Remove tag patient-choice
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Grand Rounds May 19, 2023: Aspirin or Low-Molecular-Weight Heparin for Thromboprophylaxis After a Fracture (Robert O’Toole, MD)

Rethinking Clinical Trials

Aspirin is now the most commonly used VTE prophylaxis for Arthroplasty patients, in which Aspirin and LMWH are both safe and effective prophylaxis options. Aspirin as an oral pill is a less expensive and easier option for the orthopedic trauma population, which has a high proportion of uninsured patients.

Trials 130
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A broad range of unmet needs remains in the immuno-oncology space

Pharmaceutical Technology

Immuno-oncology (IO) agents have transformed the cancer therapeutics landscape, driving long-term remissions in a subset of patients who historically had limited options. Although a subset of patients derives long-term benefits from IO therapies, a high percentage of patients still fail to respond or develop resistance to IO therapy.

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Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? (Monica Taljaard, PhD; David Magnus, PhD)

Rethinking Clinical Trials

There are two main types of clinical trials: patient randomized trial and cluster randomized trial (CRT). Investigators should provide a justification for choice of stepped wedge CRT. In most cases, a parallel arm or cluster cross would be a better choice. Ethics, Stepped Wedge Cluster Randomized Trial, Study Design. Key Points.

Trials 130
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Grand Rounds February 24, 2023: S2302 Pragmatica-Lung: New Directions for Decreasing Burden and Increasing Inclusion in NCTN Clinical Trials (Konstantin Dragnev, MD; Karen Reckamp, MD, MS)

Rethinking Clinical Trials

S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for NSCLC patients previously treated with immunotherapy performed within the Lung-MAP platform. The study does not include tissue specimen collection, image submission, or patient-reported outcome instruments.

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Orphan drugs and where to launch them: The keys to Europe’s forgotten territories

Pharmaceutical Technology

Historically, the pharmaceutical industry has failed to meet the needs of this patient population. Most famously, the US passed its Orphan Drug Act in 1983, providing innovators with financial motivation to develop orphan drugs and meet the needs of these forgotten patients. Efforts have been made to change this.

Drugs 147
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Grand Rounds Ethics and Regulatory Series February 10, 2023: Informing and Consenting: What Are the Goals? (P. Pearl O’Rourke, MD; David S. Wendler, PhD, MA; Miguel Vazquez, MD; P. Michael Ho, MD, PhD)

Rethinking Clinical Trials

ICD-Pieces studied patients with chronic kidney disease (CKD), diabetes and hypertension. The study used a patient-information sheet to inform patients about the research, how patient data would be handled, and an option to opt-out of including their data in the study. The study had a waiver of informed consent.

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Grand Rounds February 3, 2023: Pragmatic Trials For Children With Congenital Heart Disease – Insights From The NITRIC Trial (Luregn Schlapbach, PhD, FCICM)

Rethinking Clinical Trials

All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. 1,371 patients were randomized with 1,364 in the final analysis. The intervention was applied by perfusionists at a steady concentration from the start until the end of bypass. All other surgical staff were blinded.

Trials 130