Page 1 of 3 123 LastLast
Results 1 to 10 of 21

Thread: Clinical Trial Time Table

  1. #1
    Senior Member Schmeky's Avatar
    Join Date
    Sep 2002
    Location
    West Monroe, LA, USA
    Posts
    3,415
    Quote Originally Posted by metronycguy
    bullshit, i contacted them , they don't have any human clinical trial planned said it wont happen for years..
    human growth hormone is used for a lot of stuff, why so long to use for this, or do they just like writing papers
    Metronycguy,

    Of course it will not happen for years, it can't. Lab discoveries are on the average, 15 - 20 years out as far as application to humans goes. It's always been this way, it's not a reflection on the researchers, it's protocol.

    It the USA, if a sure-fire cure for SCI was discovered today, it would still be 15 - 20 years to secure funding, set up a network of clinical trials, complete all three clinical trial phases (successfully that is), then gear up for real world applications to humans. This is how the system works.

  2. #2
    Senior Member
    Join Date
    Sep 2005
    Location
    In your nightmares
    Posts
    1,740
    Quote Originally Posted by Schmeky
    Metronycguy,

    Of course it will not happen for years, it can't. Lab discoveries are on the average, 15 - 20 years out as far as application to humans goes. It's always been this way, it's not a reflection on the researchers, it's protocol.

    It the USA, if a sure-fire cure for SCI was discovered today, it would still be 15 - 20 years to secure funding, set up a network of clinical trials, complete all three clinical trial phases (successfully that is), then gear up for real world applications to humans. This is how the system works.
    Wow, how discouraging.

  3. #3
    i guess what is annoying about this finding is that igf -1 is already fda approved and available.
    i know they have approved human growth hormone for aids patients to prevent wasting.
    cauda equina

  4. #4
    Senior Member Rollin Rick's Avatar
    Join Date
    Nov 2002
    Location
    B ville, New York, USA
    Posts
    826
    Come on now Schmeky, I think you're a little far fetched, also in some of your other post, even Dr. Young has disagreed with you. I really think if sparks fly in China SCI trials it's going to spread like wildfire. You guys with your timelines is getting ridiculous and very tiresome. So if we are 15 or 20 years before anything happens, you might as well retired from this site. I see that you are in the cure forum more than any other, why waste your time? It's going to be years, get used to it.

  5. #5
    Senior Member Schmeky's Avatar
    Join Date
    Sep 2002
    Location
    West Monroe, LA, USA
    Posts
    3,415
    Rollin Rick,

    Re-read my post, I clearly stated in the USA following present protocol. The average time to bring a drug to market is 18 years in the USA.

    A good example is John McDonald. His journal publication occurred in 1999, according to his own newsletter, human application may take place in 2013, that's 14 years from his initial lab findings, plus, he is speeding up his application to humans by going to South America.

    Forum members say "right around the corner" frequently for a cure, but availability is going to take longer.

    Dr. Young has also stated the ChinaSCINET is for the Chinese.

  6. #6
    In 1991 there was one drug available to treat AIDS,today there are 25.How is it possible to get that many treatments from the lab to the patient in such a short period of time.4AP has been around that long and won't be in the pharmacy for another 12-18 months.Just wondering.

  7. #7
    Senior Member
    Join Date
    Jun 2005
    Location
    Norway
    Posts
    17,427
    I think it will take 24 ½ year and two days, better than nothing, 'blotye 'ell'.
    Last edited by Leif; 11-18-2006 at 03:23 PM.

  8. #8
    I merged the topics since they are related.

    Quote Originally Posted by Schmeky
    Re-read my post, I clearly stated in the USA following present protocol. The average time to bring a drug to market is 18 years in the USA.

    A good example is John McDonald. His journal publication occurred in 1999, according to his own newsletter, human application may take place in 2013, that's 14 years from his initial lab findings, plus, he is speeding up his application to humans by going to South America.

    Forum members say "right around the corner" frequently for a cure, but availability is going to take longer.

    Dr. Young has also stated the ChinaSCINET is for the Chinese.
    Just some thoughts. The average time for a drug to go from first discovery publication to FDA approval is about 11.4 years in the United States. If the treatment is new and not a "me-too" treatment, the minimum required is about 7 years. Let us assume that "discovery" means first credible publication of animal studies indicating efficacy in a peer-reviewed journal. Approval refers to FDA issuance of a NDA (new drug or device approval). By the way, approval by insurance companies to pay for the treatment may taken several years and is a separate process. Acceptance by doctors may also take several years.

    1. The average time for a drug to go from discovery to market is 11.4 years. By the way, this is not an "official number". Several years ago, I did a study of all the drugs approved by the FDA in the 1990's. I looked up the first paper reporting efficacy of the treatment for the given condition, using that as the "discovery date". The range was 5-18 years. Of course, this analysis included only drugs that successfully made it through to FDA approval. Many drugs don't make it at all.

    2. Minimum time for a testing new treatment from scratch after discovery. Minimum time for preclinical and clinical trials after discovery is 7 years. Assuming that there is sufficient funds and there are no delays due to lack of funding, preclinical trials take two years to complete, phase 1 trials should take a year, phase 2 trials two years, phase 3 trials two years. Two phase 3 trials are required by the FDA and they are often carried out in parallel. This takes a minimum of 7 years.

    3. Minimum time for testing new treatment in a clinical trial network after discovery. If there is an existing clinical trial network that is ready to test the therapy and all the details of the outcome measures, training, and subject recruitment have been settled, this may take as much as 2-3 years off the schedule. A treatment may be able to go through preclinical studies in one year and then phase 1 through 3 trials, in 5 years.

    4. Minimum time for an existing therapy for a new indication. Trials (i.e. non-commercial) of drugs or treatments that have already been used in humans for some other purpose often are faster because they skip phase 1 and often can go directly to phase 2b (with an efficacy endpoint). This can be followed by a phase 3 trial. These clinical trials may occur in as short a time as 3 years.

    5. "Me-too therapies", i.e. therapies that are very similar to existing therapies, often can be tested in 1-2 years and approved by the FDA. For example, Acorda Therapeutics was able to put a capsule version of tizanidine out in one year. Likewise, it should be able to get a sustained release version soon. Trials of similar drugs can also be done very rapidly.

    Delays. If delays occur, they are usually from the following causes:
    • Funding. This is often the most common cause of delays. It may take several years to raise US$12-50 million necessary for clinical trials involve phase 1, 2, and 3 trials.
    • Replication. Sometimes laboratories may be unable to replicate each other's work. Until ̉this is settled, usually treatments cannot go to clinical trial. This may take years to settle.
    • Safety. Benefit must balance risk. A treatment that is risky, however, usually requires more proof of efficacy and can only be applied to diseases and conditions that are high risk. Correspondingly, a very safe treatment (such as eating an aspirin a day, can sometimes be taken to clinical trial without a great deal of efficacy information.
    • Trial approval (IND). There is of course some regulatory delay for clinical trial approval. In the United States, the FDA is required by law to consider and approve or disapprove new clinical trial applications within 90 days. If all the safety information is available, they will normally approve the trials. This is much better than China where the sFDA may delay for 9-12 months.
    • New Drug Approval (NDA). If the clinical trial is pre-negotiated and registered with the FDA, approval usually happens fairly quickly, if all the information is available, the results meet the agreed upon criteria, and there are no outstanding safety issue. It may occur as short as 3 months after the clinical trial results are available and analyzed.
    • Availability. This availability of a treatment after approval varies a great deal. Certainly for therapies that have limited sources and availability, it may take years. For example, it took companies several years to get the manufacturing process for interferon for MS up to the point where it could meet demand. There are certain therapies with inherent limitations, such as fetal stem cells from aborted fetuses. Until methods are available for efficientlhy expanding the cells, there may not be enough fetal cells to treat more than several thousand patients per year. Cloned stem cells is another example.

    ChinaSCINet. Clinical trials are not meant to be a source of therapies for people. Their sole purpose is to document risk and benefit of therapies, so that the therapies can be approved and then applied to people. The goal is to run rigorous clinical trials that meet the standards of regulatory agencies around the world so that approval can be obtained rapidly. ChinaSCINet is for China but it is also for the world.

    Wise.
    Last edited by Wise Young; 11-18-2006 at 04:42 PM.

  9. #9
    Senior Member Schmeky's Avatar
    Join Date
    Sep 2002
    Location
    West Monroe, LA, USA
    Posts
    3,415
    Dr. Young,

    Thank you for the clarification. If you factor in the items you listed such as successful replication, raising the necessary funds to pay for the clinical trials, acceptance by the medical profession, getting the insurance companies to cover the cost, etc., there is a lot of work to do. It would be great if we could achieve this in 15 years or less in the USA.

    I have a question. Once the ChinaSCINET is established (within the next 2-3 years), then a therapy is identified as effacious, which hopefully would coincide with the final stages of the SCINET, could it take as little 2-3 years to move this treatment through the SCINET? This would equate to roughly 6 years from now. This would obviously require near perfect timing of an available, replicated treatment. After this transpires, is it possible the participating clinical trial centers in China could accept paying patients for treatment, or would the SCINET be limited to treating the Chinese population?

    Lastly, if this 6 year scenario does in fact occur, could the clinical trial methods performed in China be implemented in other "reputable" parts of the world within a "reasonable" time frame (say an 2-3 additional years)??

    I am trying to determine if effective therapies could potentially be available in 10 years, perhaps less under ideal circumstances.

    I think after successful replication and completion of clinica trials, there will be Dr's that will want to "cash" in on a successful treatment.

  10. #10
    Quote Originally Posted by Schmeky
    Dr. Young,

    Thank you for the clarification. If you factor in the items you listed such as successful replication, raising the necessary funds to pay for the clinical trials, acceptance by the medical profession, getting the insurance companies to cover the cost, etc., there is a lot of work to do. It would be great if we could achieve this in 15 years or less in the USA.

    I have a question. Once the ChinaSCINET is established (within the next 2-3 years), then a therapy is identified as effacious, which hopefully would coincide with the final stages of the SCINET, could it take as little 2-3 years to move this treatment through the SCINET? This would equate to roughly 6 years from now. This would obviously require near perfect timing of an available, replicated treatment. After this transpires, is it possible the participating clinical trial centers in China could accept paying patients for treatment, or would the SCINET be limited to treating the Chinese population?

    Lastly, if this 6 year scenario does in fact occur, could the clinical trial methods performed in China be implemented in other "reputable" parts of the world within a "reasonable" time frame (say an 2-3 additional years)??

    I am trying to determine if effective therapies could potentially be available in 10 years, perhaps less under ideal circumstances.

    I think after successful replication and completion of clinica trials, there will be Dr's that will want to "cash" in on a successful treatment.
    ChinaSCINet is established. We are currently doing an observational trial of 600 patients and have received approval for our first phase 1 trial of lithium at Hong Kong University. Over the coming 6 months, we will be doing the phase 1 trial and then the phase 2 trial to determine whether lithium alone has any neurological effects. We will then follow this with a umbilical cord blood mononuclear cell transplant and randomize the patients to lithium or no lithium. We are hoping to complete all three trials within 2 years. At the present, we are working hard to raise the funds for the trials. By 2008, we are hoping to add other therapies to the combination, including blockade of growth inhibitors, as soon as they become available. Beyond that, I can't predict.

    In the meantime, as you know, we are trying to get clinical trials going in the U.S. My hope is that part of the funding will come from CRPA, from state funds, and also from industry support. In the United States, the main bottleneck remains funding. I don't believe that the answer is for Americans to go to China. The therapies should be available in the United States within similar time-frames as for China if we are able to get a clinical trial network going here.

    Wise.

Similar Threads

  1. Replies: 6
    Last Post: 03-24-2009, 01:22 AM
  2. Am I alone again?
    By Steve in forum Cure
    Replies: 82
    Last Post: 02-23-2007, 11:36 AM
  3. The Tribulations of Clinical Trials
    By giambjj in forum Cure
    Replies: 0
    Last Post: 04-30-2004, 09:33 AM
  4. Replies: 0
    Last Post: 06-02-2003, 05:12 PM
  5. The language of clinical trials
    By antiquity in forum Cure
    Replies: 1
    Last Post: 07-27-2001, 09:44 AM

Posting Permissions

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