Topic: Regulation and Oversight

Differences Between Drug and Medical Device Trials: CSRs

While drugs and medical devices are both essential in modern medical care, there are times when standard clinical development processes seem to treat medical devices as an afterthought. For example, medical writers for a CRO conducting studies of both drugs and devices must learn to interpret a drug-centric guidance document to author an appropriate Clinical… Read more »

Addressing High Failure Rates in Drug Development

FDA has published an excellent report on 22 instances in which phase 2 and phase 3 trials had divergent results. Appendix A of the report provides justifications for essential elements of modern clinical trials, including a control group, randomization and blinding. In addition, Appendix A highlights risks of techniques for improving efficiency in early development,… Read more »

Debunking the Instant Myth of FDA as Rubber Stamp

FDA’s high approval rate for New Drug Applications (NDAs) is much in the news, with headlines like the one on a Matthew Herper post at Forbes: The FDA Is Basically Approving Everything. Here’s the Data to Prove It. The data comes from an analysis that Forbes commissioned at BioMedTracker. When FDA approves 23 out of… Read more »

Independent Pre-FDA Draft Guidances from Stakeholders

The introduction to an FDA draft guidance for industry published in June 2015, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” makes an unusual statement: Development of this guidance was preceded by the submission to FDA of a proposed draft guidance independently prepared by a consortium of stakeholders including patients, parents and caregivers, clinicians,… Read more »

New White Paper Heralds 2015 Medical Device Trends

A variety of trends will present opportunities and challenges for the medical device industry in 2015. The role of medical devices in our lives is growing by the day in a variety of settings, including at the point-of-care, in the home, in hospitals and commercial labs. With exploding growth in identification of biomarkers, the need… Read more »

New White Paper: Top 10 Clinical Development Trends for 2015

With Q4 2014 upon us, it is time to gear up for 2015. A few things are clear. Clinical development will continue to evolve against a pattern of high-failure rates for products aimed at large populations and higher success rates for targeted therapies. Orphan Drug development will remain an area of intense activity with continued… Read more »

FDA Approves Exact Sciences’ DNA Test for Colorectal Cancer

FDA has announced approval of Exact Sciences’ Cologuard, the first non-invasive DNA test for colorectal cancer. Congratulations to Exact Sciences and the entire Deep-C Study team and 90 investigational sites that contributed to the success of this  >10,000 subject study. Health Decisions was pleased to conduct the Deep-C Study on Exact Sciences’ behalf. We commented… Read more »

Amgen’s Near Miss and Maximizing Biotech Success Rates

The near miss by Amgen’s T-Vec viral cancer vaccine of the secondary endpoint of increasing overall survival in subjects with metastatic melanoma is a reminder of the slender margin between success and failure in biopharma clinical development. The p-value of 0.051 for the endpoint came within a whisker of the magic 0.05 but headlines still… Read more »