While they are on the leading edge of clinical trial innovation, researchers conducting gene therapy trials contend with a myriad of international regulations and sometimes wary patients, said experts at a RAPS (Regulatory Affairs Professionals Society) conference session on September 12.
It’s critical to understand the unique regulations enforced by different nations, said Kirsten Messmer, PhD, a principal regulatory affairs specialist for the contract research organization PPD.
Messmer cited a number of important obstacles to be prepared to address, including:
- Do sites need a special certification or accreditation to work with the gene therapy?
- What are the differences in requirements and process for deliberate release versus contained use?
- What are the national requirements for follow up?
- Are there special considerations regarding genotyping and genetic testing?
- What are the applicable data protection laws?
- Are there any special import requirements?
- Are there any special programs or classifications offered that may support the gene therapy development?
- Are there any special requirements for informed consent?
“We take informed consent very seriously,” said Tara O’Meara, vice president for clinical development operations with the biotechnology company bluebird bio. She believes informed consent often requires several visits, depending on the complexity of the trial.
In addition to partnering with key patient advocacy groups, O’Meara has had success producing educational videos and other supporting materials to assist in informed consent. All materials should be approved by the applicable institutional review board, she added.
Working to educate potential subjects is key, O’Meara noted. “There is so much information out there online, that you can find any information you want backing almost any” position, she said; therefore, it’s incumbent upon true professionals to produce and disseminate the most accurate information possible.
Author: Michael Causey