Jeremy Puthumana, MS; Jennifer E. Miller, PhD; Jeanie Kim, JD; et al Joseph S. Ross, MD, MHS. JAMA Network Open. 2018;1(2):e180283. doi:10.1001/jamanetworkopen.2018.0283
The Right to Try Act of 2017 allows patients with life-threatening conditions to access investigational medicines outside clinical trials without oversight from the US Food and Drug Administration (FDA). A better understanding of existing expanded access programs can inform the consideration and implementation of both the federal Right to Try Act and state right-to-try laws.
Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.
Jennifer E. Miller, Joseph S. Ross, Kenneth I. Moch and Arthur L. Caplan BMC Research Notes 2017 10:350 https://doi.org/10.1186/s13104-017-2687-5
We sought to determine the characteristics of “expanded access” and “compassionate use” programs registered in ClinicalTrials.gov and to determine the percentage of drugs provided through these programs that ultimately received FDA marketing approval.
Disclosing clinical trial data is a step in the right direction towards transparency, which benefits both the public and the pharmaceutical industry.
Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge
The intent of the first national clinical trials registry for cancer therapies was to help doctors find open trials in which to enroll their patients and to help researchers maintain a steady supply of research participants. However, it ended up exposing corrupt practices and tensions between ethics, the corporate need for profits, and public health goals. How did this happen?
This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating.
After years of decline in the public eye, drug companies should implement a bioethics accreditation or rating program to help appropriately restore the industry’s good name and improve its effectiveness in advancing global health and new treatments.