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Clinical Trial Side Effects Underreported
According to the study linked below clinical trial side effects are underreported. Just as important is the fact that the study shows that clinical trails use “toxicity-minimizing language.”
I am a long-term myeloma survivor living with a host of long-term side effects. The time since my diagnosis in early 1994 has been spent struggling with the emergence of these long-term side effects.
Looking back on my years undergoing conventional MM therapies, I am horrified by the absence of discussion by my oncologist about any possible side effects.
All to say that I learned about my side effects from experience, not from my oncologist. Having read 000’s of myeloma clinical trial write-ups to use as content for PeopleBeatingCancer.org, I’ve learned that side effects aka adverse events are after-thoughts.
“Safe, Effective, Better” “Safety is Paramount” The study below does not agree with this video.
I entered three different clinical trials during my active conventional therapies. I understand that testing new cancer therapies can be useful to cancer patients and survivors. I wish that oncologists were open and honest with clinical trial subjects.
Email me at David.PeopleBeatingCancer@gmail.com to ask any and all questions about multiple myeloma.
Hang in there,
David Emerson
- MM Survivor
- MM Cancer Coach
- Director PeopleBeatingCancer
Incomplete Toxicity Reporting and Use of Toxicity-Minimizing Language in Phase III Oncology Trials
Purpose
This study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.
Methods
Two-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting:
- total adverse events (TAEs),
- total serious adverse events (SAEs),
- total deaths,
- and study therapy discontinuations because of toxicity.
Guideline concordance was defined according to guidelines published in the BMJ (defined as reporting total SAEs, total deaths, and study therapy discontinuations because of toxicity). TML was defined as a set of terms that subjectively downplay the harm of therapies.
Results
A total of 407 trials enrolling 322,645 patients were included. Most
- (51%, n = 207) reported SAEs,
- 88% (n = 358) reported total deaths,
- and 84% (n = 340) reported study therapy discontinuation because of toxicity.
Although 55% of trials (n = 223) reported TAEs, only 32% (n = 131; 95% credible interval, 28 to 37) fit the criteria for CTR. CTR was more common in trials with industry sponsorship (37%) than with cooperative group sponsorship (4%).
All 131 trials where CTR was observed were industry-sponsored, and only 3% (4/131) were cooperative group–sponsored trials. TML was used in 46% of trials (n = 186; 95% credible interval, 41 to 51), with no trial-related factors (including sponsorship source) associated with the odds of TML use.
Conclusion
Toxicity in phase III oncology clinical trials is often incompletely reported and is frequently minimized in its interpretation. Industry-sponsored trials more comprehensively report toxicity than do cooperative group–sponsored trials. CTR may improve patients’ and oncologists’ understanding of new treatments; thus, a more standardized approach to reporting toxicity data is needed.
Use of subjective minimizing language at hematology and oncology conferences: A systematic review
Highlights
- The prevalence of subjective minimizing language in abstracts presented at major oncology conferences is high.
- There is frequent inappropriate use of subjective minimizing language in the context of grade III-V adverse events.
- Our findings highlight the need for oncology researchers to exercise caution when interpreting study results and assessing treatment safety…
Background
Subjective minimizing language in oncology conferences may undermine patient-centered care and hinder comprehensive treatment strategies. Subjective terms like “safe,” “tolerable,” and “well-tolerated” can vary in interpretation among individuals, making it difficult to compare results across trials and potentially downplaying significant risks and limitations associated with treatments.
Methods
This study evaluates subjective minimizing language in major oncology conferences and its use in adverse event reporting. We conducted a search of three electronic databases, ASCO, ASH, and ESMO, for published abstracts from January 1, 2019, to December 31, 2021. This study included prospective cohort studies or clinical trials in humans that used safety terms like “safe,” “well-tolerated,” “tolerable,” “no new safety signal,” or “no new safety concern” in the abstract text.
Results
Out of 34,975 reviewed records, 5299 (15.2%) abstracts used subjective minimizing language terms. The analysis included 2797 (52.8%) abstracts meeting the inclusion criteria. The majority of studies were Phase 1 trials (45.5%), followed by Phase 2 (29.6%) and Phase 3 trials (7.4%).
Solid tumorsaccounted for the most common disease category (56.5%), followed by malignant hematology following (37.1%). Subjective minimizing terms like “safe” (69.2%), “well-tolerated” (53.2%), “tolerable” (25.6%), and “no new safety signal/concerns” (10%) were used frequently.
Of the abstracts using subjective minimizing language (n = 2797), 81.9% reported data on any grade adverse events (AEs). Grade I/II AEs were reported in 62.6% of abstracts, Grade III/IV AEs in 78%, and Grade V AEs (death related to AEs) in 8.8%. Discontinuation due to AEs occurred in 11.4% (SD 9.5%) of studies using subjective minimizing language terms.
Conclusions
Frequent use of subjective minimizing language in major oncology conferences’ abstracts may obscure interpretation of study results and the safety of novel treatments. Researchers and clinicians should provide precise and standardized information to avoid overstatement of benefits and understand the true impact of interventions on patients’ safety and well-being.
clinical trial side effects are underreported clinical trial side effects are underreported