Considering obesity and metabolic surgery in Dubai? Or may be you have been referred to a doctor in Dubai for another gastrointestinal procedure? There are certain factors to be considered before a patient goes on the operating table.

Opting to have a surgery abroad is a tough decision for many. But the fact that patients can enjoy better care at significantly lower prices is making places like Dubai a dream destination for millions of patients. However, the key to success in any operation is to choose surgery clinics and hospitals in Dubai staffed by the right kind of people.

It is important to understand that any qualified doctor can easily pass off as an obesity and metabolic surgeon. However, it is necessary for patients to find certified professionals with the right training. Choose a doctor who has received their certification from an accredited board or society. This is the first step to ensuring that patients receive quality care and desired outcomes.

Besides medical training, surgeons working in surgery clinics and hospitals in Dubai must also have ample surgical experience. Procedures like gastric bypass are invasive procedures that require long years of experience in surgery. Since major organs are involved, great care must be taken to perform these procedures accurately and effectively. Keyhole procedures may look simple but the surgeon must have ample skill in performing the procedure. Experience counts a lot. Any surgery is risky. If there is an emergency on the table, an experienced surgeon is better equipped to handle the emergency with a cool head.

In addition to experience and the right qualifications, board certification is essential too. Membership with reputed societies ensures that surgeons have extensive medical training and experience. For instance, societies like the Society of American Gastrointestinal and Endoscopic Surgeons, USA require extensive training from its members. Thus physician members are required to have rigorous surgical training.

Surgeons who are proficient in their fields may also have various published papers in their field of expertise. Reputed surgeons are also recipients of awards of excellence, which is a tribute to their skill, experience and ability.

Obesity and metabolic surgery has become a mainstream option for many patients both within and outside the Middle East, in the last few years. That is why many private clinics have mushroomed in many parts of Dubai. However, huge demand also brings with it certain drawbacks and patients need to educate themselves about choosing their surgery clinics and hospitals carefully. According to reports, many facilities that offer treatment have no medical facilities on their premises. But patients must be advised of the need to choose clinics with necessary equipment and personnel to deal with emergencies that could arise when invasive procedures are performed.

Clinical management is catching up as an independent area/ profession, where many young minds can now dream of building a successful career. With the rise in computerization and technology, there is a growing need for research companies who undertake clinical trials to shift base to a completely paperless environment.
Especially to avoid human errors as far as data capture is concerned. Employment of sophisticated hardware and software will help to streamline and eliminate duplication of the clinical trial process.

There is a growing need for efficient management of data during clinical trials. This is where the necessity of having a clinical data management system in place emerges. Clinical trials are tests or experiments conducted in a research laboratory to check the effectiveness of a drug/ medicine, before making it available for prescription. The investigated data has to be recorded for future references. In order to reduce human errors, it is essential to get a superior quality data management system in place.

Many pharmaceutical companies are willing to invest in this electronic data capture process for higher validation. With technology making life so simpler, embracing a web based solution is what will give various entrepreneurs in the medical field a competitive edge.

The search for an effective solution stops online.Every opportunity has an opposition. The implementation of clinical data management system initiates decision making. It involves a lot of detailing, ensuring the systems are in place, etc. Not only is it necessary to initiate a new system in place but it is equally important to ensure that the outcome will be beneficial. The clinical data management system has the capacity to take the efficiency level of clinical trials to a completely new dimension.

An electronic data management solution will ensure:

- Faster and effective clinical trial procedures
- Efficient collection of patient information and data on the drug/ medicine
- High accuracy of data
- Full electronic audit trail

With the advent of online web based data management software, it is possible to dream about a virtual world in clinical data management. Advanced technological expertise, implementation and integration of superior clinical data management software can make this dream a reality.

Aarkstore announce a new report “Endometrial Cancer Clinical Trials Review, Q4, 2010″ through its vast collection of market research report.

Summary

Endometrial Cancer Global Clinical Trials Review, Q4, 2010 provides data on the Endometrial Cancer clinical trial scenario. This report provides in-depth information and data relating to the clinical trials on Endometrial Cancer. It includes an overview of the trial numbers and their recruitment status as per the site of trial development throughout the world, focusing on the status of participation by the developing nations. It offers coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides information pertaining to the number of trials for the key drugs for treating Endometrial Cancer).

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by team of industry experts.

Scope

- Data on the number of clinical trials conducted in North America, South And Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in each, along with the clinical trial scenario in BRIC nations
- Clinical trial (complete and in progress) data by phase, trial status and trial success rate
- Review of key discontinued trials (suspended, withdrawn and terminated)
- Overview of the enrollment pattern by phase for the past decade
- Number of clinical trials segmented by key drugs
- Clinical trial overview of top 20 companies, which include Pfizer Inc., AstraZeneca PLC, Eli Lilly and Company, and so on.
- Clinical trial overview of top 20 Universities / Institutes / Hospitals including National Cancer Institute, Cancer Research UK, Cancer Research Institute , and others

Reasons to buy

- Understand the dynamics of a particular indication as a whole
- Examine the performance of the trials in terms of their status, recruitment, success rates and others
- Obtain discontinued trial information for trials across the globe
- Understand the commercial landscape of the major Universities / Institutes / Hospitals or Companies

For more information, please visit:
http://www.aarkstore.com/reports/Endometrial-Cancer-Clinical-Trials-Review-Q4-2010-76580.html
Or email us at press@aarkstore.com or call +919272852585

If you’re thinking about having red vein treatment, then perhaps you know all about it, and know which clinic you’ll choose. If you’re not sure which clinic to choose, here’s what you need to consider.

1. You’ll either be looking at your local red vein laser clinic or asking friends and families for recommendations. You might look around on websites for testimonials too.

2. When you’ve found somewhere that you think will be suitable, you’ll want to make sure that they are regulated, and are insured to carry out this sort of treatment.

3. It goes without saying that the interior of the clinic is important. You won’t want to choose somewhere that looks untidy, or unhygienic.

4. As well as being regulated, you’ll want to make sure that staff who will be performing the procedure are qualified, and know what they are doing. This will definitely help to put your mid at ease.

5.

In addition to being qualified, you’ll want to make sure that the staff have had regular and recent training in new procedures, so that their skills are up to date.

6. It’s important that the staff are experienced, and have carried out the procedure many times. You won’t want to choose somewhere where the staff have only carried out this treatment a handful of times.

7. Even thought you might have done lots of research on red vein treatment, you’re bound to have some questions that you want answering. You’ll want to feel that you can ask any question, so that you will feel comfortable and reassured about your treatment. If you’re not comfortable asking questions, or the staff don’t or can’t answer them, then it’s not the right clinic for you.

8.

The staff at the clinic will make sure that everything is explained to you, so that you know what to expect during the treatment. You’ll also find out how many sessions they expect you’ll need. A reputable clinic will also need you to fill in a medical questionnaire, so that they know more about you, and can see if there are likely to be any issues.

9. It’s important that the clinic carries out a test patch on your skin before the main treatment. This is to ensure that the procedure will work for you.

10. It’s important that you consider the price of the treatment too. If you choose a clinic solely on cost, then you might not be receiving a treatment carried out by the best qualified and trained staff, in a nice clean environment, and who can answer your questions.

Now you know what to look for and what to think about, is now the right time for you to have red vein treatment?

Contact Lenses are regulated by the Food and Drug Administration (F.D.A.) as Class 3 Medical Devices. Class 3 medical devices are defined by the FDA as those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

Class 3 medical devices require the highest level of evidence for market approval  which is a  process  to evaluate  safety and effectiveness before the product can be brought to market. Clinical studies, scientific documentation, and reviews are required. There can also be post marketing surveillance studies after a new contact lens is released to look for further problems. Prescription drugs require a similar but much more involved process before they reach the market place.

A press release from the National Eye Institute in 2008 stated a phase one gene therapy clinical trial showed  promising  results for a blinding disease known as a congenital form (present at birth) of Optic Atrophy.

The retinal pigment epithelium is the layer of the tissue lining the back of the eye, the retina, that nourishes the rod and cone cells we see with. A mutation in a retinal pigment epithelium gene causes these cells to respond very poorly to light and results in loss of vision. Frequently we see news on gene therapy and are led to believe everything will be cured by in short order. Patients in the study received a sub-retinal injection to replace the defective gene in areas of the retina that were still relatively healthy. Each patient had visual impairment that had been present since birth due to the defective gene. Over a 90-day period there was significant improvement in vision. Day vision was improved by 50-fold and night vision by 63,000-fold compared to levels prior to treatment. Restored vision was localized to the area of treatment in the eye that received the injection. We tend to think of new drugs and medical devices as overnight miracles but researchers have been working for 15 years to get to this point. The new generation of 30 day wear contact lenses actually started with research done in the 1970′s.

All new prescription drugs and medical devices face the funding and regulatory structures that are required to pass the requirements for approval. While this process is frustrating and fraught with problems, if you spend a little time reading about the equivalent processes and equivalent oversight agency in China, you will gain a greater appreciation for the system we do have in place.

Clinical trials for prescription drugs proceed in four phases over a period of years and millions of dollars.  Actually there is a new phase zero but since it is still in transition we will cover only the 4 main phases.

The first testing of drugs in humans as referred to as phase one. Typically this involves healthy individuals in a group less than 50. The main goal of phase one trials are the to make sure there are no glaring safety issues and gain some understanding of how the drug works and is processed in the body. Normally, a small (20-50) group of healthy volunteers will be selected.

Phase 2 trials are mostly just an extension of phase one with several hundred patients. They also pry a little more into the amount of drugs needed to be effective in treatment and what time intervals are needed to administer the medication.

Phase 3 studies are what brings a new drug  to the corner pharmacy. Phase 3 trials may base tentative approval on only several hundred patients, and typically no more than 2000-3000 are in this phase. For you, that does mean a 1 in 10,000 lethal effect may not be known initially, or some other surprises may not be uncovered for several years. In Phase 3 patients are split into groups with one group receiving  placebos (no active medication) and another group receives the actual medication, Researchers typically don’t know who is getting what until the end of the study. Occasionally, it becomes so evident that a drug is saving lives or vision that the study is stopped as it is not ethical to deprive the patients receiving placebos of the full benefits of the new drug. The Woman’s Health Initiative study on hormone replacement therapy for menopause was an example of this. The study was terminated early when  it was determined  that  hormone therapy increased the risk of breast cancer.

Phase 4 is where the good, the bad, and the ugly comes out. This is also called the Post Marketing Surveillance Phase. Phase 4 trials involve the long term safety monitoring where the 1 in a million problems start to be seen over time. Also the interactions with other medications may become more evident, and  strange reactions specific to an individual may appear. Long term effects like the diet drug that caused heart problems may show up after a number of years.

Our Fort Collins office has taken part in several optometrist clinical studies with contact lenses. These are somewhat like the phase 3 clinical trials for medications. A lens may be studied by eye doctors on 500-600 patients prior to approval. While there is no such thing as a placebo lens, a contact lenses that has been approved in the past can be used on one eye as a comparison control. It a lot of fun to be involved in these emerging contact lens products but also a lot of record keeping, and when patients don’t keep their appointments the stipulations are pretty rigid about dropping them from the study. Generally we do not expect the same type of serious complications with contact lenses that can be seen with new medications.

One final bit of information. Sometimes things works out in odd ways. While drugs may have undergone all 4 phases and have approval for specific conditions, that does not restrict doctors from using medications “off label” in ways they have not been studied and approved for.The Food and Drug Administration regulates drugs and medical devices, not Doctors. Currently, the standard of care for certain eye infections is “off label eye drops.” It would be considered  substandard care to use the FDA approved medication in these special cases. This a very uncommon occurrence indicative of some weak point in the system where clinical experience is ahead of the curve. Someday there will be a way to account for these situations. Until then, we will continue to do the best with what we know today.

In a bid to shorten the time-to-market for new drugs, pharmaceutical companies utilize developments in information technology efficiently to get better and faster results. The Clinical Trials Management System or CTMS is one such web-based system that helps manage clinical trials effectively and help hasten the drug development cycle. Also, just like any other pharmacovigilance system, CTMS also helps improve the quality of drugs and protect public health.

Here are the key benefits of a web-based Clinical Trials Management System:

Streamlines the clinical trials process: CTMS consolidates monitoring and management of all activities pertaining to clinical trials so all the data are easily accessible
Anytime, anywhere access: Web-based CTMS can be accessed anytime, anywhere, even several thousand geographical miles away from the clinical trials destination. This allows for faster transfer of data and easier co-relative studies.
Better utilization of resources: As workflow process is smooth due to instant availability of data across multiple sites, teams and trials, hence, resources are better utilized
Improves productivity: Lost records can be easily retrieved, overdue tasks and incomplete records can be monitored electronically. So, this way productivity is tracked and hence can be greatly improved
Reduces costs: Effectively reduces the cost of managing huge volumes of data, as data storage is electronically processed.
Improves quality of clinical trials: Helps better evaluation of adverse reactions, minimizes data entry errors and improves tracking of drug safety issues

Faster access for regulatory authorities: The prime aim of any pharmacovigilance system is to improve drug safety and to meet up with the stringent drug regulations. A CTMS helps smoothen the regulatory assessment and reporting process, thereby shortening the time taken to develop and market a new drug.

Clinical trial sponsors can collect patient reported outcomes electronically in multinational clinical trials. Advantages include significant improvements in clinic and subject compliance, data quality, data access and monitoring, as well as reduced staff and subject burden. Yet, ePRO clinical solutions can also present challenges. By understanding some important ePRO best practices, however, sponsors can overcome major challenges.

ePRO CLINICAL SOLUTIONS: BRIEF SUMMARY OF THE CHALLENGES
One of the major challenges faced when using Electronic Patient Reported Outcomes (ePRO) in multinational trials is ensuring the quality and reliability of the ePRO systems and data files. After all, even small problems with the systems or data can sometimes damage credibility, which can lead to decreased system usage, increased enrollment, queries, and other trial costs, and at worst, the discrediting of all the data.

Another challenge is the very large number of changing variables that need to be managed.

These variables include:
- Complex protocols and lengthy questionnaires
- Long lists of countries, languages and translations
- Complex system requirements
- Interdependent schedules
- Long growing lists of issues
- A multitude of first patient dates
- International user support across different time zones in many languages.

Validity, or measurement equivalence with validated paper questionnaires, can also be a significant challenge. Due to the nature of the hardware and software, some systems cannot fully support existing validated paper questionnaires.

For instance, small hand-held devices generally have very restricted screen real estate.

IVR systems are limited because subjects can only remember short questions and answers. In these and other cases, the questions and answers from a validated paper questionnaire often have to be modified in order to accommodate the technology.

In order to then ensure that the data from the electronic systems are equivalent to the paper-based questionnaire, it is often necessary to conduct a validation study comparing the data collected on the new electronic tool with the data collected on the validated paper questionnaire. These validation studies can add significantly to both costs and project timelines.

Finally, a challenge faced by many when using Electronic Patient Reported Outcomes in multinational trials is quality assurance and auditing. Some auditors have limited experience or knowledge of ePRO systems, leading to varied interpretations of industry regulations. These diverse regulatory interpretations can cause confusion, and also have considerable cost and timeline implications.

ePRO CLINICAL SOLUTIONS: BEST PRACTICES
The challenges described above sometimes appear daunting to a study team, even though they appreciate the potential. However, there are solutions. The best practices described below offer a method to manage the challenges.

ePRO CLINICAL SOLUTIONS: SYSTEM QUALITY AND RELIABILITY
All successful systems start with an unambiguous systems requirements document. The purpose of this document is to describe the system(s) to be delivered in detail, so that all team members have exactly the same expectations of what the system will do and what data the system will provide.

The process of writing and reviewing a detailed planning document, whether it be systems requirements, a clinical trial protocol, or otherwise, forces the author and the reviewers to think through options for processes and to discuss and tweak them until there is confidence among all participants that the best solution has been designed.

So, the systems requirements definition process, properly executed, produces quality thinking on system design and is the first step towards producing quality systems. In addition, because the deliverable is a written detailed document describing how the system will work, it prevents misunderstandings, confusion and frustration at a later stage when the systems are implemented.

A systems requirements document must show all screen shots exactly as they will look in the completed system. Every edit for every data entry field, all screen and system validation checks, and all system logic (skips, conditions, calculations, error conditions, messages, and so on) must be described clearly and in detail.

This documented presentation of the system both ‘on the surface’ and ‘beneath the surface’ (logic checks, and so on) enables the sponsor team and the ePRO provider to think about the issues carefully before programming starts. It will also make certain that the system design will ensure compliance with protocol, and that the resulting data files will meet the needs of the study.

The final systems requirements document must be signed by the key sponsors and ePRO provider team members, to show agreement and commitment from both parties on the details of all systems functions and operations. When evaluating providers, the sponsor should ask to see systems requirements documents from previous projects.

The sponsor should ensure that the providers have the skills to deliver a thoughtfully prepared systems requirements document which describes a high quality system with the attributes the sponsor desires: ease of use, protocol compliance, data quality controls, rapid data access, and so on.

To deliver consistently reliable systems, the Electronic Patient Reported Outcomes provider must also have the skills to develop and execute high quality system test plans. Test plans must include thoughtful test cases that address every requirement in the systems requirements document.

To ensure every systems requirement is covered, there must be a traceability matrix which matches each requirement in the systems requirements document to the relevant test cases in the test plan. This may seem obvious, but it is often not done.

For each systems requirement there must also be detailed test cases and scenarios for both valid and invalid data, as well as standard and non-standard user actions. The expected results for each test must also be documented in advance of the test cases to ensure the integrity of the test. In addition, the test plan needs to include large data input sets that represent a wide variety of diverse scenarios.

Furthermore, it is vital that the test plan include significant load and stress testing to ensure that the systems will function properly in real world conditions, when an exceptionally large set of data has been collected or when stressful situations are encountered.

When executing the test plan, the testing specialists must document whether the tests pass satisfactorily and ensure that every data file is correct, without exception. When evaluating ePRO providers, the sponsor should also review test plans and traceability matrices from previous projects to ensure that the provider has the skills to develop and execute test plans that meet the standards described above.

In addition to the formal testing performed by the provider, the sponsor must also carefully review the software by performing a user acceptance test. The purpose of this test is to ensure that both the ePRO team and the sponsor team agree that all systems requirements have been implemented as described in the
systems requirements document.

If the provider has executed a quality test plan, this sponsor process should be quick and easy, and should provide the sponsor team final control and peace of mind before delivering systems for the first patient date. However, if the provider has not performed adequate testing, quality issues may be revealed and the sponsor then has the opportunity to delay shipment and require corrective action before the systems are distributed to sites and become a burden in the field.

ePRO CLINICAL SOLUTIONS: COMPETENT PROJECT MANAGEMENT
Because there are so many moving parts in multinational trials, it is critical that the provider can develop and maintain complicated project plans. Project plans must include hundreds, sometimes thousands, of detailed tasks and expected durations, dependencies between them, and contingencies for unexpected events.

Because the ePRO project schedule typically involves hundreds of tasks, the provider must demonstrate competencies with an electronic project management tool so that a changing environment can be accommodated quickly. During the provider evaluation process, sponsors should also look at project schedules and project status reports from previous studies to help determine the providers’ project management skills.

In addition, good communication among the project team members needs to be the rule and not the exception. Regularly scheduled project management team meetings with key staff from both the sponsor and the provider are critical to review the status of project tasks, determine if changes are needed, and to resolve any issues that arise. These project status meetings are crucial in order to ensure that sponsor and ePRO team member efforts are complementary and effective.

ePRO CLINICAL SOLUTIONS: CHOOSE SYSTEMS THAT SIGNIFICANTLY REDUCE VALIDATION ISSUES
To resolve the challenge of measurement equivalence between a validated paper questionnaire and an electronic device, sponsors can choose a technology where the validated paper questionnaire text does not need to be changed. Touchscreen tablet or internet-based systems typically offer this kind of flexibility.

Although it is beyond the scope of this article, the validation requirements for these technologies are very minimal.

ePRO CLINICAL SOLUTIONS: MANAGE QUALITY ASSURANCE AUDITORS
Given that many auditors have little experience with Electronic Patient Reported Outcomes, sometimes their statements can be confusing, and even frightening.

If an auditor imposes requirements that seem unreasonable, it is important to review the regulation(s) with the auditor and find more practical solutions. In most cases, there are various avenues to ensure regulatory compliance, and many of them are simple and cost-effective.

ePRO CLINICAL SOLUTIONS: CONCLUSION
The best practices discussed above can provide real tools for addressing the challenges that can arise in the implementation of Electronic Patient Reported

Outcomes in multinational clinical trials. While these best practices do not cover every possible situation that can occur, they will provide significant assistance in addressing key challenges, and put their clinical trials on a solid path to success.

The training has made important progress, but that most managers did not have before. There were, however, so important, that most CEOs had to redefine their budget to allocate more of training or, more specifically, to ensure that the training company that provide their benefits from these developments.

-Leaders teach leaders. One of the things essential understood the big companies are that employees will be taught by successful people. Who do you think would inspire your team, a coach or an average afternoon with Zidane? The same is true in business.

-E-learning. E-learning is the cause of many disappointments, but the basic idea, namely to provide training on time and … office is valid. E-learning can become effective if seen as part of the general process of learning. This means that although e-learning is insufficient for most needs for learning, as part of a program of higher learning is still an excellent tool.

-Simulation.

Computer simulations promise to put leaders in a situation similar to that in which aircraft pilots learn when learning to fly. If you do not let a pilot to fly a plane before making simulations of what we let a leader to lead an organization before making simulations?

-Learning transformation. The purpose of these trainings is not the transmission of information or skills development, but to change the way of thinking of the participants. The objective is that after meeting with leaders to leave the hall with a different way of seeing things. Knowing the difference between transformational learning and transfer of information and skills is crucial.

-Design education. Most training sites at school or at work are not effective.

There is a whole area, namely the educational design that attempts to correct these things. Departments need a design expert to evaluate the educational effectiveness of courses offered to employees. You know though that these experts usually focus on how traditional teaching and therefore may not know and might not even put big price on developments listed above.

Why Should You Attend:

Your clinical trial has zero chance of passing an FDA inspection or QA audit if your Trial Master File (TMF) is not in order.

The FDA frequently states that if compliance isn’t documented, it didn’t happen. Your TMF serves as living proof that you are adhering to GCP, and that your quality system is in a state of control.

Beyond simply being a get out of jail free card, a well-maintained TMF can make trial management easier; with a typical TMF containing thousands of pages of documentation, you could easily save, or lose, hundreds of hours over the life of a trial searching for individual pieces of knowledge.

Areas Covered in the Seminar:

Documents that should, and should not, make up a Trial Master File.
Maintenance and quality control of the TMF.
Start smart—the steps to take from Day One to create a compliant and useful TMF.
Red flags that scream “noncompliance”.
Common pain points that you can expect to encounter, and how to keep them from driving your TMF into noncompliance.
Note to File (NTF).
CRA contributions to and adequate monitoring of the investigator TMF.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

Clinical Research Manager
Clinical Research Coordinators
Clinical Research Associates
Clinical Trial Investigators
Administrative managers in charge of Clinical Research
Regulatory, Compliance Associates and Managers
Research Site Personnel involved in set-up and maintenance of any trial TMF
Quality Assurance of Research Sites
Research Site Personnel in Charge of Policy Development and Maintenance

Instructor Profile:
Madhavi Diwanji, MBA, CCRC is the President of MD Clinical Monitor.

She has worked in the healthcare industry in various roles for the past 20 years. She has worked in healthcare research with a primary focus on cardiology for 7 years. She has experience with conducting clinical trials, investigator initiated trials, starting a research program in a hospital, health services research, grant submission, business development and fundraising. She served on a study coordinator advisory committee of a global CHF/hyponatremia clinical trial.

For More Details:

http://complianceonline.com/ecommerce/control/trainingFocus/~product_id=701864?channel=articlesbase

Clinical trials are studies which are conducted in a scientific and regulated environment to evaluate the safety and the efficacy of a molecule which warrants therapeutic benefits.

It is done to ensure whether a particular drug is safe for consumption and ready to market. Conducted worldwide by Pharmaceutical companies, these trials are conducted through an in-house Research and Development center or outsourced to a Contract Research Organization (CRO). A panel of Investigators headed by a Principal Investigator work in conjunction with CRO team at carefully selected trial sites.

Different types of clinical trials (Phase I to Phase IV) have different approaches and regulations in place. Some trials are conducted to diagnose a disease in a better manner and some to find a better treatment for a particular medical illness. Then there are few other trials undertaken to prevent the growth or occurrence of a particular disease in some people or to prevent re-occurrence.

Ready to Volunteer

Depending upon the phase, the trials are conducted on either healthy volunteers or patients with specific disease. In all cases the study participants commonly known as subjects are well informed about the study procedures (commonly known as the Informed Consent Form or ICF), the risks and the benefits of the drug that is being evaluated and any other queries they may have in their mind for the same. These are carefully conducted research studies undertaken and led by clinicians in the field of science and medicine. This process is commonly known as the Informed Consent Process which forms the basis of todays clinical trials across the globe. The medical team is well equipped to ensure that any side effects and/or adverse reactions are well taken care of and controlled.

Clinical Trial The Agenda

Every clinical trial has a study design and a study protocol, a how-to-proceed list. This explains as to what will be done in the study, who are the people who can participate, how to go about with the trial and why each part of the study is necessary. Trials are phased out in Preclinical and Clinical Stage. After confirmation of the safety and efficacy of the drug in the in-vitro stage they are then moved into human clinical trials (in-vivo) which are conducted in different phases namely from Phase I- Phase IV.

Clinical trials have come a long way since the time they were looked upon with negativity and conjuring images of unethical treatment meted out to subjects who are treated with little or no respect. However, the awareness that has spread bringing to light the ethical framework of Clinical trials and the protection of Subject rights have all led to countries collaborating to bring to the world safer and effective healthcare at affordable costs.