Why Do We Need Clinical Trials?
People are always asking why we need clinical trials. They say, “Why don’t we just go ahead and treat people with whatever seems promising?”
Clinical trials are critical to finding a cure. They are the way to provide concrete evidence of whether or not a therapy is effective. Because of this, clinical trials are the only way a therapy will receive regulatory approval and therefore the only way a therapy will be accepted by other doctors and the only way insurance companies will pay for the treatments.
When so-called ‘treatments’ are done overseas by doctors who are charging for the therapy, they cannot do the randomized trials necessary to prove that the therapies are safe and effective. Those who charge for the therapies become dependent on the money and never show whether or not the therapy is effective.
Clinical trials provide impartial and objective information concerning therapies. Therefore clinical trials should be carried out by impartial investigators who have ‘no skin’ in the deal. This is why it is important for a therapy to be supported by two or more third party investigators before being accepted for clinical trials.
The line between science and quackery is very sharp and clear. Clinical trials provide strong and credible evidence that a treatment is safe and effective. A quack may claim a cure but does not provide credible evidence for safety and efficacy. Quacks sell unproven therapies, using testimonials as their primary support. Many testimonials have proven to be false and misleading. If someone has paid for a therapy, they want to believe it works. This is the reason ChinaSCINet and SCINetUSA emphasize that the first trials may or may not show that umbilical cord blood mononuclear cells and lithium work. If they don’t work, that information will be public.
Multiple clinical trial networks are needed. For example, with cancer, hundreds of clinical trials are carried out every year. Nearly 50% of people with cancer have the opportunity to be randomized in clinical trials. This compares with less than 0.1% of people with spinal cord injuries. Clinical trials are like seeds. The earlier and the more seeds are planted, the earlier and bigger the harvest.
Only clinical trials provide the evidence of safety and efficacy needed for a treatment to get regulatory approval and be accepted by doctors and insurance companies. And that is the only way genuine treatments will come to people.