The FDA has issued draft guidance for industry titled, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers.” The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials.
Clinical News Roundup for the week of July 16, 2017 with information on NIH’s new definition of clinical trials, Hispanics in trials, misleading registrations on clinicaltrials.gov, clinical trials in South Korea, and more.
How do top performing companies audit their CROs? When speaking to clinical executives, I found this to be one of their top concerns. At the inaugural Clinical Leader Forum, we brought together a panel of experts to discuss the topic.
Efficiently and effectively identifying high-quality drug candidates for clinical development is challenging, even for large companies like Takeda. To combat this challenge, Takeda, not unlike others in the industry, is looking to augment its internal drug discovery abilities with innovative capabilities from outside the company – at pharma and bio companies, as well as academic institutions around the world.
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.
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.
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.
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.
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.
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.