TranspariMED has filed an ethics complaint with the University of Texas MD Anderson Cancer Center over its refusal to disclose the outcomes of a clinical trial involving patients with brain tumour metastases.
Recently, the German Institute for Quality and Efficiency in Health Care (IQWiG) tried to determine whether a single treatment of radiosurgery could prolong the life of patients with brain tumour metastases.
The institute could not reach a conclusion because MD Anderson has for sixteen years failed to make public the result of an important clinical trial.
EVIDENCE GAP LIMITS PATIENTS’ ACCESS TO TREATMENT
According to reporting by The BMJ, the medical center did not even share the trial's results on request:
“In a letter to IQWiG seen by The BMJ, MD Anderson Cancer Center’s chief scientific officer, Guilio Draetta, said that the centre had been unable to publish the results in a scientific journal, but he did not say why it had not uploaded the data to the US ClinicalTrials.gov register as required. It also declined to share the results with IQWiG because they had not been peer reviewed.”
“[The treatment tested] is currently available only for hospital inpatients in Germany, as the benefits of the treatment over surgery are still not proved, [IWQiG employee] Sauerland told The BMJ.”
The University of Texas MD Anderson Cancer Center completed the clinical trial in 2005. The trial (NCT00460395) aimed to enrol 64 people with metastatic brain tumors to check whether the treatment prolonged the life of its patients.
Sixteen years later, the results of the trial still remain unreported, both in the scientific literature and on the trial registry. This means that the sacrifices made by the cancer patients who volunteered for the trial have not yielded any scientific benefit – doctors worldwide still do not know whether the treatment works or not.
VIOLATION OF MEDICAL RESEARCH ETHICS
MD Anderson’s failure to make its results public is a clear violation of the Declaration of Helsinki, which sets out global ethics rules for medical research.
Declaration of Helsinki, Article 36
“Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports… Negative and inconclusive as well as positive results must be published or otherwise made publicly available.”
The University of Texas MD Anderson Cancer Center provided the following statement to TranspariMED:
“MD Anderson believes in transparency and that the publication of our clinical trials data is important. We make every effort to comply with federal regulations, and we will continue efforts to complete data publication for our trials. In this instance, the data have not been accepted for publication despite multiple efforts and submissions by the PI.”
Cancer patient Lesley Stephen commented on Twitter:
"As a patient living with cancer it’s essential that they release results- so disrespectful to those people that gave up their time and bodies to help with research"
According to World Health Organisation best practices, the results of every clinical trial should be made public on a trial registry within one year of trial completion, but this is not legally binding.
U.S. transparency legislation only applies from 2007 onwards, so MD Anderson is not legally obliged to disclose the results of this older trial. MD Anderson has a strong track record of uploading trial results onto ClinicalTrials.gov in cases where it is legally obliged to do so.
(Similarly, some large pharma companies with strong track records of legal compliance have refused to make public the results of older trials not covered by transparency laws.)
SCALE OF ETHICS VIOLATIONS UNCLEAR
MD Anderson did not answer TranspariMED’s question how many more of its trials have never made their results public (see further below).
According to ClinicalTrials.gov data, MD Anderson has been the lead sponsor for over a hundred completed clinical trials that are missing results on the registry. Importantly, many of these trials will have made their results public in medical journals, thereby meeting the publication requirement set out by the Declaration of Helsinki.
To determine whether any of these past trials remain completely unreported, MD Anderson would have to systematically search the literature for the outcomes of each completed trial. MD Anderson did not provide detailed answers to the following questions submitted to it by TranspariMED:
Q: “How many other interventional clinical trials sponsored by your institution that were completed between 01 January 2005 and 31 December 2014 have not made their results public yet? (please enclose a list of all such trials, providing the NCT number of each)”
Q: “What work are you undertaking to ensure that trial results that have remained unreported in past years are made public?”
RESULTS COULD BE MADE PUBLIC WITHIN HOURS
Uploading the results of a trial onto a registry typically takes only a few hours. Medical journals have committed to publishing the outcomes of clinical trials even if they have previously been uploaded onto trial registries.
Till Bruckner, founder of TranspariMED, said:
“MD Anderson’s failure to make the results of this trial public for sixteen years, followed by a refusal to share the outcomes on request, is not only a clear ethics violation, but also an insult to the memory of the cancer patients who volunteered to participate in this research in order to help develop better cancer treatments.”
“Rather than spending sixteen years trundling from one medical journal to the next, MD Anderson could have rapidly shared the results on the ClinicalTrials.gov registry to enable oncologists worldwide to make better treatment decisions, and pursued journal publication afterwards.”
“Out of respect for its past and current patients, MD Anderson should immediately upload the results of this trial onto ClinicalTrials.gov, and launch an audit of its entire trial portfolio to check whether other cancer trials remain completely unreported.”
TranspariMED’s ethics complaint explicitly discourages MD Anderson from sanctioning individual researchers or staff members. Instead, it recommends that MD Anderson as an institution takes responsibility for ensuring that all trial results are rapidly made public.
UPDATE: MD ANDERSON NOW REVIEWING THE CASE
UPDATE 15 October 2021
An MD Anderson spokesperson told STAT News that the complaint is being reviewed by its compliance office. She argued that:
“Without peer review, we believe that the wide distribution of inconclusive clinical study results is inappropriate as these can lead to misleading interpretation and negative impact for patients. This is counter to the principles of scientific exchange.”
TranspariMED continues to believe that MD Anderson should upload the study’s results to ClinicalTrials.gov, where National Library of Medicine staff review data submitted before results are made public, thus providing a form of peer review. Results uploaded onto the registry meet U.S. legal disclosure requirements and form a cornerstone of WHO best practices.
TranspariMED will discuss the conclusions reached by MD Anderson’s compliance office in a future blog.
UPDATE 11 March 2022
Asked about the progress of the investigation, MD Anderson provided the following statement:
"The University of Texas MD Anderson Cancer Center does not comment on active investigations. The matter is undergoing a full a review by the institution."
A copy of TranspariMED's ethics complaint can be downloaded below: