In keeping with my commitment to ask “Why?,” I have been thinking about the word “pulse.” Do we really need to take the pulse of multinational studies in order to prove they are still vital? Maybe we mean to use the information we gather by taking the pulse of these studies to diagnose the health of our industry. Why does a research center in Billings, Mont., need to know the pulse of what is happening at a center in Kyoto, Japan? Is this merely a habit born from Good Clinical Practice, like taking a patient’s weight at each office visit? How does examining the rhythmic throbbing of every research study become a benchmark for understanding the ideal metrics of each new clinical trial?
Over the past few days, many of you have asked what I think about Pfizer’s decision to stop its virtual overactive bladder study: REMOTE. So here it is.
As the BBK team packs up for our trip to the DIA in Philly next week, I’m pondering the question: How has the digital age impacted the ethics of clinical study design and implementation – especially as this relates to patient recruitment and retention?
The phase IV clinical trial setting is taking on a new dynamic. Simple observational studies with paper diaries and handwritten records are being replaced by complex data-gathering exercises involving greater intervention on the part of the physician and patients, who are now emerging from doctors’ offices armed with iPads for taking notes.
On April 7, 1945 the United Nations established the World Health Organization (WHO). Today we honor its 67 years of service to peoples everywhere. WHO has led us to so many advancements in health – from vaccines for polio and smallpox to elimination of infectious diseases such as yaws and onchocerciasis, diseases that most have never heard of despite their impact on millions of lives.
Andre Briola and I had the chance to spend time with many members of active study teams whom we haven’t seen in too long. I continue to be struck by the unflagging passion for clinical research that I find throughout our industry in every region of the world. Despite the challenges of science, operations, regulatory requirements, and relationship management, clinical research professionals care deeply about their work and the patients they hope to help.
Topics: Mobile Strategies
I’m on my way to Barcelona for the 4th Annual Patient Recruitment and Retention in Pharma Conference, hosted by the Allan Lloyds group (21–23 Feb 2012) and looking forward to experiencing the delightfully cold winter in Europe. We haven’t had any snow in Boston since Halloween in late October which has been a big disappointment, softened only by the unseasonably warm weather.
I’m already looking forward to next year’s conference and continuing to network and connect with people in the healthcare industry. My biggest take away was the roundtable discussion I participated in. The topic revolved around country selection and feasibility. It was very interesting to me that although some of the talks were on global site selection, a number of participants were interested in learning about process and timing of country selection. It seems to me that even though most clinical trial sponsors (pharma or device companies) are conducting their studies globally, the selection of each country is done by accessibility, location of affiliates offices, etc. There is additional room for improvement, education, and progress to make the best decision about country selection that meets the clinical trial needs.
BBK is back from the 2012 CHI SCOPE conference excited and motivated for the rest of 2012 with plenty of insights to share. Below is a recap of the conference from two of BBK’s attendees. Stay tuned for Part Two of our recap.