Certara’s Best of Blogs 2015

A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.

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Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

Kelley Kendle

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells— derived from the tumor of a Baltimore woman named Henrietta Lacks. A poor, African American woman, Lacks was suffering from cervical cancer when she received treatment, including a tissue biopsy, at Johns Hopkins University. Violating the principle of informed consent, university researchers cultured the cells from Lacks’ tissue without her knowledge or permission. She succumbed to her disease in 1951, at the age of 30.

The breach of trust in creating the eponymous HeLa cell line caused lasting trauma to the Lacks family. Part of their distress may have also been rooted in the failure of the research community to share with them the incredible positive impact that their mother’s cells had on biomedical research and health outcomes. One of the things that may have brought them a sense of closure was visiting the lab of a Johns Hopkins University researcher to learn about his use of HeLa cells. Skloot described the scene wherein Henrietta’s daughter, Deborah, first saw a cryovial of HeLa cells:

“…she raised the vial and touched it to her lips. “You’re famous,” she whispered. “Just nobody knows it.”

While ethical conduct of clinical research has improved tremendously over the past sixty years, we can still do better. When volunteers participate in clinical trials, they entrust pharmaceutical researchers with their bodies. In return, we have an ethical obligation to share with them the results of clinical trials.

Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the sponsor or research center after the last study visit, leaving many volunteers wondering if their participation mattered or was appreciated. In this blog post, I’ll discuss our recent partnership with the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) to help pharmaceutical companies “Do the Right Thing” by developing lay summaries of clinical trial results to inform the general public.

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Topics: Regulatory Writing

Strategic Regulatory Writing for Drug Development Success

Kelley Kendle

Happy New Year! The start of a new year brings the promise of new opportunities for growth— both personally and professionally. As the CEO for Synchrogenix, Certara’s regulatory writing consultancy, I’ve been thinking a lot lately about how changes in the regulatory writing landscape will shape the drug development process in 2015. It’s becoming more and […]

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Topics: Regulatory Writing
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