Dataset Information

Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study.

ABSTRACT:

Objectives

Clinical trials produce the best data available for decision-making in modern evidence-based medicine. We aimed to determine the rate of non-publication of interventional phase 3 and 4 clinical trials involving patients with cancer undergoing radiotherapy.

Setting

The ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in radiotherapy with a primary completion date before 1 January 2013. We determined how many of these registry entries have not published the compulsory deposition of their results in the database and performed a systematic search for published studies in peer-reviewed journals.

Results

Of 576 trials, 484 (84.0%) did not deposit a summary result in the registry. In addition, 44.9% of them did not publish their results in a peer-reviewed journal. Similar percentages were found for most cancer subtypes: brain (41%), breast (38%), cervical (66%), colorectal (38%), lung (48%), prostate (45%), bladder (56%), head and neck (56%) and lymphoma (33%).

Conclusion

Our results show that most trials in radiation oncology did not report the results in the registry. Almost half of these trials have not been published in the biomedical literature. This means that a large number of study participants were exposed to the risks of trial participation without the supposed benefits that sharing and publishing of results would offer to future generations of patients.

SUBMITTER: Perez-Alija J

PROVIDER: S-EPMC5623516 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Publications

Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study.

Pérez-Alija Jaime J Gallego Pedro P Linares Isabel I Ambroa Eva E Pedro Agustí A

BMJ open 20170921 9

<h4>Objectives</h4>Clinical trials produce the best data available for decision-making in modern evidence-based medicine. We aimed to determine the rate of non-publication of interventional phase 3 and 4 clinical trials involving patients with cancer undergoing radiotherapy.<h4>Setting</h4>The ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in radiotherapy with a primary completion date before 1 January 2013. We determined how many of these registry entries have ...[more]

PMID: 28939574

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Project description:BackgroundRandomized controlled trials (RCTs) are the gold standard for evidence-based practice, but their development and implementation is resource intensive. We aimed to describe modern RCTs in gastrointestinal (GI) cancer and identify predictors of successful accrual and publication.Materials and methodsClinicalTrials.gov was queried for phase III GI cancer RCTs opened between 2010 and 2019 and divided into two cohorts: past and recruiting. Past trials were analyzed for predictors of successful accrual and the subset with ≥3 years follow-up were analyzed for predictors of publication. Univariate and multivariable (MVA) logistic regression were used to identify covariates associated with complete accrual and publication status.ResultsA total of 533 GI RCTs were opened from 2010 to 2019, 244 of which are still recruiting. In the "past" trials cohort (235/533) MVA, Asian continent of enrollment was a predictor for successful accrual, whereas trials with prolonged enrollment (duration longer than median of 960 days) trended to failed accrual. Predictors for publication on MVA included international enrollment and accrual completion. Sponsorship was not associated with accrual or publication. Notably, 33% of past trials remain unpublished, and 60% of trials that were closed early remain unpublished.ConclusionAccrual rate and the primary continent of enrollment drive both trial completion and publication in GI oncology. Accrual must be streamlined to enhance the impact of RCTs on clinical management. A large portion of trials remain unpublished, underscoring the need to encourage dissemination of all trials to, at a minimum, inform future trial design.Implications for practiceTwo-thirds of gastrointestinal (GI) oncology phase III randomized controlled trials successfully accrue; however, one third of these trials are unpublished and more than half of trials that close early are unpublished. The strongest predictors for publication are successful accrual and international collaborations. Initiatives to optimize the trial enrollment process need to be explored to maximize the potential for trials to engender progress in clinical practice. Moreover, this study identified a significant publication bias in the realm of GI oncology, and the field should promote reporting of all trials in order to better inform future trial questions and design.

Project description:IntroductionCurrent clinical outcome assessments (COAs) are not effectively capturing the complex array of symptoms of adults with phenylketonuria (PKU). This study aimed to identify concepts of interest relevant to adults with PKU. Based on these concepts, COAs for patient-reported outcomes (PROs), observer-reported outcomes (ObsROs), and clinician-reported outcomes (ClinROs) were selected or developed and content validity was assessed.Materials and methodsConcept-elicitation interviews were conducted with an international cohort of adults with PKU (n = 30), family member observers (n = 14), and clinical experts (n = 8). Observers and clinical experts were included to overcome the risk of lack of self-awareness among adults with PKU. The concepts of interests endorsed by ≥30% of patients, observers, and/or clinical experts were selected, mapped to items in existing COAs, and used to develop global impression items for patients, observers, and clinicians. Next, the content validity of the COAs and global impression items was evaluated by cognitive interviews with patients (n = 22), observers (n = 11), and clinical experts (n = 8). All patients were categorized according to blood phenylalanine (Phe) levels (i.e., <600 μmol/L, 600-1200 μmol/L, and >1200 μmol/L).ResultsConcepts of interests were identified across four domains: emotional, cognitive, physical, and behavioral. After mapping, eight existing COAs were selected based on the concept coverage (six PROs, one ObsRO, and one ClinRO). The six PRO measures were considered as potentially fit-for-purpose. The ObsRO measure was not deemed relevant for use in observers of adults with PKU and only a subscale of the ClinRO measure was considered valid for assessing adults with PKU by clinicians. Due to the lack of existing COAs covering all concepts of interests, global impression items for symptom severity and change in symptoms were developed, which were limited to one question covering in total 14 concepts. Upon validation, some of the patient and observer global impression items were excluded as they were subject to lack of insight or could not be reported by observers. Due to the limited interaction time between clinician and patient, use of the clinician global impression items was not supported.ConclusionExisting COAs relevant to adults with PKU were selected and PKU-specific global impression items were developed by mapping the most frequently identified concepts of interests from internationally-conducted in-depth interviews. Future studies should address the appropriateness of the selected COAs and global impression items to assess if these can be used as efficacy endpoints in PKU clinical trials.

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Dataset Information

Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study.

Objectives

Setting

Results

Conclusion

Publications

Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study.

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