by Barbara Rusin, April 4, 2019
One of the first problems that clinical investigators may face when attempting to attain medical records is patient refusal to either provide them, or allow them to be collected. At the outset of such a refusal, any potential study subject should educated as to how important medical histories are to research studies.
by PhUSE, March 14, 2019
This White Paper focuses on two approaches to produce anonymized narratives – retrospective and proactive. The retrospective section sheds light on the challenges faced with qualitative methods like redaction and what impact it has on data utility. The second part of this White Paper offers a perspective on proactive anonymization and how to operationalize it.
by Barbara Rusin, March 7, 2019
In defining the barriers to access to historical medical records, it is important to first recognize that some potential study subjects will come with no obstacles to medical history availability, while other may present a combination of issues which must be tackled.
by Staff writer, February 28, 2018
Rare diseases are often overlooked, but they affect many individuals. There may be as many as 7,000 rare diseases affecting approximately 25-30 million people in the US alone, according to the National Institutes of Health (NIH). Rare diseases are defined as conditions that affect fewer than 200,000 people…
Part 2: The Case for Better Health History Records – How Much History is Needed and How Should it be Reviewed?
by Barbara Rusin, February 21, 2019
Part 1 of this medical histories series focused on the regulations relevant to clinical trial subject eligibility, and the possible issues which can arise when ineligible subjects are enrolled. As noted, the outcomes vary depending on whether you are a clinical site, a CRO, or a study sponsor, but all are detrimental to the research in some form.
by Staff writer, February 14, 2019
In this Expert Insights interview, we sit down with Ben Kaspar, Global Submissions Manager at MMS, to discuss regulatory strategy, 505(b)(2) applications, and general submission advice for any global companies outside of the US that plan to submit to the FDA.
by Staff writer, February 7, 2019
In this Expert Insights interview, we sit down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety writing in the pharmaceutical industry, pharmacovigilance, Risk Evaluation and Mitigation Strategies (REMS), and his future vision.
by Megan Day, AA, BA, PhD (ABD), January 17, 2019
Whether writing a clinical study report or a journal article, both illustrate the summarization of clinical trial data, serving multiple functions. Regardless of formatting, structure, and organizational limitations, medical writers are tasked with the ultimate goal of communicating complex data clearly and accurately.
by Erin Booth, PhD, January 10, 2019
Approximately 90 percent of global pharmaceutical companies are using, or have plans to use real world data in the near future, according to a 2018 benchmarking survey from Deloitte. This coincides with an increased focus on the use of real world evidence from the U.S. Food & Drug Administration (FDA).
by Amanda Beaster, PhD, January 3, 2019
In the early 2000s, I sat in an undergraduate microbiology lab and caught the bug. It was not a laboratory-acquired infection, but inspiration from a world only seen under the microscope.