How a Little-Known Industry Bridges Hope Between Patients and Pharma: Insights into Clinical Trial Patient Recruitment

Fear and aversion toward cancer, coupled with the complexity and obscurity of medical knowledge, have led us to keep our distance from it and remain largely uninformed. In reality, however, cancer is not as distant as we may think.

According to statistics from the National Cancer Center, there are over 14 million new cancer cases globally each year. In China, there are 4.29 million new cases annually, including 3.804 million new cases of malignant tumors per year. This equates to an average of more than 10,000 people being diagnosed with cancer daily across the country, or one person every 10 seconds.

In the past two years, with the popularity of films and TV series such as "Go Away Mr. Tumor" and "Dying to Survive," the public has gained a deeper understanding of cancer. In fact, with the development of targeted therapies and immunotherapy, the cure rates and survival rates for many common cancers have significantly improved, allowing many people to "live with cancer."

Pharmaceuticals are a critical tool in the fight against cancer. Bringing an original new drug to market requires navigating multiple stages, including early discovery, preclinical research, clinical trials, and regulatory approval, a process that often takes ten years and costs over $1 billion.

Clinical trials are the most critical component of clinical research, referring to experiments and studies conducted on patients or healthy volunteers, with the aim of discovering or verifying the clinical value of investigational drugs and determining their efficacy and safety.

This article explores topics related to participant recruitment in clinical trials. We interviewed pharmaceutical companies, patient recruitment firms, physicians, and trial participants to gain insights into their willingness and behaviors regarding participation in clinical research, as well as how these factors will influence the development of the pharmaceutical industry.

Key Findings:

1. Participants in clinical research, whether patients or healthy volunteers, are not “guinea pigs.” The rights and safety of participants are the primary considerations in clinical research, taking precedence over scientific and societal benefits. Ethical review and informed consent are the key measures to safeguard participants’ rights.

2. Due to approval delays, many “new drugs” have already been marketed abroad—some for many years—with safety and efficacy supported by existing data while they are still undergoing clinical trials in China. Nevertheless, conducting clinical trials on imported new drugs remains necessary to further obtain safety and efficacy data based on the disease profiles of the Chinese population.

3. Against the backdrop of policies encouraging innovation in pharmaceuticals and medical devices, promoting consistency evaluations for generic drugs, and reforming the priority review and approval system, both new drugs and marketed drugs are accelerating clinical research, thereby increasing the demand for clinical trial institutions and subjects.

4. Economic factors, new treatment methods, and better treatment conditions are the primary considerations for subjects participating in clinical research.

5. Participants primarily learn about and enroll in clinical trials through physician referrals and recruitment advertisements, with online information dissemination and proactive participant engagement also serving as important channels. Innovative approaches leveraging medical big data and artificial intelligence can facilitate participant recruitment and enrollment, thereby shortening the enrollment timeline and reducing dropout rates; safeguarding participant data privacy and ensuring informed consent remain paramount principles.

The following is the main text.

Through introductions from relevant parties, I met Zhou Yuan and Wang Jigang, both of whom are liver cancer patients participating in drug clinical trials at West China Hospital of Sichuan University. Zhou Yuan is enrolled in a trial for an imported novel drug sponsored by a foreign pharmaceutical company, while Wang Jigang is participating in a trial for a generic drug conducted by a domestic pharmaceutical firm.

Zhou Yuan was enrolled in the study this September and has been receiving the investigational new drug for over a month. Prior to this, he had been treated with sorafenib tosylate tablets but developed drug resistance; the clinical trial has provided him with a new therapeutic option.

Wang Jigang was diagnosed with hepatocellular carcinoma (HCC) in March 2017. He subsequently underwent three sessions of interventional therapy in March, May, and August, which led to an improvement in his condition, although continued medication remains necessary. While reviewing relevant information, Mr. Wang proactively contacted the recruitment agency and completed the application process with the assistance of a clinical coordinator.

Regarding liver cancer, data presented by Fan Jia, President of Zhongshan Hospital affiliated with Fudan University, at the China Liver Cancer Leadership Forum has been widely cited: China bears a disproportionate burden of liver cancer, accounting for more than 50% of new cases and deaths worldwide. The five-year survival rate for liver cancer in China is only 12.5%, significantly lower than that in countries such as Japan and South Korea.

The treatment of liver cancer primarily depends on the stage of the cancer and the status of liver function. For patients with early-stage liver cancer and preserved liver function, surgical resection is the main treatment option. For those deemed unsuitable for surgery based on liver function assessment, alcohol injection therapy or radiofrequency ablation (RFA) is employed. In cases of advanced liver cancer or impaired liver function, transarterial chemoembolization (TACE) is the primary treatment, supplemented as needed by radiation therapy, alcohol injection, or ablation therapy (RFA); targeted drug therapy may also be used.

The five-year survival rate for liver cancer patients is low, which is closely linked to the lack of widespread cancer screening: in Japan, 60% of newly diagnosed patients are in the early stage, whereas in China, only about 15% are diagnosed at an early stage, meaning that 85% are in the intermediate or advanced stages. It is difficult to relate these statistics to individual patients, as no one wishes to be merely a statistical figure.

The cost of liver cancer treatment is exorbitant. The average cost per interventional therapy session exceeds RMB 20,000. The winning bid price for the original branded targeted drug sorafenib tosylate tablets under China’s National Reimbursement Drug List (NRDL) is RMB 11,437.2 per box, with two boxes required per month. Prior to its inclusion in the NRDL, the price exceeded RMB 20,000 per box. For the majority of the population, the costs associated with either interventional therapy or daily medication are undoubtedly astronomical.

The costs of the clinical trial are borne by the sponsor, meaning that participants can receive medication free of charge. Wang Jigang has been using a generic version of sorafenib produced by a domestic pharmaceutical company since last September, for over a year now. “My physical condition is relatively stable, and I maintain regular communication with my doctor. There was a period when I had to pause treatment due to thrombocytopenia. After consulting with other trial participants, I learned that this is a common occurrence. Currently, I have reduced the dosage to once daily.”

Wang Yanan, General Manager of Hope Medicine’s subject recruitment platform, summarized that there are three main factors influencing subjects’ participation in clinical trials: first, the hope of gaining access to new treatment opportunities and improving current therapeutic regimens; second, the fact that most medical expenses associated with clinical trials are covered by the sponsor, thereby alleviating individuals’ financial burden; and third, the ability of participating subjects to receive enhanced care throughout the trial process, including more comprehensive examinations and regular follow-up visits.

From the perspective of the two participants we interviewed, economic factors were likely the primary consideration. “Given that this is our fate, we might as well face it; it’s better than being unable to afford treatment. We’re trying everything we can, even if the odds are against us.” Some “savvy” patients, on the other hand, recognized the value of clinical trials from the outset, actively seeking out information about them online and volunteering to participate.

Whether the former or the latter, both reflect the resilience of life demonstrated by patients in the face of incurable cancer.

“Back in 1997 and 1998, when we first initiated clinical studies, not only patients but also physicians had little understanding of clinical research. After nearly two decades of development, the medical community has gained a substantial understanding of clinical research, and patient acceptance has significantly improved,” said Zhao Jie, Head of Clinical Development Strategy at a multinational pharmaceutical company. “In fact, the issue is no longer whether the concept of clinical research is accepted by the public, but rather whether subject recruitment can be completed on time and in the required numbers.”

“Foreign pharmaceutical companies generally choose to collaborate with medical institutions that comply with Good Clinical Practice (GCP) standards. These are typically large hospitals with a substantial patient volume, facilitating subsequent cooperation.” If a project requires a large number of subjects, multiple medical institutions will be selected to initiate the trial simultaneously; additionally, partnerships with professional patient recruitment firms are also established.

Professional subject recruitment organizations or companies emerged a decade ago, with Jsure Health being among the earliest pioneers in this field. It provides pharmaceutical enterprises with integrated clinical research subject recruitment and innovative management solutions, primarily covering pre-clinical studies, subject recruitment, and clinical IT systems, thereby accelerating the approval and market launch of new drugs. Meanwhile, Jsure Health also supports disease management for pharmaceutical companies, physicians, and patients.

Shanghai Jsure Health, Inc. was listed on the National Equities Exchange and Quotations (NEEQ) in late 2015. According to its annual report, the company’s revenue reached RMB 27.69 million in 2017, representing a year-on-year increase of 147.08%. Its top five clients were Johnson & Johnson, Merck & Co., the Soong Ching Ling Foundation, BeiGene, and Eli Lilly, all of which are foreign pharmaceutical or innovative drug companies. In the first half of this year, Shanghai Jsure Health achieved revenue of RMB 22.63 million, a 121.31% increase compared to the same period last year.

Jsure Health’s rapid growth stems from both internal expansion and favorable external conditions. Lin Feng, General Manager of Jsure Health, told VCBeat that demand for clinical trial participant recruitment has grown rapidly, driven by the accelerated approval of new drug clinical trials in China and the emergence of local innovative pharmaceutical companies.

As the industry’s first professional patient recruitment company, Jsure Health has increased its personnel investment, strengthened its system infrastructure, launched the “Medication Finder” WeChat recruitment platform, and enhanced collaborations with external internet platforms to capitalize on favorable industry developments.

Furthermore, clinical IT systems represent a strategic area of focus. After two years of research and development, Shanghai Jsure Health, Inc. has recently launched ePdata®, the first professional electronic Patient-Reported Outcome (ePRO) mobile application in China. This app enables pharmaceutical companies to collect patient-reported data via smartphones, thereby optimizing existing processes for clinical data collection and analysis. The product has successfully passed verification against relevant U.S. FDA standards.

Founded in 2013, Hope Medicine has emerged as a rising star in the patient recruitment industry, consistently dedicated to providing professional, precise, and efficient subject recruitment services for clinical trials. In less than five years, it has overcome numerous challenges to successfully join the top tier of the recruitment industry.

Although Hope Pharmaceutical was not among the first entrants in the field, it has gained a profound understanding of the development trajectory of the clinical trial recruitment industry. According to Wang Yanan, General Manager of Hope Pharmaceutical, new technologies such as big data and the internet are driving innovation and upgrading across the entire sector. By engaging in deep collaboration with medical big data platforms, Hope Pharmaceutical leverages data to efficiently and precisely empower every stage of the recruitment process. This approach not only scientifically shortens the timeline for new drug development, helping pharmaceutical companies enhance R&D efficiency, reduce costs, and accelerate the clinical application of novel therapeutics, but also provides participants with more beneficial and cutting-edge treatment options, thereby improving patients’ health outcomes and quality of life.

Overall, as China joins the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), aligning clinical research standards with international norms will introduce new requirements and demands in subject recruitment and data collection governance. Additionally, this shift presents opportunities driven by consistency evaluations and the development of innovative drugs.

From an international perspective, countries and regions such as the United States, the European Union, and Japan have specialized subject recruitment organizations to assist in the recruitment of clinical trial participants. In China, with the development of “Internet Plus,” giants such as Alibaba and Tencent, along with numerous internet healthcare platforms, have participated in subject recruitment to varying degrees.

Wang Yanan, General Manager of Hope Medicine, summarized that current methods for recruiting clinical trial participants primarily include: collaborating with physicians and medical institutions; partnering with “Internet + Healthcare” platforms; and leveraging new media channels to disseminate recruitment information directly to potential participants. The recruitment efforts mainly target patients with chronic diseases and cancer.

Wang Yanan introduced that “Mu Haitang,” the recruitment platform under Houpu Medicine, currently covers tens of thousands of physicians and hundreds of thousands of trial participants. Leveraging the capabilities of its medical big data platform, the company helps pharmaceutical enterprises precisely identify suitable participants while enabling participants to better understand clinical trial protocols, thereby guiding the public toward a correct perception of clinical trials. “Shifting perceptions cannot be achieved overnight, but Houpu has remained steadfastly focused on this mission since its inception without deviation. We aim to fundamentally reshape public understanding of clinical trials, ensuring that participants truly benefit from them,” said Wang Yanan.

In addition to Shanghai Jsure Health and Houpu Pharma, the list of subject recruitment organizations or platforms is extensive: Drug Clinical Trial Network, Subject Recruitment Network, MedSci, and Good Doctor Hui. Patient communities, patient organizations, internet healthcare platforms, and hospital websites are also publishing such information. Overall, the dissemination of subject recruitment information has become highly efficient.

Recently, VCBeat also discovered that Wuma Technology (Hangzhou) Co., Ltd., under Feng Dahui, has developed a mini-program called “Global Clinical Trials.” Users can search for disease names in the search bar to find ongoing clinical trials. The mini-program has indexed more than 300,000 clinical trial records and features key information extraction, allowing users to easily view contact phone numbers and email addresses of trial coordinators to facilitate communication.

Regulatory authorities are also following up. In September 2013, the China Food and Drug Administration (CFDA) mandated that all clinical trials conducted in China with its approval—including bioequivalence studies, pharmacokinetic (PK) studies, and Phase I, II, III, and IV trials—must be registered and have their information publicly disclosed.

The public can view all ongoing or completed clinical trials on the Drug Clinical Trial Registration and Information Publicity Platform. If a trial is currently recruiting patients, individuals may contact the sponsor using the contact information provided in the “Sponsor Information” section.

Stakeholders are also exploring innovative approaches to recruit participants and conduct clinical studies. According to the thematic report “Innovation Is Imperative: The Future of Drug Development,” jointly released by PPD and The Economist Intelligence Unit, the adoption of adaptive trials, patient-centric trials, precision medicine trials, and real-world evidence methodologies can positively impact the progress of clinical drug trials, the probability of market approval, and formulary inclusion. Implementing these innovations can increase the likelihood of drug approval by 10%–21%.

Patient-centric trials are designed to align closely with patient needs, thereby encouraging participation. Research in the United Kingdom and the United States has found that 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. To increase participant enrollment, it is advisable to involve patients in the design and execution of trials. Strategies such as remote data collection using wearable devices can attract patient participation, and the ingenuity of the trial design should be promoted within patient communities.

Online platforms enable the rapid dissemination of clinical trial recruitment information to a large pool of potential participants, facilitating the screening of eligible subjects and significantly reducing the time and financial costs associated with recruitment. Furthermore, data collection via smart wearable devices minimizes the invasiveness of clinical trials, enhances participant comfort, and reduces dropout rates.

“We are eager to see innovative approaches applied in subject recruitment and clinical research, as this will not only accelerate the drug development process but also enable innovative therapies to benefit more participants more quickly, thereby addressing unmet needs,” said Zhao Jie.

“If major internet platforms, such as Alibaba and Tencent, are willing to contribute to clinical research by opening up their platforms and user traffic, it would certainly be highly beneficial for the industry. We are also exploring collaborations with them.” “We are partnering with medical big data and artificial intelligence companies, and exploring areas such as live streaming and commercial health insurance,” said Wang Yanan. “There are many innovative directions for subject recruitment, starting with broad outreach and followed by screening.”

The primary challenges facing clinical research include a shortage of qualified institutions and approval backlogs, areas in which regulatory authorities are also taking action.

First, the relaxation of institutional eligibility criteria. Data from the National Medical Products Administration (NMPA) shows that as of November 5, 2018, there were 825 records related to the national list of drug clinical trial institutions. Assuming each record corresponds to one clinical trial institution, this means that approximately 800 clinical trial institutions had obtained certification.

Currently, most clinical trial institutions that have obtained certification are tertiary hospitals. In regions with abundant medical resources, some non-tertiary hospitals may also conduct clinical trials in otolaryngology. In contrast, in areas with relatively scarce medical resources, such activities are primarily concentrated in high-level hospitals.

On October 26, 2017, the National Medical Products Administration (NMPA) issued relevant policies stating that drug clinical trial institutions could be subject to a filing-based management system. Any medical institution, medical research institute, pharmaceutical university, or clinical trial institution established by social capital that meets the eligibility criteria may complete the filing. This signifies a substantial expansion in the number of clinical trial institutions.

Zhao Jie told VCBeat that the “diversion” effect on clinical trial projects following the implementation of the filing system would manifest gradually. “Newly designated clinical trial institutions require a period for personnel training and learning. Generally, new drugs will not be tested at these newly added institutions; sponsors will still prefer clinical trial institutions and physicians with years of approval history and extensive experience. Consistency evaluations and post-marketing clinical studies are more likely to initiate at new institutions.”

Another is the priority review and approval process, which aims to accelerate the development and market launch of new drugs with clinical value and generic drugs in urgent clinical need, covering the stages of clinical trial applications and registration applications for new drugs.

As stated in the Announcement on Issues Concerning the Review and Approval of Overseas New Drugs Urgently Needed for Clinical Use, jointly issued by the National Medical Products Administration (NMPA) and the National Health Commission (NHC) on October 30, 2018, new drugs that have been marketed in the United States, the European Union, or Japan within the past decade but not yet launched in China may be reviewed and approved through a specialized channel if they meet any of the following criteria: drugs for the treatment of rare diseases; drugs for the prevention or treatment of life-threatening conditions with no existing effective therapeutic or preventive options; and drugs for the prevention or treatment of life-threatening conditions that demonstrate significant clinical advantages. These drugs are still required to undergo clinical trials prior to formal market launch.

Starting in November 2018, the Center for Drug Evaluation (CDE) published the “Public Notice of Implicit Approval for Clinical Trials” on its official website, marking the formal implementation of the implicit approval system for clinical trials in China. This change was based on the previously issued “Document No. 50,” which stipulates that for drug clinical trial applications submitted in China, if the applicant does not receive any negative or questioning feedback from the CDE within 60 days from the date of application acceptance and fee payment, the clinical trial may be conducted in accordance with the submitted protocol.

The shift to a filing-based system for clinical research institutions, the implementation of priority review and approval, and the reform introducing implied permission for clinical trials have enabled domestic trial participants to access globally synchronized innovative drugs and therapies from the clinical stage onward. Furthermore, these measures stimulate market competition and gradually enhance China’s drug R&D capabilities.

When Cancer Comes Knocking, Everyone Strives to Defeat It.

[Recommendations for Practical Websites]

Center for Drug Evaluation, China Food and Drug Administration (for querying drug approval information, lists of clinical trial institutions, etc.)http://www.cde.org.cn/index.jsp；

Drug Clinical Trial Registration and Information Disclosure Platform (Query Clinical Trial Registration Information)http://www.chinadrugtrials.org.cn/；

Yaozhi Data (for querying drug R&D, manufacturing, pricing, etc.)https://db.yaozh.com/；

Medication Assistant (Drug Package Insert Search)http://drugs.dxy.cn/index.htm。

At the request of the interviewees, Zhou Yuan, Wang Jigang, and Zhao Jie are pseudonyms.