© Oxford University Press 2006.
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The European Commission May Network Tissue Banks to Boost Cancer Research, Promote Cooperation
Inaccessible, poor quality, and insufficient numbers—scientists have complained for years about the state of tissue samples for research. The crisis is particularly acute in the cancer field. Scientists must search far and wide to gather enough patient samples for their research. But without standard protocols governing how to collect and store tissues, samples are often inconsistent and thus unusable.
"Biobanking of research tissues has never been done on a high quality level," said Mark Rubin, M.D., chief of urologic pathology at Brigham and Women's Hospital in Boston.
But the landscape is changing rapidly. As part of a global trend, many countries have either passed laws governing tissue collection and storage or launched efforts to make the process more uniform. Nowhere is this trend more apparent than in the European Union.
The Karolinska Institutet in Stockholm, Sweden, for example, has been collecting and bar coding tissue samples in a core facility since 2002. Both Spain and France are trying to network their national tumor banks to harmonize tissue collection protocols and improve access. In 2006, England implemented the Human Tissue Act that requires any facility within England, Wales, or Northern Ireland that stores tissue to obtain a license from the Human Tissue Authority (HTA)—a government agency created to enforce the act (Scotland passed its own Human Tissue Act).
The efforts are welcome, say researchers, but they fall far short of true harmony. "There are a lot of international initiatives to bank samples," Rubin said. "But there are many different approaches to it. It's not clear that there is a best approach or that we even have a standard."
Consequently, rules governing tissue storage and collection—whether they are laws or mere guidelines—remain loose. They are small steps toward a goal that may take years to accomplish, experts said.
England's Example
Britain's overhaul of its tissue banks came about almost accidentally. In 2004 England passed the Human Tissue Act in response to scandals at several public hospitals. In addition to other ethically questionable practices, investigators discovered that hospitals had been storing organs from thousands of dead children without parental consent. The public outcry forced legislators to overhaul the country's laws governing human tissue collection and storage.
The act prioritized donor consent for human tissue intended for any purpose. In the process, though, it also addressed practices for storing and collecting tissues intended for research. Prior to the act, "the whole question of how we deal with human tissue had been a mess," said Finbarr Cotter, M.D., Ph.D., professor of experimental hematology at the London Queen Mary's School of Medicine and Dentistry. "Before, patients simply signed on to have a particular operation done," he explained. "But what happened to any tissue taken was a gray area."
In addition to creating standard procedures for obtaining consent, institutions must now also maintain high-quality records of stored tissue, ensure the privacy of those records, and designate an administrator to oversee the bank—requirements necessary to obtain a license from the HTA.
Although the act forged necessary changes, it stopped short of harmony. The HTA does not dictate exactly how a facility should collect, preserve, or store samples, nor does it specify how or to whom tissue bank administrators should release samples. In the United Kingdom, as in many other countries, samples technically belong to the research institutions where they were collected. But without laws that explicitly assign ownership, researchers who collected samples often retain control. Consequently, the decision to allow or deny access is often subjective.
The situation is no different in the United States. A few years ago, Rubin was working on a project to look for biomarkers of prostate cancer, but his group was not able to obtain samples. "The group in charge [of the samples] never agreed that any of our studies were valuable enough." Rubin eventually procured enough samples from biobanks in other countries. "But it's such problem," he lamented. "There also have to be guidelines as to what types of experiments would be worthy of samples."
Recognizing the holes in the process, England's department of health, the Medical Research Council, and Cancer Research U.K. formed onCore U.K.—an organization funded by all three agencies to tackle questions of tissue quality and access in the future.
Among onCore's goals is to become an active tissue bank, said CEO Brian Clark, Ph.D. "We plan to collect samples on a scale that has not yet been done in the U.K." OnCore is presently negotiating with National Health Service hospitals to collect samples from patients participating in clinical trials. The organization is also working on building an information technology system that will include not only details about how a sample was handled and stored but also anonymized clinical data and quality-control parameters. The system will be accessible via the Web so that researchers can search for samples with specific parameters. For now, though, onCore is hoping to share information with other national biobanks and promote better coordination by launching the U.K. Confederation of Cancer Biobanks.
France and Spain
Other European countries have been working toward the same goals, although through different paths. In France, the Institut National du Cancer and the French ministry of health now offer tumor banks grants that total 7 million euros annually. The grants help cover the costs of updating protocols and infrastructure to join a national tumor bank network. Fifty-eight centers (in France most tumor tissue is stored at hospitals) now receive funding, which was based on the banks' meeting specific requirements for data collection and donor consent.
Although informatics software across French tissue banks is not uniform, France requires each bank to log a minimum data set, which will enable them to share data through an extranet, said Laurent Borella, director of the Département of Cancéropôles (regional cancer research clusters) at the institute. Borella hopes to have the network running by early 2007. French scientists will then be able to search the system for appropriate samples and apply to the corresponding biobank for access.
Spain is pursuing a similar approach. In 2000, the Centro Nacional de Investigaciones Oncológicas (CNIO) invited the nation's existing tumor banks (also generally housed within hospitals) to participate in the Spanish National Tumor Bank Network. CNIO created guidelines for tissue collection and storage, and participating banks must comply. CNIO also inspects each bank periodically to ensure quality. The network now includes 20 hospitals. Also, several regions have established local tumor bank networks.
At the moment, however, the national and regional networks use different information technology platforms and are not linked into one system. Researchers searching for samples must contact the head office of each network, either national or regional, to search for and apply to receive samples.
Europe-wide Tumor Banks
Although most EU countries have taken steps to harmonize tumor banking within their borders, laws regarding patient consent and tissue handling remain incompatible between countries. Consequently, researchers cannot easily transport human tissue between all EU member countries. But several groups are working toward better harmony across the European Union. And some cancer researchers have set their sights on loftier goals: virtual tumor banks.
With funding from the European Commission, the European Organization for the Research and Treatment of Cancer (EORTC) launched a virtual tumor bank project, called TuBaFrost, in 2002. The goal is to create a network of human frozen tumor tissue banks across Europe. Part of the goal is to develop standards for frozen samples intended for cancer research, said Alexandre Passioukov, M.D. Ph.D., head of the translational research unit at EORTC. The agency also hopes that researchers will be able to view images of the frozen tissue taken through virtual microscopy, along with other data about the sample.
Other groups are also working toward creating networked tissue banks across Europe. "But it will take years before they are a realistic tool for research," said Gunnel Tybring, Ph.D., executive director of the biobank at Karolinska. To be of real research value, tumor banks should contain biological information about the samples linked to detailed clinical information. Although that is the goal of most tumor bank projects, questions remain regarding what type of information should be included and how to protect patient privacy. Moreover, scientists continue to debate how best to handle different tissue types. "DNA is not a problem. It's fairly stable," Tybring said. "But when it comes to biomarkers and proteins, they are very difficult to study in samples that don't have highly standardized procedures. We don't even know what those should be," she added.
Karolinska is one of few medical universities in the world that have invested in an automated system to handle samples. The system links the samples to databases containing anonymized detailed clinical information about the donor's disease, treatment outcome, and lifestyle factors by using an informatics system.
As countries work to coordinate the systems within their borders, researchers hope that international collaboration will forge more unity across borders. Following Europe's lead, the National Cancer Institute's Office of Biorepositories and Biospecimen Research has developed guidelines to unify tissue storage and collection procedures for NCI-supported biorepositories. NCI consulted with various experts, both national and international, to compile the guidelines. The National Institutes of Health is also considering creating a central tissue bank (JNCI, vol. 98, no. 17, pp. 1174–5). Many U.S. scientists have complained that the high cost of compliance will shut some banks down (JNCI, vol. 98, no.14, pp. 952–4). But closures are a necessary consequence to achieve better-quality samples, said several European scientists.
If cancer researchers could easily share tissues across borders, they would make huge strides toward better therapies, said EORTC's Passioukov. "It would really stimulate biotechnological innovation."
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