Regulatory affairs

FDA addresses lack of diversity in clinical trials in draft guidance

21-Jun-2019 By Melissa Fassbender

In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...

Clinical trials center joins ProSciento’s program for NASH trial recruitment

20-Jun-2019 By Maggie Lynch

High Point Clinical Trials Center is partnering with ProSciento to accelerate clinical trial recruitment of patients with NASH and NAFLD.

Surrogate endpoints create potential, require statistical validation

19-Jun-2019 By Maggie Lynch

Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the cut after formal validation, says drug development expert and DIA panelist.

Through the lens: Examining the opportunities and roles of females in clinical research

19-Jun-2019 By Maggie Lynch

Females as caregivers, clinical trial participants, and biopharma leaders are among the different roles to be carefully considered as the industry aims for increased inclusion, says BBK executive.

Artificial intelligence in drug development predicted to grow: DIA-Tufts study

19-Jun-2019 By Melissa Fassbender

In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.

DIA 2019: Genetics, big data, AI, and separating the hope from hype

19-Jun-2019 By Melissa Fassbender

New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.

LabCorp, Quest Diagnostics data breach under investigation. Did they do enough?

17-Jun-2019 By Melissa Fassbender

Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.

In the push for innovation, regulators are ahead of the curve as pharma and CROs lag behind

12-Jun-2019 By Melissa Fassbender

As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.

TrialAssure launches portal for plain language clinical trial summaries

11-Jun-2019 By Melissa Fassbender

TrialAssure’s new online portal enables sponsors to publicly share plain language clinical trial summaries – as the industry faces continued pressure to post study results.

STA Pharma completes clinical supply of PhoenixMD’s breast cancer treatment

10-Jun-2019 By Maggie Lynch

Clinical trial supply for the first targeted treatment of triple-negative breast cancer completed through PhoenixMD and STA Pharmaceutical agreement.

Advarra finds new owner in Genstar Capital

06-Jun-2019 By Melissa Fassbender

Genstar Capital, the private equity firm behind CRF Bracket, is set to acquire Advarra from its current owners, Linden Capital Partners.

Global oncology market is being driven by decades of investment coming to fruition: Iqvia report

05-Jun-2019 By Melissa Fassbender

The global oncology market last year set several records, though the industry continues to struggle with long development timelines, which in 2018 averaged 10.5 years from patent filing to regulatory approval and launch, according to a recent Iqvia report.

Datavant’s Health Data Link acquisition brings together ‘siloed’ worlds

04-Jun-2019 By Maggie Lynch

Datavant acquired Health Data Link to integrate commercial data with research data to create deeper patient insights.

ASCO 2019

Relaxed eligibility criteria would double patient numbers in lung cancer studies: ASCO

04-Jun-2019 By Melissa Fassbender

Broader clinical trial eligibility criteria would double patient numbers in lung cancer studies, according to a new report from ASCO, which has been leading efforts to expand access to oncology clinical trials.

Scientist.com teams up with VC firm to create marketplace for biotech

03-Jun-2019 By Melissa Fassbender

The online marketplace for outsourced R&D services Scientist.com partners with 5AM Ventures to help researchers save time and money – as the industry is "caught between a rock and a hard place," says CEO.