Compliance in clinical trials for drug development

The data collected during clinical trials serves as critical evidence for evaluating the efficacy of new drug developments. All parties involved must ensure that such data is authentic, comprehensive and reliable.

As entities responsible for collecting personal information, trial participants must conduct personal information protection impact assessments (PIAs) and handle personal data in compliance with applicable laws, covering its collection, storage, processing and use. Cross-border data transfers must adhere to relevant regulations. Once the volume of data leaving the country reaches statutory thresholds, it must be transmitted via approved pathways.

Given the duration and multiple stakeholders involved in clinical trials, it is essential to apply robust credibility assessments when selecting contract service providers. Tailored anti-bribery measures should also be implemented across different types of entities.

Compliance obligors

Key parties in clinical trials for drug development – each bearing specific compliance obligations – include the sponsor, the principal investigator (PI), the clinical trial site, and the contract research organisation (CRO).

The sponsor, typically a pharmaceutical company, is the individual, organisation or institution responsible for initiating, managing and financing the trial. It bears ultimate accountability for the quality and reliability of the clinical trial data. The PI oversees the trial’s execution at the site level and is responsible for both the standard of the research and the safety and rights of the participants.

The clinical trial site refers to an institution qualified to conduct drug trials in accordance with good clinical practice (GCP) and relevant technical guidelines. The CRO, engaged by the sponsor to carry out trial activities, assumes direct legal responsibility for the accuracy and compliance of reports and data.

(1) Data quality

Authenticity. Clinical trials must ensure that all source data is fully traceable to guarantee authenticity. Amendments to original trial data must be documented and justified, as unauthorised alterations to primary records carry a big risk of introducing critical flaws.

Reliability and consistency. In practice, ensuring consistency between clinical research proformas and original medical records is essential. During on-site inspections for phase II and III clinical trials, discrepancies in documented timings – such as between drug infusion, medical orders, patient visits and vital signs measurements – may be deemed to compromise trial quality.

In trials with very small subject populations, an unusually high incidence of protocol deviations, such as significantly unjustified delays in dosing or follow-up examinations, could also lead to a finding that the overall integrity of the trial has been undermined.

Comprehensiveness. Clinical trials must maintain comprehensive documentation of the entire investigational product administration process. In the case of injectable drugs, on-site records should include essential subject information, medical orders, treatment charts, injection administration records, dosage, injection site and post-administration observations.

(2) Data compliance

Personal information protection. The processing of personal information must comply with the Personal Information Protection Law and other regulations. Throughout the clinical trial, the sponsor, the trial site and other relevant parties may only use biological samples in accordance with the study protocol, the informed consent form and provisions governing management of human genetic resources, including approvals granted or filings made under relevant regulations.

Informed consent discussions must be conducted by authorised and qualified personnel. Individuals without relevant professional backgrounds, or those unable to explain medical aspects of the trial, are not permitted to lead these conversations.

Cross-border data transfer. Personal information collected during clinical trials is classified as sensitive, and includes: medication records, test reports and personal health data; genetic and biometric information; and identifying details such as ID numbers.

In accordance with the Provisions on Promoting and Standardising Cross-Border Data Flows, PIAs must be conducted. Should the volume of data to be transferred abroad reach the threshold of 10,000 individuals, a formal data export security assessment is required. Below this threshold, filing a standard contract is mandatory.

(3) Anti-bribery

Earlier this year, the State Administration for Market Regulation issued the Compliance Guidelines for Pharmaceutical Enterprises on Preventing Commercial Bribery Risks, mandating that companies establish comprehensive compliance management systems. Anti-bribery measures during the drug development phase must be tailored to the responsibilities of each entity involved.

When sponsors engage third-party CROs, they must implement anti-bribery clauses to govern these relationships. Contracts should stipulate that the sponsor retains the right to monitor performance and conduct compliance reviews of outsourced activities.

In practice, certain clinical trial sites, such as major cancer hospitals, often hold significant leverage when multiple pharmaceutical companies (sponsors) seek to commission them for targeted oncology drug trials, owing to their concentrated patient populations. As patient recruitment for clinical studies is not subject to open tender procedures, this environment can create opportunities for illicit benefits such as “referral fees”.

Under the GCP guidelines, payments made by sponsors to trial sites must be reasonable and aligned with market norms. Sponsors must not offer recruitment bonuses or data verification incentives intended to influence researchers to relax enrolment criteria, grant preferential enrolment status, or conceal trial-related issues.

Beyond the above-mentioned three major compliance pillars, clinical trials must also fulfil obligations in ethical review, insurance and compensation for damages. For instance, trial protocols require approval from an ethics committee, and both sponsors and PIs must promptly provide agreed insurance coverage and compensation for any trial-related injuries.

This June, the National Healthcare Security Administration and the National Health Commission jointly issued the Several Measures to Support the High-quality Development of Innovative Drugs, introducing multiple policies to foster advancement in the pharmaceutical sector. While promoting rapid industry growth, regulatory authorities continue to maintain stringent oversight over persistent misconduct within the sector.

Pharmaceutical companies should leverage these policy opportunities while rigorously defining responsibilities across all stakeholders. Ensuring trial quality and regulatory adherence is fundamental to achieving stable and orderly corporate development.

Wu Kun is a partner and Gao Yi is an associate at Blossom & Credit Law Firm