A professional career coach, Marcy has helped hundreds refine their resumes, improve their interviewing skills, and advance their careers.
It Takes Years for a Drug to Go From the Test Tube to the Market
What Happens When You Are a Paid "Lab Rat?"
People often cringe when they think about testing a drug in people before it's been approved by the FDA, and some wonder if it is ethical to do so. My answers are, "Would you want to take a drug that hadn't been tested in humans?" and "Would you want the FDA to approve a drug that hasn't been tested in people?" This usually helps people see the rationale for exposing humans to a drug not yet on the market and points out the purpose of human testing.
Get Questions Answered During the Informed Consent Process:
Federal law requires that all subjects involved in research studies be properly 'consented' before they can participate. This is true whether it's a psychology study at your university campus or a drug study in a controlled environment. The Informed Consent is supposed to tell research volunteers what they'll be given (or be asked to do), the purpose of the research, possible side effects, their rights as a research subject, that they have the right to withdraw, that they are not to be coerced into volunteering and what help is available in the event of a problem. Those are just some of the basic elements of an informed consent; there's a lot more information in such documents, which are often 10-20 pages or more.
Extensive safety precautions are taken to protect research volunteers. Yes, there can be compensation, but this is not considered at job or real employment. Volunteers are compensated to help offset their time and, sometimes, travel expenses. Without volunteer research subjects, there would be no new drugs on the market.
There are four phases of human drug research, but before a drug can be researched in humans, it must be researched in test tubes and in lab animals.
Where Do New Drugs Come From?
It can take more than a decade for a drug to go from the test tube to your pharmacy, and many formulations never make it beyond those first few days or months in a laboratory tube.
Few drugs make it into animal research, and still fewer are authorized for research in human subjects. But each year, a small percentage of the overwhelming number of drugs in some stage of research will actually get approved and put on the market so that patients can benefit from the research.
Drug patents last only a few years (about 16 or 17), and the patent clock starts ticking the minute a drug is put into human research. Since drug studies in humans take several years, this means that a pharmaceutical firm has only the years remaining on the patent to recoup its investment before generic forms of the drug (manufactured by firms that have not invested the time and money in the original research) will hit the market at cheaper prices.
As a longtime member of a board that reviews and approves drug studies for research in human subjects, I often get questions about how the process works.
Here's a short information session on the process your prescriptions went through before they made it to the pharmacy.
How a Drug Goes from Testing to Your Drug Store
Drug Research in the Test Tube Stage
The lab, or test tube stage of drug research can take many years. Major pharmaceutical firms spend a ton of money on this type of research. When you realize the amount of time and the financial expense of each research stage, you can gain an appreciation for the work pharmaceutical firms do to help fight diseases.
Yes, these firms are ultimately seeking a profit, but without their investment in research, many serious illnesses and conditions would go unchecked and greatly harm the quality of life of millions of people.
The lab stage alone (including animal testing) costs many millions of dollars. The pharmaceutical firm has to demonstrate to the FDA that the drug is ready to be tested in humans and that any risks are outweighed by potential benefits before drugs are approved for studies in humans.
A drug firm can go through thousands of test-tube formulations before discovering one that has the potential for further research (in animals, and later in humans). Each stage has added costs (animals require lab tests of blood and urine, the same as humans do). The final cost of research can be more than $1 billion for a given drug or formulation, and the process can seem excruciatingly slow to those who are waiting at the other end for a drug to be available.
New Method to Reduce Need for Tests in Animals
Drug Tests in Lab Animals
After a drug or formulation shows some results in test tubes (how it reacts with various substances, etc.), it must be tested in animals before humans can be used in research.
This is understandably a concern to those who love animals (and I am one of those people), but when you understand how important animal testing is for the safety of consumers who will one day need and use the drug, it's easier to realize why this stage of testing is needed.
Test tubes simply to not yield the information that can be learned from animal testing. A formulation might seem to work well in the test tube stage, but when it is tested in animals, other information is learned about how a drug affects the complete system of a living creature. Scientists and researchers watch animals in lab tests very closely for reactions that could occur in humans.
Animal testing yields a lot of information about how the formulation is processed through a blood system, how it is excreted, how long it stays in the system and, very importantly, whether it can harm a fetus or damage the reproductive system (including sperm and eggs).
This stage of research also helps reveal possible side effects in humans (even though the human body may not react exactly the same way). Lab scientists record whether the test animals had trouble sleeping, had changes in their appetites, developed any symptoms or changes in blood and urine tests or had other reactions that can help determine if the drug is suitable for human testing.
We all rely on drugs to keep us healthy or to treat various conditions, and animal testing is a key stage in developing drugs that are effective, but at the same time as safe as humanly possible.
Responsibilities to Protect Human Research Subjects
Phase One Drug Research
Phase I Research
Is often called 'First Time in Man,' however, many Phase I studies are in drugs that have been tested in a human population before. Phase I studies are performed under very controlled conditions. Usually, a small group of 'healthy normal' people will be tested at first, starting with very small doses and dosing is increased very carefully, under heavily monitored conditions.
Often, because of the high cost of creating a controlled research environment for human testing, drug firms will use Contract Research Organizations for this stage. These are firms that have special facilities for such research, and can create the controlled situations needed for any given drug.
The reason healthy volunteers are used for Phase I studies is to avoid needlessly exposing someone with a health condition to a research drug. It also helps give better research results, since all volunteers are screened to ensure they pass basic lab tests and are free of outside substances (such as tobacco products, or anything containing caffeine).
Phase I studies usually have set dosing periods, set meals and menus (subjects usually have to eat the same food, and they generally have to finish everything they're given), and are done in hospital-like environments. This helps protect the safety of volunteers and provides the equipment and conditions needed for blood draws, physical examinations and other tests.
The meals study subjects consume during in-house research are sometimes part of the actual study process; drugs will often behave differently in the body (or cause different side effects) under fasting conditions or after a high-fat meal. This is the sort of information consumers see on pill bottles later on, such as a warning to take the medication with a meal, or to avoid certain foods (perhaps milk) while taking the drug.
In some cases, such as with cancer drugs, Phase I research can happen in a patient population. This is for several reasons - it allows the drug to reach the target population earlier and it helps demonstrate how drugs such as this (which are complex and often toxic) react in patients who have the actual medical condition. Doing Phase I research in a patient population also helps avoid exposing healthy volunteers to drugs that are known to have serious side effects.
As with animal testing, Phase I shows how the drug is processed through the body, how it's eliminated, how long it stays in the system, and whether there are side effects. Every 'complaint' a volunteer has is recorded in the files as a potential side effect.
Research Volunteers Tell Their Story
Phase Two Drug Studies
Phase 2 research is similar to Phase I, but in a larger population. After the research done in Phase I, the pharmaceutical firm decides the level of dose to give to a wider population (since the first tests were likely small doses that may have been increased bit by bit). The drug can sometimes be studied in patient populations at this stage, too.
As with Phase I, Phase 2 research looks for side effects, monitors how and when the drug is passed through the body into the urine or feces and monitors how long the drug stays in the system before it is 'washed out.'
This stage is usually done under similar controlled conditions, but it can be outpatient as well, depending on the formulation being tested and the population its tested in.
Phase I and Phase 2 research is often done through Contract Research Organizations (CROs). These firms have advanced research facilities that offer controlled environments, emergency medical personnel and equipment, on-site lab techs and physicians, nutritionists and other professionals who are needed to conduct the study. It is often more cost-effective for drug firms (even large ones, such as Pfizer, Glaxo Smith Kline or Eli Lilly) to contract out the human phases of research rather than carrying the ongoing expense of the type of personnel when they may not have a drug in the research stage at a given point.
Often, volunteers must stay overnight in facilities; at many CROs, subjects stay in dorm-like rooms with recreation or community areas where they can watch television, surf the Internet on laptops, play games and visit with other volunteers. Strenuous exercise is usually forbidden, because it can change an individual's heart rate and other factors and can affect lab results.
People who volunteer for this type of research are generally compensated for their time (based on the number of days in the study, the number of overnight stays and return visits). This is not considered regular employment, and research firms (CROs have the right to restrict people from future studies if they have difficulty adhering to the protocol or 'house rules,' or if their safety could be jeopardized by participating. Even though it is not considered an actual job, research sites must report compensation to the IRS if it exceeds a certain amount.
If you tour one of these facilities, you will be impressed at the sophisticated technology used in the design of the building, such as providing areas where the lights can be adjusted to a color that will not interfere with the study drug for studies with light-sensitive formulations (ever wonder why pill bottles are usually tinted orange? Now you know!). You'll also be impressed and comforted at the emphasis on safety and protection of the research volunteers.
Phase Three Drug Studies
Phase 3 studies take the drug into the patient population. Once the pharmaceutical firm has studied the side effects in healthy subjects and identified the optimum dose for treatment use, research is done in patients who might benefit from the drug. As with Phase I & 2, these individuals are 'consented' before participating in the research.
Phase 3 often starts out in a limited number of patients, and as more information is gathered, the group is expanded. By the end of this stage, many thousands of people may have taken the drug in order to determine how well it treats a condition (or does not treat it, as the case may be). This stage can go on for many years in order to gather data on results and efficacy. Volunteers are monitored to see how they respond. Some volunteers might be compensated at this stage, and some will participate in order to have early access to the drug in the hopes it will help them.
Phase 4 Studies: In addition to the three research stages mentioned above, which are done before a drug is approved to go to market, a drug that is already on the market can be researched for various reasons or to adjust it in some manner (maybe it will be given in a capsule rather than a tablet). Even a drug that has been approved by the FDA will go through additional research if any changes are made to it in order to demonstrate that the formulation has the same efficacy it had before the changes.
What About You?
Some final points
The above is a very (very!) brief outline of what happens before drugs are approved and reach the pharmacy.
The IRB is involved during all four stages, but not after FDA approval for marketing the drug. Devices also go through similar research, but the process is slightly different (volunteers still need to give their 'informed consent,' of course).
An important fact to know: The patent for drug studies is very short; only about 16-17 years. The timeline for the patent begins when the formulation is first studied in humans. Since the phases of research can take many years, pharmaceutical firms often have only a few years left 'on patent' to recoup the many millions (sometimes billions) of dollars spent developing the drug. Not to defend high drug prices, but this may help you understand why the costs to the consumer are so high.
This information is meant to help shed light on the process, not to support or defend drug research, animal research or other elements of pharmaceutical development! I hope it's been helpful to you!
Kawai from Singapore on February 12, 2016:
This is a great and simple hub that sums up the drug development process..enjoyed reading it! I have been working in the clinical research industry for years - so I can totally relate to and understand your hub=) I have also written A related hub: Becoming research participants - what you should know before taking part. Can check it out if you are interested. Thanks!
Marcy Goodfleisch (author) from Planet Earth on January 22, 2013:
Hi, Rebecca - many thanks for your comments here! Yes, the research and testing process for drugs is lengthy and expensive. Often, people will say they don't like the idea of testing in animals or humans, and I always ask if they'd want to have a drug prescribed that had never been tested. It's amazing to see the advances in recent decades - and there will be even more of them, every year.
Rebecca Mealey from Northeastern Georgia, USA on January 22, 2013:
This is very interesting! I never would have realized drugs had to go through so much to get tested. That's good, though. I for one, certainly don't mind if they test them on rats!
Marcy Goodfleisch (author) from Planet Earth on June 06, 2012:
Hi, Brian - thanks for the very insightful perspective on the international elements of drug research; I've seen similar hold-ups and concerns over the years. I've also seen drugs or formuas that were approved and in use across the borders (or across The Pond, in at least one case) and were effective, but were not approved in the U.S. So there are sometimes issues where procedures or therapies aren't universally available. Sadly.
BRIAN SLATER on June 06, 2012:
hi Marcy this is an interesting hub topic. I worked all my life for a pharmaceutical company in the uk and know the lengths or hoops you have to jump through to bring a new product to market. One aside I would like to make is the expense a company will go to make it through the various stages. For a drug to become welll received throughout the world is difficult if your company can't get FDA approval which happened to ours once. The cost of not being able to gain the US market was tragic and as the testing was so demanding with delays and re-approval my company decided to pull out and concentrate on UK and Eurpean markets only. The downside was that once the FDA had made some reservations and testing on humans had begun they had to withdraw the tablet completely based on the side affects that the FDA had found over a longer period testing. The up shot was that a complete plant was shut down and the companies reputation was tarnished which took a while to recover. Voted up and shared, great article as ever.
Marcy Goodfleisch (author) from Planet Earth on June 06, 2012:
Hi, Happyboomernurse - I think you have a point; so many people don't realize the patent for drugs isn't that long. I sympathize with the concerns over high costs, but I truly 'get it' after knowing about the process and time it takes.
Thank goodness we have drug firms willing to do this research to help fight diseases!
Marcy Goodfleisch (author) from Planet Earth on June 06, 2012:
Thanks so much, Kelley - I'm so glad you like the hub; it's been fascinating to work in that industry all these years - and I agree, the cost makes much more sense when you understand the process. Thanks for reading and commenting!
Gail Sobotkin from South Carolina on June 06, 2012:
Great hub explaining the lengthy and expensive steps needed to research a new drug and gain FDA approval.
I did not realize that the patent clock started ticking at the start of the research and although I knew the process of drug development was expensive and time consuming, I didn't realize it could cost more than a billion dollars to gain approval for a single drug!
Thanks for sharing this info.
Voted up, useful and interesting.
kelleyward on June 06, 2012:
Marcy this is a hub I'm bookmarking. My background is in nursing and my sister works as a pharm rep but I love the way you detailed the process of how a drug becomes marketable! No wonder they cost so much!!! Voted up and Shared! Take care, Kelley
Marcy Goodfleisch (author) from Planet Earth on February 15, 2012:
Thanks nomorecellulite - I'm glad you found the hub informative. Drug research is a major industry and so few know about it, so this was fun to write. I will watch for your hubs!
nomorecellulite from Carmel, Indiana on February 15, 2012:
I never knew any of this. It's so interesting.
Brittany B from U.S. on January 18, 2012:
Great hub and good point about the human testing. I am considering a job in pharmacy so this information is very helpful.
Marcy Goodfleisch (author) from Planet Earth on January 18, 2012:
Thanks, Maat - I know the system isn't perfect, but we have it so much better in the USA than many other counttries do. I appreciate your insight!
Melissa Flagg COA OSC from Rural Central Florida on January 18, 2012:
Great Hub! This is stuff everyone should know. I've been a part of the human trials for a couple of ophthalmic drugs and all the parameters they set for testing while necessary are insane! Unfortunately, it's pretty easy to sway the results, at least from what I saw.