I’ve been asked countless times to write about patients and clinical trials. Guess it’s time to share what I’ve learned, along with other patient advocates, as we work beside researchers in the proverbial trenches. Just so happens that this post coincides with April Fool’s Day – hope that’s not an omen!
Why this series?
This is the first in a series on Patients & Clinical Trials (CT). Why? Because clinical trials are really the only tried & true way we get new diagnostics, treatments, and preventive approaches to people. For all diseases and health conditions.
But the research system isn’t very good at it, even after 70+ years. It’s not for lack of trying – BILLIONs have been spent on tweaking existing structures, but perplexing problems persist.
Heads up on CT activities
Other themes will also emerge, based on over 20 years of changing research and medicine culture (or at least trying to). In the meantime, here are some of my activities in the CT world:
- 4/6: I’ll be speaking at the Arena International 3rd Annual Clinical Operations in Oncology Trials Conference (West Coast), so come join a lively discussion or post your thoughts below! Slides will be posted soon.
- 4/17: Last chance to give comments on the HHS/FDA Draft Clinical Trial Protocol Template for Phase 2 and 3 IND/IDE Studies (yes, it’s quite a mouthful). If you want to test out your ideas, let me know. We’re discussing this on the Patient Advocates In Research (PAIR) list, and I’ll post my final public comments soon.
- 4/21: Join the Clinical Trials Transformation Initiative (CTTI) webinar “Case Studies on Expedited IND Safety Reporting” at noon EDT. Contact Suky Warner at firstname.lastname@example.org for more.
- 4/27-30: SWOG 2016 Spring Group Meeting. SWOG is part of the NCI National Clinical Trials Network (NCTN), where researchers from thousands of oncology practices and patient advocates meet to develop and run publicly-funded clinical trials.
- The California Technology Assessment Forum (CTAF), part of ICER, released their recommendations from the February meeting for new drugs in diabetes and asthma.
- CTTI just released materials from an expert meeting about the issues surrounding FDA streamlined approvals for new antibiotic drug development. A summary will be posted soon. You can also read a past post called Antibiotic Resistance – It’s Complicated!
- Cures Within Reach focuses on ways that existing drugs can be used for other purposes. More from this group in a guest blog post here soon!
- Two DCIS studies are being funded by PCORI to help answer treatment questions for this pre-cancer, and learn how women feel about them. You can also read a past post called When is ‘Carcinoma’ Not Cancer?
- The Center for Medical Technology Policy (CMTP) is working on recommendations to allow patients to switch treatments in a clinical trial if their cancers keep growing.
- The Metastatic Breast Cancer Alliance (MBCA) is creating a summary of their February meeting from the Research Task Force to Advance Progress.
- The NC ProCESS project on prostate cancer has convened a patient advisory board to help communicate effectively with prostate survivors in their study.
- Two groups I’m working with (MRCT and the NCI NCTN Biospecimen Banks) are discussing how to handle the challenges of giving individual research results to patients.
You can also read past CT posts about:
- How to Treat Patients
- How a Clinical Trial Failed Patients
- How J&J Promoted Risperdal Illegally
- When Clinical Trials Don’t Match Their Data
- A Plan for Real Research Improvements
- How do We Get Better Research Results?
- Informed about Changes to Research Consents?
- Patients Want Results. Share Data. Plain & Simple.
- Clinical Trial Patient Summaries Win!
There are many other clinical trial happenings – these are just some of the ones in which I’m involved! Yes, it’s heavy on cancer, but remember that cancers cover the gamut from rare diseases to millions of people.
Updates will be posted regularly. Let me know what you’d like to hear about. TTFN.
All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.