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Best Insider Tips to Find a Job as a Clinical Research Associate

Three Interviews with Like-Minded Professionals

“Clinical research associates (CRAs) are responsible for planning and coordinating clinical trials. Throughout the trial, they provide technical assistance for experiments, collect results and make sure that scientists remain in compliance with regulatory standards. Once the trial is over, they may also be involved in presenting the results to the public in a useful, understandable way. Jobs for clinical research associates are available in both office and laboratory settings.”[1]

In order to know more about how CRAs find a job, I’ve interviewed three of them. Today’s questions are:

  1. How did you find your job?
  2. Have you ever attended networking events? If you have, how did that help you in your job search?

MAIN TAKEAWAYS

– Building a diversified and robust network will greatly help you to find a job as a CRA. Whether it is through attending networking events or working in several companies.

– When you’re looking for a job as CRA, you must leave no stone unturned. An opportunity can come from alumni, following a company on social networks, contacts from a professional organization, job offers, or a recruiter finding you online.

Ian Wannenburg, CRA working at a Clinical Research Organization

1. Through work experience and exposure to different companies to get experience in a variety of therapeutic areas and also through recruitment companies and by replying to job offers.

2. I’m active in following sponsor companies and groups on LinkedIn and Facebook (with their primary interest in Biotechnology), and I’m also a member of the South African Clinical Research Association (similar to SoCRA) in South Africa.

These activities brought me great exposure to what is happening in the industry, and normally, people in the industry are happy to share their experience with you and assist where they can.

An anonymous CRA working at a Healthcare Company

1. I replied to a job offer and got help through my network.

2. Yes. Just a small networking club held at university.

Yes, networking helped me find a job. There is still a gap between academic and a career. During networking events, students or those who are not in the clinical field can truly understand clinical trials and the role of clinical trial assistants (CTA), clinical research associates (CRA) and research assistants (RA). Because  we do not have related master of clinical trial/research for people, joining networking events is crucial to know more about how to be a CRA.

An anonymous CRA working at a Pharma Company

1. I found my job through a recruiter.

2. I’ve never attended networking events.

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

[1] https://learn.org/articles/How_Can_I_Become_a_Clinical_Research_Associate_CRA.html

Post reviewed by Johanna Galyen from Glowing Still

The Many Professional Itineraries That Can Lead You to Become a Clinical Research Associate

Three Interviews with Like-Minded Professionals

“Clinical research associates (CRAs) are responsible for planning and coordinating clinical trials. Throughout the trial, they provide technical assistance for experiments, collect results and make sure that scientists remain in compliance with regulatory standards. Once the trial is over, they may also be involved in presenting the results to the public in a useful, understandable way. Jobs for clinical research associates are available in both office and laboratory settings.”[1]

In order to know more about how CRAs find a job, I’ve interviewed three of them.Today’s questions are:

  1. What is your background?
  2. Why did you want to be a CRA?

MAIN TAKEAWAYS

  • You don’t need to have a specific diploma to become a CRA. There are many different types of scientific education that can lead you to this profession.
  • You can become a CRA at any point of your career, whether you’re still at university or have been working for a while in different roles (pharmacist, pharma sales representatives, etc.).

Ian Wannenburg, CRA working at a Clinical Research Organization

1. I have a Teaching Degree (BA Physical Education) with majors in Sports Science and Mathematics. Also, I have a Medical Science Degree (M Med Sci) – Majors in Physiology and Anatomy.

2. I started in the Pharma Industry as a Sales Representative, and because of my medical background, I was very involved in promoting new products on the market but using clinical trials. I ended up at a company where I started as a junior CRA and developed through the ranks to the role as a Senior/ Lead CRA. One of the reasons to become a CRA was the fact that we are involved in the scientific development of a new product on the market. To do this,  we must work very closely together with the trial site personnel to deliver good data. I’m passionate about getting to work with people in a specialized and accredited environment.

An anonymous CRA working at a Healthcare Company

1. I majored in Biotechnology and had online course certificate (Clinical trial).

2. Interest in the field and salary are most important for me.

An anonymous CRA working at a Pharma Company

1. I studied pharmacy in school, and became a Pharmacist. Initially, I did not know about CRA work.

2. I got the job after I saw a posting for a pharma company job on the memo board at the university and applied to it.

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

[1] https://learn.org/articles/How_Can_I_Become_a_Clinical_Research_Associate_CRA.html

Post reviewed by Johanna Galyen from Glowing Still

Walking the Tightrope: How Medical Writers Balance Deadlines and Family Life

It is the stuff that commercials (and dreams) are made of; work from home and earn 6 figures.

Make your own schedule; work when you want! But is it really that simple? Is it realistic? Today, we’ll talk about medical writers’ working conditions and the issues that they face.

How do they maintain a good work-life balance?

Is their job stressful?

How do they keep their customers?

3 MAIN TAKEAWAYS

  1. They struggle with very tight deadlines.
  2. They feel like they don’t manage to reach a good work-life balance.
  3. They navigate between feast and famine cycles of assignments.

Here’s what three medical writers had to share

Lisa. M. working in a mid-size Clinical Research Organization:

Deadlines are stressful and I may overcommit.

Johanna Galyen, RN BSN, Freelance Medical Writer at Glowing Still:

WORKING CONDITIONS – my working conditions are what I make of them.

My family affectionately calls my office the dungeon because I’m tucked away in the basement of our home. I work when I want and around my schedule. I’m a mother of 4 children and I homeschool them as well, so I work between history and science lessons some days.

There are late nights and early mornings of work when I’m on deadline, but I prefer rearranging my schedule to meet my deadlines than having to clock-in so many hours at the hospital like I used to do.

FREELANCE CHALLENGES – Finding good clients is really hard.

I have to work for each one and it has taken me months and months to cultivate these relationships. It can be a feast of work or famine of nothing, and if you are a freelancer, you have to be ok with the fact you may not always have work. Additionally, I have to always be finding new relationships and growing them.

WORK-LIFE BALANCE – This is tough, especially when money is tight and I know I have to work to make money.

But I know my children and husband will suffer if I spend 8 hours a day hidden in my office and then get all upset when there aren’t any groceries in the refrigerator or clean laundry. I’m STILL a work-at-home mom and chores have to be done. So I have to plan and schedule out my time and be very flexible. Mostly, there comes a point that I just have to walk away from the work and know that I will pick it up later. There’s no point destroying my health.

Jill A. Freelance medical writer since 1995

Working in the US as a freelancer, my biggest problem is HEALTH INSURANCE.

I would love to retire (I’m 62), but I can’t because it costs so much. I need to work to get health insurance. How nuts is that!

WORK-LIFE BALANCE

I don’t feel like I have balance like that right now. As a solo practitioner, I usually have 3-4 steady clients. But those clients are not as reliable as they were in the past.

Examples: I write a newsletter about new drugs for one of them. The US government shutdown meant that no new drugs got approved between December 21, 2018 and late January 2019.

On February 20th, I got my first assignment from that client. So I had a 6-week hiatus from a steady 10-15 hours/week job due to something completely out of my control. Another client just announced a 50% cut in my budget because of financial problems. They apparently have not transitioned quickly enough from a print-based book to an online/app presence.

Here are 4 simple rules to follow to avoid such pitfalls:

Rule #1 – Don’t be ready to do anything for your clients

If working after 6 pm or weekends is not good for you (it’s actually bad for most of us!), let your clients know that they can only reach you within a specific schedule.

It can be difficult to initially set boundaries for clients, as we all want to appear available and willing to work, but good boundaries can actually make the relationship stronger. You both know what is required, and what you can offer.

You both know what is required, and what you can offer.

REMEMBER: If they have requirements as clients, you are also allowed to have requirements as service providers!

Rule #2 – Block time slots in your schedule for exercising

Your health is just as important as the health of your readers. So make sure you have set times to get away from work.

Fiona Wallace also mentioned it in her article on CRAs CRA Burnout: How Big A Problem Is It, Really?: “This tricks your stress response into down-regulation. CRAs have a sedentary lifestyle due to office work and traveling. Reduced exercise does not lower stress hormones, so the body can remain in a fight-or-flight status.”

Get up and stretch, run a mile, go out to lunch with a friend or whatever makes you happy! And never accept work in these slots!

Rule #3 – Set up an automatic response when you’re too busy

Automatic responses are not just for vacations or international travel. They are also helpful for times that you are busy with work.

Chatty (and needy) clients can interrupt you and slow you down with details that can wait. Let your clients know that you are not currently available for urgent projects or memos but that you’ll be fully available from next Thursday for example.

Rule #4 Don’t put all your eggs in one basket

We’ve all had that one client that pays really well, and it is easy to forget to be actively looking for new clients.

However, what if your preferred customer, which sends you 80% of your projects at a good rate, goes bankrupt? You’ll lose most of your income, and set you back for weeks! To avoid this painful scenario, always keep looking for other customers and don’t forget to nurture relationships with your existing clients. Big or little, they deserve your attention.

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

Post reviewed by Johanna Galyen from Glowing Still

The Benefits of a SoCRA Membership to Develop Your Career to Expert Level

Three Interviews with Like-Minded Professionals

“The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.”[1]

In order to know more about how this organization has helped Clinical Research Associates in their work, I’ve interviewed 3 of them.

Today’s questions are

  1. Which SoCRA courses and conferences did you attend to?
  2. What did your SoCRA membership change in your work?

MAIN TAKEAWAYS

  • Members generally attend the annual SoCRA conferences and the local chapters’ meetings.
  • Membership allows them to become more specialized and maintain Continuing Medical Education studies.
  • Members are able to network with other like-minded business peers and create friendships and connections, which can help the members move up in their careers.

Shobana G. Clinical Research Associate at an Academic institution

1. I attended the 2016 annual SoCRA conference and complete the courses in the SoCRA source. I also attend local chapter meetings.

2. To maintain CME (Continuing Medical Education) I have attended some workshops and courses in my institution. So it has been helpful to connect with people in institution.

Grace V. Clinical Research Associate at an Academic institution

1. I attended the 2016 annual SoCRA conference and complete the courses in the SoCRA source. I also attend local chapter meetings.

2. I feel that I became more specialized in regulatory/GCP topics. It was exceedingly helpful as a CRC (Clinical Research Coordinator) and in my current position with the DSMC (Data and Safety Monitoring Committee).

An anonymous CRA working et a Medical Device Company specilizing in Neurology device

1. I have attended a Device conference through SoCRA as well as several monthly local SoCRA meetings throughout the years. I have also attended SCDM (Society for Clinical Data Managemen) annual meetings to help with movement in my career.

2. More courses and I really like the quarterly magazine. The articles are helpful to open perspective on site management and study life cycle.

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

[1] https://www.socra.org/about/clinical-research-education-certification-networking-opportunities/


Post reviewed by Johanna Galyen from Glowing Still

Should You Hire Certified Medical Translators?

One of the many questions I am asked all the time is, “Do medical translators need to be certified?”

The answer is NO, they don’t NEED to be certified. But if you’re looking for evidence of a translator’s PROFESSIONALISM, here’s some important things you should look for:

Professional Associations

  • ATA (American Translators Association): ATA’s 10,000 members include translators, interpreters, teachers, project managers, web and software developers, language company owners, hospitals, universities, and government agencies.
  • ITI (Institute of Translation and Interpreting): Founded in 1986 and with over 3,000 members, both in the UK and internationally, ITI’s members include Language Services Businesses (LSBs) who provide a range of services across a variety of languages and Corporate Education members which are higher education establishments.
  • SFT (Société Française des Traducteurs): The SFT today counts more than 1,300 members, making it the largest professional translators’ union in France. The diversity of the SFT’s membership—which includes in-house and self-employed language service providers as well as literary translators—reflects the broad range of activities found in today’s global translation market.

Such associations have a strict professional code of conduct their members must adhere to.

Personal Training

Before asking someone to translate important documents, it is important to ensure that they are sufficiently trained. I recommend asking translators if they have

  • a Master’s degree in translation or
  • significant experience as a medical staff member

You can also ask them which types of documents they usually translate and if they have a website. This information should give you a much better idea of their expertise and experience.

Preferred Requirements

Are you sure you’re not looking for an interpreter?

Medical interpreters work with oral communications, such as assisting in a conversation between two languages. Translators work with the written word.

The National Board of Certification for Medical Interpreters has offered certification for the last 10 years.

If you don’t know where to begin to find a translator, you can read my blog post on How to find a translator or contact me directly at aureliegobet@medpharmatranslator.com

I’d be happy to help!

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

Post reviewed by Johanna Galyen from Glowing Still

SoCRA membership can help you find – or keep – a job

“The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. SOCRA, the premier educational organization for oncology site coordinators, has now emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia.”[1]

 

In order to know more about how this organization has helped Clinical Research Associates in their work, I’ve interviewed 3 of them.

Today’s question is

When and why did you become a member of SoCRA?

 

MAIN TAKEWAY

The SOCRA certification can be very useful to find a job because it is an “accepted standard of knowledge, education, and experience by which CRPs will be recognized as Certified Clinical Research Professionals (CCRP®s) in the clinical research community. The standards upon which this certification program is based have been set forth by this organization to promote recognition and continuing excellence in the ethical conduct of clinical trials.[2]

Grace V. Clinical Research Associate at an Academic institution

“In my prior position as a clinical trials coordinator, it was required that I obtain certification within the first 6 months of my job.”

Shobana G. Clinical Research Associate at an Academic institution

“2015. I earned this certification to be up to date with my knowledge at work.”

An anonymous CRA working at a Medical Device Company specializing in Neurology device

“I became SoCRA member in 2014 because it was the first point in which I was eligible and it was a benchmark for my employer at the time and also there is a preference for CRAs looking to change positions in the medical device industry.”

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

[1] https://www.socra.org/about/clinical-research-education-certification-networking-opportunities/

[2] https://www.socra.org/certification/certification-program-overview/introduction/

How do medical writers find new clients? The importance of prospecting and referrals

Welcome to MedCommTalk – a series on medical communication

Interviews from professionals in the medical communications field with real answers to business difficulties.

 

 

Today, we’ll talk about medical writers’ clients. Who are they and how did they find them?

3 MAIN TAKEAWAYS

Out of 6 respondents:

1)    50% found their clients by sending prospecting emails or letters.

2)    33% didn’t have to look for clients as they were already part of their company’s project.

3)    33% found work via referrals.

 

These figures emphasize how important it is to build a strong network when you’re a freelance medical writer. Just knowing other medical writers can bring you quite a lot of work.

Also, the benefits of sending prospecting letters cannot be overlooked. Target your ideal clients and find ways to contact them. You can either meet them at medical conferences or other industry related events. If you think they might need your services, or send them a service offer if you think they might need your services. It is, however, recommended to get to know them first because a service offer is always more welcomed when it comes from someone you already know.

 

Today’s question is:

Who are your clients? If you work as a freelance medical writer, how did you find them?

 

Lisa. M. working in a mid-size Clinical Research Organization:

My clients are already part of my projects at work for medical writing for publication. I have been asked to participate on projects.

 

Johanna Galyen, Freelance medical writer at Glowing Still:

Primarily, I write for clients/companies who want articles or blogs for their medical websites from the perspective of a nurse or explaining difficult topics in a way that anyone could understand. Most of what I write is ghostwritten, and the doctor (or the company) takes the credit for what I write.

I didn’t find work from the people I used to work for in the past. I just started looking online wherever I could find writing gigs. Upwork, textbroker, and Writer’s Access have been my best places. Sometimes I get lucky, but usually, I average 1 paying client for 30-40 proposals I send in. Thankfully, some of them are on-going clients with lots of work so that helps. Others are just a one-time writing assignment.

 

Kitty W. Freelance writer

I am a freelance writer, but I only write medical content for my firm. I worked there in admin role before taking this new content-based job with them.

 

A freelance medical writer who wants to remain anonymous

My clients are Med comm shops and small to mid-size pharmaceutical companies.

 

Jill A. Freelance medical writer since 1995

I wrote about 10 letters to organizations that I thought would be a good fit back in 1995. I got 2-3 hits. One became a major client that sustained me for most of my career. They got bought by venture capital group about 5 years ago which led to me being let go (only outside consultant). The rest have come from word of mouth.

Joanna Pendergrass Freelance medical writer and Doctor of Veterinary Medicine

My clients are primarily pet companies with websites that focus on pet owner education. I have found some clients, such as my pet insurance company clients, via a Google search. Other clients found me through LinkedIn and reached out to me via email. One of my clients was a referral from a colleague.

 

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

Post reviewed by Johanna Galyen from Glowing Still

Medical writers tend to work freelance and be involved in the medical sector

Welcome to MedCommTalk – a series on medical communication

 

Interviews from professionals in the medical communications field with real answers to business difficulties.

 

Today, we’ll talk about medical writers’ status –freelance vs. agency– and their involvement in the medical sector.

 

3 MAIN TAKEAWAYS

Out of 5 respondents:

1)    60% are working as freelance medical writers.

2)    None are working for a medical communication agency.

3)    60% have worked or are currently working as medical staff.

 

I asked them two questions:

  1. Do you work as a freelance medical writer or in an agency?
  2. Have you ever worked as a medical staff?

I’ve interviewed 5 medical writers. Here are their answers:

 

Lisa. M. working in a mid-size Clinical Research Organization: 

1.  I do this as part of my job as a clinical trial manager and personally as a health care provider.

2.  Yes I am a nurse.

 

Johanna Galyen, Freelance medical writer at Glowing Still:

1.  I work as a freelance medical writer.

2.  Yes, I have 16 years of medical staff experience. I’ve worked in the ER, Labor & Delivery & Newborn Nursery, Neuro-Trauma Med-Surg, and Office nursing – internal and family medicine.

 

Kitty W. Freelance writer

1.  I work at a law firm that specialises in medical negligence and personal injury claims.

2.  No, I haven’t.

 

A freelance medical writer who wants to remain anonymous

1.  I work as a freelance medical writer.

2.  No, I haven’t.

 

Jill A. Freelance medical writer since 1995

1.  I have worked as a freelance medical writer since 1995.

2.  I worked as a clinical pharmacist for about 10 years before moving to medical writing. But write primarily about drugs, so I’m still ‘in my lane’.

 

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this topic, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

 

 

 

 

 

Medical writers – and translators – (mostly!) are passionate self-aware women and Medcomm geniuses

Welcome to MedCommTalk – a series on medical communication

Interviews from professionals in the medical communications field with real answers to business difficulties.

MedComm Talk will be made out of interviews of professionals, such as medical writers and communication agencies in the medical communication field.

The aim of this series is to gather personal testimonials and opinions about what you actually do in your work. Let’s raise awareness together about medical communication and share the challenges you face in your work.

Medical writers – and translators – (mostly!) are passionate self-aware women and MedComm geniuses

Today, we’ll talk about medical writers’ background. I’ve interviewed 5 medical writers to learn more about how they came to medical writing. Here are their answers:

5 MAIN TAKEAWAYS

Out of 5 respondents:

1)    100% are women

2)    40% are or were nurses

3)    100% were not “born” medical writers. They all had or still have different jobs aside from medical writing. This shows that they are capable of constant self-reassessment.

4)    60% said that they would “never look back”, which shows their passion for medical writing.

5)    60% were asked by their employer to perform medical writing duties although they were not hired as medical writers. It shows that before even considering hiring a medical writer, companies look for people that might fit this function in their own staff.

Lisa. M. working in a mid-size Clinical Research Organization:

“I am a nurse who has worked in clinical research for 15 years. I am not a medical writer by title but I have participated in medical writing for clinical protocols and journals for clinical experience.”

Johanna Galyen, Freelance medical writer at Glowing Still:

“I’m slowly switching over from marriage blogging to medical writing. Initially, marriage was my only focus, but I wasn’t able to get any profit from it. So I started to look at using my nursing experience as a way to write for companies. $6,000+ dollars of income later, I realized that maybe I should switch my website over to that as well.”

Kitty W. Freelance writer at a law firm that specializes in medical negligence and personal injury claims

“I have been a freelance writer for 5 years. Two years ago I began working in an entry-level admin role at a medical negligence and personal injury firm. They asked me to create a content-based role to help their marketing strategy after I was put forward for a paralegal role, and my CEO learned from my resume about my background as a journalist.”

A freelance medical writer who wants to remain anonymous

“My original career was as a preclinical bench scientist. I left in the mid-1970s due to a legal dispute that was settled out of court. I was a writer virtually from birth (beginning at the age of 3, I read everything I could get my hands on and began writing short stories and poems a few years later).

So, given my natural interests/skills and my training as a pharmacologist at one of the best medical schools in the country, medical writing seemed a good fit. I relocated to New York City with my first job at a medical advertising agency, and never looked back.”

Jill A. Freelance medical writer since 1995

“PharmD specializing in drug information. Five years of drug information paid for my learning curve with medical writing. In 1995, our resident got a little freelance job that he didn’t have time for. I snapped it up and never looked back.”

It’s interesting to note that there are similar trends in the translation industry:

1) About 70% of translators are women.

2) Many of them have another job alongside translating.

3) Many of them are not “born” translators and come from other industries.

4) Those who remain in the translation industry for longer than a couple of years are passionate about translation.

5) In many cases, companies will just ask one their employees to translate content although it’s not one of their qualifications. They will only look for a “real” translator if they deem the content as important enough. Most of the time, they will look for translation agencies and not for freelance translators. If you would like to learn more about this, I talk about this in one of my blog posts called 3 Reasons Why You Should Change Your Translator Search Strategy.

Are you a medical writer or translator? What’s your background?

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

Did you like this article? Do you want to be notified when new articles come up? Subscribe to MedPharmaTranslator’s newsletter to get advice on easy ways to find a good translator, Medcomm industry and medical translation tips.

Post reviewed by Johanna Galyen from Glowing Still

How To Deal with Ethnic Data in French Clinical Trials

Background – Ethnic Data in US Clinical Trials

“FDA regulations require sponsors to present in certain marketing applications an analysis of data according to demographic subgroups (age, gender, race) […].

In 1997, the Office of Management and Budget (OMB) issued its revised recommendations for the collection and use of race and 56 ethnicity data by Federal agencies (Policy Directive 15). FDA now recommends the use of the standardized OMB race and ethnicity categories for data collection in clinical trials for two reasons.

– First, the use of the recommended OMB categories will help ensure consistency in demographic subset analyses across studies used to support certain marketing applications to FDA and across data collected by other government agencies […].

– Second, these categories may be useful in evaluating potential differences in the safety and efficacy of pharmaceutical products among population subgroups.”[1]

What Does the French Law Say?

“France’s Data Protection Act No. 78-17 created the French Data Protection Authority (Commission Nationale Informatique et Libertés [CNIL]).

Article 8 of this legislation states: ‘The collection and processing of personal data that reveals, directly or indirectly, the racial and ethnic origins, the political, philosophical, religious opinions or trade union affiliation of persons, or which concerns their health or sexual life, is prohibited’.”[2]

This means that the majority of ethnic differences may not be usable for pharmaceutical needs. Not having access to the information can put a company into a difficult situation, as this information is helpful, but all is not lost.

10 Exceptions

There are 10 exceptions to the French Data Protection Act. These exceptions pertain to the aim of the treatment, the conditions in which the data is collected, and the nature of the organization delivering the treatment.

The exceptions are as follows:

  1. Processing of sensitive data belonging to a person, who previously gave their express consent to this processing (unless legal texts provide that the prohibition cannot be lifted) can be used.
  2. Processing of data made publicly available by the data subject is not prohibited.
  3. The files from associations and organizations of a religious, philosophical, political or trade-union character can be shared (only sensitive data pertaining to the aims of the association may be collected and only on members who are in regular contact with the organization).
  4. Processing necessary for the establishment, exercise, or defense of legal claims is usable.
  5. Processing required for the purpose of preventive medicine can be performed.
  6. Processing required for establishing a medical diagnosis is acceptable.
  7. Processing required for the provision of care, treatment, and management of a medical condition can be done.
  8. Usable personal data must be processed in a location and by people that are already under obligations of professional secrecy in accordance with federal law.
  9. Processing necessary to the safety of human life is permitted.
  10. Processing of health-related data for medical research needs is acceptable.[3]

Why does ethnic origin matter in clinical trials?

You may ask yourself why data on ethnicity is necessary.

It’s because some diseases affect more commonly people from specific ethnic origins.

For example, “In the Netherlands, chronic diseases, such as diabetes mellitus and cardiovascular disease, are more common and have a poorer prognosis in patients of Surinamese, Turkish and Moroccan origin. Surinamese develop cardiovascular diseases more often and at an earlier age; it is recommended that their cardiovascular risk profile be checked at an earlier stage. […] Ethnic differences in the efficacy and toxicity of drugs are mainly caused by genetically determined variations in the activity of drug metabolizing enzymes.”[4]

What about you? As a Clinical Research Associate or a researcher, have you ever been in a situation where you couldn’t collect data on ethnicity because the law prohibited it? Were you able to find the information you needed, and if so, what steps did you utilize to ensure it was appropriately gathered and processed?

Do you know someone who might find this article interesting? Don’t hesitate to forward it to them! Let me know in the comments your thoughts about this important issue, and let’s learn together!

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[1]https://www.pharmamedtechbi.com/~/media/Images/Publications/Archive/The%20Gray%20Sheet/29/050/01290500018/031215_race_and_ethnicity_guidance.pdf

[2]https://www.advamed.org/sites/default/files/resource/9_19_2016_advamed_comments_on_dkt_no_fda-2016-d-0734_evaluation_and_reporting_of_age_race_and_ethnicity.pdf

[3]Translation of https://www.ladocumentationfrancaise.fr/var/storage/rapports-publics/074000339.pdf

[4]https://www.researchgate.net/publication/236224174_Chronic_diseases_in_ethnic_minorities_Tools_for_patient-centered_care_in_diabetes_hypertension_and_COPD

Post reviewed by Johanna Galyen from Glowing Still