Patient Advocacy Groups and Clinical Trials: Impressions from DIA 2018

The Health Decisions team at DIA 2018 left with the impression that the biopharma industry values relationships with patient advocacy groups but use of such groups in study planning and protocol development remains the exception rather than the rule. Health Decisions' Chief Medical Officer Andrea Lukes, MD, MHSc, FACOG, chaired a DIA forum entitled "From [...]

Patient Advocacy Groups and Clinical Trials: Impressions from DIA 2018 2018-06-29T16:08:08+00:00

CEO Takeaways from BIO 2018: Focus on Women’s Health

Health Decisions CEO, Patrick Phillips, BSc (Hons), D.Phil., attended BIO 2018 in Boston to meet with companies active in development of new therapeutic and diagnostic products to improve healthcare outcomes for women. After the conference, Dr. Phillips offered observations on a variety of trends in evidence at the conference and on Boston as a conference [...]

CEO Takeaways from BIO 2018: Focus on Women’s Health 2018-06-21T15:08:11+00:00

Key Issues in Choosing a Specialized Clinical Development Partner

Partnerships drive biopharma development today more than ever, especially in clinical development. The scope of partnerships ranges from contracts to conduct individual studies to functional-service-provider arrangements or outsourcing agreements encompassing whole development programs and sometimes even the whole of a company's clinical development activity. While clinical development partnerships are commonplace, they are seldom simple. Forming [...]

Key Issues in Choosing a Specialized Clinical Development Partner 2018-06-04T20:56:32+00:00

Social Media Recruitment: Lessons from Two Studies with Different Results

Social media are useful recruitment tools but results vary, especially as to the quality of subjects. Examples from two recent Health Decisions trials illustrate. We utilized a variety of social media in both trials, including craigslist, Facebook, a social media recruitment vendor's sites and investigators' social media sites. In one study, social media accounted for [...]

Social Media Recruitment: Lessons from Two Studies with Different Results 2018-08-14T21:03:44+00:00

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, [...]

Addressing High Failure Rates in Drug Development 2018-08-14T21:09:03+00:00

2017 – Time for a Bold R&D Initiative in Women’s Health

Despite NIH and FDA women's health policy initiatives previously described in this blog, the list of novel drugs approved by FDA in 2016 includes only one product for a woman-specific health indication. FDA granted accelerated approval in December 2016 for rucaparib (Rubraca™), a Clovis Oncology PARP inhibitor for ovarian cancer. Rubraca is indicated for patients [...]

2017 – Time for a Bold R&D Initiative in Women’s Health 2018-08-14T21:09:50+00:00

Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency's draft guidance on LDTs affirms the status quo - for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and, [...]

Settling on a Framework for LDT Regulation: Update 2018-08-14T21:10:39+00:00

Marking International Clinical Trials Day 2016

International Clinical Trials Day takes place each year on May 20, commemorating the day in 1747 on which James Lind started his controlled trial of scurvy treatments. Health Decisions marked the day internally by celebrating our own project managers, clinical trial leads, clinical research associates, in-house clinical research associates, clinical trial assistants, biostatisticians and other [...]

Marking International Clinical Trials Day 2016 2018-08-14T21:14:31+00:00

2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine

The Personalized Medicine Coalition (PMC) reports that 13 of 45 new molecular entities or therapeutic biologics approved by FDA in 2015, or 28%, were personalized medicines. The number of approved personalized (precision) medicines increased from 9 in 2014. While completing the transition to precision medicine will take years and require addressing major challenges, the momentum [...]

2015 Approvals Herald Rapid Progress, Growing Diversity in Precision Medicine 2017-09-05T21:37:05+00:00

Picking Up the Pace in Precision Medicine

Early successes in precision medicine have inspired widespread support for accelerating the transition from traditional one-size-fits-all therapeutics. In some areas, such as age-related macular degeneration, gene sequencing has identified previously unrecognized disease mechanisms and inspired development activity around new targets. In oncology, it has become commonplace to make treatment decisions informed by comparison of germ-line [...]

Picking Up the Pace in Precision Medicine 2015-12-01T16:07:56+00:00
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