Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Sunday, May 31, 2015

We Need A Webinar - The Business 101 of Clinical Trials

It's confusing.  It's a business.  We all need to be better consumers.  I think we have a big information gap that is just crying to be filled.

Clinical trials are critical to finally finding a treatment for ALS.  We all know that they are expensive, but how expensive are they?  And who pays whom to do what?  And how does the whole business process work?

If we understand the roles and the business and responsibilities and compensation better, every patient, caregiver, donor, and advocate will better understand how and why things are done.  And with that, we'll all be able to set more realistic, responsible expectations for change.

Some things that I would love to understand better --

  • Who gets paid to design clinical trials?  How do they go about it?  How does a budget play into trial design?
  • Who draws up all of the consent forms for a trial?
  • Are clinical trial sites usually paid per patient?  Are they still paid when patients drop out?
  • Why can patient travel reimbursements vary from site to site for the same trial?
  • Who is paid to be the keeper of the data?
  • Who is paid to be the analyzer of the data?
  • What is a CRO?  
  • Do for-profit CROs differ from not-for-profit CROs in what they do or how much they charge?
  • Are investigators paid individually or are their institutions paid to conduct trials?
  • Is any drug developer willing to share with us how much an actual ALS clinical trial cost both in internal expenses and in contracted services?
  • Do charitable donations play a role in clinical trials for drug candidates that are owned by private companies?
  • Do you have to pay fees to the FDA if you are conducting a clinical trial?

I obviously have  lot to learn.  Many of us do.  I hope someone will be able and willing to educate us so that we can be better informed.  Clinical trials and drug approvals are a hot topic right now, and some basic business information will certainly raise the quality-bar in the discussions.

Thanks to whomever will help teach us the Business 101 of Clinical Trials.


  1. This is an excellent idea! The multi-billion dollar clinical trial industry needs transparency. Some individuals/instituions stand to make less money if drugs are granted Acclerated Approvals (skipping the most expensive Phase 3). It is logical to assume these indiviuals/institutions may be actively opposing Accelerated Approvals for financial reasons.

  2. I think that people take designs to the FDA that they think will be approved. It's not a system that welcomes the creativity that we need to find better ways to do good science.

    In any case, I think that a clear understanding of who pays whom to do what would help us all grasp the complexity and expense of the clinical trial process.

    And this kind of webinar surely would not be difficult for someone who knows trials well.

  3. Answers from NEALS at 41:00 in this video