Evaluation of Stem Cell-Derived Cellular Therapy Products

Toxicologic Pathology ◽

10.1177/0192623319897898 ◽

2020 ◽

pp. 019262331989789

Author(s):

Alys E. Bradley ◽

Lauren Black

Keyword(s):

Stem Cell ◽

Study Design ◽

Clinical Studies ◽

Cellular Therapy ◽

Scientific Integrity ◽

Preclinical Studies ◽

Cell Markers ◽

Contract Research ◽

Research Organizations ◽

Case Basis

Although there is an increase in the development of new cellular therapies, few guidelines have been published to assist in the design of preclinical studies. As no product and therapeutic intention is entirely alike regulators and Contract Research Organizations need to treat each project on a case-by-case basis. One of the most important considerations in study design is to retain all tissues from the study, thereby allowing for further analysis of tissues should unexpected effects be seen in clinical studies. Input from the pathologist at the earliest stages of study design regarding animal selection, cell markers, and phased tissue examination improves the scientific integrity of the study.

Download Full-text

Challenges in Opening and Enrolling Patients in Clinical Trials

American Society of Clinical Oncology Educational Book ◽

10.1200/edbk_179807 ◽

2017 ◽

pp. 139-143

Author(s):

Julie M. Vose ◽

Meredith K. Chuk ◽

Francis Giles

Keyword(s):

Clinical Trials ◽

Scientific Integrity ◽

Cancer Therapies ◽

Regulatory Requirements ◽

Cancer Treatments ◽

Contract Research ◽

Trial Conduct ◽

Slowing Down ◽

Research Organizations ◽

Trial Participants

Clinical trials are key elements of the processes that account for many of the recent advances in cancer care, including decreased mortality rates and increased survivorship; better supportive care; and improved understanding of cancer risk, prevention, and screening. This research also has led to the validation of numerous exciting new types of cancer treatments, such as molecularly targeted therapies and immunotherapies. Clinical trials, however, are becoming more and more challenging to conduct. Research programs must comply with legal and regulatory requirements that can be inefficient and costly to implement and often are variably interpreted by institutions and sponsors and sponsors’ representatives, including contract research organizations. Some of these requirements are essential to protect the safety of trial participants, to promote the scientific integrity of research, or to ensure that trial conduct is efficient and adequately resourced. Such requirements are important to preserve. However, some requirements do not fulfill any of these goals and, in fact, hinder research and slow patient access to safe and effective treatments. This article discusses some of the identified issues that are slowing the process of cancer clinical trials, such as conservatively interpreted guidelines by pharmaceutical companies and contract research organizations; overprotective language for contracts; and patient protections by health systems and universities. The article also discusses possible solutions to these problems that are slowing down the cancer therapies that patients need.

Download Full-text