TrialScope Blog

The TrialScope team discusses clinical trial disclosure and compliance topics

  • Diversity in Clinical Trials Improving, but We’re Not There Yet

    Diversity in Clinical Trials Improving, but We’re Not There Yet

    Dr. Jean Bonnet, an advocate for diversity in clinical trials, says both sponsors and patients are to blame for the lack of diversity. He says grassroots communication is key to effecting change.

    Read Article
  • With Investors’ Eyes on Biotechs, Biotechs Must Be Transparent

    With Investors’ Eyes on Biotechs, Biotechs Must Be Transparent

    With the government shutdown and public outcry over drug prices, biotech companies face new challenges when courting investors. That means transparency is more important than ever.

    Read Article
  • Health Literacy the Key to Opening the Door to Clinical Trials

    Health Literacy the Key to Opening the Door to Clinical Trials

    When it comes to health literacy, it’s not enough to just know that clinical trials are out there. As patients, we need information presented in plain language that is easily understood.

    Read Article
  • A Dozen Disclosure & Transparency Predictions for 2019

    A Dozen Disclosure & Transparency Predictions for 2019

    Clinical trial disclosure and transparency experts Francine Lane and Thomas Wicks make their 2019 predictions on patient-centricity, industry watchdogs, regulatory agencies, medical devices, and data.

    Read Article
  • Why Clinical Trial Sponsors Should Become More Transparent

    Why Clinical Trial Sponsors Should Become More Transparent

    Due to pressure from patients, healthcare advocates, advocacy groups and the government, the healthcare industry is leaning toward more clinical trial transparency. There's still a long way to go.

    Read Article
  • Improving Health Through Participation in Clinical Trials

    Improving Health Through Participation in Clinical Trials

    Clinical trials not only help older adults learn more about their disease, they can help others too. But barriers such as unclear communication and lack of patient engagement hinder participation.

    Read Article
  • SEO, UX Key to Finding – and Understanding – Clinical Trials

    SEO, UX Key to Finding – and Understanding – Clinical Trials

    Sponsors’ clinical trials websites should focus patient-centric content and design, navigation and mobile friendliness. This is where user experience (UX) and user interface (UI) come into play.

    Read Article
  • Meeting the EU CTR Compliance Challenge Head-On

    Meeting the EU CTR Compliance Challenge Head-On

    Looking at public data on EU CTR as of July 16, a TrialScope analysis found a total of the over 16,000 clinical trials that ended more than 12 months earlier, only around 10,000 had results posted.

    Read Article
  • Clinical Trial Websites: Challenging the Status Quo

    Clinical Trial Websites: Challenging the Status Quo

    Read Article
  • 2 Steps for Correcting Non-compliance with EU Disclosure Regulations

    2 Steps for Correcting Non-compliance with EU Disclosure Regulations

    On the EU CTR registry, many clinical trial results unavailable, and it appears many studies were registered but never updated. Here's a two-step process on how to correct this non-compliance.

    Read Article
  • Survey Reveals Plain-Language Commitments Still Evolving

    Survey Reveals Plain-Language Commitments Still Evolving

    Results of a recent TrialScope survey reveal that most sponsors are committing to providing plain-language summaries for Phase 2 – 4 clinical trials, with some extending to Phase 1 studies.

    Read Article
  • Top 5 Best Practices for Clinical Disclosure SOPs

    Top 5 Best Practices for Clinical Disclosure SOPs

     

    Read Article
  • How Solid Is Your Corporate Transparency Reputation?

    How Solid Is Your Corporate Transparency Reputation?

      Increasing demands for clinical trial disclosure and transparency are dominating the medical journals and making their way into more general news outlets as well. Recently, Dr Ben...

    Read Article
  • Final Rule Results - What You Need to Know

    Final Rule Results - What You Need to Know

    On January 18, 2018, results for applicable clinical trials (ACTs) with a primary completion date on or after January 2017 start becoming due under 42 CFR Part 11 for Clinical Trials...

    Read Article
  • The BMJ Audit That Will Make Sponsors Rethink Their Transparency Policies

    The BMJ Audit That Will Make Sponsors Rethink Their Transparency Policies

    The recent article in the BMJ on Pharmaceutical companies’ policies on access to trial data, results, and methods, is an interesting next step in the evolution of publicly disclosing...

    Read Article
  • Noncompliant Clinical Trial Transparency

    Noncompliant Clinical Trial Transparency

    OVERVIEW: Regulatory Risk is the possibility that changing regulations will significantly affect the organization, requiring additional investments, changes in operations, or other...

    Read Article
  • Major Funders Get Serious About Clinical Trial Transparency

    Major Funders Get Serious About Clinical Trial Transparency

    INTRODUCTION: Medical research funders like the Wellcome Trust, the Bill and Melinda Gates Foundation, and others are getting serious about clinical trial transparency. On May 18,...

    Read Article
  • Uncontrolled Transparency

    Uncontrolled Transparency

    Operational Risks Overview Operational Risks is the possibility of issues arising from inadequate policies or procedures, poor data quality, insufficient systems, and human error. ...

    Read Article
  • Expanding Transparency

    Expanding Transparency

    The growing scope of global disclosure

    Read Article
  • Atlas Global Compliance: Disclose Locally, Comply Globally

    Atlas Global Compliance: Disclose Locally, Comply Globally

    Discussions with TrialScope customers and others have confirmed that challenges with global clinical trial disclosure are prevalent across organizations, regardless of size.  There are...

    Read Article
  • loading
    Loading More...