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.