Shangwu Healthcare Leverages Oncology Big Data to Accelerate Clinical Trial Patient Recruitment
New drug development is a race against time, requiring not only competition with the disease itself but also contending with the R&D speed of competitors in the same field. Gaining an early market entry advantage often becomes a critical factor influencing the peak sales level of a new drug.
Throughout the 12- to 15-year lifecycle of new drug development, more than half of the time is devoted to clinical trials. Since the second half of 2015, Chinese drug review and approval authorities have continuously tightened regulatory requirements for new drug development, thereby opening the door to the need for scientific and rigorous clinical trial protocols. In this period, a large number of Site Management Organizations (SMOs) specializing in comprehensive on-site management of novel clinical studies, as well as Contract Research Organizations (CROs), emerged to explore innovative ways to support clinical trials in new drug development. Among these players were medical big data companies; Bixun Medical, an SMO under the Medbanks Group, precisely aligned with policy trends and swiftly entered the market.
Amid the explosive growth of the clinical trial industry, demand for study participants has risen rapidly, making subjects who meet clinical criteria a scarce resource.
It is understood that patients typically learn about and enroll in clinical trials through channels such as physician referrals and public recruitment announcements by hospitals. Factors such as patients’ willingness to participate, investigators’ workload, competition among clinical trials, and the efficacy of marketed drugs may all affect the pace of subject enrollment.
Due to the uncontrollable pace of participant recruitment, the clinical trial phase has been prolonged. According to statistics from researchers in the United Kingdom and the United States, only one-third of clinical trial sites are able to fully enroll participants, while approximately half of the sites are forced to extend their recruitment periods.
“In 2018, the number of participants required for oncology clinical trials registered on the website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration approached 50,000. ‘Targeted reduction of information asymmetry can effectively reach suitable patients, which is exactly what Shangwu Medical is doing,’ said Ms. Chen Shan, Deputy General Manager of Shangwu Medical, a patient recruitment service provider under the Medbanks Group, in an interview with VCBeat.”
In 2017, Shangwu Medical was established in Beijing. As a key component of the Medbanks Group ecosystem, Shangwu Medical specializes in medical consultation technologies within the oncology field, providing patient recruitment services for new drug clinical trials to help patients identify suitable treatment options. Since its inception, Shangwu Medical has conducted patient recruitment for more than ten clinical trials.
In 2018, Shangwu Medical completed subject recruitment and enrollment within eight months, reducing the recruitment duration to two-thirds of that for similar campaigns. This effectively helped pharmaceutical companies accelerate clinical trials and reduce R&D costs, thereby securing a first-mover advantage in the market.
Shangwu Medical has adopted a unique structured approach to rapidly match subjects with investigators.
First, potential subjects (patients) are stratified based on their regularity of medical visits and whether they have a fixed location for follow-up. Meanwhile, by leveraging personalized characteristics such as tumor type, stage, treatment phase, pathological type, and molecular genetic status, targeted recruitment strategies and activities are employed to effectively establish a pre-screening connection between potential subjects and investigators.
On one hand, for patients with regular medical visits, Shangwu Medical leverages the physical infrastructure of over 70 Sifang Pharmacies deployed by Sifang Group across 29 provinces and municipalities in China. By integrating its experience in analyzing and processing real-world study data, a network of more than 2,000 oncology experts, and extensive Site Management Organization (SMO) expertise, Shangwu Medical accurately facilitates rapid matching between patients and investigators.
Ms. Chen Shan stated that, based on observations, cancer patients at Sipei Pharmacy tend to proactively seek out clinical trials upon disease progression. The follow-up patient database of Sipei Pharmacy provides Shangwu Medical with a sufficiently large pool of potential participants. Currently, more than 10,000 patients have signed agreements to receive information about joining clinical trials.
On the other hand, for patients who have not yet established regular medical consultations, Shangwu Medical leverages the robust health insurance segment aggressively expanded by Sipei Health under the Sipei Group to achieve initial outreach to insured patients who have filed claims. Ms. Chen Shan told VCBeat that, as clinical trials often provide the most advanced treatment options, a growing number of insurance companies and policyholders are paying close attention and hope to receive targeted notifications about clinical trial recruitment.
Shangwu Medical has selected specific dissemination channels for different types of information. For instance, subject recruitment messages are released directly to patients through various online and offline channels, while clear and accurate clinical trial protocols, background information, and inclusion/exclusion criteria are communicated through physicians.
Leveraging its intelligent subject recruitment platform, Shangwu enables multi-channel coordination to rapidly respond to subject enrollment applications. According to Ms. Chen Shan, Shangwu Medical can respond to subjects within 24 hours, provide preliminary screening results within 48 hours, and feedback investigator pre-screening outcomes within one week.
Following the outreach to potential subjects, Shangwu Medical will participate in subject assessment and transfer them to clinical trial centers. In this process, Medbanks’ years of accumulated expertise in the oncology field help Shangwu Medical enhance its service efficiency.
Standardized Case Information. Shangwu Medical has assembled an all-PhD medical expert team with extensive clinical experience to conduct preliminary screening of potential subjects based on their prior diagnostic and treatment histories. Subsequently, the medical expert team issues standardized case reports for further evaluation by the project physicians overseeing the clinical trials. Ms. Chen Shan stated that the involvement of Shangwu Medical’s expert team has not only alleviated the workload of project physicians but also significantly accelerated the pace of subject recruitment.
# Informed Communication with PatientsObtaining informed consent from patients (potential subjects) for clinical trials has long been a challenge in subject recruitment. Ms. Chen Shan pointed out that after several rounds of treatment, patients’ expectations regarding informed consent for clinical trials have become more diverse and increasingly specialized. Currently, numerous sponsors are conducting trials of similar drugs simultaneously, presenting patients with the choice of participating in different clinical trials. This requires recruitment teams to provide more comprehensive background information on the trials and detailed drug-related data when communicating with patients, thereby helping them make the most suitable choices for their individual circumstances.
Chen Shan told VCBeat that Shangwu Medical’s recruitment team selects clinical trial information suitable for disclosure to patients from a professional perspective, engages in thorough communication with prospective participants regarding all aspects of the trial, and obtains informed consent on this basis. “Obtaining patient informed consent is not only a challenge in recruitment but also a unique advantage that Shangwu Medical has developed in the oncology niche.”
According to Ms. Chen Shan, in the first half of 2019, Shangwu Medical entered into clinical trial patient recruitment projects for multiple specific cancer types, with indications including lymphoma, lung cancer, prostate cancer, solid tumors, and esophageal cancer.
“In the future, Shangwu Medical will continuously accelerate subject recruitment and further enhance recruitment quality, thereby providing stronger support for SiPai Group’s clinical oncology-focused medical and professional healthcare service ecosystem platform,” said Ms. Chen Shan in an interview with VCBeat.