Authors: Lee Schacter, PhD, MD; Gerald L. Klein, MD
A recent news article published in Science[1] highlights disturbing incidences of apparent maleficence by Clinical Research Organizations (CROs) in South Florida. The article stated that the biotech T3D Therapeutics found data generated by a CRO from an Alzheimer’s trial to be “medically impossible”. Issues ranged from treatment of patients without evidence of the disease to levels of the test agent in patients receiving placebo and led to the write off of a $35 million study. Challenging for any company but especially for a startup.
Other companies have been burned by CROs conducting Alzheimer’s trials including Annovis Bio and BioVie according to the article, again with the enrollment of inappropriate patients or brain scans that were copied and pasted. Big Pharma is not immune to the issue. Bristol-Myers Squibb was burnt by irregularities leading to exclusion of data in a trial of Cobenfy and needs to replace subjects. A study by Eli Lily may also be affected.
Malfeasance by CROs happens and sponsors must be careful not only in their choice of CRO but should have their studies monitored independently and often. It is not a good practice to give your clinical trial to a CRO and not be involved until it is completed. Independent consultants to help with the in-house medical and clinical operations is a cost-effective way to protect the study and the company. Reviews need to be unblinded and detailed, conducted by experienced individuals able to spot irregularities as they occur and recommend corrective action. If a CRO is also responsible for any critical elements such as the development plan, study design, statistical plan, electronic medical record creation, and maintenance; these too need to be carefully reviewed by outside experts, especially for a small company to assure they will meet the sponsor’s requirements and the regulators’ needs. The extra expense of these activities is more than justified by the risk of misconduct or suboptimal performance by the CRO.
Bottom line: when a CRO manages a trial, sponsors should trust—but always verify.
[1] Kaiser J. Alzheimer’s drug developers accuse clinical trial sites of faking data. Science. 2026;371(6524):112–115. Published January 8, 2026. doi:10.1126/science.adkXXXX