Trials and Tribulations: Reporting Clinical Trial Results Is a Legal and Ethical Duty
Susan Gubar, an ovarian cancer survivor whose life has been extended by a clinical trial, was shocked to read a recent article published online by Charles Piller on the lack of reporting of clinical trial results.1,2
Responding to his report with dismay and concern via her blog in the New York Times, “Living with Cancer: A Broken Covenant with Patients,” Ms Gubar said, “My first response was to ask: Is he a reputable journalist? Is the online venue in which the article appears legit? When the answer to each of these questions came back a resounding yes, I began worrying that cancer doctors and patients have been imperiled by irresponsible researchers.”1
According to Mr Piller, “Most research institutions—including leading universities and hospitals in addition to drug companies—routinely break a law that requires them to report the results of human studies of new treatments to the federal government’s ClinicalTrials.gov database.”2
During interviews with researchers, university administrators, and hospital executives, it became clear to Mr Piller that these professionals were not intentionally undermining the law, but instead were waylaid by intense scheduling and a lack of administrative funding. Interviewees also said that some clinical trial results are disclosed in medical journals and at conferences, but are not making it to the government database, where visibility would be the greatest.
Anchoring her response in her own experience, Ms Gubar reminded readers that “the often debilitated participants in clinical cancer trials decide on their own accord to put their lives on the line, usually with no resulting personal health benefit.”1
A Grueling Experience
After recalling her own exhausting first days of a clinical trial, Ms Gubar noted that what kept her going was the knowledge that her participation would help researchers ascertain the effectiveness of the drug she was taking. However, she wrote, “the knowledge they [researchers] gain from this study remains barren, if it does not circulate among other researchers, cancer doctors, and patients.” Ms Gubar emphasizes that the results need to be promptly reported, not only in a medical journal, but also on the site constructed to disseminate this information.
Mr Piller points out that the timely and accurate reporting of data is the main source of information for physicians who are trying to understand the efficacy and safety of the new drugs.
According to the American Society of Clinical Oncology, only 5% of adults with cancer currently participate in clinical trials, and 60% of children with cancer receive treatment through clinical trials. Overall, 75% of children with cancer survive long-term compared with 50% of adults with cancer. Doctors attribute these higher survival rates in children to their more frequent participation in clinical trials over a long period of time.
Ms Gubar firmly believes that she lives and breathes today because of cutting-edge research, but she wants to make sure that other patients can say the same thing. “Thousands of patients have kept our side of the covenant,” she wrote. “The researchers and the institutions for which they work should keep theirs.”
To improve accountability and transparency of clinical trials, researchers can begin by visiting www.alltrials.net, which promotes reporting the results of all clinical trials.
- Gubar S. Living with cancer: a broken covenant with patients. New York Times Blog. January 15, 2016. http://well.blogs.nytimes.com/2016/01/15/living-with-cancer-a-broken-covenant-with-patients/. Accessed February 5, 2016.
- Piller C. Failure to report: a STAT investigation. STAT. December 13, 2015. www.statnews.com/2015/12/13/clinical-trials-investigation/. Accessed February 5, 2016.