比中商会的成员之一,辉瑞公司 Pfizer’s Clinical Research Unit in Brussels (PCRU),目前正在为他们在布鲁塞尔的临床试验招募中国参与者。如果您有兴趣了解更多信息,请阅读以下文章。关于一些来自中国学员的感言,请点击这里!
One of the members of the Belgian-Chinese Chamber of Commerce (BCECC), the Pfizer Clinical Research Unit (PCRU), is currently recruiting Chinese participants for their clinical trials in Brussels. If you are interested in knowing more about it, please read below article. For some testimonials from Chinese participants, please click here!
Q1. 布鲁塞尔的PCRU是做什么的?
辉瑞公司布鲁塞尔临床研究单位 Pfizer’s Clinical Research Unit in Brussels (PCRU) 是一家致力于早期临床试验(第I阶段)的全球领先的研究机构。自1992年建立,已与数以千计的参试者合作,开展了500多项成功的I期临床研究,促成了许多先进药物的研发,帮助到了世界各地的人们。目前已有数以万计的包括欧洲,亚洲,非洲等地的参试者在鲁塞尔PCRU的数据库中注册。
Q1. What is the PCRU in Brussels?
Pfizer’s Clinical Research Unit in Brussels is a leading research facility dedicated to early clinical trials (Phase I). Since its opening in 1992, the Brussels PCRU has carried out more than 500 Phase I clinical studies with the collaboration of several thousand participants. Its contribution to the development of a great number of new drugs has helped people around the world. Currently, thousands of participants including European, Asian and African etc. are already registered in the PCRU database.
Q2. 什么是临床试验?我在临床试验中是安全的吗?
临床试验(或研究)是涉及人的医学研究。是在新药或医疗设备进入市场前,研究人员确定其对人体是否安全和有效的必要路径。辉瑞临床研究单位 (PCRU) 进行的大多数临床试验是I 期临床研究,所涉及的参加者是没有疾病或状况的健康参加者。
参加者的安全和福祉是临床试验中最关心的问题。研究人员必须遵守严格的规则,以确保参加者的安全,并确保临床试验符合生命伦理以及参加者的权益得以保护。PCRU首先根据科学严谨的标准和步骤对参加者进行筛选。之后参加者本人决定是否参加某项特定的临床研究之前,该研究方案的详细信息,已知和未知风险将在知情同意过程中向参加者清楚的解释。并且,欧洲药品管理局 (EMA)、美国食品和药品管理局(FDA),独立的生命伦理委员会以及数据安全和监测委员会也会对临床试验进行严格的监督。
Q2. What are clinical trials? And am I safe in clinical trials?
Clinical trials (or research studies) are medical research that involves people. It is the primary way that researchers find out if a new drug or medical device is safe and effective in people. Most clinical trials conducted by PCRU are Phase I studies involving healthy participants, who do not have the disease or condition. The safety and well-being of participants is the top concern in clinical trials. Researchers are required to follow strict rules to ensure the safety and that clinical trials are ethical and that the rights of participants are protected. Each clinical trial must follow the protocol which is carefully designed to balance the potential benefits and risks to participants, and to answer specific research questions. The known and unknown risks of participating in a specific study will be explained to participants during the informed consent process that takes place before participants decide whether to participate. The European Medicines Agency (EMA), Food and Drug Administration (FDA), ethics committees, and data safety and monitoring boards also provide oversight of clinical trials.
Q3. 为什么辉瑞布鲁塞尔 PCRU 也招募中国参加者?
对于临床试验来说,有不同年龄、性别、族裔和民族的参加者是很重要的。当研究只有一组很相似的人参加时,研究结果可能不适用于所有人或者说不能使所有人受益。因此比利时辉瑞临床研究单位PCRU全球招募参加者,当然也欢迎中国参加者加入。
另外,新药要进入中国市场,应获得中国国家药品监督管理局(NMPA)的批准。您的参加为我们提供了来自不同民族或族裔的关键数据,包括中国人。也正因如此,这种新药更容易获得中国国家药品监督管理局的批准。
Q3. Why is it important that Chinese participants take part in a Pfizer clinical study in the PCRU in Brussels?
It is important for clinical trials to have participants of different ages, sex, races, and ethnicities. When research involves a group of people who are similar, the findings may not apply to or benefit everyone. On the other hand, to be available in the Chinese market, the new drug should be approved by the National Medical Products Administration (NMPA). Your participation provides us with key data from different ethnic origins or races, including Chinese people. As a result, it will be easier for a new drug to get the approval from NMPA.
Q4. 我可以报销与试验相关的费用吗?以及临床试验的补偿如何?
辉瑞承诺向所有参加者(包括比利时境外)报销所有合理的临床试验相关费用,例如交通费、停车费及酒店费用(如有需要,只对比利时境外)。参加者因参加试验也会获得经济补偿。补偿的金额取决于诸如逗留时间的长短、来访的总数及研究过程的性质等因素。
您与我们PCRU 研究的合作是非常有意义的,因为每次参与都可以使包括中国在内的世界各地的患者更快地获得新药。
如果您已经注册到我们的数据库中,您还可以向 PCRU 介绍潜在的新参加者。通过这样做,您可以获得高达150欧元的合作费 (每介绍一位新参加者)。(有关更多信息,可访问我们的网站 https://www.pfizerclinicaltrials.com/pcru-brussels 了解我们的推荐计划 )
Q4. Can I get reimbursement of the trial-related expenses? And how about the compensation of clinical trials?
Pfizer is committed to reimbursing participants (including outside Belgium) for reasonable clinical trial-related expenses such as transportation, parking, and hotels (only for outside Belgium if necessary). Participants receive financial compensation for their participation as well. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures.
The fact that your collaboration to our PCRU studies is meaningful as each participation can lead to a faster access to new medicines for patients all over the world, including China.
If you are already registered in our database, you can also introduce potential new participants to PCRU. By doing so, you could receive up to xxx euros (for referring one new participant) for your collaboration. (For more information, please click here about our referral program: https://www.brusselscru.com/)
Q5. 我如何报名参加辉瑞的临床试验?
健康的参加者真的可以帮助我们努力实现用药物改变病患的生活。我们所研究的药物涵盖范围很广。如果您有兴趣参加,可在我们的网站https://www.pfizerclinicaltrials.com/pcru-brussels 查看 PCRU 的详细信息。
您可以直接在网站报名,或拨打免费电话:0800/99.256(比利时免费电话); 00800/2636.2636(法国、英国、荷兰、德国免费电话)或 +322/556.70.02(所有其他国家可拨打的电话)。我们首先将您登记在辉瑞的数据库中。然后我们将与您预约通过电话来完成的医疗问卷。之后,如果您是某项研究的适合参加者,您将收到相应的研究方案。在您仔细阅读该研究的详细信息后,您可以致电我们进行该研究的报名。然后我们会为您安排确切的体检时间。根据体检结果,您将被告知是否合格及如何参加该试验。
Q5. How can I subscribe for PRCU clinical trials?
Healthy participants truly make a difference as we strive for breakthroughs that change patients’ lives. The range of drugs we research is large. If you are interested in participating, please look at the PCRU’s ongoing clinical trials on our website https://www.brusselscru.com/
You can directly subscribe on the website or call the free numbers: 0800/99.256 (toll free number from Belgium); 00800/2636.2636 (toll free number from (FR/UK/NL/DE) or +322/556.70.02 (toll number for calls from all other countries). We will firstly inscribe you in our database. And then we will have an appointment with you to complete the medical questionnaire by phone. If you are an eligible participant for a certain study, you will receive the according study proposal. After you carefully read the detailed information of the study, you can call us for enrolment for the study. Then a certain screening time will be scheduled for you. As per the outcome of the screening, you will be informed about your eligibility and participation.