Thanks Peggy for your honest and incisive comments. I am hoping the time has come to revive the Declaration of Rights. Welcome Forum members comments and we also welcome anyone who wants to help .

Linda
I'm lazy today (and not feeling well). Could you research the rule that says that trial results must be open to the public and just WHEN that is required? I am sure it would be after they (results) have been peer-reviewed and published in a refereed journal, which means a lot of potential treatments are sitting on the shelf collecting dust. (or at least that is what one would assume).
peg

Peg,
As far as I know (I have not checked if the rules have changed), if its an NIH funded project, the PI has an obligation to report all the data in the form of a "Final report" to close the grant at the end of granting period. Once NIH closes the grant, I think all the data is in the public domain.I don't think, it is a requirement to publish ALL the data in a peer-reviewed journal though it is almost always done. If its privately funded clinical study, I think, its the company's decision to publish or not to publish/

The concept of peer-review for grants and papers is a strange thing, excellent ones go thru easily, make a splash and really bad ones get rejected and rightfully so. Its the middle of the curve, where the data is not so exciting disappear into thin air. If one takes the trouble of analyzing carefully, a lot of information is in there which is useful but not money making and of course, investors are not interested in "failed projects". The most recent example I can think of is Ceregene's clinical trial which "failed" and would have gone into thin air like many projects. Thanks to MJFF it is being continued and hope it results in something positive and sets an example for other studies.

I think, there should be an open access archive for all these failed projects and I bet a lot of good will come out of that. Just to give you an example, 10 years ago, I was part of a team that developed very first viral vector based gene therapy with Factor VIII for haemophilia and the trial failed because of vector-related side effects and lack of patients (this is another story where patient participation was the problem!). The project and the company disappeared after the failed clinical trial and the data was never published. I know if had that data, reevaluation of it based on new discoveries, would certainly lead to a good gene therapy product for haemophilia. But no data. It is equally frustrating as a researcher to see one's work not reaching the patient.

If you find any info on access to data from failed clinical studies please do post it .

Thanks
girija

There are also some new regs on reporting clinical trial results to clinicaltrials.gov, including trial results
Here are some references :
11/09/07 FACT SHEET (Available at http://prsinfo.clinicaltrials.gov/)
Registration at ClinicalTrials.gov:
"As required by Public Law 110-85, Title VIII
On September 27, 2007, a U.S. law was enacted that expands the types of clinical trials that must be registered in ClinicalTrials.gov, increases the number of data elements that must be submitted, and also requires submission of results data."

On http://prsinfo.clinicaltrials.gov/re...finitions.html
a draft of the basic results data elements are defined for the results database. As of July 2009 the data base doesn't seem to be up and runniing yet, however results can be included in the existing clinicaltrials.gov record

Also according to the FDA Amendments Act (FDAAA), Section 801: “Basic Results”Provisions [Source: Pub L. 110-85, Sec. 801, adding new 42 U.S.C. 282(j)(3)(C)]‘‘(C) BASIC RESULTS.—
"Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) ofthe Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act:

at: http://prsinfo.clinicaltrials.gov/FD...sicResults.pdf
the basic result elements that should be included are described, but it appears to be only for drugs that have been FDA approved, so no data on failures?

As we were saying.....
New York Times, August 7, 2009
Letter from Faster Cures

"Why Patients Turn Down Clinical Trials "
To the Editor:
Excerpt:

Re “Lack of Study Volunteers Is Said to Hobble Fight Against Cancer” (“Forty Years’ War” series, front page, Aug. 3):

see: http://www.nytimes.com/2009/08/07/op...=2&ref=opinion


"Patients can play a critical role in the search for cures, but it is time we rethink the entire paradigm surrounding clinical trial design and recruitment. .."

amen....amen..thank you.....
p

I thought all of the letters were very good - all of them but one talked of the trouble in getting trial participants. Interestingly, the one letter that expressed success in increasing participation was from Georgia, where, apparently, they are implementing an innovative program specifically geared towards recruitment and information sharing:

"What does it take to maximize cancer clinical trial enrollment? A significant investment of resources to increase availability, access and collaboration.

The Georgia Center for Oncology Research and Education, which the Georgia Cancer Coalition helps finance, has built a statewide clinical research network with 57 active sites in 26 cities. Academic cancer researchers communicate with more than 200 community oncologists in various disciplines and collaborate on trials meaningful to their patients and communities while advancing scientific objectives.

Patients and providers have access to a statewide database listing 360 adult and 80 pediatric clinical trials; training programs to educate and update cancer research associates; and a collective infrastructure for clinical trials through multiple National Cancer Institute-financed state programs. Plus, the major insurers voluntarily agreed to clinical trials coverage.

The result? Georgia’s accredited cancer centers enrolled 12 percent of patients in research clinical trials in 2006 and 2007.

William J. Todd
President and Chief Executive
Georgia Cancer Coalition"

Bottom line: we need new thinking, new systems, and innovation all around. It can be done.