Topic: Efficiency

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 »

Mitigating Risk in Neurosciences Studies with e-Source Assessments

The case for electronic data capture in neurosciences studies is strong. The high failure rate in CNS development, headlined by a series of failed Alzheimer’s studies, is one reason to seek better methods. According to a Scientific American article by Kenneth Kaitin and Christopher Milne of the Tufts Center for the Study of Drug Development,… Read more »

Recognition of Health Decisions as Best CRO – an Honor and a Springboard

The Triangle area of North Carolina represents the intersection of three cities – Raleigh, Durham and Chapel Hill – and three major research universities – the University of North Carolina at Chapel Hill, Duke University and North Carolina State University. Research Triangle Park is at the center of the Triangle area, which is home to… Read more »

Meeting the Challenges of Phase 2 Clinical Development

Some investigational products successfully make the transition from phase 2 to phase 3 while most fall by the wayside. Disregarding products that fail because they simply lack efficacy or safety, what makes the difference between phase 2 success for a relative few products and failure for most? In our view, the key to maximizing chances… Read more »

Why Diagnostics Development Is Different

All clinical trials share core requirements such as the need to exclude bias and provide evidence of effectiveness. However, diagnostics trials differ from drug trials in many important ways. As a result, diagnostics development requires substantial differences in planning, trial design and trial execution. It will come as no surprise to diagnostics professionals that diagnostics… Read more »

Rising to the Challenges of Precision Medicine: Onward!

As we enter 2015, Health Decisions’ mission – continuous innovation to reduce risk and time to market, fail unsuccessful products faster, enable cost-effective development of precision medicines and provide earlier and more affordable access to novel therapeutics and medical devices – is more important than ever. The biopharma and medical-device industries face numerous challenges. Foremost… Read more »

A Strategic Clinical Development Partnership Success Story

This post concludes a three-part series on strategic clinical development partnerships. The first post in the series discussed surveys showing widespread disappointment in existing strategic partnerships. The second post in the series identified success factors in strategic clinical development partnerships. This post provides a deidentified example of a successful strategic partnership. How to Assemble a… Read more »

Strategic Clinical Development Partnerships: Success Factors

We have had enough success in strategic clinical development partnerships to discuss success factors rather than the disappointing results of such partnerships reported in the industry surveys and studies referenced in last week’s post, A Reality Check on Strategic Clinical Development Partnerships. Strategic partnerships can work if structured to include key success factors. In our… Read more »