Medical Translation Insight

Yesterday, we looked at the China (and India) through the lens of IVD manufacturers. Today, we are still looking at China but on the topics of clinical research and, especially, bioethics.

By way of background, bioethics, according to Wikipedia, is:

...the study of controversial ethics brought about by advances in biology and medicine. Bioethicists are concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy.

When applied to China, some may argue that bioethics is an oxymoron.

Earlier today, Pharmalot's article China, Bioethics & The Wild West: Joe Explains made just this point. Noting the vast differences between East and West, interviewee Joe Powers (the "Joe" in the article's title) gave the following example:

Take a sense of autonomy, for instance. We're used to a system where the individual has the right to consent to a clinical trial or a treatment and to understand what they're going through and to be able to get out without coercion. In China, this can be very different. A family member may make decisions. There are cultural taboos in connection with certain diagnoses. A doctor is inclined not to tell a patient they have cancer and instead will tell a family member. And they'll tell the patient that they're fine... In China, a patient may enroll in a clinical trial because a physician may have coerced them or they may refrain from seeking information – all out of respect for the physician. The patient dynamic can be very different. And these are differences we take for granted, but make it challenging for running trials in China...

Oh my, those Chinese... just look at how crazy things are over there!

Or are they?

Instead of China being "crazy", could it be that the Western view of bioethics is wrong or, at least, just self-serving? One of the commentators questions the assumption that the Western standard is right, that the Western view of autonomy for example has the right to supersede a standard accepted in that society for millenia and says that it "[r]aises a question where colonialism and a sense of colonial superiority is alive and well versus the Western assumption that the "modern" global standards really are superior."

A simple and fascinating question. What do you thing, gentle readers? Is there an "absolute" standard regarding bioethics or is it just another example of the West trying to impose it's mores and norms on the rest of the world?


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India and China... Both countries are inspiring success stories and, according to a new article, are positioning themselves to play major roles in the global in-vitro diagnostics (IVD) market in the future.

China and India: Comparing Two Fast-Growing IVD Markets is a timely look at how these two countries that account for about 1/3 of the world's population stand to up-end the IVD industry. While IVDs aren't the only products feeling the heat from "Chindia", those products have seen annual growth rates of 10-20% in the recent past.

The IVD Technology article does a nice job looking at market sizes for IVD instrumentation, molecular testing, and clinical labs. It notes differences in experiences and with product registrations, for example, highlights differences:

IVD product registration is an area in which the two countries differ greatly. Product registration is going to get more difficult in India, but it still remains relatively inexpensive and rapid. India's government is making changes in the regulations for medical devices and IVD products. According to industry contacts and Ministry of Health officials, a notification is expected that would bring a group of medical devices and IVDs under the regulatory framework. The authority regulating medical devices and IVDs will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health.

In China, the situation is very different. The State Food and Drug Administration (SFDA) is responsible for regulating drugs and medical devices. Both IVD instruments and reagents must be registered, and all products must be re-registered every four years.

If you want a piece of good news, then jump to the end of the article, where the author concludes that "[a]s long as the two main market drivers—increasing prosperity and urbanization—continue, strong growth in the Chinese and Indian IVD markets is expected for many years." [Hat tip to Mel Faux!] For more on this topic, take a look at:

• China's IVD market is booming
• Medical devices & IVDs in the world's 2nd largest economy
• Growing importance of India, China for medical device, pharmaceutical firms

ForeignExchange Translations provides specialized software localization and regulatory translation services to medical device and IVD companies. Contact us to learn more.
 
 

We've said it before: Readability is important when it comes to clinical studies.

While informed consent forms (ICFs) are required in all clinical trials which are approved by an independent Ethics Committee, most ICFs are too complex to understand by an average adult patient. One obvious solution is to reduce the complexity and increasing the ease of readability.

While this has been advocated for quite a while, clinical researchers have largely resisted efforts to encourage investigators to participate in the preparation of ICFs, gain an enhanced understanding of the site specific requirements (culture, language and dialect, literacy rate, and so on), and, of course, improve deficiencies in the translation process.

Despite this foot-dragging, pressure has been growing on researchers to improve communications to trial participants. Adding even more pressure is a recently published report which states that preparing lay studies is not just feasible but generally easy to do.

For the report, technical clinical results for two drugs was rewritten in layman's language. Extra touches were added, like sending thank-you cards to volunteers and updating them on the progress of reporting the results.

In discussing the report, The Wall Street Journal notes that:

"Volunteers appreciated the thanks and the updates. And a majority felt they understood the results of their trial very well or somewhat well after reviewing the lay summaries."

Efforts like these will have a positive impact on the entire clinical research chain, from patient recruitment, reporting, and translation.


For expert medical translations of regulatory, clinical, and marketing content in 40 languages - including Spanish - request a detailed proposal from ForeignExchange Translations.

According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device. It doesn't matter if the software is integrated into the actual device or a stand-alone product. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Software validation will also be an Essential Requirement under the MDD.

As medical device companies are climbing the learning curve of software localization, many of them have been asking for help on internationalization, agile development and IEC 62304, and, of course, translation/localization. In response, the ForeignExchange team has developed an in-person training session called "Best Practices for Medical Device Software Localization".

Over the next couple of weeks, we are taking this popular seminar coast to coast. Past attendees have told us that this session really helped them develop global-ready software that will work and be effective in any language and culture.

The first event will be in Santa Clara, California on May 3rd and the second will be in Andover, Massachusetts on May 18th. Both complimentary events will be held from 8:30 until 11am with a light breakfast and time for networking.

Medical device professionals can register for the Santa Clara event here: http://info.fxtrans.com/lu20120503-best-practices-for-software-localization-ca/

Registration for the Boston event is also live; register here: http://info.fxtrans.com/lu20120518-best-practices-for-software-localization-boston We are excited to see our readers in Boston and Santa Clara!

For more on software localization and internationalization for medical devices, take a look at the following articles:

• Designing medical device software for MDD compliance
• Medical software ready to take on the world
• A conversation about software localization

ForeignExchange's QMS is certified to ISO 9001, ISO 13485, EN 15038 and compliant with ISO 14971. For your next medical translation and software localization assignment, request a detailed proposal from ForeignExchange.

The European Medicines Agency (EMA) is planning for the implementation of new pharmacovigilance legislation in July this year. The new rules (Directive 2010/84/EU [PDF link] and Regulation (EU) No. 1235/2010 [PDF link]) amend existing legislation and was adopted back in December 2010.

The main goal of the legislation is to strengthen the EU-wide system for monitoring the safety and benefit-risk balance of medicines. Four key areas will be targeted in the legislation (from PharmTech.com):

1. Collection of key medicines' information: Activities in this area will include strengthening procedures for submitting risk-management plans to the EMA, as well as the need for marketing-authorization holders to provide periodic safety update reports (PSURs).
2. Better analysis and understanding of data and information: Throughout 2012, EMA will be investing in new information technology systems and signal-detection tools. In particular, the agency aims to strengthen its side-effects collection system, EudraVigilance, by adding increased functionality and improving data quality.
3. Regulatory action to safeguard public health: Starting in July 2012, a new pharmacovigilance risk assessment committee will begin meeting, stepping up to monthly meetings from September 2012.
4. Communication with stakeholders: Transparency is explicit in the legislation and will lead to the online publishing of information, such as agendas from committee meetings, assessments, approvals, recommendations, and opinions, on EMA's website.

For more details, check out this helpful Q&A document [PDF link] and look for pharmacovigilance topics on FXConferences.com!

ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.
 

Happy Spring! After a mild winter, spring has sprung early in these parts. A good thing, too, what with our increased travels for educational events!

As we do regularly, here is a recap of the last month's most popular articles:

1. Austerity puts pressure on drug prices - and translations? - It will be interesting to see if/how translation prices will follow sinking drug prices
2. Ready for e-labeling? - e-labeling, the Holy Grail of medical device labeling managers
3. Middle East presents opportunities, challenges for clinical research - The area is growing in importance for clinical trials
4. India is the world's pharmacy? - About a high-stakes showdown between defenders of IP rights and Indian drug companies
5. Do small translation companies operate this way? - Nice infographic

Interested in past months' most popular articles? Take a look at our roundups for December, November, and October. Happy reading and happy weekend!


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From today's The Big Picture:

We are moving into the height of the political cycle over the next few months. It is apparent that the Republicans will nominate Romney and he will battle Obama for the right to be president of the U.S. Over the years I have received emails and had discussions with many people, some of whom I only know via the deep reach of the internet, about my political beliefs. These often confuse people because they are not clearly liberal or conservative, and usually not moderate. However, my beliefs do have themes that at times seem to align me with liberals, conservatives, and even radicals. In individual conversations I have encouraged people not to stereotype me, but to engage in discussions about issues.

One of my beliefs is that with the growth of the population, the introduction of technology into every aspect of our lives, the continually increasing complexity of how we communicate, and the growing desire to impact systems at all levels, our species is experiencing radical change at a pace that most of us have difficulty absorbing. At the individual level of existence, how we feel in our own skin can be anywhere from terrifying to electrifying, either creating excitement for life or fear of living. Thus we seek small groups that we can identify with that are having similar internal experiences as ourselves. We may seek to join a group of people who feel threatened by change, or who are challenged and invigorated by change. These groups come into conflict with each other and are becoming more and more vocal. They have new ways of contacting others who may have a similar experience at an even larger level of organizing through the internet, and if so inclined can link directly with those who are organizing around their shared inner experience of how the world works.

These are very interesting times. Some folks believe the political process is more polarized than ever. I believe that is relative to our age and political experience. There is certainly a polarization going on between the two major parties and within the major parties. My experience goes back to the 60′s and remembering the street battles, the loss of life at Kent State, Jackson State and other places, the yelling and the left wing suggesting we abandon families and other institutions that they claimed to be dysfunctional. At least today many of the violent political responses to differences are thus far rare. I disliked the rhetoric of the left in the 60′s, and experience the rigid positions of the far right today as being little different in the goal of dominating the political system and equally distasteful.

I believe in equality. Equality really means what it says. All people should have equal access to all systems of organizing without bias of age, sex, religion, nationality, race, or any other way that we attempt to differentiate ourselves from others. I believe in justice. All citizens of the U.S. should have the right to a system that allows us access to stating our case and bringing forth the opportunity for justice when there is the possibility of a wrong that has been committed. I believe in protecting the environment. This is a no-brainer and I am often amazed by those who see the environment as only being something to take from and not protect. If we want to survive as a species, we must take all necessary steps to protect the environment. If we want to have a high quality of life, we must protect the environment.

I believe in managing our resources, both financial and environmental. Financially there is one relatively simple rule to abide by. As we are witnessing right now, it is important to pay as you go except in times of great emergency. By most economic standards, the U.S. government, while accumulating debt, kept the debt at manageable levels until the year 2000. Beginning in 2001, our nation's will to pay for war and medical programs collapsed. We allowed our government to lower taxes when they should have remained the same and eventually increased to pay for the cost of the wars our government entered. Once we paid for our defense and medical expenditures, taxes could be lowered. Now we are faced with a nation that has no choice but to dramatically reduce its defense and dramatically change how Medicare functions.

Sometime in the next 4 years, the U.S. is going to have a financial crisis. It is almost inevitable. The only thing that can postpone it without huge changes to the tax system, the way we manage issues of defense, and a revamping of our government sponsored medical systems is if the economy allows for low interest rates to continue. If interest rates start climbing, it will impact the cost of our federal debt and will most likely lead to the financial unraveling of the U.S. government and, of course, the U.S. economy. At that point in time, massive changes to our tax system and our expenditures will take place or we will have the destruction of the dollar by rampant inflation.

I also believe in what I think of as selective regulation. If you ever want to study, or work within an area that brings forth all of the psychological difficulties of trying to create or manage wealth and all of its implications, spend time working in or studying the financial sector. Having spent 40 plus years in the financial sector, I know that it needs to have the tightest regulations possible to prevent systemic risk, the outright stealing of money from customers or the legal manipulation of the system to benefit the company and not the customer. History demonstrates regularly that human beings are not capable of managing their desire to accumulate wealth no matter what the cost to the larger system.

We also need environmental regulations to prevent those who would destroy the environment in the name of quick profits and unsustainable job creation from killing the planet. But we also need freedom from unnecessary regulation that prevents job creation and stifles creativity. These are difficult areas to manage. There are those of us who put ourselves first and the health of the larger system second, or who do not care about systemic issues at all. Individuality as the primary value can lead to the collapse of the larger system.

We are learning as a species. It has really only been in the last 100 years that we have even begun to study how organizations work, how the brain works, how we manage our emotions, what our bodies need to be healthy, how we are in relationship with our family, friends, community and now our internet acquaintances. All of these issues manage to emerge in our political systems that in many ways have not changed and resist change at every turn in the road. The current polarization I believe is representative of how political systems have always worked. But now we witness candidates and political operatives who have their own personal agenda that are really built around what they want for themselves, not what is necessarily best for the future of the U.S. They are willing to do almost anything to experience the rush of serotonin that comes with winning.

I have always been intrigued by systems and how systems work. I believe in levels of system and have learned over the years there is no really easy path to walk in trying to intervene or be with others in a system of two or a system of 350 million. It has been hard enough managing my own internal system, let alone trying to influence and, at times, simply be with others while being open to influence at the same time.

Now the biggest issue in our political system and most likely for most of us in our lives is being open to influence. It is a skill. It is hard to do. It means listening. It means reading pieces that you may not be willing to read. It means trying to understand how and why a political belief, a religious belief, an emotional response,or an intellectual position has happened and exists. It means learning about and accepting the experience of others, and not cutting yourself off from the knowledge of their experience. Being open is a very difficult challenge in a world that is now presenting more and more information about new knowledge, about how things are changing and how a ripple on one side of the world can become a tsunami for the entire world.

Being open to influence also means that we are fully aware of the very human dynamic of confirmation bias. Sometimes we like to think we are open to being influenced when what we are really attempting to do is to confirm what we believe. As soon as someone of a different persuasion says something that confirms your beliefs about how wrong they are, we crawl back into our shells and say, "see, I was right all along". Confirmation bias can be our worst enemy because it allows us to demonize those who are different.

In financial decision making, confirmation bias can lead to very bad decisions as we deny something that is happening that demands a quick response. Many money managers have sat and allowed losses to expand because they believed they knew more about what was happening than the market did.

The difficulty in any relationship is that if only one person is open to influence there maybe little likelihood anything will happen if the power is equally spread among both individuals. The same is true in politics. In today's world, neither the Republicans or Democrats have the motivation to be "open to influence". It is "my way or nothing". Ultimately this can and will lead to calamity. There have been times in the recent past where compromise took place, but it has been fleeting and without lasting impact. It was always a response to a crisis where it became obvious that compromise would only happen if it allowed for eventually winning a lopsided victory.

In my life I have seen people do battle over issues of power and control who should know better. Having power and control is an illusion. It lasts for a short period of time, and then those who are willing to do what is necessary to gain control will take over. When individuals and groups refuse to listen to those who differ, the ones who feel rejected will coalesce and offer greater resistance. Historically, in the governing process in the U.S. there has been a willingness to compromise. As we all know, it is now missing for the most part in the federal government because many are really not interested in governing — they are only interested in winning.

Hopefully the two major parties of the U.S. will cease to function as two opposing football teams in the Super Bowl. Hopefully we will learn to apply what we are learning about how our brains function and how systems can maximize their health, so that we can move towards systems of dialogue, a willingness to be influenced, and a view that recognizes that the health of any individual can only exist when the larger system believes in equality, justice, and supporting the environmental health of the planet.

How does all of this get reflected in the stock market? I have written many times that fear is the driving force in how the markets respond to events. It can be fear of losing, fear not being included in a big market rally, or it can be fear our own decision making process. If government becomes more rigid, and it becomes clear that there is little if any ability to compromise, the best place for your money will be in another country. The dollar will most likely collapse only because the world will fear that the U.S. will not be able to take the steps necessary to pay for the war in Iraq (it has never been paid for), Afghanistan and the cost of Medicare. If investors outside of the U.S. believe this to be true, the psychological, and in some ways very rational response will be not to own anything that is valued by the U.S. dollar.

We live in a world economy. That is one of the fast changing realities that many in the U.S. are in denial of on both the left and right. The power and influence of the U.S. is declining every year. Those who stand up on a stage, expand their chest, and talk about the power of the U.S. are living in the past. There is nothing we can do about the loss of influence, any more than Great Britain could in 1900. We need to adjust our vision and our way of behaving on the world stage.

If nothing else, it is only a numbers game. The population of the U.S. is 3% of the world's population and the real growth over the next 50 years will be in India, China, Brazil and other nations that have discovered their own paths to participating in the world's economy. The U.S. stock market will not be a safe haven. And in a strange way, the quicker we quietly move from a center stage of one, to a shared stage of many, the less the United States will be seen as a target to beat, and instead be seen as collaborator in solving the many problems that the planet faces. Just as we need to learn how to be in dialogue, to fully listen, and to be trustworthy human beings at an individual level, we also need to be able to do the same as nations.

Carl Haefling 4/2/12

Find out more about ForeignExchange's specialized medical translation services for regulatory, clinical, and training groups and medical device and pharmaceutical companies.
 
 

We’ve got some great educational offerings in the coming weeks.

Writing for a Global Audience – Chicago

We will be hosting a complimentary Learning Unplugged seminar in the North Chicago area entitled, “Writing for a Global Audience.” This two-hour complimentary seminar is designed to provide attendees with insight and guidance on how to author and structure English content which is targeting a global audience. Rather than simply providing an exhaustive list of do’s and don’ts in writing, the speaker will explain and provide possible solutions to some of the translation challenges posed by US/English-centric content.

The event will be held from 8:30 until 11am on April 24th at the Deerfield Hyatt. You can sign up here:

http://info.fxtrans.com/lu20120424-writing-for-a-global-audience-il-mcn

Best Practices for Software Localization – Santa Clara

On May 3rd in Santa Clara, California, we’re hosting, “Best Practices for Medical Device Software Localization,” to help device companies develop global-ready software that will work and be effective in any language and culture. According to the European Medical Device Directive (MDD) amendment of 2010, software is now included in the definition of a medical device. This inclusion is an acknowledgment of the fact that software is so integral to the functioning and therapy of a device. Given this new attention on software by global regulators, proper medical software localization is now even more important.

The event will be held from 8:30 until 11am on May 3rd at the Biltmore Hotel in Santa Clara. You can sign up here:

http://info.fxtrans.com/lu20120503-best-practices-for-software-localization-ca-mcn

Audio conference: Investigator Brochures for Medical Devices – April 18th

An investigator's brochure (IB) is required for compliance with the EU Medical Device Directives (e.g. 2.7.2) and also with ISO 14155: Clinical Investigations of Medical Devices in Human Subjects – Good Clinical Practices. The development of an IB for medical devices should reflect the engineering features of the device, in much the same way that an IB for pharmaceutical agents reflects the chemical features of the drug. As a dynamic document, the IB must be carefully constructed and, ideally, it should accurately represent the current state of all knowledge about the investigational product – including information about AEs, SAEs, and important manufacturing details as well as nonclinical and clinical study results.

This audio conference presentation provides an overview and best practices for the medical device IB, looking at some of the related issues specific to devices and discussing how the brochure is likely to evolve over time. Get more information and sign up here:

http://www.fxconferences.com/Investigator-Brochures-for-Medical-Devices-P859.aspx
 
Audio conference: Agile Software Development in the Medical Device Industry – April 19th

Decreasing development timelines and getting products to market faster benefits both patients and health care providers and is obviously a priority for any company. However, when a medical device company embraces agile software development to accomplish this goal, there are common pitfalls that can be counter-productive and might actually delay getting your product out the door. What's more, introducing agile methodology can create tension between those working in quality, regulatory affairs and R&D.

This audio conference presentation demonstrates how to avoid the most common pitfalls, how to ensure compliance with agile development, and how to strengthen the agile process and make it a win-win for departments with differing priorities. Get more information and sign up here:

http://www.fxconferences.com/Agile-Software-Development-in-the-Medical-Device-Industry-P853.aspx

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices.

Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. E-labeling provides several advantages in managing regulatory compliance but also poses some challenges.

We’ve prepared a white paper that discusses the challenges of EU e-labeling. In the paper, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling to gain competitive advantage. Download it here:

http://info.fxtrans.com/medical-devices-e-labeling-for-the-eu-market-mcn

Over the course of this year, the IP landscape for drug and device companies in Australia has the potential to change quite dramatically. These changes picked up speed last month when the Intellectual Property Laws Amendment (Raising the Bar) Bill 2011 was passed by the Australian Senate.

The Bill now awaits passage through the House of Representatives. The bill is expected to receive final approval by the middle of the year and go into effect in 2013.

If and when it is green-lighted, it will amend patent, trademark, and other intellectual property laws. Together with detailed regulations, the new law will have a significant impact on medical device and pharmaceutical companies' IP practice in Australia.

An excellent summary of the likely impact of the bill can be seen on the web site of Mallesons Stephen Jaques - take a look here.

[Hat tip to @Pharma_Life_Law]

Haven't yet had your daily fix of patents and trademarks? No worries - take a look at the following:

• Global Patent Standards
• Managing the risk of patent translation
• EPO tries to strike balance between pragmatism and linguistic pluralism

ForeignExchange translates patents and other IP for medical device and pharmaceutical companies into 40+ languages. Ask us for a detailed proposal on your next translation project.