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The Reproducibility Crisis in Clinical Trial Research
Theoretically, a researcher should be able to reproduce any clinical trial and see the same or similar findings. Yet the long-standing “reproducibility crisis” in science persists, resulting in a surge of new analyses and recommendations.
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IRBs May Need to Seek Outside Expertise; More Data Are Needed
It is impossible for any IRB to claim an exhaustive range of methodological and disciplinary expertise within their membership. Without the right expertise, the quality of IRB review comes into question. But for a variety of reasons, IRBs may not be taking advantage of the option to use outside experts.
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Greater Awareness of Reporting Bias on Antidepressants, Yet Problem Persists
An investigator who was part of a landmark study on the efficacy of antidepressants recently revisited reporting transparency in this area of research.
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Ethical Concerns Persist Over Reporting Bias in Clinical Trials
Several changes could be made, including enforcement of penalties for delays in reporting trial results; journals prioritizing accuracy between published results and the original study protocols; and mitigating the problem of selective registration, publication, and reporting on ClinicalTrials.gov.
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Many Parkinson’s Research Participants Cannot Recall Study Risks
Rather than consenting an individual in the office during the presurgical visit, at a time when the patient was already receiving a large amount of information, the outreach could be conducted by phone later. This would give the subject time to carefully review the study materials.
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Uncertainties on Future Use of Study Participants’ Data
Generally, the informed consent process needs improvement, particularly when it comes to explaining to participants what data will be used and how. Responsible data-sharing rests on making quality data accessible to authorized researchers to meaningfully advance science while respecting participant values.
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Tips for Researchers Looking to Recruit More Pregnant Black Women
It boils down to trust, communication, education, and building a presence within the community.
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IRBs Strive to Improve Consistency of Study Protocol Decisions
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB.
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Preventing Age Disparities in Cancer Trials
A leading researcher explains why patients should have equity regarding their ability to access clinical trials, to the greatest extent reasonably possible, in this Q&A.
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Analyses: Older Patients Excluded from Many Research Studies
Investigators learned age disparities were worse for industry-funded trials; for trials with enrollment criteria restrictions based on age cutoffs or performance status; for trials that evaluated a targeted, systemic therapy; and for lung cancer trials.