Monthly Archives: October 2016

What Does Patients Want from Pharma

What Does Patients Want from Pharma

Time is changing! So also different approaches and methodologies. It’s now time to listen to the patient. And look at the nose. These words were uttered many years ago during a workshop on allergic rhinitis . These deceptively simple words were spoken by Dr Bill Frankland, one of the most distinguished clinicians of the 20th century.

He emphasized on putting the patient experience first. He was of the opinion that listening to the patient was critical to understanding what interventions might be required.

His interest in treating patients like grown-ups was way ahead of its time. Even now, when the patient is speaking, the doctor may not always be listening. The opinion of the patients get filtered.

This is not just a failing of the medical profession. Though the healthcare advocates talk about patient-centricity all the time, but in practice that often remains on paper only.

Now what do you mean by patient perspective? The following is a definitive though not obvious list of patient needs, but it might provide a useful framework for discussion.

1. People and not patients

We don’t want our lives to be defined by illness. We are living beings and not passive objects. We need to live as people and not like patients.

2. High expectations

We desire importantly, even in the face of chronic or acute illness. This says the importance of mental health for a physical health, and vice versa.

3. Holistic wellness

Breaking down the barriers between the providers of education, nutrition, health, exercise, transport and social care and creating a genuinely holistic approach will need a revolution in thinking, but it is the only way to put the person at the center. The role of pharma here will be critical .

4. Rapid diagnosis

This means that the doctor will work out quickly what is wrong with us yet, sadly, and especially in rare diseases, this might not happen. For example, with Fabry disease, a leading UK expert said it can take 10 years and 10 specialists before a diagnosis is made in a child not previously identified as being in a genetically susceptible family. We need a better understanding of the costs of such delays in diagnosis in terms of wasted medical resources,family disruption, time spent and loss of childhood. For the affected individuals these costs are almost incalculable.

5. Sharing the experience

These personal costs depict the need for, and importance of, groups for patients to share their knowledge, provide each other support, speak in a strong voice and be powerful research partners. Even with more common diseases, there is a huge gap between proven best practice and what happens in the field. For instance, it took many years for ACE inhibitors to make way into everyday practice in the management of chronic heart failure and, even today, we struggle to sustain the condition in the face of really clear outcome evidence, leaving patients incapacitated, in the hospital and unable to perform simple acts of daily life.

6. Education

More education is needed at every level, and pharma sector has a big role to play in listening to and informing both physicians and those they treat. Let this knowledge be both evidence-based and respectful.

We conclude here.

In the competition of many organizations CRB Tech Solutions developed a good name. Its well known in providing the best Clinical Research training.

Clinical research jobs in Pune are increasing and to meet the increasing need of the proficient candidates , you should consider enhancing yourself with our clinical research program.

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

Related Topics:

1) What is the Career in Clinical Psychology?

2) Know how healthcare education online can transform your career

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Being Human to NGOs and Inhuman to Drug Research

Being Human to NGOs and Inhuman to Drug Research

The clinical research sector since the year 2005 has been expected to grow in double digits due of its vast patient population. But a key question on being human or inhuman with investors, analysts and all stakeholders who have been observing this market in the recent times.

But things have not been good for the industry particularly since 2010.

The data available at the Clinical trial registry of India has been witnessing a step hike in the registrations since it came into inception.

Owing to some unavoidable circumstances, defects in clinical research practices came to light in a hospital based trial in a metro city in India in 2011. This happened despite the fact that the trial was registered at all major sites and was being done by a popular pharma company. The matter came into notice when an NGO filed a petition in the Supreme Court in protest against possible anomalies in their practices. Seeing the same, the Supreme court issued an order to the Indian drug regulator to outline strict laws to conduct clinical researches in India increasing concerns with respect to Ethics and Ethics Committees, safety of volunteers, informed consent matters and volunteer compensation in case of adverse events. Based on the same, a committee was formed to present before the parliament its advice. The words of the committee were brought to the notice of the regulators and the industry leaders for their further action and comments.

Anyways the Supreme Court placed an order on the 30 September 2013 that no clinical trials can be approved till the laws are followed.

This news was published in major newspapers in India. In the current scenario, the Indian regulator cannot approve clinical trials even if the same are in view of public interest. This decision that came from the Supreme Court is expected to expedite the rule formation process. However it is difficult to say in the present times as what will be the impact of the Supreme Court order. According to the key industry leaders, an impact as a consequence would be that it is likely to take away the clinical research practice away from India.

In the name of ethics, a lot of suffering is about to fall on the world of novel drug research. Novel drug research is heavily dependent on outsourced clinical research and people will continue to suffer and die of incurable diseases. Some believes that humanity will be at stake if the law makers continue to support “only humanity”. Little do they realize that the future of humanity is at stake as “unknown” disease continue to lurk the human population.

Clinical study reports explain every aspect of the clinical trial for a novel drug, including the number of participants, methods, analysis, and conclusions. Releasing this data is a huge step in the very competitive and too secretive pharma industry, it is researchers, health care providers, and patients who stand to gain.

Either way, these test subjects came volunteering for these programs, freedom over own body etc. True, there is a chance that test subjects stand to see their health improve. But when people register to participate in drug trials, they are signing up for a casual game of Russian roulette with their health; the stakes are high.

Hope you liked this perspective on clinical research.

Among the many competition of organizations, CRB Tech Solutions developed a big name. Its better known in giving the best training in Clinical Research.

Clinical research jobs are increasing and to meet the increasing requirement of the highly able professionals , you should consider improving yourself with our clinical research training program.

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

Related Topics:

1) How Does Clinical Data Matter?

2) What Mobile Should Mean For Health Care Part 1

 

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How Does Clinical Data Matter?

How Does Clinical Data Matter?

Every year, worldwide, many new companies enter clinical research sector. Academic scientists, capitalists, refugees from big pharma all of them revitalize and entertain the scientific industry.

But the awareness of best practices isn’t always evenly distributed. Certain domains of knowledge seem to be more detailed represented in young companies. That’s a concern at Quanticate, a CRO that specializes in data management and biostatistics.

In words of CEO and chairman David Underwood, a lot of them are virtual companies with venture capital backing, and have clinical backgrounds. Hence they fail to grasp the importance of the biostatistical design and analysis.

Rescue Situation

In a startup, every dollar, every euro is precious. So often they practice allocation of limited but important resources.

Underwood said he has seen businesses find shortcuts. He said that some vital companies didn’t designed the trial properly or analyzed it thoroughly, eventually let out good drugs since they didn’t maintain any data.

Role of CSP or centralized service provider

In words of Underwood’s, a CSP is a trusted, specialized, go-to company where a sponsor designates a particular task or type of work must be always centralized. He also reported that some unknowable but quite a significant fraction of work in the clinical research is duplicated.

In some cases, Underwood said that , mid- and small-sized sponsor firms are looking at the epic CRO-sponsor deals being done by mega-CROs and sponsors. They want a different model, like the data doesn’t seem to fit in these types of relationships.

Client Templates

A United Kingdom based Quanticate has 200 people on its staff. Underwood said that they focused on data. They have a higher proportion of experienced statisticians and they try to combine the biometric functions into a central provision.

The ultimate goal is to simplify those unruly diagrams of which firms do what across all research trials. Underwood said that if they can standardize database design, then they can use the same programs again and again. He said that they’ll be using the template they set up for others. They will be get a saving. He continued to state that they work across the data across all their functions, be it biostatistics, medical writing or data management.

He believes that the savings in time and money would be serious, if all those things come under a same roof, theoretically the final point can be attained much sooner.

Mystery R&D

To mention that in a few cases, some CROs have been a bit touchy on the question of how, whether and when clients can peek at clinical data. Some CROs have addressed this and a many didn’t.

Underwood is trying to take the concern off the table. He provides customers access to an internet portal. With the right user privileges, a user should be to see any appropriate, available aspect of the project. Underwood realizes that some sponsors might want to push a button and export their data to another CRO with a different set of duties. He’s fine with that practice. He said they doesn’t want to lock the companies in.

While discussing future plans, Underwood hints of an R&D initiative within Quanticate that might matter the typical budget of standard clinical trials, especially antiquated processes that are virtually sacred in some quarters of the research industry. They won’t be sending thousands of clinical research associates all over the place. A change is required, so this practice need to be stopped was quoted by Underwood.

We conclude here.

In the competition of many organizations CRB Tech Solutions developed a good name. It has earned a name in offering the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the current requirement of the proficient candidates , you should consider enhancing yourself with our clinical research training program.

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

Related Topics:

1.) How Do Pharma Companies Find Cures For Diseases?

2.) Apple Plans Transform HealthKit From Tracker to Diagnosis Tool

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What Mobile Should Mean For Health Care Part 1

What mobile should mean for health-care part 1  In continuation with our previous blog on utility of mobile in clinical research, here is the other attributes of the related context.

Mobile is first and foremost a communication platform

Though the pure essence of mobile, is a communication tool. It provides individuals with a way to communicate and share information at any time, from any location and via various modalities.

Just imagine being able to get a text reminder system set up by your physician’s office to send you a customized text a few minutes before you need to take your medication, or an interactive system that allows you to send information about how many steps you’ve taken, your blood pressure levels or your diet for the day, and get a feedback from medical staff providing encouragement or any correction.

Hahnemann Hospital, for instance, created a pilot program to reduce its 30-day readmissions among chronic heart failure patients in 2015. The program uses a text and email system to get patients into follow-up appointments by sending reminders ahead of the visit. After 11 months, the hospital had reduced its 30-day readmissions by 16 percent among patients who got the messages. The study revealed that a simple text-reminding is considerably effective in lowering readmission — which improves patients’ lives and reduces costs for the hospital.

Limitations

Carbon Health desires to put medical data in one place for patients and their many doctors Health tech founders call for high ethical rules for use of women’s intimate data Telecom giant Telenor launched a digital health service for emerging markets Photo-sharing app for health professionals, includes direct messaging.

Of course, whether in the form of an app or an alternative , mobile does have limitations. Its limited display “real estate” and not always consistent and reliable connectivity speeds provide key constraints on its utility.

The medium is not very well-suited for processes where users need to take detailed or lengthy information, or require an extensive amount of data entry. Likewise, some matters are best addressed through direct forms of communication, like verbally or face-to-face. Typically, mHealth is not intended to be, neither it could be a complete replacement for the traditional patient care system.

Mobile should be a part of the overall customer experience

What mHealth is created for is becoming an integral part of the modern health-care system. The medium is at its peak when developers and manufacturers stick to the basics. Mobile has always been a means of communication, in real time and is available around the world. Leveraging these strengths can take the friction out of administrative systems, offer better access for and to patients and, overall, help facilitate human connections. There are few options as powerful.

In simple words, a mobile healthcare solution is a novel and exciting source of innovation for the healthcare industry. It is a flexible healthcare solution not tied to any specific form and based on an evolving platform of mobile technology. And it has the power to improve the patient experience while lowering costs for healthcare providers — as long as the industry can agree on an apt definition.

If you are looking for Clinical research course in Pune, our CRB Tech Solutions has developed a niche for itself. Its very popular in offering the utmost well training in Clinical Research.

Clinical research jobs are fast increasing and to meet the emerging need of well learned and efficient professionals , you should consider to up skill yourself with our clinical research program.

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

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How Do Pharma Companies Find Cures For Diseases?

How Do Pharma Companies Find Cures For Diseases?

The simple answer is obtain a thorough understanding of a disease and then target those aspects that can reduce the impact of that disease.

The reality is very close to that premise but the strategy to reach that goal varies with companies and labs.

To start with the disease a thorough understanding comes from:

  • Clinical observations by doctors
  • Genetic studies to find root cause(s) of the disease
  • Accidents that suggest the root causes(s) of the disease

These observations will help cell biologists and physiologists try to make a model system where they can replicate the disease or the symptoms. A good instance is ob/ob mouse for diabetes.

An ob/ob mouse

Now there is a model system, they can start attempting to connect the genotype to the phenotype.
If the research team is fortunate enough to find a link between A and B they’ll probably say something along the lines of “A causes B.” By logic, if you halt A, then you should theoretically prevent B from occuring.

This assumption is dependent on many things. For example

  • What is true in the model system is true for humans.
  • A is the major factor that leads to B.
  • A is not only correlated with B.

Before pursuing a drug, a company or a lab has to explain that A is a valid target in men. In addition, they should also explain that inhibiting target A won’t let out other side effects. It becomes important to determine all of the interactions of the target with the rest of the human body.

After isolating a target, you now need a drug. The key step for demonstrating that:

  • The drug works as per expectations.
  • The drug works quite well.
  • The drug is very safe.

This is the goal of assay development. Contrary to popular belief, that does not involve injecting monkeys with random drugs. It starts with designing a simpler assay, either cellular or biochemical, that depicts that a potential drug binds to the target. This assay can explain whether the target A is “hit,” the drugs doesn’t kill the cells, or the drug has other physical chemical properties that make it an ideal drug.

The next question is what is the new drug? One can synthesize thousands of chemicals and test them against the assay. This is the drug discovery stage and is similar to throwing the darts at board. But each dart is still expensive and there are an infinite number to throw. As a result the design of a library of drugs is important for finding a lead compound. If there is a good “hit,” a drug that shows activity against the target, then medicinal chemists or protein engineers can take the drug and make it more like the drug and bind better with the target.
Along with the activity of the drug, some other things to consider include:

  • Availability
  • Molecular weight
  • Permeability
  • Solubility
  • Metabolic byproducts
  • Ease of manufacturing

This then goes into a sequence of cycles between the assays, animal testing, PD/PK studies, and more drug making until the company finalises a drug that they believe is safe and efficacious for the disease in question. Only then will they start human trials.

In the competition of many organizations CRB Tech Solutions developed a good name. Its well known in providing the best training in Clinical Research.

Clinical research jobs are increasing and to meet the increasing requirement of the proficient candidates , you should consider improving yourself with our clinical research training program.

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

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Top 5 Problems With Using Spreadsheets to Collect Clinical Data

Top 5 Problems With Using Spreadsheets to Collect Clinical Data Spreadsheets are very basic of a tool to maintain the increasing complexity of clinical trials. Here we write about 5 reasons to stop using them. For many people Microsoft Excel is a free and familiar tool. Spreadsheets are used for a wide range of projects, but they are far from ideal when it comes to data capture in clinical trials. Originally Excel was not created to build case report forms (CRFs) or to verify patient data that is collected in clinical trials. In spite of the technological advances in software solutions, many organizations still opt using spreadsheets. Here are five problems with using spreadsheets to collect and store data from clinical trials.

1. Lack of compliance.

If you submit your clinical trial data to the FDA, there are a number of regulatory requirements to meet such as 21 CFR Part 11. One necessary aspect is traceability of any and all the changes that are made to data. In an electronic data capture (EDC) system this is possible with audit trail functionality. If someone make changes of values in a spreadsheet, the history of who created the change, the date and time the change was made, the entered old and new values , and the reason why the change was made are not available. You simply cannot trust something that you cannot track.

CDM

2.Data is not secure.

Spreadsheets have quite a limited permission controls when it comes to confining access for multiple users. This lack of protection can lead to data manipulation, which compromises the data integrity. There are also concerns with limited storage and electronic signatures.

3. Errors are not noticed.

Though you can use basic data validation in Excel with various formulas, data entry errors can still easily go unseen. There are different types of data errors in addition to misplaced, lost, or omitted data. Even though utilizing Excel usually saves time up front because the staff uses the program and therefore do not need to be trained, a certain amount of time can be wasted on consolidating files and checking for errors.

4. No central location for forms and data.

Spreadsheets are difficult to locate if they are saved to several files and folders. Often times important data is scattered and multiple copies of a document are created. If you’re still using spreadsheets. An EDC system organizes and houses a central repository of forms, permitting them to be reused across multiple protocols. This eliminates the need to recreate commonly used forms.

5.Inefficient work-flows.

Spreadsheets are not sophisticated enough to manage clinical data and can disrupt natural work-flows. Recreating newer versions of a form can happen often in clinical research, which isn’t easy to deploy in spreadsheet format. Similarly, there is no efficient way to resolve queries using spreadsheets. An EDC system is developed to have a very logical flow for everything from form creation to query management. It also thins communication between monitors, data managers, and coordinators.

Spreadsheets are used in almost every discipline. While they can provide enough functionality for certain tasks, they don’t have the technical controls in place to collect, store, and verify clinical data.

In the competition of many organizations CRB Tech Solutions developed a good name. Its well known in providing the best training in Clinical Research.

Clinical research jobs in Pune are increasing and to meet the increasing requirement of the proficient candidates , you should consider enhancing yourself with our clinical research training institute.

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

Related Posts:

1) Data entry for a clinical research
2) What is the Overview of Clinical Data Management?

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