Cancer Patients' Alliance for Clinical Trials

For Better Access to Cancer Clinical Trials

By using information technology, a massive searchable resource can be established quickly and relatively inexpensively that will give patients and physicians an enormous advantage in easily locating appropriate clinical trials. It has already been prototyped.

Cancer is the second most common cause of death in the developed world. In 2006 more than 1,500 Americans a day will die from cancer - this is not a theory but a fact.

Isn't it time that we had a more complete listing of the experimental cancer treatments that are currently under study - known as clinical trials? A searchable and straightforward listing that patients, family members, physicians, nurses, health advocates and researchers can access and use?

Only 3% of adult patients with cancer now participate in clinical trials, despite beliefs that indicate that ten times as many (or more) would be willing to do so. Also, a surprisingly high percentage of these clinical trials close prematurely without results - ironically, due to a lack of patient participation. This misalignment of intents and purposes is tragic.

We think that this project is just too valuable not to be done - creating the world's largest database of active clinical trials for cancer.

Mission

The Cancer Patients' Alliance for Cancer Trials (CancerPACT) is an affiliation of non-profit entities that have joined together to seek financial and other support for the development of an inexpensive but massive database of cancer clinical trials - the largest in the world.

The founding affiliates of CancerPACT have the technical and medical abilities to implement this database. The aim is to aggregate information on all cancer trials that are active, and can be found and verified - and to present them in an organized manner for review in a searchable display at no charge to viewers.

The main point is that it is now possible with information technology to create and maintain a database of clinical trials that has information on three to four times as many cancer trials than are otherwise widely known.

Such a database would be the largest in the world (and that has ever existed) and would be of enormous social and medical value to cancer patients, family members, physicians, nurses and researchers.

A prototype for just pancreatic cancer can be seen at: http://www.pancreatica.org/Search.cfm

Background and Methods

The founding affiliates of CancerPACT have special expertise in high tech and medical informatics. Over the past few years we've developed a high effort, high-tech way using information technology to aggregate information on cancer clinical trials. The results of this (for pancreas cancer) can be seen on the Pancreatica resource at: http://www.pancreatica.org/Search.cfm

This current database on pancreatic cancer alone has information on more than 450 related clinical trials (major updates currently about every three months). This is much larger than ClinicalTrials.gov or the PDQ under "Pancreatic cancer" at Cancer.gov.

In fact, the collection of pancreatic cancer clinical trials at Pancreatica is larger than ANY other such clinical trials aggregation for any other cancer in any venue.

To see if we could generalize our efforts beyond the pancreas, we prototyped a five-cancers database (lung, colorectal, breast prostate and pancreas: responsible for about 57% of all cancer mortality), and a brain-and-spine cancer database. We have verified that the techniques we have designed can indeed be applied to a database that covers all cancers.

Based on reasonable inference from our prototype work, the CancerPACT database will likely contain information on 5,000 to 7,000 current and active cancer clinical trials.

Contents & Timetable

The cost of creating a five-cancers database will be about that of one year's salary of an oncologist, with about the same funds necessary for yearly maintenance. The cost for the entire CancerPACT database would be about twice that of the five-cancers database.

Our thought is to roll the database out (in a staged fashion) in seven Modules, totaling roughly 25 categories of cancers in all. The first Module would be Solid Tumors I comprised of Lung cancer (includes mesothelioma), Colorectal cancer (including anal), Breast cancer, Prostate cancer and Pancreatic cancer. The other six Modules are Leukemia/Lymphoma/Myeloma, Solid Tumors II, Cancers of Childhood, Solid Tumors III, Less Common, and Rare.

Given adequate financing, the five-cancers database could be up and running in six to eight months. The entire All Cancer Trial database could be rolled out over a period of about 18 months.

Alternatives: Waiting for Godot

In our opinion, the government agencies will not ever be able to do this (meaning: gather and present the data in a pro-active way) for several reasons - the main reason being the legal issue.

Areas of the U.S. Federal government such as the National Library of Medicine (ClinicalTrials.gov) and the NCI (Cancer.gov) want the information that the FDA already possesses under protection of confidentiality agreement with the pharmaceutical and biotech firms. We think it highly unlikely that one branch of the Federal government will be able to functionally undermine an agreement that another branch has made.

The solution to this tension was thought to be a legal remedy aimed at the industry. Thus, a law was enacted in the late 1990s to force the industry itself (note: not the FDA) to give up information on clinical trials in critical health areas (e.g., AIDS, cancer, etc.). But, the industry lobbied and agreed to the bill only if it contained no enforcement provisions. Thus it passed.

There is talk of adding teeth to this existing law. But the industry will ALWAYS lobby and may even, if cornered, capitulate in ways that don't much matter ( e.g., give up information on Phase III trials that are already largely known -- though not yet found in the government databases).

It costs upwards of one billion dollars for a company or group of companies to bring a drug to market, and this does not count the anticipated future financial expectations - measured in the billions of dollars - that are expected from a drug that finally makes it to market. There is just too much money at stake for the industry to allow and abide by a law that will erode the companies' competitive positions. It is highly unlikely that such an unadulterated law will ever be enacted. If enacted, it is highly unlikely that such a law would have the effect that its supporters envision.

It is true that there has been some movement over the past 2 to 3 years -- at the margins. The number of cancer trials in CancerTrials.gov has increased. And, more recently, the National Library of Medicine has been enjoined to release its cancer trial data to the NCI's Cancer.gov database. All are laudable efforts, but functionally incremental.

Conclusion: Cut the Gordian knot

There is another solution that circumvents all of the above gridlock, at least for cancer: our solution. Apply information technology and just make the database. Treat the information fairly and put it out, free for everyone.

With the aid of information technology, the CancerPACT database can be done inexpensively and quickly - with the guarantee of enormous social good. And it would be a remarkably inexpensive way to be historic.