Study Monitoring in China?

Dear Colleagues,

 

I have a relatively new client in China for whom we are starting to plan for GLP studies in that country. They previously conducted DRF studies prior to my entry. When I indicated that I should be the Study Monitor, the Sponsor responded as follows:

 

It is almost impossible for you to directly direct or monitor the study due to the language barrier /or geographic distance/time zone challenges.  To effectively use your knowledge and experience, it would be more productive that you serve as a reviewer and advisor to the team for study design, protocol development, execution of the study and interpretation of results (report).  We will work with the lab in implementing the studies to the words per study protocol approved.

 

I am generally not in agreement with this philosophy. The idea of the client’s team (who are not toxicologists) working with the lab in implementing the studies, but having me as a reviewer/advisor, will ultimately be problematic as regulatory agencies will not exactly see it that way. It will be like having responsibility without authority.

 

I am therefore interested in hearing comments from RTC members, especially those who place/monitor studies in Chinese CROs, before I provide a response to the client. Thanks in advance.

 

Regards,

 

Barry

___________________________________

Barry S. Levine, DSc

Diplomate, American Board of Toxicology

Levine Tox Consulting, LLC

Consultants in Toxicology

  and Nonclinical Development

2440 N. Lakeview Ave.

Suite 7EF

Chicago, IL 60614

Tel (773) 697-4846

Fax (312) 546-6334

Cell (312) 550-0100

email bslevine@LevineToxConsulting.com

website www.LevineToxConsulting.com

 

11 replies
  1. rjearlyconsulting@gmail.com
    rjearlyconsulting@gmail.com says:

    Hello Barry

    I may be able to help you with this as I worked for WuXi Apptec in Suzhou China for several years. It depends on what CRO you choose. Many CROs work with international clients and are fluent in English as their research will be submitted to the US FDA or OECD and other places as well. I had study monitors fly in to monitor project first days of dosing but most did not. WuXi gets periodic inspections from the USFDA. If the research is only going to be submitted to the Chinese FDA, then the protocol and materials will likely be in Chinese. For studies that are going to be submitted to USFDA, OECD and CFDA, then they will prepare full translations in English and Chinese. The CFDA requires full translations now for submission to China

    If you would like to call me at 949-735-0166 and I can provide more details.

  2. Thomas Grizzle
    Thomas Grizzle says:

    Barry,

    I’ve been to China to monitor studies on three occasions over the past couple of years. I monitored the study start and the necropsy. I did this because I was the Study Monitor listed in the protocol. If they want to list you as the Study Monitor in the protocol, it is my opinion that you should monitor the study. You cannot properly monitor a GLP study from your office.

    I would nicely tell them that you are a professional toxicologist and will monitor the study the way it is supposed to be monitored, in person and on site, or you do not want to be the Study Monitor in the protocol. You can be associated with the program in a different way, just not as a study monitor.  

    Thomas B. Grizzle, MS, DABT, DSP

    Toxicology Services, Inc.

    (919) 967-5199

  3. Barry S. Levine
    Barry S. Levine says:

    FYI, the issue is that they want to handle monitoring without me. They just want me as an advisor/reviewer. However, my concern is that the Agency might still see my input in a stronger light.

  4. Shayne Gad
    Shayne Gad says:

    ????????
    Something else going on here.
    We have had client studies performed in Chinese CROs and monitored them with English speaking staff for more than 15 years. If the studies are for USFDA or EMA submission, English speaking scientific staff is essential.

    Shayne

  5. Henk Solleveld
    Henk Solleveld says:

    Barry,

    It is different from your situation but about 2-3 years ago, we wrote the preclinical tox and dmpk parts of an IND based entirely on the English translation of reports originally issued in Chinese. We were neither involved in protocoI development nor in study monitoring. I did rewrite and reinterpret the tox summaries of these translations clearly indicating in the IND that the summaries were based on our interpretations of the English translations. IND for a cancer indication was accepted w/o any questions from the FDA.

    Henk

  6. William Brock
    William Brock says:

    Hi Barry

    Yes, I have run into this in the past even for a North American CRO.

    How far to you want to push this? If it is a lab with “issues” then I would push harder. If it is Wuxi, for example, I would be more comfortable with the position of the sponsor. For the labs I know, the professional staff usually speaks English to some degree whereas the technical staff does not. But, at the end of the day, if the sponsor is not willing to support your travel there is little you can do. If you find problems with the report, and that might be inevitable depending on the lab, then it falls to the sponsor. As consultants, we can only recommend.

  7. Barry S. Levine
    Barry S. Levine says:

    Thanks to all who responded. I need to think this through some more before I respond to the Client. I don’t necessarily want to throw the baby out with the bathwater.

  8. Jane Allen
    Jane Allen says:

    I have had many clients who don’t want to pay for a study monitor visit, especially (but not only) for genetox studies, both in US and abroad. I serve as the advisor and reviewer, but am not mentioned in the protocol, report or submission (at least the parts that I see!) and maybe not to the CRO.  The client may or may not accept my input on the draft protocol.  This situation happens commonly and has never been a problem for me and my reputation that I know of.  The situation is not ideal (the Sponsor  won’t spot a problem, even if they are really monitoring the study instead of just signing on that line) but not uncommon.

    At my first corporate job, the project managers were the tox study monitors for most general tox studies, primarily because there were lots of them but only 2 toxicologists.  This was a management decision, not one that the toxicologists were happy with.  After I left that company for one that used toxicologists to monitor tox studies, several CROs confirmed that they were especially happy to see non-toxicologists as monitors, because they never noticed anything wrong, no matter how obvious.

  9. Barry S. Levine
    Barry S. Levine says:

    Thanks Jane.

    What you described in the first paragraph almost parrots what the client wrote to me, which I shared with the group. For me it’s not only lab visits, but routine (constant?) communications with the Study Director. As we all know, they are very busy with too many studies, so they need to be gently reminded to visit the animal rooms once or twice weekly.

    More importantly, your parting sentence put a smile on my face. That was most welcome since I am recovering from knee replacement surgery last month.

    I am carefully constructing a response to the client, so we shall see.

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