• Paul Allard

When You're Told it's a Bad Idea

They told us we couldn’t. Well, we just did!

Lakeside Life Science was founded at the kitchen table of Dr. W. Jeffrey Allard. It was at that table that our CRO began realizing its goals and our purpose became clear. The realization was simple: clinical studies are tedious, slow and expensive. A true barrier to meaningful innovation in laboratory medicine.

We had often thought about including local community centers in our research projects, but everywhere we went we heard the same advice: “Stay away from community clinical centers, they will ruin your studies. They don’t know how to conduct clinical research.” “These centers have no research infrastructure.” “You will spend too much time and money to train staff and implement procedures, and studies will not come to fruition.”

But let’s be honest, academic centers and larger community centers with established clinical research capabilities are not an ideal solution either. Lakeside Life Science realized that academic centers have important value in study design, data analysis, publications, and presentations at international medical conferences. However, running industry sponsored studies within their walls is neither time- nor cost-effective for most small to midsize start-up biotechs.

We reasoned that if the rest of our industry is avoiding small rural community clinical centers, then maybe that is exactly where we should be. We began to reach out to our local community centers to find out for ourselves why they were thought of as such a bad choice for clinical trial enrollment. We could find no reason to avoid these centers, and in fact we found that, contrary to prevailing dogma, they are ideal centers for many types of clinical trials.

With this in mind, Lakeside Life Science implemented a study to enroll 100 patients to evaluate a point of care test for Influenza A and B. This study required one nasal swab and one nasopharyngeal swab from patients with influenza-like illness, to be confirmed through PCR testing. Within a week we had the support of a local Physician Assistant who is the Chief of Medicine for the local Critical Access Hospital. Her dedication to participate in this study and her interest in clinical research for precision medicine was surprisingly positive. Her speciality is in Women’s Health, but she also splits her time at a local university health center. With her help, we wrote a protocol and ICF, obtained IRB approval, signed contracts, finalized budgets, implemented training procedures, enrolled 100 patients, and completed confirmatory PCR testing - all within 75 days of receipt of a purchase order!

Despite what we heard from our colleagues, we ran the study out of an urgent care center affiliated with the hospital in a town of 7,000 people. The positive feedback from the community was surprising and gratifying. Only 2 people declined to enroll, and all said that they were happy to help in any way. The greatest takeaway from our enrollees was that they had never been offered the opportunity to participate in anything like this before. The staff were excited to send us patients to enroll, and were active members of the team that made it all work seamlessly. Not only was the medical staff excited to join in the development of new laboratory testing, they are anxious to implement these new tests in their practice in the future. We also ran the PCR confirmatory testing in the local hospital lab. With help from the sponsor we were able to get a new test validated in this laboratory within a week, and they ran the testing quickly and effectively.

If this sounds as promising to you as we know it is, please join us as we change the paradigm of clinical research and bring precision medicine into our communities where it belongs.

(Join us next time as we dsicuss how Lakeside is cracking the code of working with the VA)

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