Page 1 of 2 12 LastLast
Results 1 to 10 of 14

Thread: clinical trials phases

  1. #1
    Senior Member
    Join Date
    Aug 2001
    Location
    bedford, n.y., usa
    Posts
    138

    clinical trials phases

    Dr. Young-

    What is the typical time pattern of a drug or therapy that does not run into any unforseen roadblocks to get from phase 1 to phase 3?

    If every potential SCI therapy is to follow these similar guidelines, we are looking at 10 to 15 years at best!

    Can't there be a way for well thought, ethical shortcuts? For those with ALS, Parkinson's, high cervical injury ( respirator. )?

  2. #2
    Senior Member Jeff's Avatar
    Join Date
    Jul 2001
    Location
    Argao, Cebu, Philippines
    Posts
    6,865

    Chris D

    This article by Dr. Young should be somewhat helpful to you:

    SCI Cure Treatment Schedule

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

  3. #3
    Senior Member
    Join Date
    Aug 2001
    Location
    bedford, n.y., usa
    Posts
    138
    damn, that is a long time indeed. suppose better than nothing.
    I feel like one injection to the lower back would refuel connections, it's soo simple, yet complex

  4. #4
    Chris,

    he average period of time required for a drug to go from discovery to FDA approval is 10-11 years. This includes the preclinical phase, phase I clinical, phase IIa and IIb, and phase III.

    The preclinical phase average about 6 years, typically ranging from 4-8 years. Think of some of the therapies that you have heard about, using the first published paper as the starting point. IN-1 has taken 12 years now in the preclinical phase. Activated macrophages, however, was initiated in clinical trial within 2 years (very fast in comparison to the average). 4-aminopyridine was first reported to have beneficial effects in spinal cord injury in 1986. The first phase II clinical trial of the drug in spinal cord injury was reported in 1992 (Hansebout) and so that was about average.

    • Phase I trials usually take about 1-2 years.

    • Phase II trials may take 2-3 years, assuming that two phase II trials are carried out and no untoward results appear.

    • Phase III trials usually take 2-4 years. FDA approval requires two phase III trials.

    • The final FDA approval and gearing up to market the therapy should take a year.

    Assuming that all the trials show efficacy and no negative side-effects are encountered that would force revamping of the therapy and repeat trials, the fastest time for a treatment to go through the gauntlet from discovery to market should be about 10 years (Pre 4 years, PI 1 year, PII 2 years, PIII 2 years, Approval 1 year = 10 years) to 18 years (Pre 8 years, PI 2 years, PII 3 years, PIII 4 years, Approval 1 year = 18 years).

    If the system is really streamlined and there were no delays at all funding issues, and no problems are encountered, it is theoretically possible to reduce the development time to 8 years, i.e. Pre 2 years + PI 1 year + PII 2 years + PIII 2 years + approval 1 year). By the way, I think that animal studies should continue even after clinical trials have started because it really helps to have as much information as possible to design PII and PIII trials. Also, one can often shortcut some of the steps if the treatment or a similar treatment has been tested in another condition.

    Many of the therapies that we are talking about are already in clinical trials and phase 1 trials may not necessary. For example, I think that copaxone for spinal cord injury can probably go directly to phase II and perhaps even phase III trials. This is because copaxone has already been approved for MS. This cuts as much as 8 years of the time frame. If phase II and phase III trials were successful completed within 4 years, copaxone should be in market within 5 years.

    Wise.

  5. #5
    Senior Member
    Join Date
    Aug 2001
    Location
    bedford, n.y., usa
    Posts
    138
    So people like myself who have parents in their mid sixties, will say good-bye to our loved ones still paralyzed and in burning pain!

  6. #6
    Senior Member cpaul's Avatar
    Join Date
    Jun 2002
    Location
    boulder co. usa
    Posts
    171

    what a forcast!

    10 to 15 years........Hmm......Lets see......With this time frame taken into consideration, I would like to congratulate all the doctors and researchers, who visit this site, for guaranteeing yourselves a job for the next decade and a half. As for myself and those in the same circumstance lets say it takes twelve years to complete all the parts for a cure. That means I can look forward to:

    17,520 more times to invade my body with a catheter.
    4,380 more bowel programs to do
    4,380 days of constant chronic pain, burning, muscle spasms and the inability to function or feel.
    I may as well get my script for viagra, because by the time there is a cure I'll be at the age where I'll probably need it anyway. I understand now why the chronics who have been at this game for a while, have become so jaded with talk of "A Cure" The whole time your listening to the promises, your life is just slipping by.

    h

  7. #7
    Senior Member Tara's Avatar
    Join Date
    Oct 2001
    Location
    BC, Canada
    Posts
    400
    These trials might be moving along faster overseas though, right?
    From what I understand, the time frame was based on when these treatments will become available in the United States.

  8. #8
    Tara, Clinical trials overseas are not really faster. In fact, because most clinical trials overseas often do not provide definitive answers, the likelihood is that they will take longer to achieve approval status or clinical acceptance in the U.S. Of course, some clinical trials overseas try to achieve the standard of clinical trials in the U.S. For example, the Proneuron trials will fulfil the requirements as registration trials for the FDA and therefore should be just as fast as a U.S. trial. On the other hand, trials of procedures such as those being carried out in Russia or China are not doing so.

    Cpaulm, I don't know whether it helps if I point out that neither doctors or scientists need to work on spinal cord injury therapies. People like myself, for example, work in the field not in order to have a job but because we want to see a cure for spinal cord injury and as quickly as possible. There are many other problems that we can work on and that would actually be less frustrating and more rewarding.

    There is a curious tendency for people to blame doctors and scientists for the system. The system was not devised by doctors, scientists, or even the pharmaceutical companies. Rather, it is the people of the United States, not the doctors or even the pharmaceutical companies, who created the current system and who have demanded rigorous criteria for treatment safety and efficacy. Congress created the FDA because people want to have safe and efficacious therapies, as well as the right to sue. It is the people who can change the system if they want to.

    It is important to understand what it takes to get a therapy approved in the U.S. and supported by insurance and third party-payers. I don't consider it a cure if we have a therapy that 90% of the people in the United States cannot have access to. Most people cannot travel overseas for therapies. Insurance will not cover the costs. As you know, I have not been critical of or oppose people who go overseas for their therapy. On the other hand, I simply don't think that going overseas is the answer for most Americans.

    Wise.

  9. #9
    Super Moderator Sue Pendleton's Avatar
    Join Date
    Jul 2001
    Location
    Wisconsin USA
    Posts
    11,007
    Originally posted by cpaulm:

    10 to 15 years........Hmm......Lets see......With this time frame taken into consideration, I would like to congratulate all the doctors and researchers, who visit this site, for guaranteeing yourselves a job for the next decade and a half. As for myself and those in the same circumstance lets say it takes twelve years to complete all the parts for a cure. That means I can look forward to:
    CPaul, Can I ask what you'e done recently to change this time table? Written Congress? Written the FDA to put all SCI therapies on the fast track schedule? Maybe decided against sueing a pharmaceutical company for what no one knew? That report of hormone replacement therapy possibly causing a few more cancers but mainly not protecting women against heart disease is barely out and already the lawyers are advertising for consumers to sue the pharmaceutical companies. The obese sued over phen-fen, some men are sueing about Viagra due to the unknown correlation to nitroglycerin pills.. You name it people will have their hands out over it.

    If you want to change the system I suggest you write your congressional reps and the FDA and find out how to "fast track" all SCI therapies. Ask how to create therapies that are really judgement proof and we will have cures in no time. Try aiming a little blame at tort lawyers too.

  10. #10
    Senior Member cpaul's Avatar
    Join Date
    Jun 2002
    Location
    boulder co. usa
    Posts
    171

    reply to Sue

    Dear Sue,

    Let me assure you, my congressmen are well aware of my feelings on this issue and hear from me quite often. I also make an effort to employ the help of all my able bodied friends and family to get behind this issue as well.

    C.n

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •