Rethinking Clinical Trials

FEBRUARY 13, 2023

All patients could receive inhalation NO during/after surgery if considered indicated by the treatment team. The recruitment began in July 2017-April 2022 and 71 percent of approached parents provided consent. 1,371 patients were randomized with 1,364 in the final analysis. All other surgical staff were blinded.

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Rethinking Clinical Trials

FEBRUARY 22, 2023

The biggest change is that the patient now has a seat at the table. Providers must now earn the trust of relatively informed and knowledgeable patients through a two-way conversation. Patients were enrolled via an app in this virtual trial. The consent form is electronic and approved by a central IRB.

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Rethinking Clinical Trials

OCTOBER 31, 2023

PaxLC brings together many innovations including online screening, digital medical record review, e-consent, home-delivery of medications, local clinical blood draws, home-based biospecimen collection, online diaries and surveys, digital medical record outcomes, and participant-centricity, and return of results. Pfizer provided feedback.

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Rethinking Clinical Trials

OCTOBER 27, 2022

Patients use the internet to search for answers, and researchers use the internet to search for new solutions. The Light Collective is an organization that represents collective rights, interests, and voices of patient communities in healthcare technology. Andrea Downing. ePatient and Security Researcher. Key Points. Learn more.

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Rethinking Clinical Trials

AUGUST 10, 2023

For example, if the method of patient reported outcomes is gamified, patients will be more likely to continue reporting their outcomes on a regular basis rather than giving up or forgetting after the first time, which may increase the quality and quantity of data for the trial overall.

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Rethinking Clinical Trials

NOVEMBER 21, 2023

The Nudge study wanted to find out if nudges could help patients improve medication adherence by promoting behavioral change through positive reinforcement. The Year 1, UG3 Phase, aims were to develop and program a nudge message library using iterative N of 1 studies to optimize content for a range of diverse patients.

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Rethinking Clinical Trials

JANUARY 26, 2023

Patient recruitment is through a network of sites in different geographic locations managed by a collaboration of AROs. EVOLVE-MI is enrolling 4,000 patients in 3 countries. So far EVOLVE-MI’s early experience in the trial has been that nearly every site enrolled a patient within days of activation. Can it be done under an IND.

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Rethinking Clinical Trials

MARCH 1, 2023

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. networks.

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Rethinking Clinical Trials

OCTOBER 19, 2022

These data increasingly include info that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. What do patients and other stakeholders desire? extraction from health records and/or have treating clinicians or patients complete measures); and trials may operate under waivers of consent.

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Rethinking Clinical Trials

DECEMBER 12, 2023

For the Jumpstart trial, a number of refinements were made to make it more pragmatic, including the creation of Jumpstart using EHR data rather than patient or family member surveys, delivering the intervention to clinicians only, automated population of Jumpstart guide fields, and automated Jumpstart delivery to clinicians by email.

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Rethinking Clinical Trials

MARCH 6, 2024

The dietician met with the patient to share education about nutrition, portion size, recipes to make food taste good, and information via an optional diabetes self-management program. Recruitment was by phone calls and physician referrals, and consent was over the phone. They also screened for complications and close care gaps.

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Rethinking Clinical Trials

AUGUST 4, 2022

The consent process is in-person, which was challenging in the beginning days of the trial. It is a single injection of peginterferon lambda verses placebo, patients were randomized within 7 days of symptom onset and positive SARS-CoV-2 test. 43% risk reduction for hospitalization (65% reduction when treated early).

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Rethinking Clinical Trials

AUGUST 22, 2022

Patients with diabetes or prediabetes were not excluded (except for those on insulin or sulfonylurea); pregnant patients were not excluded for the Metformin arm; the trial restricted participants to people who were overweight or obese to enrich the population for having a high risk of outcomes and for anti-inflammatory hypotheses around Metformin.

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Rethinking Clinical Trials

FEBRUARY 2, 2023

There are many choices clinicians must make for every emergency tracheal intubation for which the effect on patient outcomes is unknown. It was conducted with waiver of informed consent. The data collector was not clinically taking care of the patient but familiar with the procedure and trained on data collection.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The drugs were administered open label and all patients were given a low dose of aspirin.

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Rethinking Clinical Trials

DECEMBER 6, 2022

This study asks how can we better facilitate health behaviors in patients with chronic diseases and can we leverage technology? that focused on patients with heart failure and diabetes, two rapidly growing conditions that are highly morbid. Patients did not get text messages about pill adherence.

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Rethinking Clinical Trials

JULY 6, 2023

For instance, there is no discussion of the role of the health care provider in the DCTs, but it emphasizes the importance of patient voice. DCTs can make things easier for patients and the research more efficient. While similar to the FDA draft guidance, the EMA guidance differs slightly in its emphasis and lack of certain topics.

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Rethinking Clinical Trials

MAY 5, 2023

Yet, even though millions of patients have received oxygen during mechanical ventilation in clinical care for decades, the oxygen target that optimizes outcomes has been unknown. All patients in the ED and ICU were assigned together to an SpO2 target. The trial was conducted under waiver of informed consent.

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Rethinking Clinical Trials

FEBRUARY 28, 2024

There are 5 guiding principles for defining quality that should inform DCTs: Have we enrolled the right participants according to the protocol with adequate consent? Outcomes including patient reported outcomes, functional assessments including via digital technology, healthcare events or mortality may require identify verification.

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Rethinking Clinical Trials

AUGUST 28, 2023

The American College of Physicians guideline states that “physicians and patients should treat acute, sub-acute and chronic LBP with non-drug therapies.” Patients in the usual care arm clinics are then scheduled to see a PCP. Presenters also shared challenges regarding scheduling and patient insurance coverage.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

The Danish Nationwide Registries include the Danish Patient Registry (a registry of every inpatient and outpatient contact in the Danish free-for-all public healthcare system); the Danish Medicines Registry (a registry of every filed prescription at any pharmacy in Denmark including information on pill strength, pack size, etc.); Key Points.

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XTalks

AUGUST 23, 2021

Dr. Weninger’s fellow panel members echoed that sentiment and sought to address some of the most pressing concerns around trial design, patient safety and data integrity in trials in this post-approval period for aducanumab. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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pharmaphorum

OCTOBER 4, 2022

A key part of this initiative was the establishment of the Cancer Moonshot Biobank, which will ask cancer patients to donate biospecimens and associated health information to aid research. The objective is to gather patient biospecimens longitudinally to understand how patients react to treatments and how cancer develops over time.

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The Pharma Data

MAY 15, 2021

In the process, I’ve reviewed thousands of research articles, played a key role in publishing real clinical studies and as a surgeon, operated on hundreds of patients often in life-or-death scenarios. All so that I can better understand and help my patients achieve the health they always dreamed of.

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