On November 2, a panel of outside experts will review evidence for an experimental drug for depression, ALKS-5461, from Alkermes, and debate whether the FDA should approve the drug in 2019. The FDA is critical of the data Alkermes has accrued, the trial design it used, and whether the drug will be safe for patients to take. (Xconomy Boston)
Parkinson’s clinical trials need early stage patients
A Florida scientist says sponsors and care providers need to recruit Parkinson’s sufferers as soon as they are diagnosed with mild motor features, before they require meds. Recent discoveries have given researchers hope that they are on a path toward effective treatments, but that won’t happen unless we have enough patients for clinical trials at the earliest stages of the disease. Currently, less than 3 percent of Parkinson’s patients enroll in clinical trials. (CenterWatch)
Testing drug effects w/computer models more accurate than animal models
Animal testing has, to date, been the most accurate and reliable strategy for testing for possible risks and side effects of new drugs, but it is expensive, time-consuming, controversial, and some side effects can be missed. Recent research demonstrated that computational models representing human heart cells were more accurate than animal models in predicting cardiac side effects of drugs. (Smithsonian Magazine)
Drug approvals based on surrogate markers may be misleading
The FDA is allowing the approval of novel drugs based on pivotal trials using surrogate markers of the disease as primary endpoints, but new research highlights potential problems with this approach. In those drugs/indications where there were postapproval trials using the same surrogate marker as a trial endpoint, treatment effects were higher in the pivotal than the postapproval trials.
Most new clinical trials are in oncology, Immune-oncology drugs predominate
According to Global Data, oncology is the top therapy area for clinical trials initiated in 2018; most industry sponsored trials are for solid tumors; and, among all clinical trials, immune oncology drugs are the most common. North America, Europe and Asia-Pacific account for more than 90% of all trial locations, with most of the North American trial sites based in the U.S. (CLINICAL LEADER)
Pharma companies seek access to patient health records
Pharma companies are striking deals with technology companies to gain access to their big data analytics to unlock information from patient health records about how medicines perform in the real world. It used to be hard to get information on how drugs work in routine clinical practice, but now we have electronic medical records and other databases which offer a wealth of patient-level data, or “real-world evidence.” (REUTERS)
Acceptance of Clinical Data to Support Medical Device Applications and Submissions. Frequently Asked Questions
On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. Under the new rule, FDA requires that data submitted from clinical investigations conducted outside of the U.S. (OUS) intended to support an IDE or application or submission for a device be from investigations conducted in accordance with good clinical practice (GCP). This guidance document is intended to help sponsors and applicants understand and comply with these new requirements (FDA.gov)
How can we improve trials? What more do we need to know?
Clinical researchers in the UK voted these topics as most in need of research, in order to improve clinical trials: “How to boost recruitment”; “How to keep participants in the trial once they have been recruited”; and “How to choose which outcomes to collect”. Clinical researchers surveyed in low to middle income countries (LMICs), in contrast, ranked “How to choose which outcomes to collect” and “Methods to train research staff” as the most important research methods to understand further. (BioMedCentral)
“3 Top Healthcare Stocks to Buy in February”
“The Motley Fool” recommends IQVIA Holdings as one of “3 Top Healthcare Stocks to Buy in February.” (Feb 11, 2018). IQVIA (formerly known as Quintiles IMS), “pharma’s go-to partner”, is the world’s largest clinical research organization and a trusted partner in drug development; the company can also help drug developers with the commercialization process, enabling IQVIA to make money from all facets of the drug development process. (The Motley Fool)
Some practical advice for clinicians to avoid regulatory scrutiny
The Anti-Kickback Statute (1972) which prohibits clinicians and researchers from offering or accepting any payment to induce federal healthcare business, is an important legal rule pertinent to clinical studies. When agreeing to participate in clinical trials, clinicians should be mindful of the risks and possible legal scrutiny under the Anti-Kickback Statute, and follow the guidance of the Pharmaceutical Research and Manufacturers of America to minimize their risk. (Clinical Leader)
- « Previous Page
- 1
- 2
- 3
- 4
- 5
- …
- 9
- Next Page »