Archive for New Drugs
Mar
18
Stay Current With International Clinical Trials Coverage
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Nowadays, it is becoming increasingly common for insurance companies to offer clinical trial coverage for patients. But very few clinical trial providers and investigators understand the importance of building customized clinical trial coverage that will protect them. Here we present a handy guide regarding clinical trial insurance.
Manage The Risk of Life Sciences Research
As a company that conducts medical research, you are required to comply with a variety of federally mandated standards. Part of your plan of action should include an airtight insurance policy.
Companies that conduct clinical trials, research new medical devices, or test new drugs are all vulnerable to a variety of different risks. The majority of insurance companies are not properly equipped to handle life science insurance. This is why people involved in clinical trials research need to hire an insurance company that has extensive knowledge of the clinical trial coverage landscape.
If You Do Any of the Following…Then You Need Clinical Trials Insurance
Here’s a brief list of the types of companies that need to acquire customized life sciences insurance:
• Companies that research, test, produce, or distribute drugs and pharmaceuticals.
• Companies that assemble, organize, and administer clinical trials.
• Companies that perform contracted research.
• Companies that are seriously involved in the biotechnology sector.
• Companies that manufacture, market, advertise, or test medical devices or inventions.
• Companies that take part in life sciences.
According to BNet, there is an average of 4.2 million people who were enrolled in clinical trials in the past year. The number of patients who participate in clinical trials is climbing.
Rising International Life Science Studies
Many U.S based life sciences companies are administering clinical trials all over the world. This creates a variety of risk management issues that must be addressed. In fact, each country establishes strict rules and regulations for clinical trials. It is the responsibility of any life sciences company doing business in a foreign country to fully educate themselves regarding clinical trial law.
This also highlights the need for an insurance company that can build a policy to protect life sciences companies that are working internationally. Most jurisdictions require that clinical trial providers obtain local insurance. This local insurance must be purchased separately from the company’s initial insurance policy.
Be Active in Protecting Your Company
It’s extremely important for life sciences companies to manage risk proactively. Often, this means hiring underwriters who can devise complicated insurance policies for large life sciences companies.
Clinical trial administrators and investigators must ensure that they only purchase a policy from an insurance company that is highly rated. Remember, also, that life sciences coverage often requires high underwriting limits. So only insurance companies with the proper clout can take on life sciences companies.
Life sciences companies should evaluate the following factors when deciding on an insurance company:
1. The company’s adherence to mandated regulations.
2. Experience in clinical trial insurance.
3. Access to and ownership of a policy database that contains extensive information about legal requirements in various jurisdictions.
4. Works within a global network
5. Geographic reach and ability to offer customized products.
If you are a clinical trials provider, it’s imperative that you select an insurance company that will provide you with thorough coverage. You can then conduct your research securely and comply with all necessary regulations.
To build an insurance policy that will be effective and affordable, you need a company that actually customizes your policy for you. Visit us at www.rja.com to consult with an insurance professional who will construct a policy that will work for you.
Mar
09
Analyzing Mesothelioma Clinical Trials
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Analyzing Mesothelioma Clinical Trials
Who conducts mesothelioma clinical trials?
Mesothelioma trials are conducted to study and experiment on the effectiveness of the new drugs and treatments invented for mesothelioma.Visit here http://mesotheliomatreatment-option.blogspot.com
The cancer institutes, research centers and hospitals mostly conduct these trials. Doctors, private organizations and others fund them. Certain pharmaceutical companies and drug manufacturers also conduct and fund mesothelioma clinical trials. They do this because they want volunteers to test their new drugs.
How to find mesothelioma clinical trials?
The advertisement for clinical trials appears in cancer centers, newspapers and magazines. Many people enlist for the clinical trials out of their own will. They speak cancer research centers and doctors and express their wish to volunteer for clinical trial. These people do so because they want to help other cancer patients who suffer like them. However, apart from all this, the best place to check out about clinical trials is online. Lots of websites gives information about the trials taking place and how volunteers can participate in them.
What are the phases of mesothelioma clinical trials?
Mesothelioma clinical trials are normally done in three phases:
1) Phase I trial: This trial involves only very few people. It is used to test the effectiveness of the new drugs or new type of treatment.
2) Phase II trial: This trial involves a larger group of subjects. The drug’s side effects, safety, dosage and effectiveness are tested using this trial.
3) Phase III trial: This trial involves a huge amount of people from various cancer treatment Centers simultaneously. This is a comparative trial in which the new medicine or type of treatment is compared to the existing ones. The comparative risks, benefits and effectiveness are analyzed.
What are the benefits of mesothelioma clinical trials?
There are many benefits of taking part in a mesothelioma clinical trial. Some of these benefits are listed below:
1) The patients who participate in mesothelioma clinical trials have easy access to the latest drugs and treatments that have been invented. These are not available for the other non-participants.
2) Normally, the new drugs and treatments are invented after much research and experiments. So, they are more effective and work well than the current drugs and treatments. So, the volunteers would highly benefit from these new drugs and treatments.
3) The medical research personnel and doctors consider a participant in a mesothelioma clinical trial a very special person. So, the volunteer gets lots of special and close medical attention on all aspects of the treatment.
4) Every clinical trial helps medical science advance one more step. This will define the medicines and treatments of the future. The destiny of millions depends on these advancements.
5) The volunteers for mesothelioma clinical trials are contributing to a huge social cause. It is because of them that many find their life during the disease more comfortable.
The above are the various benefits for volunteers taking part in mesothelioma clinical trials.
What are the risks involved in participating in a mesothelioma clinical trial?
A mesothelioma clinical trial is only an experimental study of new drugs and new types of treatments. These may be advantageous or disadvantageous. The main risks associated with taking part in a mesothelioma clinical trial are as follows:
1) The new medicine or new method of treatment may not be better than the current one. Sometimes, it may even worsen the condition.
2) Mostly, medical researchers and doctors are not aware of the exact side effects and consequences of the new medicines or types of treatment invented by them. So, there may also arise to be risky side effects because of the clinical trial.
3) The clinical trial treatments may not be covered by health insurance. So,
It is always better to find out about this before going in for the mesothelioma clinical trial.
4) A clinical trial involves much more interaction between the doctor and the patient. So, the patient will have to go to the hospital more often. These frequent visits may be tiresome and irritating during an uncomfortable illness like mesothelioma.
5) If the patient gives a complete free hand to the doctors and researchers, then they may not have any choice in the treatment, which they will receive. This may be difficult and risky for the patient.
What is the eligibility to participate in a mesothelioma clinical trial?
Normally, there is no specific eligibility to participate in a mesothelioma clinical trial. However, sometimes there may be certain conditions that may be imposed for participating in a mesothelioma clinical trial. These are as follows:
1) Some studies may want only first-time Volunteers. Others may permit even those who have been in other studies previously.
2) Some Studies may be random, giving no choice to the patients about the type of treatment they may receive. Others may be more specific about giving a choice to the patients.
3) Sometimes, some studies may focus on only one particular type of mesothelioma. Thus, other patients suffering from other types of mesothelioma are not eligible for such studies. For instance, a person suffering from pleural mesothelioma (mesothelioma originating from the lungs) is not eligible to participate in a study involving peritoneal mesothelioma (mesothelioma originating from the abdomen).
4) Some studies may require a person in a particular stage of cancer. Thus, others become ineligible for that study For instance, a person in the second stage of cancer becomes ineligible for a study Involving persons in the fourth stage of cancer.
5) Some studies may specifically require people of a particular sex or of a particular age group.
6) Some studies may require people of a particular background. For instance, people who are smokers or people who have worked in asbestos industries or so on.
What are the types of mesothelioma clinical trials?
There are various types of mesothelioma clinical trials. Some of them are listed below:
Prevention Trials:
These trials are directed towards finding out a way to avoid the occurrence of mesothelioma. These studies use people who do not have mesothelioma or people who have had it but now the cancer is in remission. They try to find out ways to prevent recurrence.
Screening Trials:
These trials are conducted to study whether the diagnosis and discovery of cancer is effective. People who are cancer free but have factors, which predispose them to cancer, participate in this trial.
Diagnostic Trials:
These are trials, which study about the diagnostic procedures and test their effectiveness. Patients who show symptoms of mesothelioma can participate in this trial.
Treatment Trials:
This trial tests the effectiveness of new types of treatments and the various new drugs. Volunteers for this type of trial are patients with mesothelioma.Visit here http://mesotheliomatreatment-option.blogspot.com
Jan
07
New Findings – Omega-3 And Pain Management
Posted by: | CommentsAs America ages, pain related problems from knees, hips, and joints as well as sore muscles become an increasing issue. Americans are seeking relief from pain and looking for alternatives to prescription drugs. In the past 10 years, nutritional supplements have been becoming increasingly popular as Americans are becoming more aware of how supplements can improve their quality of life as they age.
Pharmaceutical companies come out with pain and anti-inflammatory drugs all the time; people are afraid of the yet unknown side effects that may follow the consumption of these existing and new drugs. Lucky for us, new research is coming out every month about natural remedies that can be an alternative to prescription drugs. One of these natural remedies is omega-3 essential fatty acids.
Omega-3 oil is found both in cold water fish and plants such as flax seed and hemp seed. The active ingredients that make omega-3 oil so powerful are eicosapentaenoic (EPA) and docosahexaenoic (DHA) fatty acids. The body needs essential fatty acids to make regulatory hormones, when one supplements omega-3 in their diet, the body can use the EPA and DHA to make anti-inflammatory compounds to help fight pain.
With more than 2000 journals, 5000 human studies, and 14,000 abstracts on omega-3, research has clearly demonstrated the effectiveness of omega-3 as a supplement. With this wealth of information, the FDA has re-evaluated its label law with omega-3 essential fatty acids to include health claims that state omega-3 can help protect against heart disease.
Recent research has shown omega-3 oil to posses anti-inflammatory properties which can help ease joint pain in individuals. A recent study published in the Journal “Pain” reported on 17 different studies ranging from rheumatoid arthritis, inflammatory bowel disease to painful menstruation. The findings showed that by supplementing omega-3 oil on a daily basis consistently reduced the pain these people experienced. This reduction in pain included pain from tender joints and PMS. Also, reported was the use of anti-inflammatory medications dropped.
The greatest results were observed after 3 months of continual use, but most of the studies were only 3 months long, further research should be conducted to determine if greater results would occur with 6 or even 9 months of continuous us,e which may lead to even further pain relief.
Several of the authors suggested omega-3 oil to be used with other chronic inflammatory pains like osteoarthritis and chronic back pain. We hope that more clinical studies will continue to reveal more of the powerful effects of omega-3 on the body.
Studies are going to be conducted on Alzheimer’s and omega-3. Researchers are going to evaluate whether omega-3 fatty acid DHA, when taken over the course of months can slow the progression of mental decline in Alzheimer’s patients with an 18 month duration, researchers will measure cognitive function to see of omega-3 is a benefit.
Another fact, in the United States, over 374,000 visits to the hospital is related to Coronary Heart Disease (CHD). By simply taking two 1000mg pills of omega-3 oil can save the health care system approximately $3.2 billion in hospitalizations and associated physician fees over five years. So for those of you, who want to boost over all health and wellness and prevent CHD, don’t forget to take your Omega-3 oil every day.
When looking for a good omega-3 oil, don’t forget that not all omega-3 is made the same. Look for an oil that is molecularly distilled to remove heavy metals, pesticides, and mercury. Also, read the label and make sure the oil has a small amount of vitamin E as an antioxidant to preserve the oil from going rancid and spoiling. Quality omega-3 fish oil can be found at your local or internet vitamin store.
Visit VitaNet Health Foods, VitaNet sells molecularly distilled Omega 3 fish oil to boost health and wellness, and prevent CHD. Please link to this site when using this article.
Dec
04
Custom Synthesis : Is this the future for development of new drugs?
Posted by: | CommentsHistorically pharmaceutical companies did all their own research and development in house. Over the last few years however, while the cost of discovering and developing a new drug has rocketed to almost $1 billion the number of new drugs approved has dropped considerably, to almost half of the level in the nineties. Many blockbuster pharmaceuticals are coming off patent in the near future. In addition, newer technologies are resulting in the growth of the number of candidate drugs that need to be tested.
These pressures are combining to change the historical models operated by pharmaceutical companies.
One of the changes is that pharmaceutical companies are increasingly turning to specialist outsourcing providers to cover both peaks in demand and to concentrate on core capabilities, which are usually research and marketing.
Chemistry services loom large in those services outsourced including custom synthesis, process development, scale-up, GMP synthesis from lead optimisation to clinical phase III.
Specialist chemistry providers carve out niches for themselves and generally offer one or two specific services, typically custom synthesis and lead optimisation or process development and GMP synthesis. A number operate as ‘one-stop shops’ and provide the whole range of chemistry services that the chemistry department of a traditional pharmaceutical company might have once provided. These cover the diverse range from drug discovery to manufacture of commercial drug substances.
The outsourcing companies can ensure that prices are kept competitive. A pharmaceutical company does not now have to maintain a large R&D workforce. Specialist outsource providers become expert in their particular areas and the pharmaceutical companies benefit from this expertise. This is particularly relevant in the custom synthesis and lead optimisation areas where suppliers can develop special expertise. Timely process development is essential as it is often on the critical path to new drug development. So is GMP synthesis when clinical trials have been committed to. Time lines are minimised using this model. This ensures the maximum period of patent protection is achieved before generic suppliers enter the market and depress prices and profit margins.
A diverse supplier database has developed in recent years and ensures that new drugs will continue to be developed and benefit mankind in the future.
Onyx scientific is one of the best resources for custom synthesis .
Nov
20
Clinical Research – A Fast Growing Industry
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A multinational and multidisciplinary industry, Clinical Research is the systematic scientific study to understand the effects, side effects, and risks of a new drug on humans. In India alone, the industry is about to reach the staggering size of Rs 5,000 crores by 2010 which outlines the vast potential and job prospects it offers over the next few years. The field of clinical trials and research in India gained attention from major players all over the world because of its over 1 billion population size with a large ratio of patient population that are seen as potential subjects by the scientists for various studies. Moreover, India also offers a large talent pool of English-speaking trained doctors and certified professionals in all the related fields as well as world-class infrastructure in its hospitals and research laboratories at very economical rates.
Clinical trials are usually conducted in four phases. In the initial stage, drugs are tested on healthy and informed volunteers to study behavior of the medicine, followed by trials on informed patients to test its effects and side effects. In the third phase, a large number of volunteers are administered the drug and kept under close supervision to generate statistics and data for regulatory and licensing authorities. Phase IV trials are conducted by the company after its limited commercial launch to monitor how thousands of patients, prescribed the drug by their doctor, are reacting to the medicine and study any unforeseen situations that might occur.
The strong growth shown by pharmaceutical companies in India and abroad and the technological and scientific advancements has given unprecedented rise to expenditure on research and development of new drugs. The processes too have quickened up and the industry is in need of trained and qualified personnel who are well aware of latest trends in the industry, and can design, handle and monitor all drug development and clinical trial projects with ease. The need for professionals, who understand the stringent rules and regulations outlined by the government and regulatory authorities and also ensure safety of human subjects and volunteers, is also on a steep rise.
Asia’s second biggest player in the field, India offers easy patient enrollment and high quality data analysis that have made a great contribution in the discovery of innovative drugs at a global level. It has also cemented its position as a global hub for clinical trials and research. Thus, the field has emerged as an attractive career option for life science, biotechnology, medicine or computer science graduates and postgraduates.
Clinical Research Industry offers packages ranging from Rs 15,000 to Rs 40,000 per month to a fresher, depending on his or her qualification and post. An exponential rise on an annual basis has also been noticed in the salary of Clinical Research professionals globally, depending on their performance and years of experience in the industry. Whether you want to join as a project manager, pharmacovigilance supervisor or clinical data manager, specific certificate and diploma courses in the industry from a good and reputed institute will multiply your chances of landing a suitable job soon
IICRT is a leading provider of Clinical Research Training, Clinical Research Courses and Clinical Data Management Training for individuals, students and organizations.
Nov
17
…I think it’s only serving that he feel like a turncoat rat for a change?
Nov
16
And what about this: ” Stanford University professor Scott Atlas points out that from 1998 to 2002 nearly twice as many new drugs were launched in the U.S. as in Europe. According the U.S. Pharmaceutical Industry Report, some 2,900 new drugs are now being researched here. America’s five top hospitals conduct more clinical trials than all the hospitals in any other developed country, according to Mr. Atlas. And a McKinsey Co. study reports that 40% of all medical travelers come to the United States for medical treatment.”
What would Obamacare do to that?
http://online.wsj.com/article/SB124588632634150501.html
subwm, I agree with that, but why would costs billed through medicare go up faster than costs billed anywhere else? Something about government management, maybe?
This doesn’t relate to the sheer medicare budget but to treatments under medicare as compared to treatments not paid for under medicare.
subwm, I dont think insurance is the answer either. I think the faceless third party payer is what causes higher costs.
Some of these answers are really interesting.
Nov
15
Paraphrase this for me please very short? 10 points best answer?
Posted by: | CommentsThere have been increasing accusations and findings that clinical trials conducted or funded by pharmaceutical companies are much more likely to report positive results for the preferred medication.[6]
In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not published, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging companies to report all findings and limit the financial involvement in drug companies of researchers.[7] US congress signed into law a bill which requires phase II and phase III clinical trials to be registered by the sponsor on the clinicaltrials.gov website run by the NIH.[8]
Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and companies often look to researchers for studies that will make their products look favorable. Sponsored researchers are rewarded by drug companies, for example with support for their conference/symposium costs. Lecture scripts and even journal articles presented by academic researchers may actually be ‘ghost-written’ by pharmaceutical companies.[9] Some researchers who have tried to reveal ethical issues with clinical trials or who tried to publish papers that show harmful effects of new drugs or cheaper alternatives have been threatened by drug companies with lawsuits.