What would you do if you had access to $3 million dollars to invest in improving the clinical research field? This might be a relatively small budget by some standards, but significant enough to make a difference and BBK has some very specific plans to do just that as we continue to deliver on our value proposition, BBK Worldwide: The Patients To Find the Cure.
This past July 15th, the FDA tilted its regulator hat and announced the release of a new Draft Guidance, Informed Consent Information Sheet, to help clinical investigators and sponsors involved in clinical trials obtain informed consent from subjects. The new Draft Guidance provides important updates to the FDA’s informed consent policies and covers the specific responsibilities of IRBs, clinical investigators, and sponsors regarding informed consent.
Topics: Patient Centricity
Earlier this month, I presented BBK’s approach to advocacy outreach and engagement for patient recruitment at the inaugural Patients as Partners conference in Philadelphia, Penn., hosted by The Conference Forum. Patients as Partners examined how we engage with patients across the entire clinical trial continuum, including early research, patient-centric protocol design, recruitment, retention, and communicating results with patients acting as ambassadors and educators. Following the conference, I had an opportunity to interview Valerie Bowling, executive director at The Conference Forum. Here is what she had to say…
I sent this message out recently when I learned that my friend Sara had died of metastatic colon cancer. Like so many others, Sara fought the hard fight: driving her cancer into remission for nearly seven years before a recurrence got the upper hand.
Recently I was struck by two of the lead articles in the FierceBiotech news feed. At the top of the list was a story from the U.S. – Specialty med price shock rattles ill-equipped payers. And two items later, this one from Europe - EC promises $187M for ambitious effort to spawn 200 new rare disease drugs.
Lasting relationships with patient advocacy and community groups can be an important part of a patient recruitment program. The question is, how do you build those relationships? And once you’ve built them, how do you maintain them? Here are a few ways you can work with advocacy groups as a patient recruitment tactic.
November can play many meaningful roles in our lives. Whether it’s football, family and friends coming together over a Thanksgiving meal, the seasonal change, or mustaches. Yes, mustaches! Starting with the ever so startling peach fuzz and growing into the sublime full grown mustache. It drove the Hulkamaniacs wild and gave us the Theory of Relativity. But why does November honor thy mustache? For the research.
The day is warm, the rain is gone, and to my amazement, I’m standing in a parade of pink!
“Ok, so I'm coming out the closet about something... I have psoriasis... There, I said it. Well, it's really not coming out the closet now, because in recent years I've been very vocal about my condition and the effects it has had on my life. But for years I hid in shame. Here, I'll share my struggles, but most importantly I'll share my accomplishments when dealing with this disease.” - Alisha Bridges
I was sitting in my synagogue for the Jewish New Year when the rabbi began his sermon. It was all about his friend who participated in an oncology clinical trial (end-stage cancer) and how he seemed to be responding to the treatment but, subsequently went into failure. He survived long enough to find out that he had been in the placebo arm of the study. (Study reached completion and therefore his doctor was able to provide this information.) “He received the placebo,” the rabbi said emphatically.