Editorial Perspectives On Patient Recruitment
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Beat AML Utilizes Innovative Master Trial Configuration
12/15/2017
Acute myeloid leukemia (AML) is a cancer that develops in bone marrow where new blood cells are created. It quickly moves into the blood, where it can be fatal in a matter of months. A new trial using a Master Trial configuration will provide hope for patients.
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J&J Announces First Efficacy Study For HIV-1 Preventive Vaccine
12/6/2017
On the eve of World AIDS Day 2017, the Bill & Melinda Gates Foundation and the National Institutes of Health (NIH) have joined forces with Johnson & Johnson (J&J) to advance a potential “global vaccine” that could prevent a wide range of viral strains responsible for the world’s HIV pandemic.
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Trial Aims To Kill Cancer Without Chemotherapy Side Effects
11/20/2017
Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.
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Can GAP Double The Number Of Patients In Alzheimer's Trials?
11/13/2017
According to research performed on recruitment, 85 percent of trials are delayed due to enrollment issues and more than 30 percent of total trial time is spent simply recruiting patients. Those issues are present in all therapeutic areas, including Alzheimer’s disease. To mitigate these problems, cut the time of trials, and get needed medicines to patients faster, the Global Alzheimer’s Platform (GAP) Foundation is implementing a new model that promises to increase patient participation in Alzheimer’s research.
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Clinical News Roundup: FDA Awards Funding To Pediatric Clinical Trials
11/10/2017
Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.
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How Poor Communication, Patient Recruitment Plague Clinical Trials
11/6/2017
Two issues continue to be a headache for those working in the clinical space: patient recruitment and communication. New technologies, including social media, seem to offer a glimmer of hope to getting more patients involved in trials. Unfortunately, the problem of poor communication between sponsors, CROs, and sites is an issue still in need of novel solutions. In this Q&A, Mary Rose Keller, VP of clinical operations for Heron Therapeutics, shares her insights.
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Turning A Ship: How Janssen Is Changing Its Culture For Patients
11/1/2017
For years, pharma has had a model in place for dealing with sites and patients: Design a trial protocol, hand it to sites and patients, and tell them what they need to do. While that model seemed to work, it also created patient and investigator recruitment problems that were never solved. Addressing those issues is a primary goal of Janssen’s patient and investigator engagement group.
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In Genome Editing Trials, The Effects Last A Lifetime
10/13/2017
Sangamo Therapeutics is involved in the quickly growing field of genome editing, but with a twist. The biotech is currently recruiting patients for three rare disease clinical trials which will mark the first time a company performs genome editing in vivo. In a nutshell, the treatments will replace a patient’s defective or missing gene with a therapeutic gene that will be permanently stitched into the liver cells of the patient.
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Clinical News Roundup: China To Accept Foreign Clinical Trial Data
10/13/2017
Clinical News Roundup for the week of October 9, 2017 with information on China accepting foreign clinical trial data, Janssen launching iSTEP technology toolset for trials, FDA’s first Patient Engagement Advisory Committee Meeting, and CTTI issuing recommendations on investigator recruitment and retention.
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Clinical News Roundup: FDA Says Clinical Trials System Is Broken
9/29/2017
Clinical News Roundup for the week of 9/24/2017 with information on FDA’s digital health pre-certification program, standard care in oncology, new clinical research definition causing concern for researchers, minorities in trials, and more.