Trials Not Operating at Best Practice Levels, Survey Says

Sixty-five percent of clinical operations teams responsible for managing and overseeing trials don’t see themselves operating at best practice levels when it comes to identifying issues quickly, according to a new survey about trial oversight.

A new survey conducted by Medidata and Informa Pharma Intelligence cites trial complexity, increasing workloads with fewer resources, growing amount of data needing to be captured and evaluated, and rising difficulties in patient recruitment as reasons why they’re struggling to prioritize their responsibilities.

Another key drag on the ability to successfully run trials, respondents complained, is that they’re mired in tasks that don’t advance the goals of the trial. When asked where they focus their time, almost half of respondents stated that at least 25 percent of their time was spent on tasks and issues with minimal impact on outcomes.

Only 2 percent of respondents claimed to have completed all their tasks on time; 25 percent of respondents completed 75 percent to 99 percent of tasks on time; and another 48 percent only completed 50 percent to 74 percent of their tasks on time.

To read the survey, click here: https://bit.ly/38RFAlc.

NLM Seeks Input on Improving ClinicalTrials.gov

ClinicalTrials.gov users will have a chance to weigh in on strategies for improving the database at a public meeting scheduled for April 30.

The National Library of Medicine (NLM), which administers ClinicalTrials.gov, is looking for examples of new uses of the ClinicalTrials.gov website, resources for linking from ClinicalTrials.gov and specific examples of how the website is currently used.

NLM seeks input on initiatives, systems or tools for improving the submission process for ClinicalTrials.gov and ways to enhance information quality and content. In addition to participating in the meeting, stakeholders can provide written feedback by March 14.

Read the NLM’s notice here: https://bit.ly/2PfdWXz.

Addendum to ICH Trial Guidelines Offers Recommendations for Statistical Analysis

Effective July 30, an addendum to the International Council for Harmonisation’s (ICH) trial guidelines will provide phase 3 trials in the EU with new recommendations for statistical analysis.

The addendum defines the appropriate use of estimands and sensitivity analyses in clinical trials. An estimand is the treatment effect of interest in a clinical trial. The guideline also discusses the impact of estimands on clinical trial design and conduct.

To read more about the guidance, click here: https://bit.ly/2T62PB3.

FDA Compiles Drug Approval Data into Searchable Format

The FDA has launched a compilation of drug approval information in a searchable data file for public use, the agency announced last week.

The dataset on new molecular entities and biologic approvals draws from the FDA’s internal databases and document records, presenting data in a downloadable data file.

The first edition of the compiled data includes drugs approved between Jan. 1, 1985, and Dec. 31, 2019. It will be updated periodically to include the latest drug approval data.

Access the compilation here: https://bit.ly/39M0imu.

Health Canada Announces It Will Accept Submissions in eCTD Format

Health Canada has announced that it will accept clinical trial submissions in an electronic Common Technical Document (eCTD) format, an announcement that comes following the completion of a successful pilot of the eCTD in August.

Based on this pilot, Health Canada says that the implementation of clinical trial regulatory activities in the eCTD format will now immediately begin for preclinical trial application consultation meetings, clinical trial applications (CTAs) with a seven-day administrative or a 30-day default performance standard, CTA amendments with a seven-day administrative or a 30-day default performance standard and CTA notifications.

The Canadian public health organization says that use of the eCTD format is optional for clinical trial regulatory activities. If the eCTD format is used, sponsors must submit all regulatory transactions using the Common Electronic Submissions Gateway.

Related instructions and guidance documents on using the eCTD format can be found here: https://bit.ly/2Vb08AV.