To Trust the Drugs We Take
[By Luke S.]
It’s a subject that most people will be aware of but may not know much about [except doctors]; and one which constantly raises questions of morality and ethics – the matter of the clinical drug trial. As long as there are illnesses requiring medical intervention there will be a need for drug trials; it is essential, therefore, that all parties involved, as well as the general public, familiarize themselves with the processes and reasoning involved to understand clinical trials with more clarity.
The importance of clinical trials
Used widely from the mid-20 th century, clinical trials are essential in the development of new drugs, helping pharmaceutical companies to analyze the effects of new compounds on different people, as well as enabling them to make marked steps forward in the treatment of an array of illnesses and conditions.
Two Concerns
The role of the clinical trial is to answer two very key questions.
- Firstly, is the new drug better than similar medications currently available, or at least as good?
- Secondly, is it a viable medication for production? It is important to assess whether a drug’s side effects or ineffectiveness rule it out as a medical option.
Essentiality
As long as there are new drugs being developed, clinical trials are essential, giving those working in the pharmaceutical industry an insight into how their medicine performs in a monitored environment. Trials will assess where a drug does and doesn’t work, provide a broad scope of potential results, give an idea of any potential problems or side effects, and provide an overview of a drug’s potential to treat certain symptoms and conditions. This stage of drug development is absolutely essential, identifying negative side effects and a drug’s efficiency before it is distributed for public use.
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Pharma Responsibility
The clinical trial is a matter of responsibility on the part of pharmaceutical companies; those who are likely to need the drug need to be able to trust that it is safe and that it will help them in the most effective way possible; the fact that their new medication has undergone a rigorous and regulated testing process will be of immense reassurance to a patient.
Human Testing
Testing new drugs on human volunteers, as well as prospective patients further down the line is essential in the manufacturing of all new medications. It enables pharmaceutical companies to assess the effects of their drugs on a broad spectrum of subjects under strict conditions and means that any potential problems can be caught early. As well as upholding the law, clinical trials are essential for the pharmaceutical industry; they help manufacturers to move forward with their development, assist with the analysis of data, and allow new medications to be created, even if the results of a particular trial are unsuccessful.
Investment Potential
Clinical trials also have the potential to win vital investment for pharmaceutical companies, based on the outcome of particular tests. This will in turn lead to better resources becoming available; in short, drugs testing can help potential backers to assess the drugs market and make financial decisions. This can only be a positive thing in the development of new drugs.
Trial Successes and Failures
As with any process, clinical trials are subject to successes and failures that will ultimately decide the fate of the medication being tested. It was recently revealed that only one in ten new drugs tested between early 2003 and late 2011 were actually approved; a relatively low success rate that meant nine in ten drugs were rejected at the trial stage. While it may be a shocking statistic, it does emphasize just how important the clinical trial is. Another interesting fact is that this statistic is down from the one in five or six drugs that were successfully trialed in previous periods; this shows a marked advancement in drug creation.
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The Failures
There are a number of reasons that a new drug may fail during the trialing process. These include a lack of research or detailed analysis during early development, the potential for dangerous side effects becoming apparent, instances of the drug affecting test subjects in too varying ways, or very diverse results that can provide no solid conclusions. A drug may also prove a failure if too many external factors are seen to alter its effectiveness. Food and drink, other medications, or existing medical conditions can all affect a drug and must be carefully considered during the trial process. One thing is for sure, a new drug will be barred from further development if the clinical trial fails; these trials have to be strict, and more drugs will fail than pass at this vital stage of development.
Extreme Disappointments
There have been some extreme, albeit limited, examples of clinical trials going wrong, with instances of a drug causing adverse reactions that have put the volunteers lives and health at risk. This includes the “Elephant Man Trial”, which was conducted in the UK in 2006. During a trial of the drug TGN1412, six healthy male volunteers suffered severe and life-threatening reactions and now live with the knowledge that they are at an increased risk of developing cancers or autoimmune diseases.
Failures such as that are luckily few and far between and emphasize the importance of clinical trials; it would be ethically and morally wrong to allow drugs to enter the distribution phase without any idea of the damage they could do. The risks associated with drug trials are often outweighed by the benefits of developing a new drug that could be used to treat a multitude of serious illnesses and conditions.
Review and Distribution from Trial to Pharmacy
The process of taking a new drug from development to distribution is a long one. Following a lengthy and rigorously monitored trial period, all data will be collated and analyzed and, if successful, further development of the drug, with new investment and resources, can then begin. If, after all trials are complete, a drug has been found to be effective and safe, as well as marketable, an application for new drug status will be made. It is then, and only then, that the new drug can be manufactured and made available to patients, either via their healthcare provider, pharmacy, or an online pharmacy.
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Assessment
This prolonged process emphasizes just how far a drug must go before it can be deemed safe and effective. This reinforces the trust that patients should, and can, have in their medication.
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Conclusion
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Filed under: Drugs and Pharma | Tagged: Clinical Pharmaceutical Drug Trials, Drugs and Pharma | 3 Comments »
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