Regulatory Affairs Editorial

  1. As ClinicalTrials.gov Turns 10, Will We See Compliance Improve?
    1/9/2018

    The FDAAA Title VIII, which required clinical trial results to be disclosed on ClinicalTrials.gov, went into effect in September 2007. The industry has now reached the 10-year anniversary of the act, which is a good time to reflect on progress that has been made and whether the requirement has actually improved transparency in clinical trials.

  2. Clinical Trial Deaths — Will Clearer Informed Consent Documents Be Enough?
    1/9/2018

    In October 2017, the watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, grabbed headlines when it filed a lawsuit against the FDA. The suit takes aim at informed consent regulations, seeking to ensure that potential trial participants receive sufficient information to truly evaluate the risks and benefits of participating in a drug trial.

  3. Best Practices In FDA Orphan Drug Submissions
    12/29/2017

    A common misconception in the industry is that an orphan designation is one of the easier regulatory milestones to reach. The guidance the FDA has issued on obtaining an orphan designation is relatively straightforward, perhaps so much so that it is easy to overlook some of its key elements.

  4. CRS Lawsuit: Does FDA Guidance Require More Clarity?
    12/5/2017

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.

  5. 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.

  6. 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.

  7. 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.

  8. 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?

  9. 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.

  10. 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.