Lani's Biospecimen Repository Proposal -- PLEASE READ

[Cynthia]

Friends,

I have been following with great interest the excellent discussions that Lani began about the possibility of creating a Her2+ biospecimen repository. I agree with the observations made by several others – the creation and running of a biorepository is fraught with many, many obstacles. Some of them relate to complex legal issues, consistency of collection practices, lack of annotated clinical data to accompany the tumor samples, privacy issues, Institutional Review Board (IRB) concerns, unwillingness of hospitals to part with samples, and of course – money. Having said that, the National Cancer Institute (NCI) recently announced that the number one impediment to advancing cancer research is a lack of properly collected, well annotated (i.e., with accompanying information about what happened to the person to whom the tumor once belonged), human cancer specimens. I have spent the past year of my professional life focusing (though not exclusively) on how biospecimen repositories work, how they don’t work, and how they could help to advance cancer research if best practices were employed.
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I have learned a great deal over the past year, including the following:
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1. Researchers/hospitals recognize the value of human tissue for research purposes and don’t want to share freely.


2. There are currently no uniform collection and storage practices.


3. If the NCI had its way and all research institutes were to collect and retain samples in the manner NCI would like, it would be cost prohibitive for the vast majority of biospecimen repositories to comply.


4. NCI has not succeeded to date in collecting the tissue samples from academic institutions across the country it so desperately wants for use in its Cancer Genome project.


5. Many patient advocate groups understand the importance of biorepositories, but due to the costs and complexities, with a few exceptions (e.g., the Multiple Myeloma Research Consortium Tissue Bank), patient groups have not successfully stood up meaningful repositories on their own.


Thus, I think that Lani has proposed a truly unprecedented approach to creating a biorepository dedicated to Her2+ tissue samples. In a number of ways that I would be happy to address in a later posting, I believe that what Lani proposes differs from any other repository now in existence in this country (and probably in the world). Thus, I suggest that if we undertake this effort we, as the donors, insist that our tissue be given not to a research facility that will keep it solely for its own use (no matter how promising or earnest that facility’s research efforts appear), but rather to a facility that will serve primarily in the role of honest broker. By this I mean the recipient of our samples and medical information should be tasked with allowing the information derived from the samples, and at times the samples themselves, to be used by researchers around the world who demonstrate that the samples and data will be put to the highest and best scientific use. Thus, all applications for samples and data must be vetted by an independent scientific review board that meets frequently (i.e., virtually) and that allows only proposals with strong scientific merit to access actual samples – though digital data can be more freely shared since digitalized data do not diminish in size. Additionally, I suggest we insist that there always be at least one, if not more, of us on the oversight board to keep everyone honest.

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I waited until now to weigh in on the discussion because I wanted to ask around to see if there is strong interest from the medical side in doing something like Lani proposes. I had a very promising meeting yesterday with the director, head pathologist and senior research nurse of what I have been told is probably the best and largest breast biorepository in the world. I am informed that while Lani’s project could result in a great deal of work and expense, it could produce something of great and truly unique value to the cancer research community at large. Thus, as a precursor to further discussions, I have been asked to obtain some information from those of you who might be interested in donating some or all of your tumor blocks. (By the way, I understand that once personal information is obtained from you as a part of the donation process, all of your samples and corresponding medical records and history would be de-identified so that no one doing research within the repository would be able to identify you. More information on this and many other points will follow if we proceed with this.)

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Thus, if you are inclined to donate your tumor block to this type of a project, would you please answer the following questions in a reply post:
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1. Please state the name and location (i.e., city and state) of the hospital that likely retains your tumor block.

2. Please indicate if you have copies of (and would be willing to provide them if asked) the following medical records:

a. Your surgical report(s)


b. Your pathology report(s)


c. Your cancer treatment records (e.g.., oncology, radiation therapy)


3. If you don’t have copies of the records referenced in Item 2 above, would you be willing to obtain copies of them from your hospital/physician and send them in?

4. Would you be willing to respond to a detailed online questionnaire about your history, your habits, etc.?


5. Would you be willing to be interviewed by a research nurse by telephone?


Once I receive ample responses to the above, I will meet again with the principal investigator to discuss at greater length his level of interest, likely impediments, etc. If there is enough interest on his and our end to move forward, I would certainly disclose to you at that time the identity of the facility in question, more details on the proposed structure, and everything else you care to know.
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Please understand that I have absolutely nothing to gain financially from this endeavor. If we can pull this off, rest assured I will donate my tumor block and personal information. Thus, I am pursuing this for the same reason all of you are – because we all want to help advance a cure for this dreadful disease.
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Thank you and stay well.
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Cynthia
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