This Article is About
clinical trials
sized group
new drugs
time and money
quality of life
How Are Clinical Trials Designed?
Join 1000's of Authors at StreetArticles Today!

How Are Clinical Trials Designed?

Clinical trials have a specific design which allows for a step by step analysis - slow and deliberate - of new drugs, new treatments, new diagnostic tests, as well as quality of life and economic issues. Research teams made up of scientists and physicians from around the world gather together regularly to discuss protocol (trial) design. Now in advanced research, researchers collaborate so as not to duplicate work which wastes time and money. Instead researchers are looking to complement each others work to advance progress more hastily.

Clinical Trials are categorized into four phases as follows:

Phase I - The first time a new drug is introduced to humans. During this phase researchers are looking for the maximum safe dose that can be administered. The emphasis in this phase is monitoring and determining side effects. The new drug is first administered at a very low dose to a small group of people. Doses are increased as they see that patients are safely tolerating the drug until the maximum safe dose is reached.

Phase II - Once the maximum safe dose has been reached the drug is offered to a moderate sized group of patients to measure safety and effectiveness.

Phase III - This is the point in the discovery process when researches learn if the new drug or new treatment option is going to be effective and make a difference. Working with a new treatment option versus a new drug means researchers may be working with a currently approved FDA drug but are now observing this drug working against a different cancer then originally approved for, or with a new combination of drugs, or with a patient at a different stage of their illness. For Phase III research a large number of patients, usually in the thousands, are enrolled. Researchers monitor to confirm effectiveness and safety- meaning side effects. They compare outcomes between new treatments and current treatments always trying the find the best option for patients.

Phase IV - These are trials that monitor drugs and treatments being used after FDA approval. Continuing to determine best use of drug and safest use of drug. Long term effects are determined.

Research has been able to make amazing progress regarding long term survival for many cancer patients. It is also important to know that researchers acknowledge there is more to treatment than medicine and extending life. Researchers involved with cancer also care about 1) Quality of Life and 2) Economics.

You will find that within Clinical Trials there are opportunities to participate in sub-trials. These sub-trials are based on subjective information by patients. Diaries and questionnaires are the instruments used. Researchers want patients to tell them how the medicines and treatments impact their Quality of Life. This information is valuable to how they continue to pursue certain lines of treatment. The third important factor to consider when trying to find cures for cancer is economics. The cost to the patient. The cost to the insurance companies, and the cost to our health care system. Economic analysis studies are done when patients consent to allow their treatment costs to be reviewed.

Clinical Trials are thus designed with three important issues in mind. First and foremost the continued improvement in medicinal and diagnostic treatment. Secondly, the cancer patients quality of life. Patients choice of treatment and their final outcomes are directly related to anticipated quality of life. Thirdly, the economics of medicine matters.

My hope is that as more people are made aware of the availability, the design, and the purpose of clinical trials then more will ask to participate. The more that participate the sooner we will find the best treatments and cures for the wide range of cancers that take so many lives.


Street Talk

No comments present
You May Also Like
Myths About Clinical Trials - Lets Clarify!
Fact or fiction? Often we are afraid of what we don’t understand. Right? I know before I took part in a clinical trial I didn’t know what they were all about and I was a nurse! So I want to share with you some of the myths that keep folks…
  Likes: 0

Having a baby, and the reality of preparing yourself
For expectant parents having a baby is a huge process.Buying baby gear is just the start. What people don't tell you is the grim reality of not preparing your mindset before baby comes along. Here are some tips to help you prepare yourself for the new arrival.
By: Suzie Walker in  Home and Family  >  Pregnancy   Feb 05, 2011  
0
  Likes: 2

Side Effects From My Third Medication for CML 2007-Present
Greetings! This is the third of three articles I wrote to share my experience and side effects of the three medications I have taken for my CML. The first drug was Interferon, followed by Gleevec, and currently I continue with Sprycel. I was diagnosed back in 2003 and am delighted…
  Likes: 1

Common Personal, Genetic, And Environmental Risk Factors for Myelodysplasia
The exact cause of any type of cancer is most likely due to a wide variety of factors. Even though the exact causes for a particular cancer cannon be pinpointed the main risk factors that have been shown to contribute the most to cancer development are personal genetics , and…
By: Devon in  Cancer  >  Leukemia Lymphoma Cancer   Sep 13, 2012  
0
  Likes: 0

Side Effects From My Second Medication for CML 2004
Greetings! This is article 2 in a series of 3 articles describing the side effects I have experienced on each of the three drugs I have been prescribed while treating my CML the last 8 years. Article 1 "Side Effects From My Second Medication for CML 2004" referenced the side…
  Likes: 1

Side Effects From My First Medication for CML 2003
Greetings! I imagine if you have chosen this article to read either you or someone you know has Chronic Myeloid Leukemia (CML). This is actually the first of three short articles describing the side effects I have experienced from the three medications I have taken over my last 8 years…
  Likes: 6

Will I Die From Chronic Myeloid Leukemia?
Chronic Myeloid Leukemia (CML) is one of four major types of leukemia. Leukemia is one of a number of blood cancers. Groundbreaking discoveries have been made in the last 10 years in the treatment of CML. Due to the major advancements in medication treatment patients no longer hear the devastating…
  Likes: 7

Do You Know A Hero?
Imagine being told you have Stage IV cancer and you are only 25 years old. Imagine it is the end of the summer you’re preparing for your first day on the job as a new high school teacher and you have just been told that you will be starting chemotherapy…
  Likes: 2

The Road Back: Recovering From Hodgkins Lymphoma
Life has many twists and turns. You never know what's coming your way, so you have to be ready for the challenges that will inevitably come. In December of 2013, I was faced with the biggest challenge of my life when I was diagnosed with Non - Hodgkin's Lymphoma. Unfortunately,…
By: Kelvin Lambert in  Cancer  >  Leukemia Lymphoma Cancer   Aug 31, 2015  
0
  Likes: 2

Cancer Clinical Trial Participants Are Heroes
Gratitude. “Thankfulness, gratefulness, or appreciation is a feeling, emotion or attitude in acknowledgment of a benefit that one has received or will receive.” Oprah often spoke about gratitude and how important it is each and every day of our life to stop and give thanks. My work with cancer patients…
  Likes: 3

Article Views: 2693    Report this Article