Community Spotlight

Full Disclosure: The DIA CTD Community In Motion

Francine Lane
CTD Community Chair


he Clinical Trials Disclosure (CTD) Community focuses on the global trend to put more and more clinical trial information in the public domain, driven by regulation, transparency advocates, and the general public. Our community has grown to 375 very active members. We host a monthly conference call and annual conferences, and we also enjoy the active involvement from the teams at and the European Medicines Agency (EMA).

Over the past few months, the CTD Community has appointed a new leader (Francine Lane) after the long and successful chairmanship of Bob Paarlberg. In the next year, the Community will continue the inclusive and sharing atmosphere that Bob has cultivated. We will focus on three areas:

  1. Improve global transparency and compliance: Educate new and existing members on the regulations, requirements, trends, and best practices that are driving global clinical trial transparency and improve global compliance.
  2. Keep current with the requirements: Nurture the Community’s relationships with regulators, transparency advocates, and patient communities to stay current with their expectations.
  3. Outreach: Clinical trial transparency impacts anyone conducting clinical research and many of them aren’t aware that this Community is a useful resource.

The community’s core team has 11 members and includes representation from a variety of organizations and experiences that help keep the Community informed: Joe Archer (Baxter), Suzanne Heyd Carlson (Consultant), Kelly Coulbourne (Allergan), Merete Jørgensen (NovoNordisk), Erik Lakes (PRA), Bob Paarlberg (Consultant), Nathanial Root (Ionis), Anamika Sharma (Merck KGaA), Patricia Teden (Consultant), Kathy B. Thomas (Consultant), and Matthias Zerm (Merz).

To address areas of specific interest, the Community has several focused working groups:

  • Policy 0070 led by Shalini Dwivedi.
  • Policy 0043 led by Laura Dodd.
  • Plain Language Summary led by Renee Entzminger.
  • Global Registries led by Kristi Whiteside and Thomas Wicks.
  • Interdisciplinary led by Bob Paarlberg and Eileen Girten.
  • QC Comments led by Pat Teden.

In September 2018, the DIA hosted two conferences closely aligned with the CTD Community, one on Clinical Trial Regulations in London, UK, and the other on Global Clinical Trials Transparency in Rockville, Maryland, US. The regulations conference focused on challenges and impacts around the pending EU Clinical Trial Regulation, anticipated to enter into force in late 2019. The transparency conference tackled a wide range of topics including data sharing and anonymization, GDPR (General Data Protection Regulation), and plain-language results summaries.

We host a monthly conference call and have launched a series of guest speakers. In September, for example, Dr. Raquel Billiones, presented GDPR and Its Impact on Clinical Research. She summarized the regulation and provided some practical examples relevant to clinical research.

Our lineup of guest speakers continues in October with a representative from Health Canada discussing their new data sharing requirements. In November, we’ll explore the upcoming EU Device regulation and the European Databank for Medical Devices (EUDAMED), and in December a speaker from the International Committee of Medical Journal Editors (ICMJE) will examine their new requirement for data sharing statements.

As you can see, we have a full schedule for this year and more to come in 2019! We hope you’ll join us!


“The Clinical Trial Disclosure Community has proved invaluable to me over the years for understanding evolving transparency requirements and operationalizing them throughout my organization.”

Joyce Swart, Alcon, a Novartis Division

“As an SME in this industry with over a decade of experience in disclosure, I have not encountered another vehicle that allows sponsors, service providers, and patient advocacy groups to convene on such a candid platform. […] It’s comforting to know when you have a disclosure question, you can direct it to hundreds of your industry peers, oftentimes receiving multiple constructive responses. ”

Renee Entzminger, Clinical Alliance Partners