The Blog @AG Mednet

As we all know, investigator sites around the world are the most important partners a sponsor or a lab can have in their quest to determine the efficacy of new therapies.  Investigator sites are small groups of committed researchers and trial coordinators who are dedicated not only to improving their patients current medical condition, but are making an effort to prevent, slow down or reverse disease progression in the future.

In an interesting interview in Bio.IT World (http://bit.ly/yGtHxd), Glen DeVries, the President of Medidata Solutions, spoke about the evolution of clinical trial processes and how we’re inevitably going toward cloud solutions.  I couldn’t agree more.  As Glen points out, we’ve seen this phenomenon across a multitude of industries: The advent of good software packages moved things from paper to terminals; the development of cheap computing lead us from terminals to software applications on powerful personal computers; Finally, the transformation of computing power into a commoditized utility, and the ubiquitous nature of broadband, is moving the entire venture to the cloud.  Any attempt at stopping this evolution in clinical trials is futile.

Earlier this week, Forbes published a somewhat startling article (http://onforb.es/uhWpsh) about HIPAA violations in the U.S.. The gist  of the piece is that violations are occurring more than one might think, that data that people consider to be non-confidential details are in fact protected by law, and that organizations are being successfully sued for millions of dollars for these serious transgressions.  Patient privacy is a very serious business, not only in the U.S. but in most other countries, particularly those in the EU, as well as Japan and Korea.

Clinical trials are inherently risk management exercises, where sponsors, CROs and investigators work as a team to determine the effectiveness of a compound or treatment.  In the late 1900’s, form data submitted by investigators to CROs was sent using the latest in technology: Fax.  Prior to that, forms were mailed.  The advent of EDC systems promised not only to reduce or eliminate data entry errors, but also to enable real time submission of the data to clinical research organizations. It took EDC close to 10 years to enjoy full adoption. 

In the world of clinical trials, we are constantly reminded of national privacy regulations and 21 CFR Part 11 restrictions when using electronic means to submit medical imaging data.  National regulations (NRs) include the European Union Directive on Data Privacy, The Canadian Personal Information Protection and Electronic Documents Act (PIPEDA), HIPAA, OECD and their equivalents in other parts of the world.

Clinical trial sponsors have focused for years on finding the right investigators who can recruit patients, and choosing the best core laboratories to do the necessary data analysis.  Without a doubt, having the best thought leaders associated with a trial can increase the level of success (defined as pursuing the right path and abandoning the wrong one) and thus lower the risk of the whole trial enterprise.

We are seeing more and more imaging trial protocols requiring the analysis of subject eligibility to occur under tightening deadlines. 

Although the trial impact of a single data point may not be major, the aggregate of these situations can cloud the overall picture.  Think of it like a loom, where you are trying to weave a certain design.  Having a single thread break during the process might not affect the final product.  However, losing many, may cause the pattern to be dull and harder to recognize.

There is a lot more riding on the success of an imaging trial today than ever before.  The world economy, mergers and acquisitions, the state of sponsors' pipelines and changes in the regulatory environment, have created the most demanding market for clinical trials ever.  One of the results of this evolution is the increased focus sponsors put on the finest detail of each project, and on the most esoteric budgetary line item.

There are a number of challenges when designing and building solutions for the collection and delivery of image submissions for clinical trials. One of them is compliance with global regulations governing the process. While regulations set forth by agencies such as the FDA, HIPAA, and their equivalents in Europe and Asia can be complicated, and in certain cases, open to interpretation, two of them are actually very clear and obligatory. They state first that submission data must be protected, and second that patient privacy must guaranteed prior to submission. Meeting these requirements with an electronic system is complex, and may be one of the reasons some companies still use courier services.