clinical trial

Time is of the essence.  But how do you decide what clinical trial you should be part of?  How do you weigh the risks?  It's overwhelming even as someone with some science background and some medical background to sort through the trials - I can't even imagine how someone without any education or training could make a reasonably informed decision about everything.

A few good questions to ask are found here:
http://www.centerwatch.com/clinical-trials/volunteering.aspx#questions

For example

• length of trial
• location
• treatments used (and route of administration)
• purpose of the trial
• safety
• risks vs. benefits
• alternative treatments
• sponsor of trial
• cost (if any)

What was fascinating to me is that some trials require the patient or patient's insurance to pay for the cost of administering study treatments; the study hospital only provides the drugs.

Another thing that came up frequently in the consent forms is whether they can take additional tissue for testing and research, some of which may not be directly relevant to the study or even that particular type of cancer.  I think this is very good - but what I found a little disturbing was that some hospitals will assert ownership over any discoveries that arise from that.  

While I think the knowledge aspect is very important, I'm not sure how I feel about them potentially making tons of money off tissue and not sharing any rewards with the people or families of patients who donated it.  I would not dispute their right to do that based on technological discovery based on (for example) the genomic data from the tissues, but what if it was a cell line?  Or what if they patented the genetic code (as happened for the BRCA1 gene for breast cancer) and used it to make the genetic testing extremely expensive and inaccessible to further research? This was a for-profit company that as far as I know was not involved in any clinical trials, but it is this type of possibility that I find more concerning than any money that might be made (and probably deservedly) from potential new treatments or technologies.  Restricting the knowledge that came from patient tissue seems really wrong.

For example, in the case of Henrietta Lacks, an African American woman whose cervical cancer cells founded the first human cell lines that could survive outside the body, in the course of her treatment Johns Hopkins took a sample and developed a cell line that became used worldwide in biological research.  However, because this occurred in 1951 before the implementation of the stringent ethical guidelines in place today, the physicians and researchers did not ask (and perhaps did not think to ask) permission, and ultimately none of the proceeds ever went to the family.

Would I give my tissue for research, even if this had a clause?  Yes.  I think for the vast majority of cases, this goes to help scientists run experiments that 

Additionally, two that I didn't think to ask are 

• what happens if you end up harmed by the trial?
• can you remain on the treatment even after the trial ends?

Regarding harm, what I found interesting is that in most clinical trials, the treating institution will not treat anything beyond the immediate results - they are not committing to long-term care if harm is caused by the experimental treatment.  Regarding continuing treatment, I have not see any of the descriptions of clinical trials mention anything about that option, but I think it is a really good one to ask.