What is Clinical Trial?

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Rina
Rina's picture
What is Clinical Trial?

Every day, research uncovers new information about diseases and their treatment. Clinical research studies are an important step in making new medications available for future use. Here are a few definitions of Clinical Trial:

What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators. – from http://clinicaltrials.gov/ct2/info/understand

Rina Glozman

Guy Sovak
Guy Sovak's picture
Hi Rina,

Hi Rina,
Thank you for starting with this new category.
Where do one learns how to become a clinical researcher, do you need to have a diploma or just with couple of years in academic research you can look for a job in this area?
Guy

Fraser Moss
Fraser Moss's picture
Here is an example of a Job

Here is an example of a Job posting for a Clinical trials Project director

http://www.biospace.com/job_view.aspx?JOB_ID=29943

quoted key job requirements are:

REQUIREMENTS:
* Bachelor’s degree or RN.

* Six years clinical trial experience including monitoring and four years managerial and supervisory experience.

Rina
Rina's picture
Clinical Research

Clinical Research Professionals come from a wide variety of backgrounds with even more varied job descriptions. Some Clinical Research Professionals are MDs, while other are RNs, some may have a degree in medical technology, business administration, health information management, statistics, biology, teaching, or other areas. Every one of these backgrounds brings special areas of expertise to the clinical research field. Much of our training has come after our employment as a Clinical Research Professional. Every institution and discipline have unique requirements. (From SOCRA- http://www.socra.org/html/certific.htm#Background%20Information)

A clinical research associate (CRA) is a profession defined by Good clinical practice guidelines (ICH GCP).
The main function of a clinical research associate is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO). A clinical research associate ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators. A clinical research associate is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of Good clinical practice and local regulations. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex.( from Wikipedia)

Common Qualifications/Requirements for CRA position will be:
- University Degree in Life Sciences, Pharmacy or Medicine
- At least 1-2 years experience as a CRA- Understanding of ICH-GCP guidelines
- Clinical Monitoring Experience
- Excellent communication skills
- Computer literate
Clinical Research Associate (CRA) positions are often sought after careers. But how can you break into this role? One option for someone to break into a CRA position is by working in a clinical entry level position, such as: Project Assistant , Clinical Data Associate , Document Maintenance Specialist , Clinical Coordinator Assistant and other.

Here are some testimonies from science professionals who break into Clinical Science:
http://sciencecareers.sciencemag.org/career_magazine/previous_issues/articles/2002_04_05/noDOI.15495717378751859676

Rina

Shubhangi
Shubhangi's picture
Yes people in this field may

Yes people in this field may come from different educational backgrounds like doctors, pharmacists, lab technicians and last but not least statisticians.
Special cources are available for detailed education in this field as it is one of the growing branch of medicine from commercial point of view.

vaibhav kapoor
vaibhav kapoor's picture
clinical research

A clinical report includes  research using human volunteers (also called participants) that is intended to add to medical knowledge.There are two main types of clinical studies: 1.clinical trials (also called interventional studies)2.observational studies. ClinicalTrials.gov includes both interventional and observational studies.Clinical Trials:In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These intercessions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical preliminaries may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases.

Stephannie Baker
Stephannie Baker's picture
Clinical trial

What is a clinical trial?A clinical trial is a research study performed on subjects to gather information about the effectiveness of a certain treatment, drugs, therapy, medical device, etc. It is performed on humans, animals, etc. Extensive experimentation is conducted in the laboratory before the clinical research organization can start testing on human subjects. The laboratory experiments give the scientists an idea about the fatality and side effects of the drugs or treatment being tested. Clinical trials give rise to new remedies for various diseases, using the old treatment in a different way, etc. which can provide a cure. These trials can give the scientists a better indication of the drug being tested as it is performed on people of different ethnicity, region, age group, gender, etc. There are four phases in a clinical trial:

  1. Phase I: Testing on a small group of people
  2. Phase II: Testing on a larger group of people which can go on for several years
  3. Phase III: Effectiveness of the drugs is checked with different dosages and in varying population. The drug gets approved or rejected in this phase.
  4. Phase IV: After approval, the drug is tested on a diverse population

 Importance of clinical trials:

  • These trials give rise to cure for diseases and disorders which are not available
  • A trial performed in human subjects gives scientists better knowledge of the drugs being tested
  • The effectiveness of medical devices on human systems can be determined
  • Drawbacks of certain drugs for various races of people can be known