The Critical Role Clinical Drug Research Studies Play in Advancing New Drugs To Market

Posted in: Clinical Trials

SPRI Clinical Trials is a medical research facility that specializes in the conduct of Clinical Trials NYC.  Because of their long history of reliably and successfully conducting quality research studies, pharmaceutical companies consistently invite them to partner with them to help them demonstrate the effectiveness or safety of drugs they are in the process of developing or improving upon to treat important medical conditions for which there is the recognition of a significant unmet medical need.

Several weeks ago (3/14/17), I wrote about the pros and cons of participating in a clinical trial.  However, something I may have failed to emphasize strongly enough was the overall impact clinical trials play in advancing the approval and availability of new or better drugs.

Drugs cannot get to market without first demonstrating that they meet some here-to-for unmet need or provide a significant additional degree of benefit in terms of either effectiveness or safety to what has already been approved and currently available.

If people do not volunteer to participate in clinical drug development trials, the overall development timeline will be compromised.  This, in turn, will delay the approval and availability of new or improved drugs from becoming available to those who sorely need them.  In some cases, this could be a matter of life and death.

For example, Mitsubishi Tanabe Pharma Corporation just received approval on May 5th from the Food and Drug Administration (FDA) for a new drug (Radicava or edaravone) to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease.  ALS is an incurable neurological disease that causes damage and death to motor neurons within the brain and spinal cord.  This, in turn, leads to the progressive development of muscle stiffness, twitching, paralysis, difficulty breathing, and ultimately death.

Radicava is the first new drug to be approved by the FDA to treat ALS in 22 years.  The only other drug to be approved to treat this devastating disease is riluole that was originally approved in 1995.  Prior to that time, there was no drug approved to treat ALS.  If people had not been willing to participate in one of the clinical trials the sponsoring drug company was required to conduct to demonstrate its effectiveness and safety, Radicava would not now be a second important option for the treatment of ALS.

It is, therefore, important for people to understand that participation in a clinical drug trial is not only relevant if you, personally, are the one seeking a better, more reliable means of treating your particular medical condition.  It is also important to others who may one day benefit from what drug companies and medical research learn from how you did or did not respond to the drug under evaluation.

Even if you don’t live in Brooklyn, you can find out about clinical trials being conducted near you.  To this end, there are sites on the web that list clinical research drug trials being conducted throughout the United States. These include, and the National Institutes of Health.  These sites permit you to search specifically for a given medical condition, as well as where the sites (facilities) are located that are currently looking for volunteers to participate in these studies.  They also provide important information about what the studies involve and what they are trying to accomplish.  From there, you can decide whether you would like to find out more about the study in question or to volunteer.



1 Comments for : The Critical Role Clinical Drug Research Studies Play in Advancing New Drugs To Market
    • Janice
    • June 4, 2017

    My mother was diagnosed with ALS in May 2014. Her doctor put her on riluzole, letting her know there was no cure but the medication might provide her a few more months of delayed symptoms. ALS progresses at different rates and affects different body parts first. My mother, being 73 at the time, fell into a category of what they call “fast progression” (older female). Her arms weakened first, then her hands, her mouth, and throat, and finally her lungs. Throughout her two-and-a-half-year ordeal, she was able to walk with assistance nothing was really working to help her condition.I took her off the riluzole (with the doctor’s knowledge) and started her on amyotrophic lateral sclerosis herbal formula i ordered from Health Herbal Clinic, her symptoms totally declined over a 5 weeks use of the ALS disease natural herbal formula. She’s now almost 76 and doing very well, the disease is totally reversed!! Visit there website www. healthherbalclinic. net

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