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Thursday, March 25, 2010

Clinical Trials medical research research studies clinical studies

"What are Clinical Trials ,Types of Clinical Trials ,Clinical Trial Phases ,Phase I ,Phase II ,Phase III , What is randomization in Clinical Trials,What is a Double blind trial, and using a placibo in a Clinical trial."

Clinical Trials (medical research, research studies, clinical studies )
A clinical trial is a investigational research study where in a drug or pharmaceutical or a treatments or therapies are tested in group of peoples to find out whether they are safe and effective. Clinical trials also facilitate researchers to find out which drug or pharmaceutical or a treatments or therapies are more efficient than others. The knowledge gained out of clinical trials assist in improving medical care and contributes to the understanding of diseases and conditions and therapy (progression of disease and to find the its effects on different systems in the body).
Each clinical trial is based on a particular protocol, protocol it is a written document that, explains comprehensive plan and why clinical trial is needed, its intentions, and how it should be conducted. Clinical trial protocol is compiled by the clinical trial's principal investigator (in charge of the clinical trial).

Also see what is a protocol of a clinical trial

Types of Clinical Trials

*Treatment trials assess treatments on a particular disease or condition.

*Prevention trials find out the ways to reduce the risk for a disease in healthy individuals

*Early detection and screening trials study find out the new methods of diagnosis of a diseases or conditions before symptoms develops.

*Diagnostic trials find out the new methods to identify, early and accurately, whether a person have a diseases and conditions.

*Supportive care clinical trials, also termed as quality of life trials, study the methods of providing patients with more comfortable and a better quality of life.

Clinical Trial Phases
As a clinical trial tests treatments in group of peoples, there has to be a proof that the tested drug or pharmaceutical , treatment or therapy is likely to work before the actual clinical trial starts . This proof or evidence comes either from earlier laboratory research studies or from reports on the therapy's used by peoples.

Clinical trials take place in phases.

In Phase I trials, researchers test the drug or pharmaceutical or a treatments or therapies in a small group of people, just focusing on safety and adverse effects, dosage and schedule of drug administration.

In Phase I following aspects are thoroughly investigated are

1.What is the safe dose for a drug / pharmaceutical?

2.How a treatment affects the human body?

3.How a treatment should be given?

In Phase II trials, the treatment is given comparatively to a larger number of group of peoples to conclude prospective effectiveness and to further assess its safety and adverse effects. Phase II trials can last several years.

In Phase II trials following aspects are thoroughly investigated are

1.Does the therapy or a drug under investigation cause any adverse effects?

2.Are theses adverse effects tolerable?

3.It also finds out evidences about the drug or pharmaceutical or treatment or therapy’s usefulness in treating a disease or condition.

In Phase III trials, the drug or pharmaceutical or a treatments or therapy is usually given to more than hundreds or large group of peoples to validate its effectiveness and finally identify any adverse effects. In Phase III trials often drug or pharmaceutical or a treatments or therapies under investigation is compared with a approved drug or pharmaceutical or a treatments or therapies which are standard and are in current use for the disease or conditions.

In Phase III trials following aspects are thoroughly investigated are:

1.Is the drug or pharmaceutical or a treatments or therapy better than, the same as, or worse than placebo or a standard (and widely accepted) treatment or approach?

A fourth phase in clinical trials is a real time observation is carried out as some times largest clinical trials may not efficiently asses the occurrence of a rare side-effect.

What is randomization in Clinical Trials
Clinical trials can be a randomized. In a randomized trial, each participant is assigned a drug in random order , by chance through a computer or a table of random numbers—to either an investigational group or a control group. To ensure that the study results are attributable to the treatment and not to unrelated factors that might bias the outcome or the interpretation of the results.
Randomization is used in all Phase III studies and in some Phase II studies.

What is Double blind trial

Clinical trials are usually double blind That is neither the researchers nor the participants know who has been assigned to which group and which drug is given to which individual. Blinding a trial helps in reduce the chance of bias influencing of the clinical trial results.

Measuring the desired effect :

Researchers design a specific endpoint as a measure which determines whether the treatment under study has desired effect or not. example of an endpoint could be reliving of pain after treatment.

What is a multicenter clinical research trial?
When a clinical trial is conducted at more than one center they are termed as multicenter clinical trials. Usually a trials requiring large number of subjects to be studied are carried out as multicenter trials, such trials are mostly phase III trials.Large number of subject can be enrolled and studied in a multicenter clinical trail such participation also enables investigator to conduct study on subjects from different geographical locations, as the efficacy of a treatment or a drug or a device being studied may show variations due to difference in genetic and environmental and ethnic or cultural factors. Multicenter trial dispersed in proper way can properly evaluate effect of these factors.Subject enrolled in multicenter clinical trial can be allocated in a planed manner to a center where there is less number of subjects enrolled, so as to ensure enrollment of subjects for the study as planed.

Use of  Placebos in Clinical Trials:

A placebo pharmaceutical which contains an inactive ingredients a placebo is designed to resemble the actual drug being studied. An example of a placebo is a pill containing sugar instead of the active ingredient under study.
Giving a placebo to one group of participants and the other group a active ingredient containing, drug or a active treatment under study , helps in comparing how two groups respond. This gives the researchers a complete truer picture of the drug under study.
One can compare the physiological effects of environment emotional factors and conditions under which study is carried out.

Other type of placebo, which is termed as "sham," it is used in the treatment under study is a procedure and is not a drug or other substance. A sham procedure is intended to imitate the active treatment but does not have any active treatment qualities.

There are many organisations and universities which offers courses for conducting , data management and interpretations for clinical trials and its statistics ,this field is also known as clinical research , and organisation involved in clinical trials are also called as clinical research organisations , the institute providing cource in clinical research take Doctors and Pharmacists and Biotechnology graduates and post graduate students for courses, after completing this cource one can get job in a clinical research organisation and salary given are also high.
Most of the clinical research organisations under take responsibilty to conduct and provide detailed data on clinical trials on a contract basis.

Requiremets US FDA Inspections of Clinical Investigators of Clinical Trials

Clinical trial Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects

Also see US FDA requirements of reporting of adverse events in a clinical trial US FDA has recently updated its requirement.


Following are some of articles which;will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs in pharmaceutical industry

Pharmaceutical Validation , types of validation in pharmaceutical manufacturing
http://whoguideline.blogspot.com/2010/03/validation-in-pharmaceutical.html

Requirements of documents for validation of sterilisation process

http://whoguideline.blogspot.com/2009/11/us-fdas-requirements-of-documentation.html

How to investigate OOS out of specification results
http://whoguideline.blogspot.com/2009/09/how-to-investigate-out-of-specification.html

Determination of Phenol coeeficient of a disinfectant
http://whoguideline.blogspot.com/2009/04/determination-of-phenol-coefficient.html

Sterility testing
http://whoguideline.blogspot.com/2009/04/sterility-testing-of-pharmaceuticals.html

Cleen Room Classification
http://whoguideline.blogspot.com/2010/02/clean-room-classification-aspects-of.html


Time limitations in sterile pharmaceuticals processing
http://whoguideline.blogspot.com/2010/02/time-limitations-in-aseptic-process.html

Aspects of validation of manufacturing process in sterile pharmaceuticals
http://whoguideline.blogspot.com/2010/02/aspects-of-validation-of-aseptic_26.html

Good manufacturing practice in pharmaceutical industry

Here is intresting article on world wide pharmaceutical industry
Pharmaceutical industry pharmaceutical industry

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2 comments:

jyothi said...

thank you so much for your help...these articles were very usefull to every pharma person.kindly send articles relating to drug disintegration time,disolution time etc.

Attik said...

Thanks,
This is very nice site I got for regular updation in pharma field.
THis is very great effort by peoples involved in this job.

Posted by: Martin

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