Compliance In Focus

In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:

On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of
 cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.

In July, 2014, FDA released a new draft guidance to reflect current thinking on the informed consent process:  Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors.

In August, the FDA issued the final guidance document on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. The intention of this guidance document is to improve the quality and consistency of available data regarding device performance in both sexes for devices that require clinical information in support of a marketing submission or post-approval/post-market surveillance submissions. The primary limitation on devices involves devices that are sex-specific; for instance, urology devices that are designed to be single-sex only.

As the clinical research world becomes increasingly technologically advanced, we have seen more and more sponsors choose to use Electronic Data Capture (EDC) Systems to document Case Report Form (CRF) data.  FDA published a guidance in September 2013 to address the questions associated with this growing trend.

The FDA issued its final guidance on electronic source documentation.  Back in January 2012 the FDA published its draft guidance to much criticism and debate. The new guidance broadly follows the second draft of the guidance which was released in November 2012.

As demonstrated in many FDA warning letters, a commonly cited source of bias in clinical research can be found in the financial ties between investigators and sponsors. Perhaps more clarity is needed in order for those in the clinical research industry to be brought into compliance with 21 CFR 54?

Not too long ago we posted a blog on cell therapy trials. This is an emerging field in clinical research and one we are very excited about. While the FDA is still in the process of building a foundation of the cell therapy industry, there exists a need for this type of medical development to meet the needs of patients. Before any of these life-saving innovations can reach the public, they must meet the requirements for being proven safe and effective in clinical research- and have success in clinical trials. Looks like FDA is taking steps in this direction.

Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.  Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias.