Regulatory affairs

White males overrepresented in clinical trials for first-time cancer treatment

24-Jan-2020 By Ben Hargreaves

The levels of patients enrolling for a clinical trial as a first form of treatment for cancer is 0.1%, whilst also being predominantly made up of white males with private insurance.

EMA welcomes Court of Justice transparency finding

23-Jan-2020 By Ben Hargreaves

EMA wins court’s decision in favor of citizens being able to access clinical study and toxicology reports submitted to the agency.

WCG continues acquisitive streak with biostatistical consultancy buyout

23-Jan-2020 By Ben Hargreaves

WCG adds to its portfolio of solutions for clinical trial sponsors by acquiring Statistics Collaborative.

FDA places Innate cancer trial on partial clinical hold over CMO issue

14-Jan-2020 By Nick Taylor

The US FDA puts Innate Pharma trial on partial clinical hold after learning of CMO problems.

Tools for doctors key to increasing clinical trial diversity, say experts

06-Jan-2020 By Nick Taylor

Sponsors should ‘continually’ think about providing tools to help healthcare professionals discuss clinical trials with women and older people.

Pharma companies slow to adopt AI will be ‘left behind’

11-Dec-2019 By Ben Hargreaves

Though pharma companies now accept the value of AI and machine learning, extra effort is required by the industry to realize the potential business and patient benefits, says Iqvia exec.

Growth in risk-based approaches the ‘main challenge’ to address in 2020

11-Dec-2019 By Vassia Barba

This year brought the ‘biggest momentum shift’ in the adoption of risk-based approach to trial management in the clinical research industry, says CluePoints executive.

BASi completes PCRS takeover, continuing deal-driven expansion

10-Dec-2019 By Nick Taylor

BASi buys PCRS, adding surgical and medical device contract services to growing portfolio.

Zosano readies contract manufacturers for pre-approval inspections

25-Nov-2019 By Nick Taylor

Zosano Pharma prepares contract manufacturers to host pre-approval inspections to support filing for approval of migraine drug.

Sosei Heptares pulls dementia trial to minimize CRO expenditure

18-Nov-2019 By Nick Taylor

Sosei Heptares withdraws Phase II dementia with Lewy bodies trial to reduce spending on contract research while clinical activity is suspended.

The next act: ACRO, R&D Caucus moving forward with second Cures bill

07-Nov-2019 By Melissa Fassbender

ACRO is collaborating with the Congressional Research and Development Caucus and others to bring forth a new Cures bill focused, in part, on patient engagement, data, and digital health – with draft legislation anticipated early next year.

People on the Move: Outsourcing-Pharma roundup October ‘19

01-Nov-2019 By Melissa Fassbender

This month’s people on the move includes a new therapeutic lead at Advanced Clinical, with plans to create a network of investigation sites, as well as CEOs at AIT Bioscience and Pharm-Olam, who discuss plans for moving forward.

Sponsors need to understand and prepare for CCPA: Greenphire

30-Oct-2019 By Melissa Fassbender

California’s data privacy law will provide clinical trial participants with confidence that their information will not be misused – though additional clarity is needed as the pharmaceutical industry faces mounting pressure to increase transparency.

Letter to the Editor

Counterpoint: 3 reasons Right to Try is less flexible than expanded access

29-Oct-2019 By Richard Klein, director of expanded access programs and policy, GE2P2 Global Foundation

In a letter to the editor, Richard Klein, director of expanded access programs and policy for the GE2P2 Global Foundation, outlines three reasons why Right to Try is less flexible than expanded access.

FDA guidance ‘a step in the right direction’

11-Oct-2019 By Melissa Fassbender

The FDA has published the second in a series of guidance documents that aim to accelerate research and the use of patient input to inform clinical development programs, says Iqvia head.