Tag Archives: trial design

Patient-Driven Research Relies on Open Web Info 1

by • Clinical Trials, LCOI • Tags: , , , , , , , , , , , , ,

Ben Harris is a medical physicist from Indiana and an example of a patient conducting a Do It Yourself (DIY) study.    Diagnosed in January of 2011 with ALS (amyotropic lateral sclerosis, also known as Lou Gehrig’s disease), Harris became both the clinical researcher and the single-patient subject in his search for effective treatment of the disease.

It was six months after his diagnosis that Harris took part in a sponsored clinical trial for a new experimental drug.  The treatment gave him some relief from his ALS symptoms and hope that the progression of the disease could be inhibited.  Other patients had similar results.

“Accounts similar to Ben’s began to emerge in the chat-rooms,” says Harris’ brother, who is documenting the events surrounding the ALS diagnosis and the pursuit of this new treatment. “There’s one small problem: the FDA’s process would take between 5 and 7 years before [this new drug] would be approved and made available.  My brother could be dead by then.”  In clinical research, time can mean everything, particularly to patients.

Harris began an intensive Internet search for information about the compound used in the trial. More…

A Physician’s Tale (and video guide) Reply

by • LCOI • Tags: , , , ,

Last week we had the privilege to sit down with a physician who shared challenges in planning a clinical trial. She had been working for years on this trial, and continued to face resource consuming and frustrating issues. Recently she attended a two hour meeting where some basic questions were left unanswered, and – even more frustrating – the traditional paths to getting those answers were not promising.

One, she was struggling to find subjects to qualify for the trial. Two, she was wondering about what investigator sites might be appropriate.

She knew that there were others who were conducting trials on this disease, but couldn’t quickly and easily get at key information about those trials. If she could find the right trials and learn about the investigator sites used, it could help her with strategies to find potential sites and qualified subjects.

Enter Clinical Collections. More…

A Chat With Tom Krohn 7

by • LCOI • Tags: , , , , ,

Tom Krohn is the Business Lead for the Lilly Clinical Open Innovation Team. Tom’s career began as a practicing pharmacist.

His experiences in building and eventually serving as GM of the largest healthcare organization in Madagascar shaped his frame of reference, as he realized that healthcare was not only about delivering much-needed treatment and medicine, but also about logistics, business models, and the accessibility of information.

In this interview, Tom tells us the story of how his “personal passion and commitment to use my talents to serve the marginalized of society” was shaped over time – and how this passion can be realized through his work in clinical open innovation.

You have a varied and interesting background: You’ve been a pharmacist, a CFO then GM for the largest healthcare organization in Madagascar, you have experience in an IT organization… How did that evolution happen?

The experience in Madagascar showed me a lot about what information systems and appropriate uses of technology could do for healthcare – both to help get things done and, especially, to empower the people doing the work.
More…