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.
Last month, at the DIA's Annual Meeting in San Diego, we launched Adaptive Patient Recruitment, a new specialty in clinical trial marketing that helps solve today's unique challenges around global enrollment. Through a custom and balanced mix of cutting-edge technology, data-driven consultation, and strategic branding and advertising, our Adaptive Patient Recruitment discipline allows today's global study community to work more collaboratively, respond rapidly to often unforeseen enrollment challenges, and make more informed decisions at critical study milestones.
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.
I cannot profess to have attended all 49 of the previous DIA meetings – and imagine there aren’t too many among us who possibly can. Nevertheless, BBK Worldwide has participated for most of our 30 years in business – yes, this is a big anniversary year for the company. Some elements of DIA are tried and true, others perhaps a little tired, yet every year there is something that sparks the imagination of each attendee. And these small sparks become profound influences on how we spend the days, months, and years ahead.
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.
While the push for sponsors to go global with clinical studies is old news, choosing the right sites and the right countries to host a particular study remains one of the industry’s most impenetrable challenges. Over the past few weeks, I have participated in several conferences on clinical operations improvements and remain baffled by the limited progress study teams have made in this area over the past five to 10 years. Ultimately, site selection matters because investigator sites are the only place where study volunteers can participate in clinical research. Enrollment is the end game – further drug development, regulatory submissions and marketing are contingent on having these data.
That said, it makes sense to start from the final step – patient enrollment. Begin by analyzing the protocol from a patient recruitment perspective – its particular enrollment challenges, and compare them to a set of patient-related factors in each country in order to determine which countries are the best fit for the study. Effective site selection is dependent on identifying the countries that have the fewest recruitment barriers and are likely to enroll the most patient in the least amount of time.
It’s difficult to look back on 2012 without the month of December coloring the year. From the FDA’s last-minute approvals of several drugs, to the flurry and fury of the fiscal cliff debates, to the unfathomable massacre in Newtown, CT, December not only changed the complexion of last year, but also reset the tone for our industry in 2013.
Last week, the Allan Lloyds Group brought to Chicago the very successful Patient Recruitment and Retention Summit - USA. This summit is an excellent occasion for business, with presentations on interesting case studies and ample opportunities for knowledge sharing. An exceptional group of clinical development professionals were generous in sharing their experiences, insights, and ways in which they are pushing the envelope to engage patients in clinical studies.
As the summer holiday season comes to a close in the northern hemisphere, sponsors shift their focus to two major considerations: making serious progress on site activation and patient enrollment before the holidays, and preparing budgets and timelines for studies that will start in 2013 and 2014.
For the past two months I have been on the road—mostly in Asia and the United States—both on professional and personal travel. It’s always an opportunity to step away from day-to-day work and listen acutely to the quiet voices of our industry. Often, I find the long-standing concerns as powerful in their continuity as I do the novel observations in their potential for innovation. Here are the stand-outs from early summer 2012.