中文 English
Newsletter Details

CQAF 2021 Q1 Meeting Newsletter

2022-12-07 17:31:58

Our CQAF Q1 2021 meeting went through in virtual in the afternoon of 26th March to maintain social distance and reduce the spread of Coronavirus. We were pleased to have Sean Xu from Zigzag Associates as the host of the meeting and have about 140 CQAF members joined in.                                      为保持社交距离并尽量减小COVID-19的传播CQAF季度会采用虚拟会议的模式,于2021326日下午召开我们很高兴邀请来自Zigzag Associates的徐晓刚先生来主持此次会议并有大约140位会员参会。

We would like to take this opportunity to thank our speakers, who shared their experiences and insights on the following topics during the meeting: The Consensus on Ownership of Clinical Data and Q&A, Interpretation of  <Technical Guidelines for Image Evaluation Procedures in Clinical Trials of Antitumor Drugs>  as well as the sum-up of the responds to the 2021 CQAF Members Satisfaction Survey. For more details, please refer to the attachment of this newsletter.                    我们借此机会感谢各位讲者为我们带来的经验分享,包括:临床数据权属共识与问答,解读《抗肿瘤药临床试验影像评估程序标准技术指导原则》,以及对2021年会员满意度调查做出的总结和回应。具体调研结果参见newsletter附件。

Let’s take a look at the summary of our discussions:                                           

 让我们一起来回顾下主要讨论和分享的内容:

图片1.png 

 

 


Topic 1: The Consensus on Ownership of Clinical Data and Q&A   临床数据权属共识与问答

Presented by: Yifeng Shen沈一峰

The Ownership of Clinical Data has been being discussed in the industry while implementing the clinical trial. There is no law/regulation on this area in China, but some joint consensus had formed in a meeting hosted last December by Drug Clinical Research Professional Committee, Shanghai Pharmaceutical Association and Drug Clinical Trial Professional Committee, Shanghai Pharmacology Society. Dr. Shen shared with us his understanding to the ownership from three aspects: Background, Consensus and Interpretation. The consensus aims to clarify the ownership of data and normative use of data. The ownership of clinical trial data and related information belong to the subjects and the medical institutions. The sponsor obtains the right to use the data for specific purposes (usually application for registration) through contract signing and transfer of subject's right. Some questions are asked and answered as below: 

业界一直在讨论临床数据的权属问题。目前在中国还没有相关的法律/法规,但是在去年12月份上海市药学会药物临床研究专委会(Drug Clinical Research Professional Committee, Shanghai Pharmaceutical Association)和上海市药理学会药物临床试验专委会(Drug Clinical Trial Professional Committee, Shanghai Pharmacology Society)联合发布了一个共识。沈博士从背景、共识和解读三部分与我们分享了他个人的理解。共识旨在阐明数据的权属关系,促进规范使用。临床试验数据和相关信息的所有权属于受试者和医疗机构共有,申办者通过合同签署和受试者的让渡获得针对特定目的(通常指申请注册)使用权。汇总以下几个问题和答复供参阅

 

Q: Whether the ICF for the use of authorized data must be reviewed? For example, many apps or data collection will need this consent.

对于授权数据使用的ICF是否必须EC审查,例如现在很多app或者在收集数据时会有这个知情。

A: Yes. Ethical review is required.

是的。需要伦理审查。

 

Q: When the subjects recruitment companies collect information, there are requirements of the informed consent which is quite similar as that of banks’ when you register their apps. Will this kind of informed consent requires an ethical review and subject’s signature?

受试者招募公司,在收集信息时,app上在注册时会有个类似银行app知情的内容,这个知情同意书是否需要伦理审查和患者签字?

A: Legal compliance is a prerequisite. If the subject's personal information needs to be used, an ICF signed with the subject must be obtained with the approval of the ethical review.

合法合规是大前提。如果需要使用受试者的个人信息,必须获取伦理审查同意的和患者签署的ICF

 

Q: Is the above subject recruitment company entitled to use this data after obtaining the ICF? Is there a compliance risk of the business model of a recruiting company? Can the subject withdraw his or her consent?

上述受试者招募公司是否有权在获得ICF后,就可以使用该数据?招募公司的业务模式是否存在合规性风险?受试者可以撤回知情吗?

A: Legal compliance is a prerequisite. A study ICF is usually only used for the study itself. The out-of-scope using requires additional informed consent, and the subject has the right to terminate informed consent. How recruitment companies get personal information initially is critical to the compliance risks. The healthy volunteers’ personal information are usually authorized by individuals themselves to the recruitment companies with no big problem. But in terms of the patients' personal information, how they were initially obtained by the recruitment companies presents clear compliance risks.

合法合规是大前提。通常针对一个研究项目的ICF仅针对这个项目的研究内容,项目之外的使用需要额外的知情同意,而且受试者有权终止知情同意。招募公司最开始如何获得个人信息是合规性风险的关键,健康志愿者通常是个人授权招募公司使用,问题不大;而患者的个人信息,最初如何被招募公司获得,存在明确的合规性风险。

 

Q: Are there any compliance risks that some hospitals allow the CRA to conduct remote monitoring through hospital information systems which contain certain information about the subjects? What kind of processes are required?

某些医院允许申办者CRA通过医院的信息系统进行remote monitoring,这些信息系统含受试者的某些信息,这个有合规性风险吗?需要什么样的流程呢?

A: The information systems of these hospitals should be verified. There is no big problem if the CRA is provided the relevant information same as that from the traditional models (e.g. routine medical records systems). The additional notification is required for getting extra information.

From the hospital’s perspective, there are three main aspects: the hospital's cautious assessment (can do), the ethics committee review ( agree to do), the subject's personal informed consent (willingness to do).

这些医院的信息系统应当通过计算机化系统验证。如果远程监查提供给申办者CRA阅读的相关信息与传统模式(如常规病历系统)相同,问题不大;如果涉及额外信息,需要有额外的告知。

从医院方看相关流程,主要3个方面:医院的审慎评估(是否可以这么做),伦理委员会审查(是否同意这么做),受试者个人的知情同意(是否愿意这么做)。

 

 

 

Topic 2: Interpretation of <Technical Guidelines for Image Evaluation Procedures in Clinical Trials of Antitumor Drugs>   解读《抗肿瘤药临床试验影像评估程序标准技术指导原则》

Presented by: Qingmei Shi/史青梅, Jun Jiang/姜军, Wenjing Zhu/祝文静, Dawei Wu/吴大维

The ‘Technical Guideline for Image Evaluation Procedures in Clinical Trials of Antitumor Drugs’ was issued by CDE on 14Jan2021. During the CQAF quarterly meeting on 26Mar2021, the representatives from sponsor, investigator, radiologist and QA of independent reading facility were invited and the interpretations of the guideline from multiple angles were deeply discussed.

CDE于2021年1月14日发布了《抗肿瘤药物临床试验图像评价程序标准技术指导原则》。2021年3月26日的CQAF季度会邀请了来自申办方的代表、研究者、放射科医生和独立阅片设施QA人员,从多个角度深入讨论了对该指导原则的诠释。

Dr. Qingmei Shi, Vice President of CStone Pharmaceuticals, provided the audiences with a general consideration of Image Evaluation in Oncology Clinical Trials. The purposes of the CDE guideline consisted of, standardization of trial specific imaging process standards, optimization of the imaging data quality in oncology clinical trials, stipulation of the roles and responsibilities of sponsor, investigator, and imaging CRO, and assurance of the quality of imaging results. Dr. Shi further elaborated the considerations during study design for imaging data-based study endpoints, including the choices of study endpoints, imaging modality and Independent Review Committees (IRCs). Based on the introduction of Dr. Shi, the audiences were aware of the importance of oncology clinical trials where imaging data-based study endpoints were used. They were the appropriate choice of imaging endpoint and modality based on the tumor type, the standardization of the imaging process, the standardization of the imaging data interpretation, the independency, and data stability/accuracy of the IRC.

基石药业副总裁史青梅博士为观众提供了肿瘤临床试验中图像评估的一般性思考。CDE 指南的宗旨包括:标准化试验特定影像评估过程,优化肿瘤临床试验中的影像数据质量,规范申办者、研究者和影像 CRO 的角色和职责,以及保证影像结果的质量。史博士进一步阐述了在基于影像数据的研究终点的研究设计过程中的考量,包括研究终点的选择、影像模式和独立评审委员会(IRCs)。基于史博士的介绍,观众们意识到使用影像数据为研究终点的肿瘤临床试验的要点在于:基于肿瘤类型选择合适的影像终点和影像模式,影像评估流程的标准化、影像数据解读的标准化、IRC 的独立性和数据稳定性/准确性。

Dr. Jun Jiang, Associate Chief Physician, Department of Image Diagnostics, CICAMS, introduced the considerations of study design for imaging data-based endpoints, as well as the critical elements and the common difficulties while implementation of the image evaluation procedures required by the guideline at the investigator site. Again, it is critical to choose different imaging endpoints based on the types and the features of the tumors. Moreover, it is also equally important to choose appropriate image evaluation methods at the site. Dr. Jiang shared his ‘golden standards’ of selection of the image evaluation methods, which were cost-effectiveness, timeliness, maneuverability and relative accuracy. In actual fact, the requirements of image evaluation procedures in clinical trials are higher than the ones in the routine medical practice. Therefore, the ultimate goal of management the image evaluation procedures in the clinical trial is to ensure that all the clinical investigator sites meet the minimum requirements of the standardized evaluation procedures designated for the trial. Last but not the least, Dr. Jiang emphasized the importance of the imaging evaluation procedures during baseline period. It was reported that many image evaluation issues were occurred during the subjects’ enrolment period at the baseline visits. Common issues included but were not limited to, non-active lesions, unconfirmed lesions, non-measurable lesions, differences in evaluation methods, insufficient spacing scope, and lack of consideration of other risk indicators. In the meanwhile, Dr. Jiang also explained the utilization of remedial image evaluations in case that any important evaluation timepoints were missed in the clinical trial.

医科院肿瘤医院影像诊断科副主任医师姜军博士介绍了基于影像数据为终点的研究设计的考量,以及在研究中心实施指南要求的影像评估程序时的关键要素和常见困难。同样,根据肿瘤的类型和特征选择不同的影像终点也是至关重要的。此外,在研究中心选择适当的影像评估方法也同样重要。姜博士分享了他选择影像评估方法的"黄金标准",即成本效益、及时性、可操作性和相对的准确性。事实上,临床试验中对影像评估程序的要求高于常规医疗的要求。因此,在临床试验中管理影像评估程序的最终目标是确保所有临床研究中心都符合试验指定的标准化评估程序的最低要求。最后,同样重要的是,姜博士强调了在基线期间影像评估程序的重要性。许多影像评估问题发生在受试者入组时的基线期访视。常见问题包括但不限于,选择了非活动性病灶、未经证实的病灶、不可测量的病灶,不同评估方法上的差异、扫描体位的范围不足以及缺乏对其他风险指标的考虑。同时,姜博士还阐述了在试验中如错过了任何重要的影像评估时间点时,采取补救性影像评估措施的重要性。

Ms. Wenjing Zhu, QA Manager, Zigzag Associates, shared her experience when working for a central imaging reading facility as a QA responsible, especially in how central reading facilities should ensure the reliability, repeatability, and traceability of the image evaluation data. Ms. Zhu summarized the key points from the aspects of people, system, and process. In addition to the qualification of the image reader, the independency of the image reader became one of the most critical factors for the central reading facility. The subject’s treatment assignment and the investigator’s image evaluation result should not be disclosed to the image reader, and the image reader’s evaluation result should not be affected by the sponsor, the IRC and other personnel involved in the clinical trial. Moreover, the sponsor should not be always in pursuit of the consistency of the image evaluation results between the investigators and the central reading facility. Intra-variability and inter-variability are the common tests utilized by the central reading facility in order to evaluate the reading quality of the image readers. Since there was no standards indicated in the guideline (i.e., error rate of intra/inter variabilities), it was recommended by Ms. Zhu that the central reading facility could define its own standards in the SOPs or discuss with the sponsor for a study specific standard.

Zigzag Associates的质量保证经理祝文静女士分享了她担任中心化影像阅片机构QA一职时的经验,特别是在中心化阅片机构应如何确保影像评估数据的可靠性、可重复性和可追溯性方面。祝女士从人员、系统、流程等方面做了重点总结。除了影像读片人的资质,影像读片人的独立性也成为中心化阅片机构最关键的因素之一。受试者的治疗药物分配和研究者的影像评估结果不应向独立影像读片人披露,影像读片人的评估结果不应受到申办方、IRC和其他参与临床试验的人员的影响。此外,申办方不应总是追求研究者与中心化阅片机构之间影像评估结果的一致性。个体和组间差异是中心化阅片机构用来评估影像读片人阅片质量的常见测试。由于准则中没有注明标准(即个体/组间差异的可接受标准是多少),祝女士建议中心化阅片机构可以在SOP中定义自己的标准,或与申办方讨论一个研究的具体标准。

After presentations, all the speakers as well as Dr. Dawei Wu, Ethics Director/Full-time Study Investigator, CICAMS were invited to join a panel discussion and Q&A session. Dr. Wu shared his interpretation of the guideline from an investigator’s point of view. Specifically, Dr. Wu emphasized the importance of the collaboration between the radiologist and the investigator for the image evaluation at the site. In a summary, the key successful factors for image-based endpoint data evaluation are: appropriate/fit-for-purpose design and choice of image endpoints as well as image evaluation methods, clearly defined roles and responsibilities of sponsor, investigator and IRC, standardized image evaluation procedures which are created based on current medical practices both in global and in local, qualified/independent image readers, reliable image reading systems and robust quality control procedures to ensure the quality of the image data interpretation results.

演讲结束后,所有讲者以及医科院肿瘤医院药物临床试验研究中心(GCP)伦理总监/全职研究者吴大维博士应邀参加了小组讨论和问答环节。吴博士从研究者的角度诠释了对该指南的理解。具体来说,吴博士强调了放射科医生和研究者合作对研究中心影像评估的重要性。综上所述,基于影像数据为试验终点的影像评估的成功关键因素是:适当的/符合目的的影像终点和影像评估方法的设计和选择,明确界定申办者、研究者、影像CRO和 IRC 的角色和责任,基于全球和本地当前的医疗实践所创建的标准化影像评估程序、合格/独立的影像读片人、可靠的影像读取系统和充分的质量控制程序,以确保影像数据解读结果的质量。

图片1.png       

 

 

 

 

 

 

------------------------------------------------------------------------------------------------------------

Upcoming CQAF Events

 

2021 CQAF Annual Meeting ---  May 19, 2021

------------------------------------------------------------------------------------------------------------

 

We welcome you to join us to propose topics and/or act as a speaker to share your experience in the future quarterly meeting. Please feel free to provide your thoughts via the following link or QR code:

 

Survey link

 

图片2.png

1 2