Safety/Efficacy Featured Articles
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Clinical Trials Site Identification – Standing Out By Investing In Quality
6/28/2017
One of the most common phrases used to describe investigative sites sought after to participate in clinical trials is ‘high quality’. Quality can be somewhat of an elusive term, however. Although the definition is quite clear, ‘quality’ in itself is not always tangible. The quality of a diamond is clearly observed by the level of flawlessness and clarity; however the quality of the ring setting may be more subjective. How do we measure quality when there is no formal scale on which to evaluate? What defines a ‘high quality clinical trial site’?
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Bayer Uses Lessons From Past Trials To Beat Liver Cancer
6/23/2017
It has been approximately 10 years since Bayer’s medicine Nexavar was approved for the treatment of advanced hepatocellular (liver) cancer. Despite all of the research and money put into this effort since then, there has not been another drug approved for this disease. However, in April 2017, patients did finally see a new treatment (Stivarga) approved by FDA.
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How To Align Your Clinical Trials With ICH GCP E6(R2)
6/20/2017
The International Council for Harmonization (ICH) efficacy guideline on Good Clinical Practices (GCP) aims to help sponsors keep up with these major shifts and implement improved practices in the industry. This article discusses how the ICH has changed with the recently approved Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) and outlines some of the major areas where sponsors can develop more efficient approaches in the design and conduct of their clinical trials.
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Lupus Research Alliance Enhances Clinical Trials for Patients
6/16/2017
The Lupus Research Alliance is the largest non-profit health organization raising money for research into the cause, cure, treatment, and prevention of Lupus and its complications. The research programs funded are typically collaborations with hospitals, medical schools and universities, as well as pharmaceutical companies from around the world. While treatments are available, Farber notes they are far from perfect. This has led the Lupus Research Alliance to step up its efforts to improve clinical trials and get ned medicines to patients.
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Could RTT Ease Access To Critical Drugs?
6/14/2017
The NYUSOM Working Group on Compassionate Use and Pre-Approval Access recently released a paper noting inherent problems with the proposed Right To Try (RTT) legislation proposed by Sen Ron Johnson and 46 cosponsors. The key findings were that RTT legislation would not allow patients to get drugs faster, and that FDA actually helps, rather than harms patients. Of course, not everyone agrees with the findings of the Working Group. One of those individuals is Michael S. Smith, Vice President of the Gastroparesis Patient Association for Cures and Treatments, Inc. and a patient who has lived with Chronic Intestinal Pseudo-Obstruction for nearly 30 years.
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SCRS Drives Site Payment Solutions
6/7/2017
Earlier this year, site payment issues were front and center at the European Site Solutions Summit that took place in Barcelona. The Summit, presented by the Society for Clinical Research Sites (SCRS), provides a forum for clinical stakeholders to discuss opportunities to improve clinical trials. In this Q&A, Dan Milam, VP of Global Engagement for SCRS, discusses the Summit, the issue of site payments, and what progress is being made.
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Clinical News Roundup: Should Cancer Patients Find Their Own Trials?
6/2/2017
Clinical News Roundup for the week of May 29, 2017 with information on cancer patients finding their own trials, Marken launching a new hybrid clinical trial service, a call for clinical trial overhaul, and Califf making a new start with Verily.
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Site Payments Still A Global Problem
6/1/2017
Collecting payments has long been an issue for clinical sites, especially those without the financial resources to withstand payment terms of 90 to 120 days. At the SCRS Global Site Solutions summit last fall, I even heard site personnel state they will pay less attention to studies where the sponsor or CRO does not make payments in a timely manner. We know that 40 percent of sites have cited slow payments as a primary operating concern. Financial stress at sites may even be negatively impacting the success of clinical trials.
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Why Is Study Start-Up Still So Inefficient?
5/30/2017
The Tufts Center recently completed a study on the clinical trial start-up process, which solicited responses from more than 300 individuals at pharma companies and CROs. This was actually a follow-up study to one that was conducted in 2009. That study specifically looked at the site initiation process, examining the timeframe necessary to complete certain activities.
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The Flawed Thinking Of Right To Try Legislation
5/24/2017
The Trickett Wendler Right To Try (RTT) Act was introduced in May 2016 by Sen Ron Johnson (R-Wis). According to Johnson, the bill would ensure terminally ill patients, their doctors, and pharmaceutical manufacturers were allowed to administer investigational treatments where no alternative treatment exists. But for all the fanfare around RTT and the slow federal drug approval process, would the RTT legislation actually help patients?