FDA Ponders New Risk-Benefit Requirement for Opioid Trials

June 24, 2019

Under a new FDA draft guidance, sponsors of opioid drugs would have to include in their trial design a risk-benefit comparison to prove their candidates are better than currently approved drugs.

The draft guidance also would require sponsors to go beyond just trial-generated data in their NDAs and address the broader public health effects of new opioid applications.

Comments on the draft guidance are due Aug. 20 under docket number 2019-13221. The FDA will hold a public workshop on the draft guidance on Sept. 17.

Read the draft guidance here:

Half of Post-Approval Trials Remain Unpublished, Yale Study Finds

Some drug sponsors are flouting FDA requirements for post-approval clinical trials, a team of Yale researchers has found.

Researchers analyzed 110 novel drug approvals between 2009 and 2012. The FDA required 15 percent of the sponsors, as a condition of approval, to conduct and report on post-approval trials. To date, results from half of those trials remain unpublished.

The researchers say the lapse is troubling in the face of the FDA’s move toward a “lifecycle evaluation process” of drugs and devices — a process that requires evermore “post-market evidence as a component of therapeutic evaluation.”

Read the study here:

Certification Improves CRA Performance, Study Says

Certified clinical research associates outperform their non-certified peers in key competency areas, a new data study shows.

CRA Assessments LLC conducted a blinded study, in cooperation with ACRP, of more than 500 U.S. and Canadian CRAs and found that certified CRAs identified 14 percent more informed consent problems, 10 percent more protocol compliance issues, 23 percent more source documentation and data errors, and 19 percent more fraud, scientific misconduct and delegation of authority issues.

Pfizer to Expand Oncology Reach With $11.4 Billion Merger

Pfizer has announced it will acquire Array BioPharma for $11.4 billion in a merger agreement that will significantly expand its oncology drug portfolio.

Array’s portfolio includes a promising combination therapy — Braftovi (encorafenib) and Mektovi (binimetinib) — currently being investigated in more than 30 clinical trials, including the Phase III BEACON trial in BRAF-mutant metastatic colorectal cancer.

In May 2019, Array announced interim results from the Phase III BEACON mCRC trial that showed statistically significant improvement in overall response rate and overall survival compared to the control group, reducing the risk of death by 48 percent.

Sanofi, Google Team Up on Real-World Database

Sanofi is teaming up with Google to create a virtual “innovation lab” that marries Sanofi’s real-world database and Google’s machine learning technology.

The collaboration will focus on three key objectives: to better understand patients and diseases, to increase Sanofi’s operational efficiency and to improve the experience of Sanofi’s patients and customers.

Under the deal — the financial terms of which were not disclosed — Google will offer its analytics technologies to help Sanofi’s research and development and to focus on personalized medicines. They’ll also use artificial intelligence to better forecast sales and inform marketing and supply chain efforts.

Parexel and CLARINESS Join Forces to Enhance Patient Access in China

Clinical research consulting organization Parexel and patient recruitment firm CLARINESS have launched a digital platform for patient engagement in China.

Parexel will use CLARINESS’ ClinLife patient portal to find and recruit subjects for clinical trials conducted in China. The companies predict the platform will allow them to reach more than 770 million people in the country.

In December, Parexel also announced a collaboration with Eli Lilly to launch a training program for China’s clinical trial sites and investigators.