Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing. Go→
News, articles and issues specific to clinical trial practice and implementation at the investigative site level. Go→
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News, articles and issues specific to laboratories role in the clinical trial, including ECG, imaging, genotyping, tissue samples and more. Go→
News, developments and strategies for clinical trials conduct in relation to the FDA, EMEA and other global regulatory authorities overseeing the drug development industry. Go→
News, articles and strategies related to clinical trial design which impact postmarketing studies, therapeutic areas, adaptive trials, statistics, protocols and more. Go→
It’s no secret that I have spoken with a lot of clinical trials professionals in my day. For articles, at conferences, in emails and on the phone...I never tire of it. I get to speak to smart people that work in a very challenging industry in times that are in flux. Because the work that is conducted in clinical trials is so broad, I also know that there are many, many different jobs that keep this big machine rolling. But I can also say of these professionals, each and every one, they love what they do. People who get excited about patients, data, processes, business strategies, relationships, changing paradigms, drug safety testing, protocols, endpoints…all of it. This is a dedicated group.
You are also the same group of people that write articles and put yourself through the peer-review process in hopes of sharing your information, experiences and knowledge in a meaningful way. The peer-review process is not without its bumps and bruises. Believe me, even after all these years of writing, I still am not thrilled when someone critiques an article I wrote, even if it in the end it makes for a better article. I get it, you are putting yourself out there.
Almost one year ago, Ken Getz introduced me to Linda Strause to discuss an article she had drafted titled the Voice of the Patient. The article approach had two twists: Linda has a PhD in neurophysiology and is Executive Director and Head, Clinical Operations, Vical Incorporated, a biotechnology company. The second was that her article chronicled her experiences with her husband’s diagnosis of glioblastoma, an incurable brain cancer. Because of Linda’s professional and personal experience, she had a unique position from which to offer insight to the industry. However, I told her in an email “We have never included a peer-review article from the voice of the patient / caregiver, so I'm unprepared to offer a lot of upfront advice.” But over the next few months, we went back and forth with each other and members of the Applied Clinical Trials Editorial Advisory Board, who are the peer-reviewers, to work through this very difficult topic.
Even when interviewing Linda for a series of vidcasts about the article, it was difficult for me to hear her experiences because her husband did not survive. And her article comes to discuss enrollment; ethical issues surrounding life-or-death illnesses in clinical trials in regard to informed consent, information understanding, and decision-making for patients and caregivers from the vantage point of hope. That is what defines motivation in a life-or-death illness diagnosis is hope and that hope is a huge determinant of behavior.
When you listen to this first vidcast, titled Oncology Clinical Trials: Patients on the Edge of Hope and Science, you’ll hear Linda explain the peer-review process; the reasons why she wrote the article; and you’ll hear the dedication she has to both her profession and her family. In upcoming pieces, you can listen to Linda discuss further the challenges and suggested solutions to oncology patient enrollment, as well as read the article online in mid-March.