Frank Rockhold, Perry Nisen and Andrew Freeman
Sharing patient-level data from clinical trials can improve the quality of research and our understanding of disease and medical treatments. Various concerns have been voiced about data sharing; they involve privacy, consent, intellectual property, costs, infrastructure, data standards, free-riding researchers, and potentially erroneous conclusions. Many of these concerns cannot be totally eliminated, but they can be mitigated and managed.
Bernard Lo and David L. DeMets
Sharing of data from clinical trials benefits patients by enabling new discoveries, meta-analyses, and confirmation of published results. As the table shows, the European Medicines Agency (EMA), a number of drug companies, and one other trial funder have already implemented data sharing. A comprehensive Institute of Medicine (IOM) report recommends the sorts of data that should be shared, how long after a trial, and under what conditions. The International Committee of Medical Journal Editors (ICMJE) proposes that the analytic data set supporting a published article be shared no later than 6 months after publication.
Robert L. Grossman, et.al.
For the past 2 years, the National Cancer Institute (NCI), the University of Chicago, the Ontario Institute for Cancer Research, and Leidos Biomedical Research have been developing an information system called the NCI Genomic Data Commons (GDC) (see figure). The GDC will initially contain raw genomic data as well as diagnostic, histologic, and clinical outcome data from NCI-funded projects such as the Cancer Genome Atlas (TCGA) and the Therapeutically Applicable Research to Generate Effective Treatments (TARGET) program.
Antonella Surbone and Paolo Tralongo
The number of people diagnosed with cancer who live longer than 5 years from diagnosis or end of acute treatment, along with the number of patients who live with cancer in a chronic state, is increasing in industrialized countries. Consequently, survivorship care is now an established branch of oncology and is a growing health care and research priority. Yet, several gaps in the contemporary study of survivorship were identified through an American Society of Clinical Oncology (ASCO) electronic survey of 679 members who acted as principal or coprincipal investigators of survivorship-related studies and of 838 professionals engaged in survivorship research at National Cancer Institute–designated cancer centers.
Erica L. Mayer and Harold J. Burstein
Triple-negative breast cancer (TNBC) remains defined by what it is not: the breast cancer that lacks a biomarker for rational use of a targeted therapy. Yet chemotherapy, that nonspecific and often toxic anticancer weapon, can be effective against TNBC and remains the sole proven systemic approach for prevention of recurrence and improvement of survival in patients with TNBC. The Oxford Overview meta-analysis has shown unequivocally that combination chemotherapy that includes the alkylator cyclophosphamide augmented by anthracycline and taxane agents is valuable for TNBC.1 Omission of either the anthracycline2 or the taxane3 yields inferior outcomes in TNBC. The question is: Would additional chemotherapy be beneficial?