Feasibility Studies Featured Articles
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Are We Moving From Strategic Partnerships Back To FSP Relationships?
11/23/2015
What changes can you expect to see in clinical trials going into 2016? George Betts, Senior Director of Medical and Regulatory Affairs for Ipsen Biopharmaceuticals, believes patient recruitment and technology will continue to be a focus for sponsors going forward. He also believes that the specialty CRO market place will continue to grow as many sponsors move away from strategic partnering and go back to FSP relationships with smaller, specialty CROs.
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How To Increase Patient Enrollment By 600 Percent
11/19/2015
The process of getting patients to engage in a clinical trial is a headache that will keep many recruitment specialists awake at night. The Cancer Research Institute notes only two to three percent of oncology patients who are eligible for a clinical trial actually participate. Many are not even aware that trials are an option for them. More importantly, 95 percent of cancer patients might be missing out on a potentially lifesaving new treatment.
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Will NPRM Changes Affect Your Clinical Trials?
11/17/2015
The current regulations on the use of human subjects in clinical trials were put in place in 1981, with the last major revision occurring in 1991. The NIH version of the regulation was written so as to be adopted by any agency and to date the U.S. Department of Health and Human Services (HHS) and 15 other federal departments have adopted it. A Notice of Proposed Rulemaking (NPRM) is looking to update a few aspects of the regulations.
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Good Planning And Enrollment Lead To Clinical Success
11/12/2015
When preparing for a clinical trial, many factors can affect the success of your effort. Roger Mills, MD believes two of the biggest factors are proper planning and recruitment. Mills recently retired from the pharmaceutical industry, but before doing so had a long and successful tenure in the industry. His final position was as a clinical lead for Janssen R&D where he was responsible for study activities.
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How To Bring Patients To The Table…And Use Their Feedback
11/10/2015
As the Director of Global Oncology Patient Advocacy & Professional Relations for Boehringer Ingelheim (BI), one of William Tunno’s primary responsibilities is bringing the patient voice into the company. But when discussing the topic of patient centricity, he is quick to note it is not just the patient voice he is trying to bring into BI. The company is taking a thorough look at how it is interacting with all stakeholders, including patients, professional associations, and patient advocacy groups as well.
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How To Eliminate Site & Patient Phone Tag…And Increase Recruitment
11/5/2015
“There is a lot of innovation happening around patient recruitment,” says Joe Kim, Senior Advisor, Clinical Development Innovation for Eli Lilly. “But all these really great whiz-bang ideas, tools, and tactics often end up in the same place…and that is in a game of phone tag that pushes people away. The patient ends up getting messages from the site, and the site ends up getting lots of messages from the patient. This creates a terrible bottleneck ... It ends up being a huge waste of time and it is frustrating to the patients.”
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Can Electronic Health Records Bring Down Drug Prices?
11/2/2015
Protocol development is a difficult task, even with the experts we have in pharma companies and clinics. One way of measuring the quality of those protocols is looking at the number of protocol amendments pharma companies generate. These are generally due to a protocol being too complex, or the criteria being too strict. Generally, the end result is not enough patients enrolled in the study on time. One solution to that problem might be the reuse of electronic health records (EHRs).
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For October 2015
10/29/2015
In October patient centricity took center stage on Clinical Leader as the top downloaded article for the month featured Dr. Anne Beal discussing her efforts to bring a patient-centered focus to Sanofi. The second most popular piece focused on the pharma industry and whether it is truly an enemy of the American people, or just a punching bag for politicians. An article on transparency in clinical trials and whether it can ever be achieved, featuring Dr. Brad Thompson, CEO of Oncolytics, was the third most popular article.
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Does Pharma Really Want Transparency In Clinical Trials?
10/27/2015
My recent article on transparency in clinical trials, featuring Dr. Brad Thompson, CEO of Oncolytics, solicited a good number of comments and emails from readers. While most readers agree that more transparency would be good for patients and the industry, there seems to be a lot of disagreement over how it can be achieved, and if it can actually be achieved at all.
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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.