What are the Clinical Trials?

OK,
Everything before was just pre-clinical study.
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Now it is the time to test the promising compound on humans. Clinical trials are clinical studies to test medical products in humans. Sounds simple, isn’t’ it?

How do they control clinical trials and their integrity?

Well, the rules of clinical trails were developed in XX century and still continue to be refined. Here are several International Agencies. Each one oversees their own set of rules. However the trend in recent years is to standardize between different counties as much as possible. The clinical trials are governed of by ICH GCP rules and Helsinki Declaration. However, those rules are mostly general ones, not with particular details.

Basically, any research organization must now to comply with ICH GCP rules.

One of the most developed set of additional instructions is made by American FDA (Food and Drug Administration)

Ok, how the modern rules for the clinical research were set up?

There was the Nuremberg Code which basically said the following:
The voluntary consent of the human subject is absolutely essential;
Anticipated scientific results should justify the experiment;
During the experimentation subject must have a right to withdraw from that at any time.
Human experimentation should be based upon prior animal experimentation;
Physical and mental suffering and injury should be avoided;
There should be no expectation of death and disabling injury from the experiment;
Only qualified scientists should conduct medical research;

Then in the mid-1960 Helsinki Declaration was issued by the World Medical Association.
The Helsinki Declaration made the distinction between clinical therapeutic and non-therapeutic research.

Majority of Rules were actually put after somebody broke them (before that they were just some commonsense ethical considerations) or after somebody did particularly nasty things to a group of people. During the years there some additional rules were introduced, like what to do when study involves children and cognitively impaired individuals
Helsinki Declaration was revised several times, clarification notes were done...

Basically, everything was done more and more to protect the rights of patients. For example, they not just test drugs now against placebo (dummy pill or dummy procedure), but against a best known method of treatment or diagnostics or whatever they study.

In 1949 UNESCO and WHO created The Council for International Organizations of Medical Sciences

The International Ethics Guidelines for Biomedical Research Involving Human Subjects were written down in 1980s.

And now everything is governed by ICH GCP.

What is ICH GSP?
 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (joint conference for the European Union, Japan and the United States) in  1996 developed   Guidelines for Good Clinical Practice,

They discuss how to deal with studies leading to the approval of new drugs
Basically, Guidelines for Good Clinical Practice contain ethical standards for the conduct of research involving humans.

So, who do review the studies and ethical standards?

Who are they? Whom will you ask if you participate in a trial?

Institutional Review Boards - that’s who they are.

Clinical trial procedures are checked by institutional review boards (IRBs). Or - independent review boards.

These boards should include at least five members (scientists, doctors, and ordinary people)
So, supposedly, you also can participate in that approval process, if you like.

And the IRB must approve every clinical study within their domain.
There are several levels of IRBs.  Usually it is at least a hospital IRB.
All details of protocol and paperwork should be approved.

Suppose, there is small change in protocol – like, let’ say, an investigator left or instead of 50 patients they want now 60, or there are couple words are changed in the protocol or informed consent form (that's form is usually 10-15 pages of print explaining for a layperson why the study is done, what are benefits and what are potential risks).  Let's say, instead of the hospital lab, they started to use a lab down the road.

All those changes require bunch of documentations and all should be agreed upon by many people. Sometime the paperwork takes months. Half a year is not so uncommon.
Other levels of IRBs - national ones.

Any study should have at least one IRB - national or local, and often they have both.

The goal an IRB review is to ensure that the rights of patients in the research are protected.

If the risks to is too great, the IRB disapprove the research and require changes in design or clarifications to reduce the risks.

 Also, IRBs checks inclusion and exclusion criteria. Which means that they watch if the people recruited to the study do really fit into the design of the study.

For example, in modern days majority of studies strictly exclude women in childbearing age, if they do not use some form of contraception.

Or let's say liver disease is classified in 5 grades. They use only three grades that would probably most benefit from the therapy. So, if you are too sick, or in opposite way, not very sick, you may not participate. And so on.

In Germany for example, they require to exclude all people with cancers in past.

IRBs also check how recruitment for clinical trials done. They want to see if all your agreements are voluntary and you do not participate in trial just because you are afraid to displease your doctor, or want to earn quick backs, hurting your health.

They check if the informed consent paper follows laws, and can be read and understood by a layperson.

National IRBs:
In Russia it is NEC (National Ethics Committee)

In United Kingdom - Nuffield Council on Bioethics (since 1n 1991)

They also published a report “The Ethics of Healthcare-Related Research in Developing Countries” in, 2002

Research Ethics in the United States

See part 3.

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