Molecular Analysis

From Center Watch Monthly

Collecting genetic and biomarker data adding to site administrative burden

A s the analysis of genetic data is fast becoming a significant part of clinical research programs, both to enroll study participants and understand how drugs work, investigative sites are increasingly asked to collect genetic samples and conduct genetic screenings for clinical trials.

Research sponsors want investigators to collect genetic material that either can be analyzed as part of the study or stored for future testing. Depending on the relevance of the genetic analysis to the clinical development program, the genetic sample collection may be a core requirement for study participation or an optional component of the study.

“We are seeing more industry-funded research that wants to do genetic testing to make sure that they are on the right pathway in their drug development and in targeting populations,” said Megan Bailey, manager of the Office of Research Compliance, CHOC Children’s Research Institute at the California-based Children’s Hospital of Orange County (CHOC). “We’ve also seen an uptick in the number of protocols that look at genetic testing along with tissue banking because of not knowing what tests may come in the future and wanting to prepare for those.”

While the increasing use of genetic biomarker data can enhance medical knowledge, lead to more efficient drug development and ultimately deliver more beneficial therapies, the approach also has implications for the efficiency of the study conduct process. Interviews with investigators and site staff members suggest that the informed consent process takes longer for studies that include a genetic component, for example, since investigators need to ensure study participants understand what will happen with their genetic information and answer questions about how the data will be protected.

Some sponsors require a separate consent form for the genetic component of the study. For clinical trials that target enrollment of patients with rare genetic biomarkers, sites may also be required to screen a larger number of patients to find qualified study participants.

When genetic information isn’t needed to make enrollment decisions for a clinical trial, there can be questions about whether the genetic analysis adds unnecessary procedures for investigative sites and contributes to the growing complexity of clinical trial protocols.

Yet investigators interviewed by CenterWatch view genetic screening and the collection of genetic materials not as a burden, but as an essential part of clinical research going forward.

“Any time there is anything extra in a clinical trial, it takes more time,” said Ryan Welter, M.D., Ph.D., CEO and medical director of Massachusetts-based Regeneris Medical, which specializes in biological studies and regenerative medicine research. “But I wouldn’t necessarily call it a burden. Genetic information is incredibly important in terms of screening and understanding disease processes. It is invaluable in making clinical, research and biologic decisions.”

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