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Toxicity Underreported in Clinical Trials
According to the study linked below, toxicity is underrepresented in clinical trials. Are you a myeloma patient? Do you rely on info from clinical trials to guide your therapy plan? I have.
The main issue presented in the TED talk below is that half of all clinical trial results are never published. Toxicity is only a part of this larger issue but the video makes an important point IN ADDITION to the study below.
And that is that multiple myeloma patients and survivors know little about possible side effects aka adverse events from the therapies that they take.
The hidden side of clinical trials
During my active MM therapies in ’94, ’95, ’96 and ’97, I volunteered for three different clinical trials. Believing that MM was incurable with an average life expectancy of 3-5 years, I decided that the information garnered from a clinical trial was worth the risks that I was taking. I was nieve. I never saw the results of any of those trials.
When a study examining clinical trials lands in my inbox I read it and write about it. Newly diagnosed MM patients should understand the pros and cons of the therapies they rely on.
- Multiple Myeloma Clinical Trials- Conflict of Interest
- Are Myeloma Clinical Trials Too Good To Be True?
- Myeloma Clinical Trials- Exclusion Criteria
- Myeloma Clinical Trials Misleading
Are you a newly diagnosed MM patient? Are you thinking about volunteering for a clinical trial? Email me at David.PeopleBeatingCancer@gmail.com with questions.
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Toxicity May Be Underreported in Phase 3 Oncology Trials
Toxicity may often be underreported in two-arm, superiority-design, phase 3 oncology trials, and may frequently be minimized in its interpretation by researchers, according to findings from a cross-sectional analysis published in the Journal of Clinical Oncology.
Of the 407 trials from 2002 to 2020 included in this study, 51% reported serious adverse events (SAEs), 88% (n = 358) of trials reported total deaths, and 84% (n = 340) reported discontinuation due to toxicity.
Additionally, 55% reported total AEs, although 32% (n = 131; 95% CI, 28%-37%) of the trials had complete toxicity reporting (CTR). CTR was more commonly observed in trials sponsored by industry (37%) compared with cooperative group sponsorship (4%).
Of note, all of the trials that reported CTR were industry sponsored, compared with 3% of (4/31) of trials sponsored by a cooperative group.
Ninety-eight percent of trials found to be in accordance with previously established toxicity reporting guidelines were industry sponsored, and 6% were cooperative-group sponsored.
“These findings, specifically the lack of CTR in the majority of trials, are consistent with previously published research that suggests that AEs are not just incompletely reported but reported on the basis of widely variable criteria,” wrote the authors of the study.
Toxicity minimizing language (TML) was used in 46% (n = 186; 95% CI, 41%-51%) of trials. No factors related to the trial, including the source of sponsorship, were linked with the likelihood of TML use.
In the 407 trials that researchers assessed, a trial was found to completely report toxicity if it reported total adverse events (AEs), total SAEs, total deaths, and discontinuation of study therapy due to toxicity. Researchers found 44% of trials (95% CI, 40%-49%) to be in concordance with guidelines from a prior study on toxicity reporting, defined as meeting the aforementioned criteria with the exception of total AEs.
Likewise, terms that could soften the perception of toxicity in a trial including
- “acceptable,”
- “safe,”
- “well tolerated,”
- “tolerable,”
- “feasible,”
- “favorable toxicity profile,”
- and “manageable”
constituted toxicity minimizing language.
Of note, 43% of trials that assessed therapies that were granted FDA approval completely reported toxicity. Forty percent of therapies that were approved by the FDA based on the trials did not concord with prior toxicity reporting guidelines, and 35% of approved drugs based on these trials used TML.
Medical writers assisted with reports for 227 trials (56%) altogether, 102 of which had CTR, meaning those reports accounted for 78% of all trials where toxicity was completely reported. Guideline concordance and TML were identified in 72% and 58%, respectively, of trials where medical writers were involved.
TML terms were most often used in the discussion (44%) and abstract (19%) of trial reports, and the most frequent TML terms found in the trials were “tolerable” (24%), “manageable” (16%), and “acceptable” (12%).
“Therefore, in addition to what is already recommended by current guidelines, we encourage CTR, which includes [total AEs] along with total SAEs, total deaths, and study therapy discontinuations because of toxicity,” researchers noted.
Even after adjusting for confounders, industry-funded trials published more recently had greater odds of CTR (adjusted OR = 1.25; 95% CI, 1.14-1.37; P < .01), as did use of medical writers (adjusted OR = 2.25; 95% CI, 1.35-3.75; P < .01).
Similarly, publication year (adjusted OR = 1.18; 95% CI, 1.09-1.28; P < .01) and use of medical writers (adjusted OR = 1.92; 95% CI, 1.20-3.08; P = .01) were also associated with greater odds of guideline concordance in industry-funded trials.
Studies involving thoracic cancers were most common in the CTR group compared to other disease types, comprising 30% of CTR trials (OR = 3.94; P < .01), followed by hematologic cancers (19%; OR = 2.90; P < .01).
toxicity is underrepresented in clinical trials toxicity is underrepresented in clinical trials