As the name suggest, Pre-clinical Development/Research is before starting the clinical research/trials. The safety testing of a drug which is conducted in vitro (in the test tube or laboratory) and in vivo (in animals), which must occur before a drug can be tested on humans, is known as Preclinical Research (Prior to Clinical-Research).
All the Clinical research should follow the FDA's rules and regulations. As per the FDA requirements for research in clinical trials, a sponsor must first submit data before any kind of clinical trials, showing that the drug is reasonably safe for use in initial, small-scale clinical studies/research.
The sponsor(conductor of clinical research) may have several options for fulfilling this requirement depending on whether the compound has been studied or marketed previously,
(1) The Sponser can compile existing nonclinical data from past in vitro laboratory or animal studies on the compound;
(2) The Sponser can compile data from previous clinical testing/research or marketing of the drug in the United States or another country whose population is relevant to the U.S. population; or
(3) The Sponser can undertake new preclinical studies(or preclinical research) designed to provide the evidence necessary to support the safety of administering the compound to humans.
At the preclinical stage, the FDA will generally ask, at a minimum, that sponsors:
(1) develop a pharmacological profile of the drug;
(2) determine the acute toxicity of the drug in at least two species of animals, and
(3) conduct short-term toxicity studies ranging from 2 weeks to 3 months, depending on the proposed duration of use of the substance in the proposed clinical research studies.
Preclinical research can answer the following questions:
How much of the compound is likely to be absorbed?
Where is it likely to work?
Is it likely to reach the target cells/tissues?
How much is it likely to be changed by organs, such as the liver, kidneys, skin or lungs?
What harmful chemicals and break-down products is it likely to produce?
Will it do more harm than good?
Could it potentially cause cancer or harm an unborn child, for example?
How quickly will it be cleared from the body?
Will it stay in the body long enough to do its job, but without causing other problems in the process?
If it becomes clear that the compound is potentially unsafe or unlikely to work, no further tests will be done and it will not be developed further. This way preclinical trial is actual pre-requisite for actual start of clinical research (Four Phases of Clinical Research).
The Food and Drug Administration(FDA) is an agency of the United States Department of Health and Human Services and it is one of the nation's oldest and most respected consumer protection agencies.
FDA's mission is:
- to promote and protect the public health by helping safe and effective products reach the market in a timely way,
- To monitor products for continued safety after they are in use, and
- To help the public get the accurate, science-based information needed to improve health.
FDA-regulated products are many things from the most common food ingredients to complex medical and surgical devices, lifesaving drugs, and radiation-emitting consumer and medical products.
At the heart of all FDA's regulatory activities is a judgment about whether a new product's benefits to users will outweigh its risks. Science-based, efficient risk management allows the agency to provide the most health promotion and protection at the least cost to the public.
Some of The FDA Activites and Responsibilties:
•FDA safeguards the nation's food supply by making sure that all ingredients used in foods are safe, and that food is free of contaminants -- like disease-causing organisms, chemicals, or other harmful substances. The agency must approve new food additives before they can be used in foods.FDA also monitors the safety of dietary supplements and the content of infant formulas and medical foods. * Meat and poultry products, however, are regulated by the USDA.
•FDA regulates all medical devices, from very simple items like tongue depressors or hermometers to very complex technologies such as heart pacemakers and dialysis machines. However, only the most complex medical devices are reviewed by the agency before marketing.
•FDA also protects the public from unnecessary exposure to radiation from electronic products. These include microwave ovens, cell phones, x-ray equipment, lasers, medical ultrasound and MRI machines, and many other consumer, industrial, and medical products. FDA's responsibilities in this area include special monitoring of mammography facilities to be sure that their equipment is safe and they are properly run.
•FDA regulates drugs and devices used for animals, both pets and animals that produce food. Before manufacturers can market animal drugs (including drugs used in animal feeds), they must gain FDA approval by providing proof of their safety and effectiveness. Veterinary medical devices do not have to be pre-approved by FDA before marketing, but they still must be safe, effective, and properly labeled. Livestock drugs are evaluated for their safety to the environment and to the people who eat the animal products. FDA makes sure that any drug residues that remain in these foods aren’t harmful to the consumers who eat them.
•FDA monitors cosmetic products to be sure that they are safe and properly labeled. But these products and their ingredients are not reviewed or approved by FDA before they are sold to the public, and FDA cannot require safety testing.
•Consumers rely on product labels to know what the product is and how to use it. FDA regulates what's on these labels to ensure that they are truthful and that they provide useable information that helps consumers make healthy, safe decisions when using the product.
The Food and Drug Administration is the U.S. government agency responsible for ensuring the safety and effectiveness of all drugs. The FDA web sites provide information to consumers on its activities in regulation and approval of drugs.http://www.fda.gov/
The FDA provides the following general information about newly approved prescription drugs on its Center for Drug Evaluation and Research (CDER) website:
Information on how drugs are developed in the U.S., read "From Test Tube to Participant: New Drug Development in the U.S.," third Edition, September, 1999:
Consumer information about drugs approved since 1998:
Information on products regulated by FDA:
New and generic drug approvals since 1988:
FAQs to CDER:
The FDA Electronic Orange Book, which gives current approved drug products:
MedlinePlus Guide to over 9,000 prescription and over-the-counter medications:
The National Cancer Institute (NCI) is the U.S. government's focal point for clinical trials on cancer. Most U.S. government agencies that conduct cancer research, such as DOD or VA, do so in partnership with NCI. http://www.nci.nih.gov/
NCI provides information on understanding cancer trials, types of cancer, finding trials, resources for researchers, most requested pages, and more: http://www.cancer.gov/clinical_trials/
NCI Clinical Trials Education Series provides publications for individuals and health care professionals to understand clinical trials, such as self-paced workbooks, slide programs on CD-ROM, booklets and videos:http://www.nci.nih.gov/clinicaltrials/resources/clinical-trials-education-series
The Veterans Administration (VA) and NCI provide information on their interagency partnership agreement in clinical trials for cancer:http://www.va.gov/cancer/
The FDA Cancer Liaison Program, Office of Special Health Issues with NCI answers questions directed to FDA by participants, their families, and participant advocates about therapies for life-threatening diseases:http://www.fda.gov/oashi/cancer/cancer.html
National Cancer Institute, Office of Liaison Activities Presents, Understanding NCI: Toll-Free Teleconference Series http://la.cancer.gov/teleconference.html
Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
What is the purpose of the study?
Who is going to be in the study?
Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
What kinds of tests and experimental treatments are involved?
How do the possible risks, side effects, and benefits in the study compare with my current treatment?
How might this trial affect my daily life?
How long will the trial last?
Will hospitalization be required?
Who will pay for the experimental treatment?
Will I be reimbursed for other expenses?
What type of long-term follow up care is part of this study?
How will I know that the experimental treatment is working? Will results of the trials be provided to me?
Who will be in charge of my care?
Protocol in the context of clinical research can be defined as code of correct conduct.
These protocols are nothing but the guildlines for the end to end procedure involved in clinical trial/research.
Since clinical research has a direct impact on human life, it causes the protocals to be more specific and very very tight in order to mitigate the risk of human life.
Check out the link providing the document about clinical research protocol.
There are various roles in the field of clinical research.
The following is the list of some of the roles and responsiblities which could be part of various fields of Clinical Resarch.
1. Clinical Research Associates
2. Clinical Research Team Lead
3. Clinical Development Manager
4. Clinical Database Designer
5. Clinical Data Entry Operator
6. Clinical Data Validator
7. Clinical Statistician
8. SAS Programer
9. Data Manager/ Lead Data Manager
10. Medical Writer
11. Clinical Study Co-ordinator
12. Clinical Research Protocal Manager
13. Medical Affairs Manager
14. Clinical Research Quality Contoller
15. Many more...
Also Check out this link for more detailed description about clinical research roles.
Clinical trials are no longer away from the one of the biggest industry of the world which is compute software. New Clinical Research Softwares are not only helping helping clinical trials to handle the project efficiently but it is also resulting into the cost and time reduction.
Softwares are providing flexibility to clinical trial projects.
Check out this link for more detail.
The most important part of the Clinical Trials in the Clinical Data Management. The System which is used for managing the data of the clinical trial is called Clinical Data Management System or CDMS.
CDMS is a robust system which can verify the data entered into it for any kind of possible error. There are various methods which can be used be the CDMS in order to find the possible human error while inputting the data into the system.
CDMS is not only used for data verification purpose but it is also used for the statistician help who might be working on the clinical trials. It can be used to generate various kind of reports needed as part of the clinical research. These reports could be submited to associated regulatory authorities who in turn can review this report and can give approval for the same.
First of all, if you want to know what the Clinical Trial is then click on the link to find about Clinical Trials.
After discovery of the drug and preclinical testing, Clinical Trials/Research of any new drug passes following standard four phases:
Phase I - A small group of healthy volunteers(about 20 to 80) is selected in this very first phase of clinical trials. These people will be kept under observation for the evaluation of the drug safety, determination of safe dosage range and identify side effects.
Phase II - This second phase of clinical trials consists of larger group of volunteers(about 100 to 300) . This phase study is mainly focused on drug efficacy and how well the drug works. This phase further evaluates the experimentals drug's safety.
Phase III - This third phase of clinical trials consists of larger group of patients of different medical condition(about 1000 to 5000) . This phase's study is focused on assessment of the drug safety data to support marketing claims for the drug. In this phase the drug is used to monitor side effects and compare it with other commonly used treatments.
Phase IV - This fourth phase is also known as Post-marketing surveillance as these studies are done after the drug has been introdued to market. These studies are conducted over much larger portion of the patients to continue testing the drug to collect information about drug's effect in various populations. This study also gathers the data on any side effects which could result from long-term use of the drug or the side-effect which could be seen after a long term of drug usage.
Clinical Trials means study of the drug which involves the testing at very stages and at various cells in order to make sure that the drug is safe and effective and in turn it can be launched into the market.
Every day is a new day and it is very true in case of drug discovery as well. Each day new discoveries are happening in various Clinical Research Labs. But these drugs can not be introduced into the market without the approval of the approving authorities. These approving autorities might be different for different geography.
All the drug approving authorities have some norms and in order to fulfil those norms, the pharma companies have to submit the result/report to this authorities in standard format. These reports are actually the outcome of the clinical trials.
It takes on an average 15 years of clinical trials before the drug can get introduced to market.
1. Clinical Research Project Management: This is the first phase of the Clinical Research and It includes the following:
Clinical Research Project Planning.
Clinical Research Protocol Writing
Clinical Research Investigator/Site Selection.
Clinical Research Regulatory/Ethical Clearance.
2. Clinical Trial Execution : This is the second phase of the Clinical Research and It includes the following:
Clinical Trial Study Initiation
Clinical Trial Site Monitoring/Management
Clinical Trial's Quality Control/Quality Assurance
Clinical Trial's Project logistic handling
3. Clinical Research Data Management : This is the third phase of the Clinical Research and It includes the following:
Development of Data Validation Plan / Field Audits.
Clinical Data's Statistical Analysis.
Following is the list of Some of the Clinical Trial Companies:
ABBOTT CLINICAL RESEARCH Group
Accutest Research Laboratories (I) Pvt. Ltd.
Ace Biomed Pvt. Ltd.
Adroit Insights Lifesciences Pvt. Ltd.
Asian Clinical Trials Pvt. Ltd.
Catalyst Clinical Services Pvt. Ltd.
Clinigene International Pvt. Ltd.
ClinInvent Research Pvt. Ltd.
ClinTec International Ltd.
Clintrac International Pvt. Ltd.
ClinWorld Pvt. Ltd.
iGATE Clinical Research International Pvt. Ltd.
Jubilant Clinsys Ltd.
Kendle International Inc.
Lambda Therapeutic Research Ltd.
Lotus Labs Pvt. Ltd.
Manipal Acunova Ltd.
Materiamedica Services Pvt. Ltd.
Neeman Medical International
Omnicare Clinical Research
Pharmaceutical Product Development, Inc.
Pharmanet Development Group, Inc.
Quintiles Spectral Ltd.
Reliance Clinical Research Services Pvt. Ltd.
Sipra Labs Pvt. Ltd.
SIRO Clinpharm Pvt. Ltd.
Suven Life Sciences Ltd.
Synchron Research Services Pvt. Ltd.
Veeda Clinical Research Ltd.
Vimta Labs Ltd.
Wellquest International (India)
Clinical Research Education might prove good for the people who have done graduation or Post-graduation in one of the following subjects:Ayurvedic Medicine
Hyderabad 500 034
Mob: +91 9963992084/2579
632 West End Marg,
Off M.B. Road,
Lane Number 3,
New Delhi 110 030.
Mob: +91 97170 94112/13/14/15/16
22nd Cross Road,
3rd Block, Jayanagar,
Opp NMKRV College
Bengaluru 560 011.
Tel: 080-4142 5578-79
Mob: +91 99723 61942/69/70
Silver Astra Building
Wing A, 3rd & 4th Floor,
Mumbai 400 059.
Mob:+91 99877 70761/62/63/64