Convincing people of the safety and efficacy of a new medical treatment is all about data. Whether you are talking patients, doctors or regulators, people want to see hard and fast clinical data before throwing their support behind a new treatment. Such data is lacking in the regenerative medicine field. However, case studies are not. They could be the answer.
In an interview with a Los Angeles television station, regenerative medicine clinician Dr. Steven Sampson mentioned how his clinic has established a not-for-profit registry enabling doctors across the country to share data related to their PRP and stem cell treatments. Sampson’s clinic is feeding data from their own clinical trials into the registry in hopes that others will do the same. The amassed data could eventually be used to encourage insurance companies to cover regenerative medicine procedures.
Case studies could be useful in this endeavor. While not all regenerative medicine clinics conduct clinical studies, most do keep track of how patients respond to treatment. In other words, they conduct before and after assessments for the purposes of tracking efficacy. That information could be turned into case studies and fed into a central registry.
Clinical Trials and Case Studies
Step back and consider just what clinical trials and case studies really are. If you think it through to the most logical conclusion, you discover that clinical trials are nothing more than large-scale case studies involving multiple patients. Both forms of scientific evaluation utilize the same means of measuring efficacy: medical testing and patient reporting.
In a clinical trial, multiple patients are offered a treatment for whatever ails them. There are control and test groups evaluated at baseline, during treatment, and at certain intervals following treatment. All the evaluation data is then compiled to determine efficacy.
Case studies are similar except that they deal with patients one at a time. There is one pronounced difference though: case studies do not involve both test and control groups, which is not necessarily a negative. If a doctor or clinic approaches case studies from an unbiased perspective, the compiled data will account for both success and failure.
Case studies do not carry the same weight as clinical trials because of the lack of testing control groups. But that does not mean the data they generate is useless. In fact, the data is quite valuable. If a doctor treats 10 patients for osteoarthritis and eight of them respond positively, the data compiled on all 10 patients becomes useful for evaluation purposes.
The More Data, The Better
All of this does not mean much unless data is fed into a central database where it can be compared and statistically analyzed. That’s where the Los Angeles clinic’s registry comes into play. The more data fed into that registry, the more valid it will be for statistical purposes. More data means more opportunity for unbiased analysis.
Clinical data in the regenerative medicine field is lacking at the current time. And unless the FDA reverses course, the lack of data is likely to continue for the foreseeable future. Why? Because as Utah-based Apex Biologix explains, most of the regenerative medicine procedures offered at clinics like Sampson’s do not require FDA approval. Therefore, clinics are not likely to invest the kind of time and money needed to produce large-scale clinical studies.
A central registry of case study data combined with small-scale clinical trials could eventually grow into a sizable and reliable database that proves the efficacy of regenerative medicine once and for all. That’s the goal, anyway. Let’s hope that goal is someday realized.