Clinical trials are a crucial step in evaluating the safety and efficacy of innovative drugs and medical devices before they are approved for market. They play a vital role in medical advancement and are considered the cornerstone of building a biopharmaceutical industry stronghold.
In the past, clinical trials mostly relied on passive recruitment methods, such as selecting participants from hospital outpatient or inpatient populations or issuing recruitment notices, which led to limited sample sizes and difficulties in controlling follow-up compliance. According to Professor Zhou Huan, the Mobile Clinical Trial Unit shifts the focus from the hospital to the patient, providing direct door-to-door service. This not only effectively expands the radius of subject selection but also avoids problems such as subject dropout due to transportation difficulties.
The Mobile Clinical Trial Unit is not simply about "leaving" the hospital premises; the greater change comes from the accompanying digital ecosystem, which includes modules for source data collection, intelligent subject matching systems, remote informed consent, remote medical care, remote nursing, and electronic patient reporting of clinical outcomes, among others. This enables intelligent and paperless operation of clinical trials. Through process redesign and collaboration with international quality system research teams (doctors, nurses, pharmacists, research assistants, etc.), trial accuracy and data sharing can be effectively improved. Through the synergy of hardware and software, clinical trials can truly be driven by digital ecosystems to reduce costs, improve quality, and enhance efficiency.
The First Affiliated Hospital of Bengbu Medical College was one of the first in China to establish a research ward with over 500 independent beds, consolidating clinical trials that were previously scattered across various departments and achieving centralized management. Currently, the hospital ranks sixth nationally and first in Anhui Province in terms of the number of clinical trial projects.
"If establishing a research ward was the first transformation of clinical trial productivity, then the mobile unit represents the second transformation, achieving breakthroughs in digitalization, portability, and mobility," revealed Qian Zhigang, Secretary of the Party Committee of the First Affiliated Hospital of Bengbu Medical College. The Mobile Clinical Trial Unit has applied for multiple invention patents and software copyrights, and both medical equipment vehicles have special medical vehicle licenses. The next step will be to expand clinical trials to a wider area centered around the First Affiliated Hospital of Bengbu Medical College.