The US FDA is enhancing its clinical trial transparency policy

The FDA announces today (January 16, 2018) that

  • Starting from January 2018, clinical study reports (CSRs) and other information of pivotal clinical trials of some of the recently approved drugs will become available to the public on its new website.
  • The identifier numbers (NCT#) of clinical trials will be linked to drug application materials that the FDA uses for drug approval

Regarding its Clinical Data Summary Pilot Program, the FDA clarifies that

  • Only portions of the CSR (eg, summary of clinical evidence) will be posted on its website;
  • The protocol and amendments and the statistical analysis plan for each study will also be posted; but
  • Raw data will not be posted.


Giving Thanks

Giving thanks

Today is Thanksgiving here in the US. At this time of year, adults in the US tend to ask children (at home and school) what they are or should be thankful for.

This year, I decided to ask myself this question. As I started to write things down, I realized that my list is long.

Here is a part of my list related to work.

Work in general: This year I didn’t become rich, and my medical writing and communication business didn’t grow as big as I had sometimes hoped. But I am thankful for what I have managed to achieve.

Clients: Thank you for the many exciting and, at times, challenging projects. Because of you, I get to work on projects that are interesting and meaningful to me. Thank you for letting me be part of your teams that are making a positive difference in the world.

AMWA: I want to thank all the staff members and volunteers at American Medical Writers Association. Thank you for welcoming me to the medical writing and communication community more than a decade ago, for helping me constantly learn and grow, and for opening doors and providing opportunities over the years. I wouldn’t be able to grow and develop in this profession without you.

Colleagues, friends, and mentors: Through AMWA and other professional organizations, I have met so many colleagues with whom I can share thoughts and bounce off ideas. Many of you have become friends and some of you have become mentors. Thank you so much for your friendship and support.

Recruiters: Thank you for reaching out to me with different job opportunities. I am not looking for a full-time job, but I appreciate your time and effort to reach out. Many of you even took the time to read my posts and writing samples before sending me a message. Thank you for your dedication and professionalism.

Those who post encouraging messages on LinkedIn: We all face challenges at work and we often feel pressured and frustrated, even depressed at times. A few kind words, an encouraging message can make a big difference. Many of you have brightened my days with positive and helpful postings. You may not realize this, but you are making an impact in your followers’ lives with positive and helpful messages.

Thank you, and please continue to do so.

Trends and Opportunities in Medical Writing and Communication: Observations From the 2017 AMWA Annual Conference

2017 AMWA Medical Writing ConferenceAs a scientific and medical writer, I find AMWA’s annual conference a great place to learn medical writing skills and network with other writers. This year’s program was especially attractive to me. Trends and Opportunities for Medical Communicators. Who doesn’t like that?

Determined to catch the trends and grab opportunities, I rearranged my schedule last week and flew to Orlando, where the 2017 AMWA Annual Conference took place.

My main objectives were to 1) observe the landscape of medical writing and communication, 2) assess the strengths and weaknesses of my own business based on the information gathered during the conference, and 3) position my business accordingly.

And here are my observations from the conference.

  1. Regulatory medical writing played a predominant role. Medical writing is a diverse profession. But this year’s program appeared to be heavily regulatory writing oriented. Workshops, open sessions, posters, and roundtable discussions covered a wide range of topics for new and experienced regulatory writers.
  2. Medical writing business models are evolving. Based on my conversations with freelance medical writers at the conference and the insights I gathered from hiring managers at large pharmaceutical companies, more and more pharma companies seem to be choosing to work with “preferred” medical writing agencies with large capacities and scalabilities. Opportunities for freelance medical writers to directly work with pharmaceutical companies seem to be shrinking.
  3. Regulatory medical writing opportunities for newbies are increasing. For years, regulatory medical writing has been known as a profession that is difficult for newbies to break into. This year I noticed that some medical writing agencies and pharmaceutical companies started to offer training opportunities to aspiring writers through internship and fellowship programs. Here are a couple opportunities that I know so far.
    1. Internship at Whitsell Innovations, Inc. The agency has designed an internship program for aspiring medical writers with strong scientific backgrounds. For more information about the program and how to apply, visit medical writing Interns at WI.
    2. Postdoctoral Fellowship at MedImmune. This is the first postdoctoral fellowship in medical communications that I am aware of. The program appears to be an excellent opportunity for interested PhDs or PharmDs to learn more about regulatory writing and publication planning. For more information, visit Post Doctoral Medical Communications.
  4. Growing demand for public disclosure of clinical-regulatory documents. Both FDA and EMA have incorporated data disclosure and transparency in their guidelines. I was glad to attend sessions on these topics at the 2017 AMWA annual conference. As Aaron Bernstein stated in his presentation on the CORE reference, the trend is changing the way regulatory documents such as clinical study reports are written and organized. Companies adjust their practices early may save time later.
  5. Challenges and opportunities associated with clinical trial registration and results posting. Trial registration has become a common practice. Many countries (e.g., US and China) have their own registration requirements. The World Health Organization also maintains its own trial registration database. In addition to trial registration, results posting on in the US is required by the law. The site has unique requirements regarding what information needs to be posted. Many companies have set up teams to take care of this type of important yet time-consuming work. Because of resource constraints, some companies however are hiring freelance medical writers to assist with the task.
  6. Global medical writing is on the rise. As the leading organization in global medical writing and communication, AMWA’s annual conference attracts attendees from all over the world. In addition to medical writers from Japan and India, quite a few medical writers from China attended this year’s AMWA annual conference. I expect to see more Chinese medical writers at future AMWA conferences as medical writing has become a rapidly growing new profession in China.

Despite of the many learning opportunities offered at this year’s conference, however, I do feel like this year’s program did not provide enough educational programs for non-regulatory medical writers. Here are the areas that I wish this year’s program could have had more coverage.

  1. Scientific and medical publications. Publications is arguably the second largest segment of the medical writing profession, following regulatory medical writing. With the increased demand for transparency and data sharing, I can see only growth in transparent scientific and medical publications. Known challenges (eg, acknowledging the contributions of medical writers) will likely remain in the future. In addition to following medical journals’s guidelines, is there anything else medical writers can do to help improve the situation? Will new technologies change the way clinical data are disseminated? What’s the best way for aspiring writers to break into this field? And what are the career advancement options for experienced writers?
  2. Medical writing for healthcare providers. Regulations change, business models evolve. But the need for providing timely updates on new treatment options to healthcare providers remains. Has anything (besides CME) changed in this area of medical writing? What are the current and coming trends? Any new opportunities for medical writers interested in this type of writing?
  3. Medical writing for patients and the general public. Patient-centered treatment. Value-based reimbursement. These are the reality of today’s drug development and healthcare. But again, sessions on these topics were few. Helen Osborne—winner of this year’s Alvarez Award–gave an informative and entertaining presentation on health literacy. Drs. Lisa Schwartz and Steven Woloshin—co-winners of this year’s McGovern Award–addressed the importance of communicating benefit and harm the same way. Many medical writers at the conference expressed interest in these topics.
  4. The role of new technologies in medical writing and communication. Big data and data analysis, artificial intelligence and machine learning. These are not just buzz words anymore. They are already affecting how data are gathered, analyzed, and disseminated. But there were no sessions on these topics.

Did you attend the 2017 AMWA annual conference? What are  your observations and thoughts? Please share.