• Paul Allard

Better IVD's through Strong Patient Relationships.

There is a relationship between patient emotional well-being and IVD commercial success. What motivates patients to participate in diagnostic clinical studies? Potentially life saving treatments offered through clinical trials provide tangible benefit. Patients understand that this new treatment "may save my life." However, donation of a tube of blood to a company across the country involved in creating the latest Next Gen sequencing technology does not have the same tangible benefit to patients. Compensation of 50-100 dollars may be welcome, but does not satisfy patient's emotional needs. We need to give our patients a reason to trust us and a reason to feel good about participating in clinical research with no immediate benefit.

To avoid the time and the perceived cost of putting patients first, we as an industry have adopted ineffective modes of obtaining patient samples. Remnant samples, although legal, ethical, and moral, are limited in their utility, have limited clinical data, and are becoming increasingly difficult to obtain. NIH recently proposed revisions to the Common Rule that would have curtailed the use of remnant patient samples for research. With stricter consenting procedures being proposed every day, this may yet happen. Archived patient samples have their own problems of limited patient consent, and limited clinical data. And we often overlook pre-analytical issues of stability, storage conditions, and chain of custody in the rush to get samples in the door.

As an industry we waste millions of dollars every year trying to save money on cheaper samples that don't suit our needs. In doing so, we put samples before patients. The solution is not access to more remnants. Nor is it millions of samples in a freezer. The key is strong relationships with patients that are willing to participate in IVD clinical studies. We can do this by understanding our patient's needs. Why would they donate blood? Why is it important to medicine? Why is it important and rewarding to them? Can we as an industry create an atmosphere of trust and transparency with our patients leading to faster enrollment, consents that fit our researchers needs, and samples and data that meet the needs of IVD development? Patient well being does matter and leads to studies that are done right at affordable cost, the first time.

Coming up: Can a prospective clinical study provide patient samples in the same time and at the same cost as retrospective approaches? Yes! But, how?

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