Safety/Efficacy Featured Articles
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Clinical Staff Shortage: “Growing Plague” For Pharma & CROs
11/2/2016
Anyone involved with clinical trials knows a continuing and growing problem in the industry is the lack of qualified clinical research staff. A new report from BioPharm Insight (BPI) acknowledges this trend, noting the staff shortage is a “growing plague to the CRO industry which will need to be addressed in order to ease liabilities.”
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Clinical News Roundup: FDA Approves Oncology Trial For Cuban Treatment
10/28/2016
Clinical news roundup for the week of October 23rd with information on an oncology treatment developed in Cuba, AZ suspending recruitment on two trials, an SCRS white paper on site payments, a new platform for wearables in clinical trials, the CRA shortage, and more.
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SCRS: Site/Sponsor Relationship Needs Improvement
10/28/2016
At the 2016 SCRS (Society for Clinical Research Sites) Global Site Summit, Christine Pierre, president of SCRS, shared the results of a survey conducted of site professionals from around the world. The survey is conducted every year, just prior to the summit, to gauge the opinion of site professionals on various issues and trends. If the results are any indication, there is still room for improvement in sponsor/site relationships.
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PatientsLikeMe And Duke Bring Novel Approach To ALS Trial
10/26/2016
Can the peptide Lunasin help to reverse the debilitating effects of ALS? After one patient (and three experts) noted it could, PatientsLikeMe and the Duke ALS Clinic decided to get involved. Their novel trial will feature an unlimited number of patients, sharing of all patient data, and electronic patient reported outcomes. It also eliminated the use of a placebo.
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Clinical News Roundup: Sanofi Invests To Bring Clinical Trials Home
10/23/2016
Clinical news roundup for the week of October 21, 2016 with information on Sanofi and Science 37 bringing clinical trials to the home, SCRS Eagle Award winners, a precision master trial for AML, promoting trials to patients, stopping the progression of Alzheimer’s disease, and more.
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The Benefits Of Outsourcing Clinical Regulatory Requirements
10/20/2016
When I sat down to speak with Paul Bridges, Ph.D., corporate VP and Interim head of PAREXEL Consulting at the 2016 DIA Annual Meeting, we had recently heard the news of Great Britain exiting the European Union. Bridges seemed to take it completely in stride, noting there will always be changes occurring that can disrupt and erect obstacles to your drug development efforts. While we can’t stop them, we can certainly take advantage of the resources available from partners to better navigate them and mitigate their effects.
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Opportunities And Challenges Of Cancer Immunotherapy And Other Advanced Therapies
10/14/2016
The immunotherapy field holds great promise. Currently, as an example, these therapies represent a “breakthrough“ in cancer treatment as they have the potential to revolutionize the way we treat many forms of cancer, as well as other diseases and disorders. In this very specialized, and increasingly competitive area of drug development, biopharmaceutical companies developing these innovative therapies gain a distinct advantage.
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TransCelerate Seeks To Improve Clinical Trial Quality
10/12/2016
TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.
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Clinical News Roundup: Biotrial Opens Research Facility In The U.S.
10/6/2016
Clinical news roundup for the week of October 3, 2016 with information on Biotrial facility in the U.S., clinical trials in Australia, pancreatic cancer research, minority enrollment in trials, and cardiac gene therapy.
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Three Questions To Ask When Evaluating a Patient Recruitment Plan
10/6/2016
Today is a big day. Today is the day your clinical protocol is finalized. Your inclusion and exclusion criteria are polished to perfection. Your informed consent form has “IRB APPROVED” stamped on it in big, bold letters. Now is the time to deliver it into the eager hands of eligible patients.