Inspired Spinal Cord Injury Support Forum

Lαrα
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Understanding clinical trials in Spinal Cord Injury Mar 4, 2014 12:41:29 GMT -8

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Post by Lαrα on Mar 4, 2014 12:41:29 GMT -8

I thought i would starts some threads that explained some of the basics of trials and research.

We have had several discussions on the forum on the subject of Spinal Cord Injury cure and trials which have successfully confused me to say the least and i have a feeling that im not alone!

So lets try to make some sense of it!

Clinical trials are a critical stage in the development of new treatments. Because the time and expense of conducting clinical trials can be great, it may seem attractive to look for short cuts.

However, it is only by conducting properly controlled clinical trials that we can ensure safe and truly effective treatments become available for those that need them.

Why are trials conducted?

to test a new treatment

to test a new combination of treatments

to examine ways to prevent or reduce impact of a disease

The article goes on to explain about why clinical trials fail...due to concerns over safety or effectiveness. Its easy to see how much money must go into this that is potentially 'wasted'. Maybe its a case of 'nothing ventured, nothing gained'.

Large pharmaceutical companies were traditionally responsible for the majority of drugs entering clinical trials but in the last decade or more biological treatments such as antibodies, therapeutic proteins, cell- and genetic-based therapies has seen increasing numbers of smaller biotechnology companies or groups of clinicians working together with basic scientists to bring treatments through to the clinic.

This new era brings great promise but also many unknowns, particularly in terms of safety.

Before a trial can be carried out it has to meet certain conditions of criteria. An ethics committee will consider all aspects of the trial. This committee ensures that the correct questions are asked about the trial so that safety is priority.
The committee will also oversee who and who cant participate in the trial...its has to be of potential benefit to the individual and with no risks that can affect their health.

Removing Bias

There is very strong motivation from patients, doctors and those developing new treatments to see a new treatment work. This can potentially introduce unintentional bias in how the trial is carried out and how the results are interpreted.

From this point of view i can see that it would be very likely that a drug company would want to push through a trial and prove it successful...its big money and business. I would hope that at this stage of removing bias...that it is truly effective because otherwise there is the potential for dangerous drugs to seep out for use on the public.

So removing bias includes offering a placebo group who have been randomly selected an inactive drug or therapy so that fair results are achieved.
It should show the effectiveness of the trialed drug/therapy also.

Source of Information- Click here to read

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kilg0retr0ut Advanced Member Posts: 2,507 Post Likes Received: 1,862 Date Joined: July 2013 Injury: L4/5 Cauda Equina Date Injured: 7-15-10 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 4:17:37 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by kilg0retr0ut on Mar 5, 2014 4:17:37 GMT -8 I admit, I'm clueless, so thanks Lara.]
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Lαrα
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Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 4:36:59 GMT -8

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Post by Lαrα on Mar 5, 2014 4:36:59 GMT -8

Mar 5, 2014 4:17:37 GMT -8 kilg0retr0ut said:

I admit, I'm clueless, so thanks Lara.]

Lol..dont worry.kilg0retr0ut, your not on your own and hopefully i can try and shed some light on everything

...so watch this space because il keep posting in the section and i will attempt to keep it all simple...for all our sakes lol

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tbone57
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Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 9:45:26 GMT -8

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Post by tbone57 on Mar 5, 2014 9:45:26 GMT -8

This article goes on to explain the different phases of clinical trials. That is Phase 0, 1, 2, 3, and 4

ClinicalTrials.gov
A service of the U.S. National Institutes of Health
Glossary Definition
PHASE
Food and Drug Administration (FDA) categories (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm) for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:

Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

(See also Study Phase data element on ClinicalTrials.gov.)
TO TOP

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Do it,Do it do it till your satisfied

Lαrα Global Moderator STAFF Posts: 7,350 Post Likes Received: 3,100 Date Joined: August 2013 Injury: CES Date Injured: March 2011 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 10:19:14 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by Lαrα on Mar 5, 2014 10:19:14 GMT -8 Thankyou tbone57..you have saved me the job..this was my next post
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Butiki Advanced Member Posts: 2,270 Post Likes Received: 1,154 Date Joined: July 2013 Injury: L 3 ASIA B CES Date Injured: 16/11/2012 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 15:33:24 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by Butiki on Mar 5, 2014 15:33:24 GMT -8 I'm still lost.
	Lαrα likes this Just do it

Lαrα Global Moderator STAFF Posts: 7,350 Post Likes Received: 3,100 Date Joined: August 2013 Injury: CES Date Injured: March 2011 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 5, 2014 18:04:32 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by Lαrα on Mar 5, 2014 18:04:32 GMT -8 Mar 5, 2014 15:33:24 GMT -8 Butiki said: I'm still lost. Butiki, il do a step by step guide for you soon.... im joking..dont tell me off

DJ Administrator STAFF Posts: 8,162 Post Likes Received: 2,829 Date Joined: July 2013 Injury: C6 - ASIA B Date Injured: June 2011 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 12, 2014 6:29:27 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by DJ on Mar 12, 2014 6:29:27 GMT -8 Great info Lαrα and tbone57, thanks for sharing! It definitely gives you a better understand on how these trials work
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freewheeler Senior Member Posts: 258 Post Likes Received: 119 Date Joined: July 2013 Injury: T10 Date Injured: Dec 2012 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 12, 2014 13:25:13 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by freewheeler on Mar 12, 2014 13:25:13 GMT -8 Thankyou Lαrα, hopefully this will help more members understand this process now and what is involved

sherry
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Understanding clinical trials in Spinal Cord Injury Mar 14, 2014 20:27:23 GMT -8

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Post by sherry on Mar 14, 2014 20:27:23 GMT -8

Mar 5, 2014 9:45:26 GMT -8 tbone57 said:

This article goes on to explain the different phases of clinical trials. That is Phase 0, 1, 2, 3, and 4

ClinicalTrials.gov
A service of the U.S. National Institutes of Health
Glossary Definition
PHASE
Food and Drug Administration (FDA) categories (http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm) for describing the clinical trial of a drug based on the study's characteristics, such as the objective and number of participants. There are five phases:

Phase 0: Exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals (for example, screening studies, microdose studies).

Phase 1: Studies that are usually conducted with healthy volunteers and that emphasize safety. The goal is to find out what the drug's most frequent and serious adverse events are and, often, how the drug is metabolized and excreted.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition). For example, participants receiving the drug may be compared with similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing. These including postmarket requirement and commitment studies that are required of or agreed to by the sponsor. These studies gather additional information about a drug's safety, efficacy, or optimal use.

(See also Study Phase data element on ClinicalTrials.gov.)
TO TOP

I wonder if Canada uses these same Phases? I was contacted this week for a clinical trial. If all goes well, I will have to go to Montreal, QC twice. Once to meet the Dr. and the second time to take the tri-therapy. Will keep you posted. I think if they use the same system, it would be Phase 1 or 2 seeing it is a one-time shot at this stage.

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Lαrα
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Understanding clinical trials in Spinal Cord Injury Mar 14, 2014 23:10:22 GMT -8

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Post by Lαrα on Mar 14, 2014 23:10:22 GMT -8

sherry, im not sure about Canada but i have a link here that you can take a look at. It may just give you some helpful pointers and considerations

Guidelines for the conduct of clinical trials for spinal cord injury as developed by the ICCP Panel: clinical trial inclusion/exclusion criteria and ethics

tbone57 Senior Member Posts: 258 Post Likes Received: 235 Date Joined: December 2013 Injury: C5, C6 incomplete Transverse Myelitis Date Injured: October 19, 2009 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 15, 2014 8:18:32 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by tbone57 on Mar 15, 2014 8:18:32 GMT -8 sherry, very interesting, wish you all the best with trial. Would love to hear updates!
	DJ and sherry like this Do it,Do it do it till your satisfied

kilg0retr0ut Advanced Member Posts: 2,507 Post Likes Received: 1,862 Date Joined: July 2013 Injury: L4/5 Cauda Equina Date Injured: 7-15-10 Member is: Offline Send PM	Understanding clinical trials in Spinal Cord Injury Mar 15, 2014 15:49:26 GMT -8 Quote Select Post Deselect Post Link to Post Back to Top Post by kilg0retr0ut on Mar 15, 2014 15:49:26 GMT -8 Me too Sherry , very interesting. You never know what it may be the start of. Wish you well
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Understanding clinical trials in Spinal Cord Injury

Post by Lαrα on Mar 4, 2014 12:41:29 GMT -8

Post by kilg0retr0ut on Mar 5, 2014 4:17:37 GMT -8

Post by Lαrα on Mar 5, 2014 4:36:59 GMT -8

Post by tbone57 on Mar 5, 2014 9:45:26 GMT -8

Post by Lαrα on Mar 5, 2014 10:19:14 GMT -8

Post by Butiki on Mar 5, 2014 15:33:24 GMT -8

Post by Lαrα on Mar 5, 2014 18:04:32 GMT -8

Post by DJ on Mar 12, 2014 6:29:27 GMT -8

Post by freewheeler on Mar 12, 2014 13:25:13 GMT -8

Post by sherry on Mar 14, 2014 20:27:23 GMT -8

Post by Lαrα on Mar 14, 2014 23:10:22 GMT -8

Post by tbone57 on Mar 15, 2014 8:18:32 GMT -8

Post by kilg0retr0ut on Mar 15, 2014 15:49:26 GMT -8

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