This article is more than 5 years old. Information may no longer be current.
NCI resource improves research community’s access to clinical trial data, specimens
Click Here to Manage Email Alerts
NCI has established a new resource designed to improve the research community’s access to specimens and data collected from cancer treatment trials.
The National Clinical Trials Network (NCTN) Navigator provides access to specimens donated by adults who participated in published NCI-sponsored phase 3 cancer trials.
The NCTN Navigator inventory also contains data from nearly 100 trials, more than 50,000 patients, and more than 850,000 specimens.
Investigators who submit proposals and receive approval can use the specimens, along with clinical information from the trial participants, in their own research.
HemOnc Today spoke with Grace Mishkin, MPH, public health analyst at NCI, about how this initiative came about, what it is designed to accomplish, how the proposal submission and review process works, and the benefits this resource offers to the research community.
Question: How did this initiative come about?
Answer: The NCTN, established in 2014, was designed to take more of a network approach to cancer clinical trials. Before NCTN, these trials were conducted as part of the cooperative group system that had been in place for decades. NCTN Navigator came out of the work of the NCTN Groups — Alliance, Children’s Oncology Group, ECOG-ACIRN, NRG Oncology, SWOG and Canadian Cancer Trials Group — and particularly the work of the group specimen banks.
Hundreds of trials have been conducted through these groups and millions of specimens have been collected. Some of these specimens are still banked. They are quite valuable because they were collected on clinical trials and are associated with considerable treatment and outcomes data that most specimen collections may not have.
Q: What is this effort designed to accomplish?
A: This initiative is designed to align with the goals of NCTN by taking a more network-wide centralized approach to making the specimens from these trials more available to the wider research community. It also is tied into the growing movement and need to make the data and resources from NIH-funded research more accessible to researchers. The goal, in part, was to bring these research resources together. The NCTN groups have collaborated extensively to make this possible.
Q: How does the proposal submission/review process work?
A: The inventory of specimens is listed on the NCTN Navigator website. At the moment, the inventory is limited to larger adult trials and specimen collections. This includes 97 trials with more than 850,000 specimens. Older trials will be added and, as new trials complete, they also will be added. Researchers can go to this site and search the inventory by trial, specimen or patient level. They can identify specimens that relate to their research questions. They then can go back to the trial publication to see the data available from this trial, and they can develop proposals that mesh those two resources.
After they conduct their search and develop a hypothesis, they will submit a letter of intent that describes which specimens and data they are interested in. The letter of intent is not scientifically reviewed, but it is used to assess whether the requested specimens and data exist. The feasibility step is important, but it comes with a big caveat: This does not actually confirm that the specimens are available in the exact numbers that the researcher has requested. This step helps guide the researcher and ensures that their process can move forward. Once the letter of intent is marked as feasible in the navigator system, the researcher can submit a proposal. This much more extensive form includes background and preliminary data, as well as a detailed plan. The proposal is reviewed by NCI and extramural experts on the Core Correlative Sciences Committee. If the proposal is approved, the researcher can move forward with acquiring funding and obtaining necessary regulatory agreements to transfer the specimens and clinical data to carry out their project.
Q: What benefit does this resource offer the research community?
A: NCTN Navigator is a unique resource. It helps researchers identify the specimens that come from clinical trials and have extensive clinical data. This combination of specimens and data will make it possible for researchers to conduct hypothesis-driven work. Ultimately, the goal is to have studies come through the navigator process and evaluate biomarkers that can hopefully be used in future clinical trials.
Q: Is there anything else that you would like to mention?
A: As researchers become aware of NCTN, we hope they will be more interested in these specimens because we think they are very valuable. We also hope researchers will continue to check to see when more specimens have been added. We look forward to adding specimens from pediatric trials, which will be important. We hope for this to be available in the next year.
Reference:
NCTN Navigator: A clinical trials specimen resource. Available at: navigator.ctsu.org. Accessed on June 28, 2018.
For more information:
Grace Mishkin, MPH, can be reached at National Cancer Institute, 9609 Medical Center Drive, MSC 9739, Bethesda, MD 20892; email: grace.mishkin@nih.gov.
Disclosure: Mishkin reports no relevant financial disclosures.