How Patients Navigate and Enroll in Clinical Trials Across China
Patient Roadmap · Official Registry Portals, Informed Consent Rights, and Protections
Medical Disclaimer: The following content is compiled based on the latest authoritative guidelines at home and abroad. It is for reference only for patients and their families and cannot replace the professional medical advice of the attending physician. Please be sure to follow the doctor's advice for the treatment plan.
Core Conclusion
Evaluating an interventional clinical trial in China is an established medical pathway, protected by national regulatory statutes and independent ethics committees: joining a trial is not a desperate gamble, but an early, zero-cost access channel to breakthrough therapies.
Families navigating China's oncology landscape should understand the structural protections, verified registry portals, and legal rights that govern all authorized studies.
1. Verifying Trial Authenticity in China
Every authorized interventional trial in mainland China must be formally registered and approved before subject recruitment begins. Legitimate trials can be validated through three checks:
- National Medical Products Administration (CDE) Registry Code: All commercial and registrational studies carry a public registration number beginning with CTR (e.g.,
CTR20241656), searchable on the official CDE portal (chinadrugtrials.org.cn). - Institutional Review Board (IRB) Approval: The protocol must hold a written approval seal from the host hospital's independent medical ethics committee, explicitly detailing patient protections and safety stopping rules.
- Strict Zero-Fee Policy: Clinical trial enrollment in China is 100% free of charge. Under national GCP law, neither hospitals, sponsors, nor investigators may charge patients an entrance fee, consulting fee, or broker commission. Commercial intermediaries charging "matching fees" are operating outside regulatory frameworks.
2. The Five-Step Standard Enrollment Roadmap
Navigating from initial inquiry to investigational administration follows five disciplined milestones:
Step 1: Record Collation ──> Step 2: Protocol Prescreen ──> Step 3: Informed Consent (ICF) ──> Step 4: Baseline Screening & Washout ──> Step 5: Day 1 Dosing
- Step 1: Collate Primary Records: Gather initial bone marrow biopsy reports, cytogenetics (FISH), exact start/stop dates of each prior therapy line, and recent laboratory panels.
- Step 2: Expert Prescreening: The Principal Investigator (PI) or study team assesses inclusion and exclusion criteria to confirm eligibility.
- Step 3: Informed Consent (ICF): The doctor reviews the study rationale, potential toxicities, and alternative therapies in detail. The patient and caregiver sign voluntarily.
- Step 4: Formal Screening & Washout: Free in-hospital testing verifies bone marrow and organ function, while a mandatory 2 to 4-week washout clears prior antimyeloma agents.
- Step 5: Official Allocation and Dosing: Once all baseline parameters clear medical monitor review, treatment begins according to protocol schedule.
3. Financial Boundaries: Sponsor Coverage vs Self-Pay
The financial division in Chinese clinical research is transparent:
| Covered by Trial Sponsor (Free) | Covered by Patient / Health Insurance |
|---|---|
| Investigational drugs, antibodies, and cellular products | Medications for unrelated pre-existing conditions (e.g., insulin, antihypertensives) |
| Protocol-mandated blood tests, flow cytometry, and MRD tests | Non-protocol diagnostic consultations |
| Protocol bone marrow biopsies and PET-CT / MRI scans | Routine transport and meals (often offset by scheduled trial stipends) |
| Treatment of protocol-related adverse events | Standard general ward bed co-pays if not sponsored |
This guide is published by China Myeloma Digital Network (CMDN) to promote objective patient literacy and ethical trial navigation.
FAQs
- Will patients in a myeloma clinical trial in China receive an inactive placebo?
- No. In life-threatening hematologic malignancies, institutional ethics review boards in China strictly forbid pure-placebo control arms. Randomized registrational Phase 3 trials always provide the national standard of care (such as established triplets or quadruplets) to the control group, ensuring baseline efficacy and patient safety are never compromised.
- Can a participant withdraw from a Chinese clinical trial after signing informed consent?
- Yes, at any time without penalty. Under NMPA GCP guidelines, informed consent is a voluntary agreement, not a binding contract. Participants retain the unconditional legal right to leave a trial at any stage for any personal reason, and treating physicians are prohibited from altering standard clinical care as a result.
- What medical expenses are covered by the trial sponsor in China?
- Sponsors fully cover investigational drugs or cell products, protocol-mandated laboratory monitoring, bone marrow aspirates, and scheduled PET-CT/MRI scans. General ward bed fees and concurrent medications for pre-existing conditions (such as diabetes or hypertension) remain billed through standard insurance. Most trials also provide travel stipends.
- How can families verify whether a Chinese clinical trial is legitimate?
- Look for three official hallmarks: 1. A verifiable registration code on the NMPA CDE platform (prefixed with CTR); 2. A formal approval letter from the tertiary hospital's Institutional Review Board (IRB); 3. Absolute absence of registration or matching fees. Any third party demanding broker fees to access a trial is illegitimate.
- How long does it take from medical prescreening to receiving the first trial dose?
- The standard sequence spans five phases: medical record prescreening, signing the Informed Consent Form (ICF), comprehensive baseline screening (1 to 2 weeks), drug washout (typically 2 to 4 weeks), and official enrollment. The entire process generally requires 2 to 4 weeks.
Related reading
References used for this guide
Selected National Multicenter Phase 3 Clinical Trials in China
Key Phase 3 clinical trials strictly compliant with NMPA GCP standards:
A Two-Stage, Randomized, Multicenter, Controlled, Open-Label, Phase III Study Comparing Iberdomide Maintenance Therapy with Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
This project is a Phase III clinical trial sponsored by Celgene (Bristol Myers Squibb/BMS), primarily targeting patients with newly diagnosed multiple myeloma (NDMM). Eligible patients must have received 3 to 6 cycles of prior induction therapy (including a proteasome inhibitor and an immunomodulatory drug), subsequently completed autologous stem cell transplantation (ASCT), and achieved at least a partial response (PR). Patients are randomized to receive maintenance therapy with either the investigational drug Iberdomide (a novel immunomodulatory agent administered for 21 days of each 28-day cycle) or the control drug lenalidomide (a conventional immunomodulatory agent administered continuously in 28-day cycles) until disease progression or unacceptable toxicity. The trial is conducted concurrently across 38 premier centers in China (including Hong Kong and Taiwan)—such as Peking University People's Hospital, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Zhejiang University School of Medicine, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, and Qilu Hospital of Shandong University—as well as leading international medical centers across 32 countries, including the United States, the United Kingdom, France, Japan, and Australia.
A Phase III, Randomized Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy (Including an Anti-CD38 Antibody and Lenalidomide)
This study aims to evaluate the efficacy and safety of JNJ-79635322 versus teclistamab in the treatment of multiple myeloma. The trial mainly enrolls adult participants with relapsed or refractory disease who have received 1 to 3 prior lines of anti-myeloma therapy (including an anti-CD38 antibody and lenalidomide). Eligible participants will be randomized to receive subcutaneous injections of JNJ-79635322 or teclistamab. This is an international multicenter study conducted simultaneously in multiple hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.
A Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of SG301 Injection Combined with Pomalidomide and Dexamethasone Versus Placebo Combined with Pomalidomide and Dexamethasone in the Treatment of Relapsed/Refractory Multiple Myeloma (RRMM)
This project is a Phase III clinical trial sponsored by Hangzhou SJ Biosciences Co., Ltd. (Hangzhou Shangjian Biotechnology Co., Ltd.), primarily targeting participants with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of therapy, have not previously received pomalidomide, and whose prior anti-CD38 antibody therapy was not determined to be refractory/ineffective. The treatment regimen utilizes an anti-CD38 monoclonal antibody (SG301 injection) combined with an immunomodulator (pomalidomide) and a glucocorticoid (dexamethasone), administered in 4-week (28-day) cycles until disease progression or intolerable toxicity. The trial is being conducted across a total of 78 top domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; The First Affiliated Hospital of Soochow University; Beijing Chaoyang Hospital, Capital Medical University; The Second Affiliated Hospital, Zhejiang University School of Medicine; and Sun Yat-sen University Cancer Center, among others.
A Randomized, Double-Blind, Parallel-Controlled Phase I Study Comparing the Pharmacokinetic Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC Versus DARZALEX FASPRO Combined with Lenalidomide-Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma
This randomized, double-blind Phase I study sponsored by Shanghai Henlius Biotech, Inc. enrolls adults with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation. It compares the pharmacokinetics, safety, tolerability, and immunogenicity of subcutaneous HLX15-SC with DARZALEX FASPRO; both are administered with lenalidomide and dexamethasone (Rd). The study is being conducted at 66 sites in China, including Zhongshan Hospital, Fudan University and Peking University Third Hospital.
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