Compliance In Focus

Many sponsors in the medical device research industry are challenged with the decision between having a remote or on-site initiation visit. An initiation visit is imperative to the overall success of a study as many tasks are accomplished during these visits.

It’s been a long time coming but at last the “rules”- the Physician Payment Sunshine Act is final. These are intended to give the public easier access to information on healthcare providers and their financial ties to companies in order to decrease any underlying or potential bias. How will this be accomplished?

Do you know why rules, regulations and standards exist? What exactly is Good Clinical Practice and how does this help protect patients and data integrity?

At times, a Sponsor may provide a site with a memo allowing the site to enroll a patient who does not meet all inclusion or exclusion criteria. Or a Sponsor may give the site pre-approval to deviate from the protocol-defined visit windows. Is this waiver enough? Would the investigative site be covered in the event of a federal audit?

In August 2011, FDA released a draft guidance document recommending a Risk-Based approach to monitoring. Risk- Based Monitoring combines the vigilance and data surveillance (key features of Electronic Data Capture systems) with traditional on-site data verification targeting critical data points. Rather than a standardized monitoring plan, Risk-Based Monitoring aims to adapt the monitoring plan to the changing needs of the Study, Site and Investigational Product.

In order to run a well-controlled compliant study at the site level, one must ensure that the study team has been trained, and is knowledgeable on the rules and regulations. Although it is the Investigator who is responsible for the conduct of the study, there is a larger team at work to complete all the required activities. The research coordinator carries out many of the day-to-day activities and touches nearly every study milestone.

“The new proposal aims to fulfill a European Parliament request for more stringent med-tech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.”  Sound familiar? You might be surprised to learn that this excerpt was not in reference to FDA.

Your site is weeks past study initiation and all the candidates that you expected to be screening for the study have not materialized.  Would trial-related advertising or recruitment materials enhance your sites' enrollment efforts? 

In the United States, all new drugs and/or medical devices are subject to various levels of scrutiny by FDA.  The Food, Drug, and Cosmetic act of 1938 set into play the requirement for new drugs to be determined safe before they can be marketed.  Sometimes the regulatory process can be time consuming, but the whole reason regulations exist is for the protection of the U.S. population at large.    History is full of examples of treatments with good intentions causing more harm than good.  Think of it as a necessary evil if you will. What is the perfect balance between fastest path to market and proper safety evaluation?

The question of the day: Should sponsors be required to publish results of clinical trials for the public to view? A new bill proposed to the US House of Representatives would require this action. The bill titled “Trial and Experimental Studies Transparency Act of 2012” or the “TEST Act” for short, hopes to further human subject protection by ensuring disclosure of additional information surround a clinical trial.

At the site level, having a great working relationship between monitors and research coordinators can really make a difference in the performance of the site.  To do this, monitors walk a fine line between being personable and relatable, but also being respected and trusted.

Since 2003 FDA staff has used a guidance document to satisfy (21 CFR 814.42(e)) which identifies the criteria for filing a Premarket Approval (PMA). While this guidance has served its purpose in helping provide a basis for FDA to accept or refuse a PMA, a new guidance was just released, “Acceptance and Filing review for Premarket Approval Applications” which FDA hopes will “clarify the criteria for accepting and filing a PMA, thereby enhancing the consistency of our acceptance and filing decision.”

In previous blogs, we have discussed investigator oversight and how it relates to the overall protection of the rights, safety, and welfare of study subjects.  We have also looked at investigator oversight and the relationship to device accountability.  But how does oversight relate to the overall conduct of the research study?

Prior to conducting a FDA sanctioned medical clinical trial, you need to have Investigational Device Approval (IDE).   An article in Healing Innovations provides some good tips on when to not have a pre-IDE meeting with the FDA.