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The Importance of Clinical Pharmaceutical Drug Trials

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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.

  1. Firstly, is the new drug better than similar medications currently available, or at least as good?
  2. 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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clinical trials

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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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clinical drug trials

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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.

*** matrix pills

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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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Twelve Reasons Why Patients Still Come FIRST in Healthcare

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More on Patient Engagement

[By Innovation Health]

After a 3 day-long virtual brainstorming session, contributors to the Innovation Health Jam shared their conclusions on why patient engagement remains a top healthcare concern.

patient engagement

Assessment

Click through this link for an infographic summarizing the findings:

12 reasons why patients still come first in healthcare

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Divorcing your EHR Sytem [A How to Approach]

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Planning for an Escape Hatch

[By Shahid N. Shah MS]

Shahid N. ShahAs a doctor, or physician executive, you will spend weeks or months in the “sales and demo cycle” for selecting an EMR. If you’re lucky you will have time to consider all workflows; if you’re even luckier you will test drive the UI and make sure training goes smoothly.

You will also try to ensure that deployment will be easy.

However, another thing not to forget is to plan how to get out of an application or system after it’s been installed for a while.

It’s Harder to Get Out – Than Get in

Why is getting out important? Every application looks better in a demo than in a working environment and every solution becomes “legacy” sooner or later. Every system will be replaced or augmented at some point in time. The cost of acquisition (“barrier to entry”) is well understood now as something we need to calculate. But the “barrier to exit” or switching cost is something you must calculate at the time you decide what systems to purchase.

If you can’t answer the “how, in 6, 18, or 24 months, will I be able to move on to the next-better technology or system?” question then you’ve not completed your due diligence in the sales cycle. Vendor sales staff are quite reticent to answer the “how do I leave your system” question; you will need to press hard and ask for a plan before signing any contracts.

Some Vendor Queries

When preparing an RFI or RFP, ask vendors specific questions about how easy it is to get out of their technology (rather than just how easy to it is to deploy and interoperate). Put in specific test cases and have your folks consider this fact when they are looking at all new purchases.

Here are some specific factors to consider:

  • Do you own your data or does the vendor? If you don’t have crystal clear statements in writing that the data is yours and that you can do whatever you want with it, don’t sign the contract. Look for a new vendor.
  • Is the database structure and all data easily accessible to you without involving the vendor? If only your vendor can see the data, you’re locked in so be very wary. Find out what database the vendor is using and make sure you can get to the database directly without needing their permission.
  • Are the data formats that the system uses to communicate with other vendors open? If not, you don’t own your data. Be sure that at least CCR and CCD formats are available and that all document data is accessible in standard PDF or MS Office friendly formats. Discrete data should be extractable in XML or HL7.
  • How much of the technology stack is based on industry standards? The more proprietary the tech, the more you’re locked in.
  • Are all the programming APIs open, documented, and available without paying royalties or license costs? If not, when you try to get out you’ll pay dearly.

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EHRs

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Chapter 13: IT, eMRs & GroupWare

Update on US Health Insurance Coverage

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Census Bureau 2013 Data

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Is Medical Licensing Really Necessary?

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Licensing Doctors – Do Economists Agree?

[By Staff Reporters]

In the US, the various state medical boards dictate the rules for physician licensure and discipline. Would-be physicians must complete an approved medical training program and pass a standardized test.

Scope-of-practice laws prohibit other health professionals from offering similar services.

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Google School of Medicine

[Google School of Medicine]

***

Given the resources involved in licensing doctors, taxpayers might be surprised to learn that the link between licensing and service quality is tenuous at best.

In fact, some economists like Shirley Svorny PhD, who’ve examined the market for physician services, may view medical licensing as a constraint on the efficient combination of inputs and a drag on innovations in health care and medical education.

Assessment

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Today is “World Pharmacist” Day

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Brainchild of the International Pharmaceutical Federation [IPF]

[By Dr. David Edward Marcinko MBA CMP™]

DEM blue tieWorld Pharmacists Day was the brainchild of the International Pharmaceutical Federation (IPF), with the council of this organization voting to establish the event in the late 2000s during a conference they staged in Istanbul, Turkey.

The aim of the day is to bring attention to pharmacies and the positive benefits they offer when it comes to health and FIP encourages all its members to get involved to make the event a success.

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WPD

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Each year the organization announces a different theme so that associations and individuals in the pharmaceutical industry can put together national campaigns or local projects to showcase the good work they do in helping to improve the health of people around the world. This can include giving lectures, holding exhibitions, or organizing an activity day for adults and kids to demonstrate the many ways that a pharmacy can help them.

Link: http://worldpharmacistsday.org/

Conclusion

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Is the Financial Services Industry All F***ed Up?

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More on the Fiduciary Problem

By Rick Kahler MS CFP® http://www.KahlerFinancial.com

Rick Kahler CFPIf you consult an attorney or a doctor, you don’t have to ask whether their advice is intended to serve your best interests.

It’s understood they have a responsibility to put your welfare first.

The Financial Services Sector

There is no such understanding when it comes to financial services. Some financial advisors have a fiduciary duty requiring them to act in your best interest. Others do not. Even more confusing, the same professional can be held to a fiduciary standard at some times but not others. It’s hard for consumers to know the difference.

My Talk

Last week I promised a “five-minute” solution to clear up this confusion. Here it is: Before engaging any financial advisors, ask them to sign a written statement that they are fiduciaries, that you are a client, and that either the advisor receives no income from commissions or any commission income is trivial (with “trivial” clearly defined).

If advisors sign such statements, you can be assured they have a fiduciary duty to you as a client. If not, you then understand you are a customer and “caveat emptor” (buyer beware) applies.

The Conundrum

Now – a little background on the confusion. It exists largely because of the influence that large financial institutions (who earn revenue through the sale of financial products) have on legislators.

The IAA of 1940

For example, the Investment Advisors Act of 1940 requires that anyone giving investment advice must be acting in a fiduciary capacity. The intent was to separate the financial salespeople, who had significant conflicts of interest, from the investment advisors, who had few to none.

If you know very little about financial products, would you rather be educated as the customer of a commissioned salesperson or the client of a fee-for-service advisor? Hands down, you’d want the fee-for-service advisor.

***F*ed up***

Financial Product Sales

Of course, the financial institutions selling products understood this. They were able to influence the drafting of the 1940 Investment Advisors Act, to exclude “any broker or dealer whose performance of such [advisory] services is solely incidental to the conduct of his business as a broker or dealer.” So if salespeople just happen to give some financial advice that is “incidental” to the sale of a product, they and their companies are not held to the fiduciary standard. Congress allows financial companies to advertise as if they are fiduciaries while their sales forces are not held to a fiduciary standard.

Certified Financial Planner® Designation Conflict

The same conflict arises in some professional designations, like the Certified Financial Planner® designation conferred by the CFP® Board. The designation initially certified the completion of training in financial planning. In 2008 the Board added a fiduciary requirement to the designation.

The Caveat

However, CFP®’s are only held to a fiduciary requirement when they are doing what the CFP® Board defines as financial planning. If a CFP® professional is giving advice to a client, the fiduciary standard applies. Yet the same professional can sell the same client an annuity with high fees and high commissions, even if the product may not be in the client’s best interest, as long as no “financial planning” is part of the transaction. The result is significant confusion for consumers.

My Suggestion

The bottom line is this: when you look for financial advice or financial products, don’t assume the advisor is looking out for you. It’s your responsibility to find out whether any financial professional owes you a fiduciary duty.

Assessment

So, I suggest you ask directly, “Am I a customer or a client?” The answer is almost always “a client,” as most financial services salespeople honestly don’t know the difference. After you explain that difference, ask them to verify their fiduciary duty in writing. That five-minute solution may have a lasting impact on your financial well-being.

Link: http://www.CertifiedMedicalPlanner.org

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