Research and Trials 2

Pro FIH (First-in-human) On Patients, Contra FIH on Healthy Volunteers

In this part of our seminar, we will concentrate on the profit of FIH on patients and give arguments against FIH on healthy volunteers. Before giving pro arguments about advantages and achievements related to FIH on patients, we want to give the basic concepts what a FIH, clinical trials etc mean. Let's start with the definition of FIH.

What is FIH? Clinical Trials?

FIH is also known as first-in-human or first-in-man study. This study consists of clinical experiments or medical procedures developed in different ways which are first tested on human subjects. Sometimes this is called a phase 0 study. This kind of experiments are called clinical trials. Clinical trials are observations made in clinical environments on patients or healthy volunteers. This clinical trials include trying new medications or new treatments such as drugs, vaccines, medical devices, intervention etc. Of course, as can be understandable this FIH clinical trial, despite it is on healthy subjects or patients, has it's own advantages and disadvantages. The possibility of risk still remains. The main idea is to valuate which of them, it is worth the most and which gives the best results and has more benefits. [1], [2], [14]

Why FIH on Patients?

Carolyn R. Aldige, president and founder of the Cancer Research Foundation of America: "Anyone with a cancer that cannot be effectively treated should aggressively seek out participation in a clinical trial. The chances of receiving the latest and best treatment is so much higher." [4]

First of all, a basic information you need to know when it comes to first-in-human clinical trials is that these kind of experiments are very observed and the scientists and researchers put a lot of effort into their work and make some before-hand trials before deciding that the new drug or medical device or etc is ready to be tried on a human, nevertheless if it is a patient or a healthy volunteer. Clinical research studies are the reason medical care has improved leaps and bounds in the past few decades. The drugs (but not only) that they want to try may be for different diseases and different physical conditions so not everyone is suitable to proceed with the clinical trial. Obviously there are some phases where the specialized team decides if a human subject is appropriate for that kind of experiment. The question is why patients and not healthy volunteers? The reasons are explained down below. [3]

First of all, patients that decide to participate into a clinical trial get better medical care than most other patients (this doesn't mean that other patients not in clinical trials are not taken care of as they should). Since the behavior of their body system is being observed all the time, these patients have more blood tests, CT scans or other cancer tests. They also have check ups more often and for longer than usual with the research doctor or research nurse.
This patients are monitored by their trial team so they safety is assured and the treatment has no risk and the patients can not be harmed. Clinical trials have a high degree of protection for patients. Every trial is approved by the FDA (to assure that the product being tested will be safe, and by an institutional review board, consisting of experts at the institution where the trial is taking place. The review board, among other things, assures that patients receive the information they need to decide whether to participate.
They can get a new advanced therapy that usually it is new and not applicable or available to other patients. Patients get a new treatment that works, that they could not get outside the trial. New carefully designed tests for new therapy, new drug, treatments, procedures or devices are designed for specific patients. In cancer trials, patients always receive either the best standard treatment or an additional treatment that may be even more effective. Also, it may happen that the new method has less side effects than the usual care.
If patients are part of a clinical trial and don't get the new strategy being tested, they may receive the current standard care for their condition. This treatment might be as good as, or better than, the new approach. Obviously they will have the support of a team of health care providers, who will continue to monitor every step of their treatment closely. This is a very positive part and patients still benefit since this doesn't leave them without a cure or with no treatment at all.
During clinical studies, extensive information is gathered from the patients - their disease or condition, how they react to the treatment, and potential side effects, which are observed and monitored. Even if patients do not directly benefit or have positive and promising results from the experiment they take part in, the information gathered can help others with the same disease (or not) and gives the scientific trial team, important information to process and to try find a better treatment, drug or therapy. They can provide researchers with the information they need to continue developing new procedures and introducing new treatment methods. All the data gathered from the patients trial is also called scientific knowledge which is very useful. Patients could be helping to improve cancer treatment (and not only) for future patients.
Patients have the chance to play an active role in their own health care and gain a greater understanding of their disease or condition.
Patients who take part in clinical trials are vital to the process of improving medical care. Without all these clinical trials, the development of new ways of treatments would not be possible and would not progress.
Patient treatment costs may be decreased, because many of the tests and doctor visits that are directly related to the clinical trial are paid for by the company or agency sponsoring the study. To cover this kind of treatments everything depends from the type of insurance and the insurance company the patient has. [4],[5],[6],[7],[8], [11]

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Why not FIH on Healthy Volunteers?

When it comes to clinical trials on healthy volunteers there's a totally different story. Healthy volunteers, as can be understandable, are physically healthy and do not have any concerning disease. They are used to experiment new drugs or new therapies. What maybe these volunteers do not take into count is the risk they face during this clinical trials. It is true that, the new drugs are observed and monitored and may have been tested on animals before like mice etc but this doesn't mean that it won't have negative effects for the human subject. Why healthy humans decide to participate in these clinical trials? Beside the ethical reason to help the medical developments go further and help find a drug which can be beneficial and crucial for other sick people in the future, most of people decide to join these clinical trials for the monetary reward they got. And to be honest, that is not a bad reason. Unlike patients where they may get paid, but that depends from the experiment and their insurance company. There are a lot of healthy young men who need money for their living, but this is not considerable since they may have a lot of side effects. When experiencing side effects they turn into patients and will need money to treat their condition. There are evidences that healthy people have died from clinical trials. [10] It may occur that patients die from clinical trials, but at least they were sick with a severe disease. Also, even why the drugs for clinical trials are monitored for both of participants, they may not have the desired effect and output on a healthy human as it may have on a patient. The human body is very different and testing a drug for a specific disease on a human subject who has not that disorder it is worthless. How can the doctors know that, the treatment will have the same impact on a patient's body? How can they decide if that specific method is useful for the patients and will help them? These experiments may be unpleasant, serious, or even life-threatening side effects, even though companies are trying to make clinical trials more safe for healthy humans. We understand that the drugs given may not have a major side effect or healthy patients are used mostly on the phase 1 of clinical trials but nothing is sure and absolute, conditions may change, we are talking about human lives. There is no joke when it comes to life safety! [11],[12],[13],

A final thought

It is absolutely true that both, patients and healthy volunteers play a crucial role when it comes to clinical trial. They have a huge impact on drug, method or treatment development and help the medicine field to find treatments that really work and sometimes saving a lot of people life. That is amazing! But, this doesn't mean to use healthy volunteers for drugs that may harm them, even though unintentionally and in some cases be fatal for them. Especially when it comes to healthy children participating this clinical trials. We have provided a documentary from BBC related to a drug trial and the healthy volunteers giving their experiences.

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Seitenhierarchie

What is FIH? Clinical Trials?

Why FIH on Patients?

Why not FIH on Healthy Volunteers?

A final thought

Bibliography:

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