeting the target of 440 patients with a screen failure rate of only 1%. OCT is currently partnering on COVID-19 projects, including vaccine trials, to meet recruitment needs in a particularly challenging research environment.
Project Management in Clinical Trials for COVID-19
Beyond the initial enrollment period, contract research organizations need strong project management capabilities in order to retain patients and keep an open line of communication with the sponsor. Infectious disease CROs must utilize technology to accomplish this, starting with robust Clinical Trial Management Systems (CTMS). Experts also advocate for remote monitoring, which may help with recruitment delays and other obstacles.
The importance of project management, both in the patient recruitment phase and beyond, cannot be overstated in the context of time-sensitive infectious disease trials. Urgent timelines require teams of professionals that work seamlessly to achieve research goals within tight parameters.
Eastern Europe’s Leading CRO for Infectious Disease Trials
Partnering with a qualified CRO for infectious disease trials is the best way to ensure seamless communication as well as timeline and budget adherence. With the demands of the COVID-19 pandemic, OCT Clinical offers sponsors the experience necessary to test their therapies with total compliance and efficiency. Our portfolio includes 18 infectious disease studies, as well as 17 in respiratory diseases (including two COVID-19 studies).
OCT Clinical has been managing clinical trials for over 15 years. We have helped conduct over 300 studies, including over two dozen rescue studies, in the CEE and CIS regions. Among our core strengths are the abilities to meet enrollment targets, streamline project management, and properly manage data to optimize research quality. In the midst of the demanding circumstances created by the COVID-19 pandemic, our CRO services provide much-needed efficiency to reduce the burden of drug development timelines on study sponsors worldwide.