Clinical Trials
The FDA Commissioner wants sponsors to incorporate diversity into their development programs prior to Phase III.
As drug companies continue to explore the use of social media data to support their submissions, a panel of EU regulators have drawn up a seven-point action plan to help evaluate the usefulness and impact of such data in regulatory decision-making.
US FDA officials said dose optimization for rare diseases should not be sacrificed in the name of speeding access to medicines, but is the oncology approach spreading to rare diseases?
The International Council for Harmonisation has issued for comment draft guidance, which when finalized, is expected to provide the industry with flexibility to embrace non-traditional, innovative approaches in clinical trial design.
Stakeholders must work together to “identify the most promising products based on evidence” to treat childhood cancers, as drugs developed for adults do not always work, the scientific officer for the pediatric medicines office at the European Medicines Agency says.
Japan has implemented a streamlined regulatory system designed to enable speedier approvals of selected drugs for designated categories of infectious diseases, which does not require Japanese clinical data.
A session at the recent KoNECT conference in Seoul looked at Korea’s strengths in clinical trials but also at what's needed to further improve its global competitiveness as a location for studies.
China has proposed new guidelines designed to head off potential bribery by pharma companies related to the conduct of clinical studies and possible manipulation of outcomes.
The Health Research Authority says its new toolkit explains the differences and similarities in the research approval and set-up processes across the four UK nations so that researchers and sponsors are clear on what they need to do if they want to conduct a study in more than one of the countries.
US FDA Commissioner Robert Califf offers some thoughts on improving the informed consent process during a Patient Engagement Advisory Committee meeting that reflect concerns informed consent documents are too long and complex, but also do not address everything that may be important to patients.
The UK’s drug regulator, the MHRA, is exploring new opportunities to work closer with its counterparts from Australia, Canada, Singapore and Switzerland under the ACCESS Consortium group, with a focus on pre-submission scientific advice.
Transitional provisions have been put in place to ensure the smooth implementation of new trial rules and requirements in Switzerland.
The UK’s Health Research Authority has updated its General Data Protection Regulation “transparency wording template” with more information on how data about research participants would be handled if it is sent abroad.
The EU Clinical Trials Regulation has “so far failed to improve Europe’s competitiveness,” according to a new report commissioned by the pharmaceutical industry body EFPIA.
Oncology staff also said more work is needed before patient registries can be used as an external control in clinical trials, but they strongly encouraged continued investment.
EU regulators have recommended extending a pilot on the use of raw clinical trial data in medicines evaluations after an interim review of the initiative found that using such data improved regulatory decision-making.
New nods for Boehringer Ingelheim’s survodutide, Sagimet’s denifanstat and Mirum’s volixibat bring the FDA’s non-infectious liver disease breakthrough therapy designations to 15, with six designees already approved.
A court order encompassing funding, drug pricing, clinical trials and overall policy implementation aspects is expected to cause a paradigm shift in the treatment of rare diseases in India. Sarepta, Roche and Sanofi are among the companies that have been part of pricing discussions.
Flexibility on the geographic location of clinical trial participants will depend on the underlying reasons the FDA wants diversity in the study, the agency’s Oncology Center of Excellence Director said.
Sponsors can expect to see a copy of final guidance on how to comply with the UK’s new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026.