This is not a place for learning for the first time on the fly-it demands careful application of all the wisdom you have gained from years of conducting research. Transition or rescue of a study from a sponsor to a CRO, or from a CRO to another CRO, requires highly detailed processes that have been developed over time with insights borne from experience. The answer is one that is not always appreciated at first as with any successful complex delivery, it is down to planning, process, and discipline. Now the question is “How?” How exactly do you go from getting an approval after a one-year interim data cut of a five-year (often 10-year) clinical study, to transitioning the post-marketing/post-approval follow-up phase of the same study, without stopping, to a CRO? (This situation also applies to changing from a current CRO to a new CRO-a classic “rescue study.”) So why would you transition an ongoing project away from our immediate care and into the arms of a CRO? To make sure that it is getting the attention it needs with the scientific and quality rigor that we expect from robust clinical trials and, most importantly, that patients who have been subject to experimental therapies have appropriate follow up and ongoing care. Time for some deep soul searching-are the factors described here keeping the leading scientific innovators in your organization working to midnight, and returning to the office before sunrise? I’m sure they aren’t, because these innovators are always seeking a better result than they got today-they are looking forward all the time, and revisit the past only for how it informs the future. It’s not about profitability, it’s about viability even not-for-profit organizations have to remain economically viable.īottom line, there aren’t just regulatory commitments that must be delivered upon, but there is also a community of patients, prescribers, and payers to keep happy, for both patient-centric and economic reasons. Let’s now look at our “primary objective of gaining regulatory approval.” The most obvious comment here is that there is so much more that hinges on your pivotal trial than gaining regulatory approval.īeing approved goes only so far, getting buy-in from the medical community is of huge value, and still more importantly, getting the payers to understand your economic proposition is the only way to be truly successful. It’s not tied to patient outcomes (we usually can’t change those post-hoc) and it’s not tied to revenue. How do you keep true attention on a legacy product that we no longer market or generate revenue from, but for which we have ongoing moral and regulatory obligations to patients and regulators? This is a “soft” challenge-and when I say soft, I don’t mean that it is easy I mean that it is intangible. Post-market commitments are maintained for legacy products in parallel with the latest innovations, and it is realistic to assume that the enthusiasm for the latest product garners the greatest attention. Unlike the drug study experts, this means we device folks are often faced with multiple iterations of a product undergoing simultaneous clinical trials. A drug that changes or evolves is a different drug, plain and simple. Professionals in medical device companies are dissimilar to those in drug companies in that their products change and evolve. Don’t Let Perfect be the Enemy of Goodįirst up, let’s look at “managed reasonably well.” Whatever your background, whichever company you have worked with, can you really claim perfect delivery? I hope you can, but face it, we all encourage an environment of continual improvement-one which would be redundant in a perfect world. Let me break down the question into bite-sized chunks-how I like to look at every problem, because the solutions are far less daunting when you take this approach. Let’s start with “Why?” Why would you transition an ongoing study that is being managing reasonably well, and for which you have obtained your primary objective of gaining regulatory approval? It is time, however, that we took a more pragmatic view of why this should happen, and contemplate whether we should be considering and enabling it more often. There can be a negative perception around a device clinical trial being transitioned to a contract research organization (CRO). Clinical Researcher-August 2018 (Volume 32, Issue 7)
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