Where Should Clinical Recruitment Go After the 'Gene-Edited Babies' Scandal?

Dec 04, 2018 14:42 CST Updated 14:42

Author: He Yan

“Gene-Edited Babies” News Sparks Widespread OutcryRecently, news of “gene-edited babies” caused a major stir, quickly becoming the headline story across major media outlets and drawing global attention from scientists and ethicists. In an interview, He Jiankui stated that he recruited the couples participating in the experiment through the Beijing-based HIV/AIDS rights organization “White Birch Forest.” The founder of this nonprofit organization told reporters, “I feel quite wronged, as if I had been deceived. Two months after the recruitment notice was posted, more than 100 interested individuals contacted us. After my initial screening, I shortlisted 50 candidates and shared their WeChat contacts with He Jiankui’s team.”

This incident has thrust the little-known patient recruitment industry into the spotlight, undoubtedly exerting a profound impact on future patient recruitment efforts. In light of this, our reporter interviewed He Yan, founder of Xinglinbang, a company specializing in patient recruitment services. Below are some of the insights shared by He Yan:

Patient recruitment is the most critical and challenging phase in drug development.

Clinical research is inseparable from patient (subject) recruitment, which is also one of the critical components of drug development. Following China’s National Medical Products Administration (NMPA), formerly known as the CFDA, joining the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), all aspects of clinical research will gradually align with ICH guidelines, including subject recruitment. Currently, the most significant challenge throughout the clinical trial process is identifying, recruiting, enrolling, and retaining subjects while ensuring their successful completion of the trial. Globally, the lawful recruitment of volunteers for clinical validation of innovative drugs is a crucial step in facilitating their market approval.

However, the difficulty in recruiting volunteers for clinical validation poses a practical challenge for R&D. According to public information, only 45% of clinical trials conducted in China are able to complete patient enrollment on schedule. As a result, the market launch of many new drugs will be delayed, postponing patients’ access to novel therapies.

Three Major “No-Go Zones” for Patient Recruitment

First, according to ICH GCP 4.8.3: “The investigator and the clinical research staff must not coerce or unduly influence a subject to participate or to continue in a clinical trial.” Phrases such as “latest therapy,” “most effective new drug,” “free treatment,” and “rare opportunity,” which are akin to street vendors shouting “Don’t miss out as you pass by!”, constitute undue influence on patients and are non-compliant with GCP requirements.

Second, whether public advertisements for patient recruitment had obtained prior approval from the Ethics Committee. ICH GCP Section 3.1.2, which outlines the responsibilities of the Ethics Committee, stipulates that the Ethics Committee must receive the following documents: the protocol and protocol amendments, informed consent forms (ICF) and amendments, subject recruitment procedures (e.g., advertisements), written information provided to subjects, the Investigator’s Brochure, safety information, information on payments and compensation to subjects, the investigator’s curriculum vitae (CV) and other documents attesting to the investigator’s qualifications, as well as other relevant documents. Furthermore, ICH GCP Section 4.4.1, concerning the responsibilities of the investigator, also stipulates that before initiating a clinical trial, the investigator or institution should obtain written approval and dated signatures from the Ethics Committee for the following documents: the protocol, informed consent forms and updates, subject recruitment procedures (e.g., advertisements), and any other written information to be provided to subjects. Meanwhile, GCP specifies that the subject recruitment process requires approval from the Ethics Committee, rather than specifically mandating that subject recruitment advertisements alone must obtain such approval.

Third, if subject information is obtained by third-party recruitment agencies, it may constitute an infringement of the subjects’ privacy rights. According to ICH GCP 4.8.10(n), “The informed consent form must explain to the subject that the subject’s medical records may be accessed by monitors/auditors/the ethics committee/regulatory authorities.”

How to Avoid “Red Lines” in Patient Recruitment?

Given the pervasive regulatory red lines, how should patient recruitment be conducted?

In the project management of clinical trials, patient recruitment has always been the most heavily scrutinized component. For Phase II and III clinical studies, patient recruitment methods are generally limited to advertising, referrals from physicians in other departments, and community-based recruitment. According to He Yan of Xinglinbang, patient recruitment often fails to proceed according to the recruitment plan, primarily because the project management plan is not effectively implemented.

Meanwhile, for both Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs), patient recruitment is not reflected in their actual time-tracking systems. Under Good Clinical Practice (GCP), the responsibilities of a CRA do not include subject recruitment; the CRA’s role is merely to “report on the progress of enrollment” (ICH GCP 5.18.4, Responsibilities of the Monitor). Therefore, time spent by CRAs on patient recruitment should not be recorded in the CRA’s time-tracking system.

Therefore, the correct recruitment approach for third-party recruitment companies should be to communicate with the project manager and assist the project manager and project team in effectively implementing the subject recruitment plan.