The bigger, the better? When multicenter clinical trials and meta-analyses do not work

Seifirad, Soroush; Alquran, Lance

doi:10.1080/03007995.2020.1860922

Cited by 13 publications

(5 citation statements)

References 39 publications

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“…Despite these benefits, they face methodological, implementation, and statistical challenges that can affect study validity. Effective coordination between centers and study governance mechanisms is essential for successful implementation, along with transparent communication to foster productive collaboration among investigators ( 55 – 59 ).…”

Section: Resultsmentioning

confidence: 99%

Global trends in clinical trials involving engineered biomaterials

Lele,

Kapur,

Hargett

et al. 2024

Sci. Adv.

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Engineered biomaterials are materials specifically designed to interact with biological systems for biomedical applications. This paper offers the comprehensive analysis of global clinical trial trends involving such materials. We surveyed 834 studies in the ClinicalTrials.gov database and explored biomaterial types, their initiation points, and durations in clinical trials. Predominantly, synthetic and natural polymers, particularly silicone and collagen, are used. Trials, focusing on ophthalmology, dentistry, and vascular medicine, are primarily conducted in the United States, Canada, and Italy. These trials encompass a broad demographic, and trials enrolled fewer than 100 participants. The study duration varied ranging from 0.5 to 4.5 years. These biomaterials are mainly bioresorbable or bioinert, with the integration of cells in biomaterials remaining an underexplored area. Our findings shed light on current practices and future potentials of engineered biomaterials in clinical research, offering insights for advancing this dynamic field globally.

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Section: Resultsmentioning

confidence: 99%

Global trends in clinical trials involving engineered biomaterials

Lele,

Kapur,

Hargett

et al. 2024

Sci. Adv.

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“…As mentioned above, the main disadvantages of our study are its retrospective nature and the relatively small patient cohort analyzed. However, to the best of our knowledge, our work offers the longest follow-up after failure of 1L-2GTKI and the advantage of being monocentric, which ensures homogeneity of clinical data and patients’ management [ 23 ]. For these reasons, the present study contributes to the increasing pool of evidence and helps to delineate the best practice in the management of this challenging scenario in CML treatment pathways.…”

Section: Discussionmentioning

confidence: 99%

Long-term outcomes after upfront second-generation tyrosine kinase inhibitors for chronic myeloid leukemia: managing intolerance and resistance

Claudiani,

Chughtai,

Khan

et al. 2024

Leukemia

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Second-generation tyrosine kinase inhibitors (2GTKI) are more effective in inducing rapid molecular responses than imatinib when used first-line in patients with chronic myeloid leukemia in chronic phase (CML-CP). However, failure of first line-2GTKI (1L-2GTKI) still occurs and there is no consensus regarding subsequent management. We retrospectively analyzed the outcome of 106 CML-CP patients treated with 1L-2GTKI and with a median follow-up of 91 months. 45 patients (42.4%) switched to an alternative TKI, 28 for intolerance (26.4%) and 17 (16%) for resistance. Most patients who remained on 1L-2GTKI achieved deep molecular responses (DMR) and 15 (14.1%) are in treatment-free remission (TFR). Intolerant patients also obtained DMR, although most required multiple TKI changes and were slower to respond, particularly if treated with 2L-imatinib. Inferior outcomes were observed in resistant patients, who failed alternative 2L-2GTKI and required 3/4GTKI and/or allogeneic hematopoietic stem cell transplant (alloSCT). 7yr-OS was significantly lower for these individuals (66.1%) than for intolerant patients and those who remained on 1L-2GTKI (100% and 97.9%, respectively; p = 0.001). It is apparent that failure of 1L-2GTKI is a challenging problem in modern CML therapy. Intolerance can be effectively managed by switching to an alternative 2GTKI, but resistance requires early consideration of 3/4GTKI.

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“…Both the single- and the multicenter designs have advantages and disadvantages. 26,27 While this design may limit the generalizability of certain domains, the centralization and pragmatic inclusion and procedural details make it relevant to most clinical settings.…”

Section: Discussionmentioning

confidence: 99%

Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial

Mian,

Feustel,

Aziz

et al. 2024

Journal of Urology

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Purpose: The comparative effectiveness of transrectal and transperineal prostate biopsy in detecting clinically significant prostate cancer is not well understood. We conducted a randomized clinical trial to determine whether transperineal biopsy improves the detection of clinically significant prostate cancer. Materials and Methods: Of the 840 men randomized, 93% were White, 44% had a previous biopsy, with a median age of 66 years and median PSA density of 0.14. Of these, 384 underwent transrectal and 398 underwent transperineal prostate biopsy. Prebiopsy prostate MRI was performed in 96% of men. Grade Group 2 prostate cancer was classified as clinically significant. Odds ratios were calculated using logistic regression to evaluate the effect of biopsy procedures on cancer detection rates. Results: The detection rates of clinically significant prostate cancer were 47.1% and 43.2% (odds ratio 1.17; 95% CI, 0.88-1.55) for transrectal and transperineal biopsy, respectively. Age, PSA density, clinical stage and Prostate Imaging Reporting and Data System score were associated with the diagnosis of clinically significant cancer, whereas history of previous biopsy, anterior tumors, and biopsy procedure (transrectal or transperineal) were not. Clinically significant cancer detection rates in biopsy-na€ ıve men undergoing MRI-targeted transrectal or transperineal biopsy were 59% and 62%, respectively. The overall cancer detection rates following transrectal and transperineal biopsy were 72.1% and 70.4%, respectively. Conclusions: There was no significant difference noted in the detection of clinically significant prostate cancer following transrectal or transperineal prostate biopsy. Urologists may utilize either biopsy procedure that best suits their patients' needs and practice setting.

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The bigger, the better? When multicenter clinical trials and meta-analyses do not work

Cited by 13 publications

References 39 publications

Global trends in clinical trials involving engineered biomaterials

Global trends in clinical trials involving engineered biomaterials

Long-term outcomes after upfront second-generation tyrosine kinase inhibitors for chronic myeloid leukemia: managing intolerance and resistance

Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial

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