Monday, December 6, 2010

How to find a clinical Trial

The decision to join a clinical trial is a personal one, which I believe is best made between the person with type-1 diabetes (or parents), and their doctor.  However, I know that some type-1s don't have regular endocrinologists, and also some doctors don't tell their patients about available  trials (for a number of reasons).  Therefore, I've put together this blog on how to find clinical trials, so that people with type-1 diabetes, who want to, can discuss these trials with their medical team.

Non-Honeymooners: Don't think that just because you have established type-1 diabetes, there are no clinical trials worth participating in!  This is not true, on two separate fronts.  First, there are some trials aimed a curing established type-1 diabetes. (LCT, Exsulin, Liraglutide, Xoma 52, are examples.)  Second, there are always lots of trials about better treatments for type-1 diabetics (which I do not cover in this blog) but which can improve the "standard of living" of established type-1 diabetics.

Honeymooners: Many of the studies currently underway that may lead to a cure somewhere down the line, are only recruiting "honeymoon" diabetics.  Usually, people who have had type-1 diabetes for a few weeks or less. (Although this varies study to study.)  So, for trials aimed at curing type-1 diabetes, honeymooners are most in demand.  But the honeymoon time period is also the hardest for type-1 diabetics and their families.  They are getting used to so many new things: blood checks, counting carbs, dosing, needles or pumps or both, etc.  So in that way, it is a bad time to be participating in a clinical trial.  This is a fundamental dichotomy that each family must work out for itself: do you want to participate in a clinical trial soon after diagnosis, or not?

Finally, please don't wait for me to publish a posting calling for volunteers for a specific clinical trial: I don't do that.  I publish when a study starts, but often it is only recruiting at one or two places then.  More recruiting centers often come "on line" in the weeks or months after I post.  So use the web sites described below to see when a trial is recruiting near you.  While I don't push specific clinical trials, I do hope that all type-1 diabetics (both newly diagnosed and long established) consider the available clinical trials.  While the decision to enroll is for each person/family to make themselves, I think it would be a shame not to even consider the possibility.

How To Find Clinical Trials for Type-1 Diabetics

If you are looking for clinical trials, then JDRF already has exactly what you are looking for:
https://trials.jdrf.org/selfreg/
I'm not sure how good the coverage is internationally, but in the US, it seems quite good.

If you can not go to the link above, then go to JDRF's  main page: http://www.jdrf.org/
and click "Get Involved"
and then "Participate in a Clinical Trial"
and then "Register Now"

It you need to fill out some data, like how old you are, and when you were diagnosed, and some other stuff, and then it matches you up with clinical trials in your area. Pretty sweet!

Although run by the JDRF, it returns clinical trials no matter who is funding them.  You get a list of results, and the trials that are funded by JDRF have a little "JDRF" icon on them.  Once you are registered, it will send you email every now and then telling you about new clinical trials in your area, for your age, and that match your profile.  You configure how often you get these emails.  The emails contain links to simple data pages, that tell you the basics of the clinical trial, where it is being done, the inclusion/exclusion criteria.   All very nicely done.

If you want to do more searching on your own, then you can check out the following web sites:

http://www.immunetolerance.org/
The Immune Tolerance Network (ITN) is a very interesting organization, which I view as part of the "infrastructure" of diabetes research.  They help researchers organize and run clinical trials aimed at stopping autoimmune attack, and similar subjects within the immune system.  They cover research into type-1 diabetes, and also related autoimmune diseases.  At any one time, they usually have a dozen or so studies going on, and a couple are recruiting all the time. 

Because ITN runs a network of doctors who cooperate in clinical trials, their trials often recruit at many different sites all over the US (and sometimes the world), so you have more chances to enroll.   Their studies are more likely to be available near you.

About ITN: http://www.immunetolerance.org/public/about-us
Type-1 Studies Recruiting Now: http://www.immunetolerance.org/public/clinical-trials/Autoimmune+Diseases/Type+1+Diabetes+

http://www.clinicaltrials.gov
This is the official FDA registration site for clinical trials.  It covers just about everything in the US, and many trials not done in the US are registered here as well.  It contains a lot of information, but is a little clunky to use.  I think it is more designed for research professionals, than random people looking for a trial.  You can search for phrases like "type-1" and "diabetes" and limit your search to studies that are recruiting right now, and even by location where they are recruiting.   Personally, I've found the JDRF site has the same information and is much easier for a patient or parent to use.  But the FDA site has more info, so if you find a trial using the JDRF site, you can look up the same trial on this site, and learn more about it.

http://www.ukdrn.org/
This is the UK's official registration site for clinical trials.

http://www.who.int/trialsearch/
This is the UN's official registration site for clinical trials.

http://www.trialspotting.com.au/trialspotting/Default.aspx
You can try this in Australia.

Finally, if you are near a major university or diabetes research center, you might want to "reach out" to them.   I know that UC San Francisco, Stanford, The Barbara Davis center at University of Denver, DRI (in Miami), University of Florida at Gainsville, the Joslin center and Harvard (both in Boston) are all doing multiple studies.

Some of the information in this blog entry comes from a "sticky" Diabetes Daily thread: http://www.diabetesdaily.com/forum/research-clinical-trials/1006-how-find-clinical-trial

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.  I have no relationship with any person or company running any clinical trial or recruiting for any clinical trial.
Blog: http://cureresearch4type1diabetes.blogspot.com
Web: http://joshualevy.pbworks.com/DiabetesCureReadyForHumanTrials
Email:  To get these blog entries emailed to you join this Google Group:  http://groups.google.com/group/type-1-diabetes-clinical-trials-news

7 comments:

trialspotting said...

Great article, in Australia people can go to http://www.trialspotting.com.au to find a wide range of medical research studies that need volunteers.

Joshua Levy said...

Thanks very much! I added that site to the main body of the blog entry.

Joshua

Anonymous said...

LCT gets green light from Russia for Type 1 diabetes treatment Diabecell

http://www.lifescientist.com.au/article/370963/lct_gets_green_light_from_russia_type_1_diabetes_treatment_diabecell/?fp=2&fpid=1

Anonymous said...

Giving name of diamyd just for example purpose :
If Diamyd can stop auto immune and beta cells keep on regenerating then people who have taken diamyd after "some" years should not have type 1 diabetes. Diamyd trials have been going on many years.. why did Diamyd guys not see any change to established type 1s.

Anonymous said...

http://news.smh.com.au/breaking-news-national/animaltohuman-transplant-first-20101210-18sfk.html

Danny Rose, AAP Medical Writer
December 10, 2010 - 3:19PM
.AAP

A world-first treatment for type 1 diabetes using insulin-producing cells grown in pigs has been approved for sale in Russia, and Australia is the "next big target country".

Professor Bob Elliott, who trained in Adelaide but now heads a laboratory in New Zealand, said two hospitals in Russia could begin offering the treatment next year once their training was complete.

The therapy would initially cost around $150,000 per patient, but "that will go down as we get an an economy of scale", he said, adding the treatment "makes a huge difference" to managing the condition.

Advertisement: Story continues below Type 1 diabetes is a genetic condition in which the pancreas stops making insulin, requiring a person to inject it several times a day while keeping a close eye on their blood glucose levels with regular finger-prick tests.

Prof Elliott's pioneering Diabecell treatment, from Living Cell Technologies Ltd, is the world's first xenotransplantation (animal to human) treatment approved for sale by a major industrialised country.

It takes insulin-producing cells from a special breed of pig and encases them, so they can be transplanted into humans without the need for immunosuppressant drugs.

Two patients who took part in a clinical trial were able to cease insulin injections altogether for eight months.

The treatment also rules out the risk of hypoglycaemia unawareness, a condition responsible for many diabetes-related deaths as blood glucose can drop quickly and not be detected until a person loses consciousness.

"This is not a cure for type 1 diabetes, but it will make it easier to control," Prof Elliott told AAP on Friday.

"Their diabetes becomes easier to control with fewer highs (in blood glucose), fewer lows, and if they have unaware hypoglycaemia we can pretty much guarantee to get rid of that.

"It makes a huge difference to their lives."

Prof Elliott said further clinical trials were under way in New Zealand, and the therapy may be available through NZ hospitals in 2013, when Australians could "fly across the ditch" to access it.

He also hopes to have it approved for use in Australia, saying it could reduce the high life-long cost of caring for people with the condition.

"It is a terribly costly disease, type 1 diabetes. Currently it costs the government are about a million dollars per patient for a lifetime of treatment," he said.

"About 90 per cent of that is from long-term complications, and if you can avert those you can save a lot of money - $100,000 for a transplant is peanuts if you can avert those costs."

Prof Elliott welcomed the recent lifting of Australia's moratorium on xenotransplantation.

"Australia has just lifted the moratorium on animal cell treatments about this time last year, but the regulatory pathway is not yet in place," he said.

"But, having said that, our next big target country is Australia."

Layne Adams said...
This comment has been removed by a blog administrator.
Luis Manuel Gonzalez Fernandez said...

UK Clinical Trials Web site is here:
http://www.nhs.uk/Conditions/Clinical-trials/Pages/clinical-trial.aspx

Your link doesn't work.
Thanks for sharing.