Clinical Research Units Featured Articles
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Clinical Leader Expands Editorial Advisory Board
12/17/2015
Clinical Leader relies on the feedback of pharma industry professionals and consultants to guide its focus and direction. The website’s editorial advisory board, composed of consultants and executives from the pharma and bio industries, help guide the direction and focus of the site’s editorial content. Clinical Leader has announced that in 2015 it added 17 distinguished individuals to that board, including representatives of Eli Lilly and Company, Pfizer, The Avoca Group, PatientsLikeMe, BMS, Novartis, Shire, and more.
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The Challenge Of Vendor Selection, Cost Overruns, And Change Orders
10/23/2015
If you are in charge of clinical operations for a small pharma or bio company, you are likely very familiar with the challenges and frustrations associated with vendor selection, vendor management, timeliness, cost overruns, and change orders. I recently had the opportunity to speak with the director of clinical operations for a small pharma company that currently has assets in Phase 1 trials. Although he has spent a good amount of his 20-year pharma career working in Big Pharma, he was able to give me a nice perspective of the challenges he faces in his current company, and how he is attempting to overcome them.
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Transparency In Clinical Trials: Will It Ever Be Achieved?
10/1/2015
A lot has been made recently about transparency in clinical trials. In the EU a new regulation is about to address the issue, and CISCRP recently sent a petition letter to the FDA asking it to pass a similar regulation in this country. The petition, signed by hundreds of patients, hopes to make trials results more accessible to patients. It’s also not hard to understand why a patient participating in a trial would want to know the results of the study, and whether or not they received the active drug or a placebo. But while changes might help companies with patient recruitment and retention issues, will true trial transparency ever be possible?
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Is The Sunshine Act Reducing Clinical Research Spending?
8/24/2015
The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.
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Improve Clinical Sites By Bringing Together Pharma, Biomedical R&D and CROs
2/18/2015
How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public?
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How Do I Get My Compound Into Phase I?
4/2/2014
The primary challenge for pharmaceutical and biotechnology companies in developing their drugs is to carefully assess the relationship between efficacy and toxicity prior to entering into human clinical trials. By Dr. Scott E. Boley and Greg Ruppert