An advantage to clinical testing is being able to come up with a breakthrough medical device/technique that treats many patients to unique illnesses while of course, being lucrative. A disadvantage is risking a high-cost study that yields adverse results with several ill/dead patients. It’s true that there’s only so much that laws and controls can do regarding the safety and efficacy of clinical trials, however these trials have also undergone many milestones of their own, a lot of which aim to proceed away from compromising the health of the patient. For example there was a study involving the culturing of hepatocytes on 3D constructs that were administered fialuridine for treating hepatitis B (1). Fialuridine however, was toxic in that it can result in liver failure (and has resulted in clinical losses in the past). The cultured hepatocytes however, were able to express the hep B infection that went undetected in preclinical studies, preventing any potential harm to patients who would have undergone the trials had the 3D technology not been available. Even cosmetic companies such as Loreal use either skin from organ donors or 3D tissue-engineered skin for testing their products for cytotoxicity, sensitivity, carcinogenicity, etc.

On the contrary, studies done in the U.K. have attempted to treat rheumatoid arthritis and leukemia with a drug (TGN1412), which instead caused chronic inflammation and organ failure in its patients, so sometimes great attempts lead to drastic failures. Could the advancements in medical technology today be achieved without applying what we know now from human clinical trials? Are there any other studies done that foresees the testing on humans as obsolete? How risky do human trials need be to justify achieving an effective product for a particular condition such as skin irritation? What about type I diabetes or Alzheimer’s?

Reference:
(1) Ng, Soon Seng et al. “Long-Term Culture of Human Liver Tissue with Advanced Hepatic Functions” JCI Insight, June 2017