Topic

Articles

Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.

Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?

Researchers aren't taking full advantage of advances in trial technologies. A lack of clarity in the current version of the International Council for Harmonization "Guidelines for Good Clinical Practice", could be the problem. 

Clinical Trial Evolution: The Drive to Update ICH E6

Recent webcast addresses what organizations can do to prepare for the next revision of ICH E6.

E6 (R3) on Horizon

Looking back on regulatory challenges created by COVID in 2020.

Pandemic Shines Spotlight on Clinical Trial Conduct and Regulation in 2020

COVID-19 pandemic forces compliancy within organizations following FDA’s 2018 revision of Good Clinical Practice in federal registry. 

Managing Risks in Clinical Trials During a Pandemic with ICH E6 (R2)

Kenneth Getz is a senior research fellow at the Tufts Center for the Study of Drug Development.

Battle for trust ensues as vaccines are set for approval.

Public Trust and the ‘Last Mile’ for COVID-19 Vaccines

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.

COVID-19 pandemic shifts traditional process for medicine development in Europe.

COVID-Related Changes Have Implications for Public Acceptance of Innovation

FDA’s Vaccines and Related Biological Products Advisory Committee addresses issues related to testing and approval of potential COVID vaccines.

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

The FDA hints that their increased speed in issuing guidances during the pandemic could become the new norm.

FDA Reassurances Always Go a Long Way

Declarations made by Beate Wieseler don't align with those of many regulators and HTA bodies in Europe and will prove tough to transform.  

Gold Standards Remaining Gold Standards for Germany's HTA

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available.

Europe's COVID Vaccine Bids Still Veiled in Secrecy

Though members of the industry have made reassuring comments about progress with candidate COVID vaccines, they acknowledge it could be next year, at best, before any real response would be available. 

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

Study offers clues for installing rapid R&D tactics post-pandemic.

Applying Pre-Pandemic Benchmarks to Assess Future Speed Strategies

As biopharma companies and research institutes advance the development of promising vaccines against COVID-19, policy makers and health officials have intensified deliberations on strategies for ensuring fair and equitable distribution of anticipated preventives.

Debate Accelerates Over Who Gets COVID Vaccine First

FDA to resume “prioritized domestic inspections” for certain regulated products put on hold by COVID-19.

FDA May Delay Approval of Drugs Where Necessary Inspection is Not Feasible

Despite the rush for an effective COVID-19 therapy, biotech industry leaders insist rigorous research and complete data will be the standard preceding approvals.

FDA’s ‘Gold Standard’ Critical for Biopharma R&D

Europe is aiming to improve its medium-term planning for citizens' health with an agenda that aims to "enable and leverage research and innovation in regulatory science."

EU Planning to Respond to Drug Innovation With Smarter Regulation by 2025

Officials struggle to maintain the credibility of its drug regulatory process after accusations of intentionally delaying COVID-19 vaccine testing for political reasons.

Regulatory