Monthly Archives: July 2016

Bone Marrow Transplantation

Bone Marrow Transplantation

Often in clinical research or clinical trials we come across the term bone marrow transplant. In this article we would introduce bone marrow transplant and its application.

This is a process to substitute damaged bone marrow with healthy bone marrow stem cells.

What is bone marrow?

It is the soft, fatty tissue inside your bones which produces blood cells. Stem cells are undifferentiated cells in the bone marrow that give rise to all of the different blood cells.

Bone marrow transplants can be used for treating patients with:

  • Leukemia….a life-threatening blood cancers
  • Aplastic anemia….disease which result in bone marrow failure
  • other immune system or hereditary diseases

There are 3 types of bone marrow transplants:

  • Autologous
  • Allogeneic
  • Umbilical

A stem cell transplant is performed after completion of chemotherapy and radiation. The stem cells are passed through into bloodstream usually through a tube called a central venous catheter. The process is similar to a blood transfusion. The stem cells pass through the blood into the bone marrow. Mostly no surgery is required.

Donor stem cells are collected in 2 ways:

  • Bone marrow harvest
  • Leukapheresis

Risks

It might cause the following symptoms:

  • Chest pain
  • reduction in blood pressure
  • Fever
  • Headache & nausea
  • Hives
  • Nausea
  • Pain
  • Shortness of breath

Several researches on transplant has led to increase the survival rates with time, which has led to more patients seeking for this treatment and getting benefited. For many diseases, bone marrow transplant is the only cure option at this time.

Outlook (Prognosis)

How successful the transplant is depends on:

  • The type of transplant
  • How well the donor’s cells matches
  • What type of cancer or illness treated
  • Age and health
  • Type and dosage of chemotherapy or radiation therapy that has been given
  • Any complications that might arise

A bone marrow transplant may completely or partially cure the illness. If the transplant is a success, one can go back to most of their normal activities as soon as they feel well. Usually it takes up to 1 year to recover fully, depending on what complications occur.

Complications or failure of the bone marrow transplant can lead to death.

Why the Procedure is done?

A bone marrow transplant replaces bone marrow that is either damaged or has been destroyed (ablated) by chemotherapy or radiation. Physicians believe that for many cancers, the donor’s white blood cells might attack any remaining cancer cells, very much like the white cells attack bacteria or viruses when fighting an infection.

A physician might recommend a bone marrow transplant under following concerns:

  • Certain cancers for example lymphoma, leukemia, myelodysplasia and multiple myeloma
  • A disease that affects the production of bone marrow cells, like aplastic anemia, congenital neutropenia, severe immune system illnesses, sickle cell anemia, and thalassemia
  • Undergone chemotherapy that destroyed the bone marrow

How a transplant works

An autologous transplant is used for treatment of cancer using very high doses of chemotherapy that damages the bone marrow as a side effect. The autologous blood cell types replace the damaged marrow. This is how such transplants are used to do away with certain types of cancers such as lymphoma.

An allogeneic transplant also treats blood cancer, and offers the advantage of utilising the donor’s immune system to recognize and kill the cancer cells. Allogeneic transplant is also used for treatment of some non-cancerous diseases like sickle cell anemia. In diseases besides cancer,the transplant substitutes defective marrow cells with the donor’s healthy ones.

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Clinical research jobs are increasing and to meet the increasing need of efficient professionals , you should consider improving yourself with our clinical research institute.

This Clinical Research review by CRB Tech Solution will help you in considering a clinical research career this field.

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1)Clinical Data Management Course and Certification Programs

2)4 Benefits Of Blended Learning In Clinical Research

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ABPI Launched clinical-trial disclosure toolkit

Keeping with its promises, Association of the British Pharmaceutical Industry has launched a clinical-trial disclosure toolkit to help its member businesses observe with transparency needs for information from or about clinical trials.

This was initiated in February, when the ABPI unveiled a new set of measures to help improve compliance with data-transparency clauses in its Code of Practice.

As per the code, all member businesses must register a clinical trial within 21 days of the first patient being admitted to the trial and post the results within a year of the novel drug being granted a marketing authorization.

The disclosure toolkit would be updated regularly to depict changes in international regulatory requirements like the new data transparency policy scheduled for a launch by the European Medicines Agency , comprises 11 documents including disclosure checklists, good practice guidelines and a template standard-operating procedure (SOP).

What are the minimum requirements?

It is not intended as regulatory or legal solution. A Points to Consider document provided as part of the toolkit notes that country laws, the International Federation of Pharmaceutical Manufacturers and Associations’ Joint Position paper and the ABPI Code of Practice give the framework and define minimum requirements for disclosure of clinical-trial information.

But it adds a sponsor company might decide to go beyond the minimum requirements. Some businesses have chosen to release information about all clinical researches, regardless of phase, design or participant type, while others at least disclose information about all patient trials either interventional and non-interventional and regardless of the phase of the trial.

To mentions, any such decision is endorsed by senior management who would own the company disclosure policy,as stated by the the document.

Patient-level data

The considerable points also address critical issues for example third-party access to patient-level data, which calls for a robust process to remove any information that could contribute to the re-personalization of clinical-trial data.

If a business decide to share patient-level data, the document points out, it should clarify and define in a Disclosure SOP concerns such as :

  • Explanation of patient-level data

  • Whether requests from any entity either commercial or not will be considered.

  • What criteria the requesting party needs to content in terms of evidence of capability and availability of good analysis practice.

  • What the requester requires to submit with respect to an analysis, quality-control and publication plans.

  • Controls to assure adequate anonymity of patient level data and removal of other sensitive data.

  • Timeliness for providing response and satisfying data requests.

Strong advocate

The ABPI is a strong supporter for transparency in clinical research information, as stated by Stephen Whitehead, the association’s chief executive.

He added that earlier this year they committed to provide a clinical trial disclosure toolkit to businesses and he’s delighted that this is now available on their website for any company usage.

Whitehead added that as part of a global industry and with the UK contributing fewer than 2% of all patients recruited to clinical researches worldwide, they are actively engaging with their European and international counterparts to input into ongoing discussions around clinical research transparency.

Clinical data transparency is an important issue for all.

  • It important to ensure that any research practices are transparent, responsible, and fully compliant with applicable laws, regulations and guidelines.

  • It needs dedicated and trained staff for purposes of timely registration of clinical trials, communication of trial results, and publication of all sponsored trials and research studies.

  • A proper collaboration with external medical researchers to advance clinical research and enhance public health.

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Clinical research jobs are increasing in Pune and to meet the emerging need of efficient professionals , you should consider optimizing yourself with clinical our clinical research institute.

The Clinical Research review by CRB Tech Solutions will help you in optimizing your clinical research career in this field.

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1)Scenario of Clinical Research In India

2)New Study Raises Doubts Over Heart Stem Cell Therapy Benefits

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26 Novel Drugs Permitted For Dale Without Trials In India

Clinical research or clinical trials are conducted as an attempt to produce novel drugs and to assure that there are no clinical side effects. Yet some discrepancies and many news about negligence makes it way.

Besides strong warnings by the parliamentary standing committee on health, novel drugs continue to be approved for marketing in the country without holding any clinical trials on Indian patients to test their safety and efficacy.

Officials of the Indian health ministry admitted that approximately 26 novel drugs were given approval since 2010 without any conduction of any proper clinical trials on local population to test their significance.


Its reported that eight novel drug molecules of biologicals and non biologicals were given approval by the country’s apex drug regulator, the Central Drugs Standard Control Organization (CDSCO).

Reports say that 13 such novel drugs were approved in 2010 and three more got approval in 2011.

Officials said that new drugs have been approved without clinical researches after taking adequate caution.

They said that such drugs are used in medical emergencies and where trials are not possible in the country due to lesser patient output and many times owing to the rarest nature of the diseases.

The officials stated that it is only after taking expert opinion that such drugs got approval.

To mention. the approval to 26 new drugs without local trials came within two years of the parliamentary panel exposing how 38 novel drugs that were approved without trials on Indians between January 2008 and October 2010.

The committee for the while came down heavily on the drug controller for allowing untested drugs to be used in India. It is reported that many such novel drugs did not fall in the category of emergency medicines.

The report had focused nation’s poor drug regulatory state and soughed immediate corrective measures.

Following the report, the health ministry introduced several adoptive measures aimed to ensure safety of drugs.

The CDSCO has also written to states to prove and give evidence within 18 months the safety of all such fixed dose combination drugs which have been approved by states directly without seeking prior approval of the apex drug regulator.

In latest developments, the Indian Government has introduced a series of steps that would help promote more clinical trials in the country.

In a circular issues, Central Drug Standard Control Organization said if a novel drug has already got approval outside India after conducting clinical /toxicological studies on animals, such studies are not needed to be repeated while approving their proposal for import or manufacture in India unless there are some specific concerns.

The move was initiated in wake of concerns raised by people which complained of repeat tests and data submissions to authorities in CDSCO meetings with top officials from the health ministry.

In another decision, the Drug Controller General of India told that Ethics Committees can also approve requests for new clinical research sites and new investigators to be added to a clinical trial without CDSCO’s acknowledgement as long as the ethics committees conduct has no issues.

The new norms say clinical researchers will no longer need the permission of the Drug Controller General of India for “academic/research purposes that are non-regulatory in nature. But , the Ethics Committee is still required to inform the DCGI of the study and the DCGI will have 30 working days to object to the decision to not seek its approval.

In the race of many organizations CRB Tech Solutions has created a big name. Its very popular in offering the best training in Clinical Research.

Clinical research jobs are rapidly increasing and to meet the emerging need of efficient professionals , you should consider optimizing yourself with clinical our clinical research institute.

The Clinical Research review by CRB Tech Solutions will help you in considering a clinical research career in this field.

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Clinical Research and Scandals

News about mortalities are rare during a clinical trial, mainly during the initial stages. But in January 2016, six men in France who had enlisted in a phase I trial of a pain relief drug suffered brain damage. One man succumbed.

The report was sidelined saying a coincident.

According to the FDA, there were no clinical trials of the drug in the United States, That does not mean, however, that the U.S. industry won’t feel blow back from the incident that happened thousands of miles away. Indeed, learning from past experiences, the scandal could prompt the FDA to tighten regulations.

In the meantime, FDA regulators began working with their French counterparts in the Agence Francaise De Sécurité du Médicament et des Produits de Santé to apprehend what happened to the six men who signed up to test the drug, goes by the name BIA 10-2474.

A History of Scandals

The last major phase I clinical trial catastrophe in Europe occurred a decade ago in London when six men suffered permanent organ damage, and the loss of fingers, sue to some severe immune reactions during the testing of an arthritis and cancer drug,as per reports.

The main reason of a clinical trial is to give proof to authorities that a drug is safe and effective when used as recommended. Fact is that, many experimental drugs never make a pass through the first stage despite years of testing.

Gagnon said that the French equivalent, the Agence Francaise De Sécurité du Médicament et des Produits de Santé, abbreviated as ANSM, is a very genuine and sophisticated regulatory body. French clinical research organizations have to follow the country’s domestic rules and regulation programs as well as international and European Union regulations. Gagnon added that France and other EU countries are no different from the United States in requiring organizations to conduct proper clinical researches that will be safe for participants. The FDA basically conducts more inspections of sites, manufacturing facilities, labs and companies, mainly because FDA regulators have more resources to do so.

One of the most infamous scandals happened half a century ago and involved a sedative, thalidomide, which caused severe malformations among babies whose mothers took the drug to do away with morning sickness.

Thalidomide, yielded by a West German company and marketed in 46 countries, never made it to U.S. consumers. Frances Kelsey, a FDA drug reviewer said that in next to no time the fighting over the new drug laws that had been going on for five or six years suddenly melted away.

That scandal added another dimension to the review process, according to an account by FDA historian Suzanne White Junod. After thalidomide, drug manufacturers not only had to prove that a drug was safe, they also had to show “substantial evidence” that the drug was effective based on “adequate and well-controlled studies.”

Balancing Risk and Rigor

Today the scale of approval of new therapies has become very high. The FDA holds patient safety as foremost in their review decisions,which helps pharmaceutical and medical device companies meet safety regulations.

In the race of many institutes CRB Tech Solutions has created a niche. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly and to meet the emerging need of efficient professionals , you should consider upgrading with clinical courses.

Clinical Research review by CRB Tech Solutions will help and guide you in considering a clinical research career in this field.

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Clinical Trials : In The Clouds

Cloud technology in the life science industry

The cloud system has the ability to ingress important services from everywhere with a level of simplicity. Its flexible and cost efficiency. The cloud gives on demand access to software/applications, platforms and infrastructures commonly known as:

  • Software-as-a-Service (SaaS)
  • Platform-as-a-Service (PaaS)
  • Infrastructure-as-a-Service (IaaS)

Professionals in Clinical trial use public clouds but mostly for administrative, IT, marketing or sales purposes but very few of the cloud services are directly related to health care.

Cloud-based systems are gaining popularity in most of the industries, but the adoption rates for this new technology is very low in the health care sector. Some IT vendors in clinical trials like Medidata Rave are saying that they are offering cloud services, whereas the services rendered by them are neither self-service nor on a pay as you go basis. Not a uncommon scenario though; many organizations exploit the cloud marketing buzz, yet give services that are neither self-service, automated nor cost-efficient.

In clinical research, cloud technologies are a new opportunity to lower the raising costs. Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) or ePRO systems would be configured and implemented at a faster pace and at a lower cost. In January 2012, Forbes calculated the average cost of bringing a novel drug to market at $1.3 billion (at times $4B to $11B for big pharmaceutical companies), this calculation also takes failed drug application in account.

But owing to the automated properties of the cloud, drug development cost is suppose to decrease since clinical researches will be started and ended faster than ever before.

Benefits of running clinical trials in the cloud:

Quick implementation

Users can start building studies and manage data at an instant

Ideal for finite resources and small clinical departments

No programming experience needed

CDASH compliant eCRF library for fast start up

User empowerment

Study builders can configure and deploy studies without dependencies on IT

Self service platform and intuitive drag and drop tools

Instant scalability

CPU cycles , memory and network bandwidth are given at an instant on growing demand

Hardware resources can be instantly scaled down if no longer required

Designed to handle noteworthy data and store the data for real time usage and historical analysis

Lower costs

50% of all businesses use cloud to influence cost efficiencies

Plug and play system: no initial investment required in IT or any device

Summary

  • Implementation time is lessened from 7 weeks on average to 1 week according to ClinCapture’s users.
  • More than two thirds of users claim easy utilization of ClinCapture .They can concentrate on drug development.
  • Cloud-based EDC is perfect for flexibility, scalability, and rapid study start up.
  • Minimal investments for infrastructure maintenance and upgradation.

In the race of many organizations CRB Tech Solutions has created its own name. Its very popular in offering the best training in Clinical Research. This clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing rapidly and to meet the emerging need of efficient professionals , you should consider optimising yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will help and guide you in considering a clinical research career in this field.

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Research areas in the Clinical Psychology

Research areas in the Clinical Psychology

Clinical psychology research is very significant to the nation’s health and well being as other clinical research. It works in the same way as the same way as clinical scientists try to understand the prevention and spread of different genetic and infectious diseases, scientists conduct rigorous psychological research studies to comprehend , prevent, and treat the human condition as it applies psychologically to individuals,families and diverse communities.

Factual results gathered from psychological research studies help practitioners in developing effective interventions and techniques that clinical physicians execute proven, reliable results that improve lives, help troubled relationships, help addicts, and help manage and treat a variety of other mental health issues.

In order to evaluate this body of research, clinical psychology students must undergo proper clinical research training to make significant professional contributions to the field , staying current and up-to-date with the research taking place at universities and research labs across the world. Doing research, investigating unique ways to understand the human mind, and finding solutions to enrich the lives of all others.

Most of these research studies basically fall within one of three main areas integral to clinical psychology:

Assessment

An important aspect of clinical psychology research, involves assessment – or producing significant and reliable tests. Assessments take the form of written tests e.g. intelligence tests, vocational tests and other tests created to measure aptitude for specific careers, interests, and personality types.

Clinical psychologists interview individuals, review their medical data, and conduct clinical trials as part of the assessment process. A comprehensive assessment approach confirms that psychologists apply the most effective and appropriate psychological treatments and interventions.

Roberts and Hardi stated that measurement of treatment procedures, treatment integrity, behavioral changes, functional performance, objective measurements, change of perceptions, and satisfaction from a variety of sources, follow-up assessment, etc., are needed to finalize the ‘scientific credentials’ of each therapeutic approach.

Diagnosis

After gathering sufficient data, they consult the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-R), which lists criteria and generalized definitions for mental illnesses and conditions. Categories of symptoms differentiate one mental illness from another, and the basic course of each illness.

Beyond the DSM-IV-R, however, research in the field of diagnosing mental health problems remains one of the most exciting research areas in the field today – thanks to rapid advances in technology. Numerous techniques of brain imaging that map brain structure and function now give researchers “images” of both normal and unusual brain functioning. Scientists are using CT, MRI and PET to come up with greater accuracy in diagnosing various mental illnesses.

Psychotherapies

A set of procedures or techniques that psychological problems, and come up with different ways of thinking, behaving, or feeling – has exploded in popularity since the middle of the last century. Most psychotherapies come within one of the four main psychotherapeutic frameworks:

Psychodynamic Therapy

Psychodynamic therapy discovers an individual’s unconscious, seeking reasons or explanations for the individual’s present behavior. This treatment, also called insight-oriented therapy, attempts to bring underlying factors grounded in beginning life to the individual’s attention, increasing self-awareness and self-understanding.

Psychodynamic therapy originates from Sigmund Freud’s psychoanalysis, making it the most old form of psychotherapy. As a result, a large body of research exists to either help or refute the effectiveness of this approach.

Because the results of psychoanalysis research are difficult to measure than behavioral-oriented therapies, research methodologies and outcomes of treatment have been questioned – especially those of the previous studies.

Psychodynamic therapy requires long-term treatment, sometimes a year or more, also complexing the research process. However, researchers today apply the most rigorous scientific processes, including statistics studies completed over a number of years, to study of efficacy of psychodynamic practice and techniques, and many studies report significant positive outcomes.

In the race of many institutes CRB Tech Solutions has created its own niche. Its very popular in offering the best training in Clinical Research. Our clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing gradually and to meet the emerging need of efficient professionals , you should consider upgrading yourself with clinical courses.

The Clinical Research review by CRB Tech Solutions will support and guide you in considering and taking up a clinical research career in this field.

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Hormone Therapy Side Effects And Management

Hormone Therapy Side Effects And Management are as follows

What Is Hormone Therapy

Hormone therapy is gaining grounds in the are of clinical research , Hormone therapy or hormonal therapy is the usage of hormones in medical treatment. Treatment with hormone antagonists might also be referred to as hormonal therapy or anti hormone therapy.

The general classes of hormone therapy are carcinogenic hormone therapy and hormone replacement therapy, of which there are various kinds (e.g., for menopause,wither male of female or for sex change).

Hormone therapy is a type of systemic therapy that functions to add, block or remove hormones from the body to slow or halt the growth of cancer cells. At Cancer Treatment Centers of America (CTCA), they use hormone therapy to fight various forms of cancer alongside Integrative Oncology Services to fight the side effects.

Hormones are the body’s chemical messengers and are produced in the endocrine glands, which include glands such as the pancreas, thyroid, ovaries in women and testicles in men. Hormones can influence the growth of some cancers, such as breast and prostate. But, in some cases, they can kill, slow or halt the growth of cancer cells.

Hormone therapy generally involves taking medicines that prevent cancer cells from getting the growth hormones. In some cases, the physician may surgically remove the gland responsible for hormone production. The physicians may use hormone therapy in combination with other cancer treatments, such as chemo and radiation therapy.

CTCA clinicians work in concert to give all possible treatment options. The care team would consider hormone therapy as a treatment option if one is diagnosed with breast, prostate, ovarian or thyroid cancers. Several factors influence the type of hormone therapy one might receive, including the age, type and size of the tumor, and the presence of any hormone receptors on the tumor.

Patients are at the center of treatment decisions at CTCA. They understand there are many factors that might influence the treatment option they choose, such as any desire to have children. They listens to the patients and work as a team to develop a treatment plan that could meet individual needs.

General side effects of hormone therapy

The side effects might depend on the type of hormone therapy being administered. Only generalized side effects are mentioned here. More information about the side effects of specific hormone therapies can be obtained in the specific drugs section.

General side effects include

  • Tiredness
  • Digestive system problems
  • Menopausal symptoms
  • Hair thinning
  • Effects on your muscles and bones
  • Weight gain
  • Headaches
  • Memory problems
  • Mood swings and depression
  • Blood clots

Side effects management

Some hormone therapies can cause many side effects, depending on the type of cancer involved. For example, breast cancer patients may experience dryness and irritation, hot flashes, vaginal discharge, decreased sex drive; and mood changes.

Prostate cancer patients might experience reduced ability to achieve an erection or orgasm. Aromatase inhibitors also can cause joint and muscle pain, and an increased risk of bone thinning i.e. osteoporosis.

Throughout the entire treatment, the patient would be provided integrative oncology services to help combat these side effects. Nutrition therapy,naturopathic medicine,mind-body medicine and spiritual support can help reduce side effects, as well as improve the overall quality of life.

In the race of many institutes CRB Tech Solutions has created its own name. Its very popular in offering the best training in Clinical Research. Our clinical research institute has created a niche for itself in this field.

Clinical research jobs are increasing gradually and to meet the emerging need of efficient professionals , you should consider upgrading yourself with clinical courses.

The Clinical Research Review by CRB Tech Solutions will help and guide you in considering and taking up a clinical research career in this field.

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New Study Raises Doubts Over Heart Stem Cell Therapy Benefits

New Study Raises Doubts Over Heart Stem Cell Therapy Benefits Science and findings many times don’t have a concluding phase. And the same goes with the heart stem cell theory. Numerous clinical trials have been attempted to test the benefits of using a patient’s own stem cells to treat heart disease. Results have been very conflicting; some claim real improvements in heart function, whilst others report none.

A group at Imperial College London investigated the possible reasons for this disparities and found strange but unexplained discrepancies within reports of many of the clinical trials.

Results:

- 133 reports of 49 clinical trials were investigated
– 600+ inconsistencies were found
– Disparities ranged from minor to serious mistakes and wrong data
– Reports with the most faults claimed most benefit to patients, while those without showed no improvement in patients’ health

Idea behind the study

Improvement in heart function is mainly measured by the increase of ejection fraction (EF). Bone marrow stem cells have been widely studied as a powerful therapeutic for patients who have suffered heart failure or heart attack. Stem cells are taken from the patient’s own bone marrow and after treatment transplanted into the heart. This is an autologous therapy; Some claim real improvements whereas others report no improvement at all.

Improvement in heart function is routinely calculated by the increase of ejection fraction (EF) In 2013, researchers from the National Heart and Lung Institute at Imperial College London analyzed 5 ground-breaking clinical trials. Each report on these trials claimed positive results for patients but numerous unexplained disparities were discovered. These findings prompted a deeper investigation by the DAMASCENE . Their aim was to find whether discrepancies in clinical trial methodologies and reporting are the reason for the mixed reported effects of this therapy.

What did this study reveal?

Clinical trials with more discrepancies in their reports also appeared to depict more effect of the treatment on patients. Discrepancies in trial reports were identified using meta-analysis. Its a statistical method used to compare results from different studies and by regression; measuring the results of each study based on the number of patients in the trial. In this way, the various sizes of the trials were taken into account; results from a trial of 100 patients would be considered double as influential as a trial with 50 patients.

This therapy is at the latent stage and is not a routine treatment for patients. Previously this therapy has been stated as safe, but more than 40 discrepancies have now been discovered in the reports from a clinical trial that tested safety. Although the main focus of this study was on discrepancies and their relationship to effectiveness of the treatment, separate issues were identified in some trials which suggest that well being should also be further investigated.

The results from this study on early phase trials suggest that it is not clear whether this therapy is effective in the treating heart disease. Clinical trial reports free from identifiable mistakes could be considered the most reliable but these have shown no positive effects in patient’s conditions. Two international phase III clinical trials have started recruiting participants in Europe and will focus on the efficacy of utilizing stem cells from the bone marrow to treat heart patients. However, if the findings from this new statistical study are correct, many previous clinical research reports could now be considered unreliable. This raises doubts over autologous bone marrow stem cell therapy as a valid powerful treatment for heart disease.

In the race of many institutes CRB Tech Solutions has created its own name. Its very popular in offering the best Clinical Research Training courses.

The Clinical Research review by CRB Tech Solutions will help and guide you in considering and taking up a career in this field.

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Benefits Of Clinical Trials Training Program For Physician

Benefits Of Clinical Trials Training Program For Physician The pharma industry is developing novel drugs and is progressing in a huge momentum to replenish their drying pipelines. This has produced a stunning increase in the number of clinical trials which increased a greater contribution to be made by physician investigators. Moreover, the real potential of clinical trials is unlikely to be achieved without offering by physicians trained in clinical research.

Many strategies have been developed to deal with the challenges faced by physicians who want to pursue careers and who are pursuing career in clinical research. One approach is giving online clinical research training. These training programs offer knowledge, skills and training required for physicians to perform clinical trials more efficiently and in accordance with necessary regulatory guidelines and also in relation to newer methodologies like personalized medicine.

Young physicians may need training in research methodologies and boo-statistics in order to develop skill sets on top of their core clinical knowledge. Need-based training will support role integration of care providers and researchers and will create doctors to turn into patient-focused clinician-researchers. Numerous programs are designed in order to provide them with research understanding and skills that would help them to efficiently build their career in clinical research.

To overcome the challenges faced by physicians in understanding clinical trial process and pursuing career in clinical research James Lind Institute created online clinical research programs to prepare physicians to do, implement and understand clinical trials.

Who Should Join Clinical Research Training Programs

Individuals who are keen in the conduct, design and execution of clinical research that turns biomedical findings into clinical practice and advances the delivery of high quality medical products. These programs are developed to bring different professions together to look after the growing gap between pre-clinical trials and clinical trials and from clinical trials to deliver high quality medical products.

How Physicians Benefited with Clinical Trials

A clinician researcher is regarded to be an essential professional in drug discovery and health care research and there is importance in involving more physicians in patient-focused research. Clinical research lead to the broadening of evidence base of medicine and offers physicians a chance to practice latest cutting-edge treatments. Engagement in clinical research gives first-hand experience in medical advancement and fulfills the quest for intellectual interest, growing research provisions, and supporting career advancement. Contribution in clinical research may add recognition of physicians in their practice or medical fraternity. A research performed in the United States revealed that a significant number of doctors involved in pharmaceutical industry financed clinical studies in an attempt to increase their salary along with improve their reputation, understanding, and professional status.

Advantages of Clinical Research Programs to Physicians

  • Obtain basic skills and techniques to be capable to efficiently collaborate with co-workers in basic sciences and other disciplines in the successful conduct of great quality clinical trials.

  • Develop excellence in study-design exhibiting the depth and difficulty of clinical and translational science applications.

  • Understand how to do and control clinical trials.

  • Gain knowledge about various regulatory authorities and their specification to knowledge marketing of medical products.

  • Engage in activities that create the abilities necessary to lead ahead multi-disciplinary research teams.

  • Gain knowledge on the use of medical data, data evaluation, and the use of databases.

  • Create expertise in communication, problem-solving, educational approaches, research and management, associated to a clinical trials.

Do give a thought to the Clinical Research Courses that is offered by many reputed organizations and also by CRB Tech who has its own name in this field.

Clinical Research review by CRB Solutions is sufficient to make you consider and take up a career in this field.

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4 Benefits Of Blended Learning In Clinical Research

4 Benefits Of Blended Learning In Clinical Research The work of Healthcare professionals is carried out in high-pressure and under very stressful environments, where they must be prepared on a regular basis for any and every situation, life-threatening or any. So it is not safe to say that it benefits everyone when these professionals have the most effective ways for training, and education. Clinicians’ knowledge and the clinical courses have to be up-to-date, and it needs to be delivered with efficiency. The teaching, the practice, and the enforcement of this knowledge and information is an integral part of the healthcare system, and the inclusion of these components helps it work as it does.

In this article we would look over which aspects of blended learning can benefit the way clinical research is delivered in health-care.

4 Benefits Of Blended Learning In Clinical Research

Online Learning

Clinicians can complete online modules that give them with a basic foundation of the topics they will be learning. These modules ensure that everyone is on the same level, based on the same background info prior to classroom or hands-on training. It also provides freedom to incorporate non-traditional learning materials. Another key attribute of online learning is the ability to learn from colleagues in the network. Works can be compared, and your reports with others within your facility, your department, your region, and/or your nation. This allows you to see how you rank amongst your colleagues, what you are excelling at, and where you might be falling behind.

Simulations

Simulation is the imitation of one act or system by another. A good example of this within a health-care setting is practicing patient care on a manikin. Simulations are great for with respect to personal development and goal setting. They allow clinicians to practice their skills in an environment that is same as the one they will be working later. The repetitive practice allows for the development of muscle memory, and specific problem solving skills that will be beneficial in real life situations. They help ensure that clinicians are well versed to react and respond quickly to life-threatening situations in a high-stress environment. As well, simulations are also a great way to facilitate team building and team training. The health care environment is not one that thrives on the work of individuals, but on a group of people. Effective communication is essential in the high-stress environment of health care facilities, and this requires a proper team based training.

Coaching and Mentoring

An important feature in any learning environment, is one-to-one training. Coaching is very essential to learning and growth because it provides support and guidance. Coaches inform candidates of what they are doing correct, what they need improvement on, and overall, encourages self-esteem so that candidates feel ease and confident in their skills. Coaches should be skilled and experienced in the topics they are teaching, so that they can draw from their own acquaintances to help clinicians with their challenges. In a learning environment whih is based on technology, there still needs to be a human component, and coaches play that role.

Classroom Learning

Classroom learning is the conventional learning method that, when combined with non-conventional learning methods, has great added value. Students now have the basic information they need i.e. online learning, they have the practical knowledge , and they have the support and guidance they need to achieve their learning goals. Classroom learning is the final piece of the process for a blended learning approach in health care. Students can share ideas , can interact to learn from one another, and they can come to conclusions together. It is really a community building aspect of learning that motivates health-care professionals and makes them bond over their common interests and goals. It creates a good environment for clinicians to work, grow, and thrive in.

In the race of many institutes and CROs, CRB Tech Solutions has created its own niche. Its very popular in offering the best Clinical Research Training programs.

The Clinical Research review by CRB Tech Solutions will help and guide you in considering and taking up a career in this field.

Related Posts:

1) Clinical Research training in CRB Tech

2) Clinical research training course in CRB Tech

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