Teaming up with sites during trial design

2020-10-13T13:37:04-05:00

National Women’s Health Week Part 3 With hands-on experience, site staff can provide valuable insights for proactively addressing challenges in clinical trials By: Dr. Andrea S. Lukes, MHSc, FACOG, Chief Medical Officer, Health Decisions According to the Tufts Center for the Study of Drug Development (Tufts CSDD), nearly half of all clinical studies require substantial—and [...]

Teaming up with sites during trial design2020-10-13T13:37:04-05:00

Designing trials for patients

2020-10-13T13:38:04-05:00

National Women’s Health Week Part 2 To deliver more meaningful clinical trial results, we need to take the time to gather patient insights By: Elizabeth Yarber, Senior Clinical Project Manager, and Kristen Snipes, Director of Clinical Operations, Health Decisions Clinical development is about finding new healthcare solutions that improve lives. This starts with identifying what [...]

Designing trials for patients2020-10-13T13:38:04-05:00

Hearing patients loud and clear

2020-10-13T13:39:31-05:00

National Women’s Health Week Part 1 As the FDA reinforces the use of the patient voice in the clinical development process, we need to listen to the women sharing their experiences By: John R. Nocero, Senior QA Auditor, Health Decisions In honoring National Women’s Health Week, it’s important to acknowledge the female volunteers in clinical [...]

Hearing patients loud and clear2020-10-13T13:39:31-05:00

Webinar: Regulatory Changes and Operational Challenges for Dx Developers

2020-10-06T03:17:05-05:00

Health Decisions is offering a complimentary webinar December 14, 2017 to assist diagnostics developers in addressing regulatory changes on both sides of the Atlantic and key operational issues such as the transition to subject-based testing. Changes at FDA include faster turnaround times for some diagnostics reviews. In the EU, new Device Directives will require developers [...]

Webinar: Regulatory Changes and Operational Challenges for Dx Developers2020-10-06T03:17:05-05:00

Differences Between Drug and Medical Device Trials: CSRs

2020-10-06T03:21:57-05:00

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 [...]

Differences Between Drug and Medical Device Trials: CSRs2020-10-06T03:21:57-05:00

Addressing High Failure Rates in Drug Development

2020-10-13T15:47:07-05:00

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, [...]

Addressing High Failure Rates in Drug Development2020-10-13T15:47:07-05:00

Expedited Development for All: the Phase 2c Pathway

2020-10-06T03:39:22-05:00

FDA's Expedited Programs for Serious Conditions, as well as the Orphan Drug Designation, remain exceptional by design. However, the time has come to consider ways of transforming the exception into the rule: providing the benefits of expedited programs beyond products for serious conditions with unmet medical needs. The success of FDA's expedited programs demonstrates that [...]

Expedited Development for All: the Phase 2c Pathway2020-10-06T03:39:22-05:00

Debunking the Instant Myth of FDA as Rubber Stamp

2020-10-06T03:40:23-05:00

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 [...]

Debunking the Instant Myth of FDA as Rubber Stamp2020-10-06T03:40:23-05:00

Independent Pre-FDA Draft Guidances from Stakeholders

2020-10-06T03:40:47-05:00

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, [...]

Independent Pre-FDA Draft Guidances from Stakeholders2020-10-06T03:40:47-05:00
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