Regulatory Affairs Editorial

  1. 3 Steps To Capitalize On Real-World Data Under 21st Century Cures
    11/21/2017

    Randomized clinical trials (RCTs) of prescription drugs and other medical products have been considered the gold standard of evidence to support decision making by clinicians and policymakers. However, it is increasingly recognized that most RCTs are unable to generate information about a product’s real-world effectiveness. Measures such as long-term outcomes, comparisons among multiple treatment options, and utilization are not well captured in trials. Furthermore, benefit-risk balance and value for money are best learned in cost-effectiveness or cost-benefit analyses.

  2. Trial Aims To Kill Cancer Without Chemotherapy Side Effects
    11/20/2017

    Getting a new oncology drug to patients involves navigating an obstacle course of costs, timelines, safety and effectiveness data, and regulations. Starting the clinical process with a molecule that has already been proven to kill cancer cells and be safe for patients will eliminate much of the risk. That is exactly what NanOlogy, a clinical-stage oncology company, is attempting to do.

  3. Clinical News Roundup: FDA Awards Funding To Pediatric Clinical Trials
    11/10/2017

    Clinical news roundup for the week of November 6th with information on FDA funding pediatric trials, clinical trials for heroin addicts, Marken’s home delivery app, Seeker’s patient enrollment portal, and minority recruitment in trials.

  4. Really? Only 6 Percent Of Companies Ready For GDPR
    11/8/2017

    A survey of top corporate data protection challenges has found only 6 percent of companies are prepared to be compliant with the EU’s General Data Protection Regulation (GDPR), which goes into effect on May 25, 2018. The regulation will have a significant impact on the industry, so why are so few companies prepared for it and discussing it?

  5. Clinical News Roundup: New Alzheimer’s Drugs Reach Clinical Trials
    11/3/2017

    Clinical news roundup for the week of October 30, 2017 with information on new Alzheimer’s disease trials, clinical monitoring salaries and turnover, emphasizing patient-centric trials, and GDPR compliance concerns.

  6. Wearable Devices: A New Look For The Modern Clinical Trial
    10/30/2017

    In the last few years there has been significant buzz in the life sciences industry surrounding the use of wearable devices that can be utilized for remote patient monitoring in clinical trials. Many believe wearables have the potential to significantly impact overall trial costs and efficiency, and recently they have returned to the spotlight due to fresh approaches that harness artificial intelligence/machine learning.

  7. Clinical News Roundup: CRS Files Lawsuit Against FDA
    10/26/2017

    Clinical News Roundup for the week of October 23, 2017 with information on CRS’ lawsuit against the FDA, FDA boosting patient access to medical devices, the Bracket acquisition of mProve, why Alzheimer’s drugs fail, and more.

  8. CRS Files Lawsuit Against FDA
    10/26/2017

    The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.

  9. FDA Draft Guidance On Electronic Records And Signatures: The Next Chapter
    10/26/2017

    The FDA has released a Draft Guidance titled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers. Certainly, the development of this draft guidance was driven by the repetitious questions the FDA has received from industry stakeholders as well as the extensive technology advancements.

  10. In Genome Editing Trials, The Effects Last A Lifetime
    10/13/2017

    Sangamo Therapeutics is involved in the quickly growing field of genome editing, but with a twist. The biotech is currently recruiting patients for three rare disease clinical trials which will mark the first time a company performs genome editing in vivo. In a nutshell, the treatments will replace a patient’s defective or missing gene with a therapeutic gene that will be permanently stitched into the liver cells of the patient.