Tag Archive | FDA

iPads, iPhones, Androids, Windows Mobile Phones, Life Sciences and Compliance

Apple has sold millions of iPads in the past 18 months. The adoption of the device in the market is phenomenal. This trend is reflected in Life Sciences & Healthcare industry as well. A mobile Health News article (2012: About 62 percent of physicians use tablets) puts the adoption of tablets by the physicians at 62%. Another report by IDC puts the Smart Devices sales exceeding the combined sales of laptops and desktops. All these trends are indicative of the rate of adoption of mobile and smart devices by the population in general. The healthcare and life sciences industries are no exception to this.

While the adoption is growing in general, the challenges and bottlenecks are numerous for adoption of the devices in an Enterprise/Business setting. To make this even more complex, consider using the tablets and smart phones in a validated environment to capture and manage personal health information of patients.

Some key questions to be asked while considering adoption of Mobile devices in a validated environment are:

  • Will the device and application be considered a Mobile Medical Device?
  • If so, what should we do to validate the application?
  • What are the regulatory requirements and guidance from the agencies?
  • Should we consider a native application vs. a web based application?
  • If so, how does the validation activities and artifacts differ?
  • Would the data be stored on the device or would it be transferred to the server as soon as it is captured?
  • Should we make it available offline to enable usage without internet connectivity?
  • What are the synchronization challenges?
  • How do we handle identity management?
  • How do we ensure data security?

While some of these questions are applicable to any enterprise mobile application, they are even more important to consider if the Mobile device is slated to be used in a regulated environment. For customers in the US, one key document to be considered as input, to answer some of the questions, is FDA’s DRAFT Guidance for Mobile Medical Applications.

mHIMSS Policy & Regulatory Implications Workgroup has provided a very good summary of how the guidance should be interpreted with respect to Mobile Medical Applications. You can read the summary here (needs registration).

FDA also provides more useful information on Mobile Medical Applications here.

I look forward to comments and insights into any specific experiences that you might have had with respect to developing Enterprise Mobile Applications in a regulated environment. These applications may or may not be companion applications to devices, but may fall under the MMA purview as defined in the guidance.

Advertisements

Risk based monitoring and SDV – Increased adoption of ECM

It is universal fact that the escalating costs of discovering new medicinal products are driving sponsors and CROs to scrutinize every dollar spent in the process. The situation is escalating fast as pressure mounts with the blockbusters of yester years come off patents. This means that there is a need for all the stakeholders in the value chain to revisit their approach to existing processes and come up with innovative ways to save costs.

Key Trends:

Risk Based Site Monitoring:

US FDA has also recognized this fact and come out with a “Guidance for Industry Oversight of Clinical Trial Investigations – A Risk Based Approach to Monitoring”. As per this guidance the objective of the guidance is “to assist sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof”. As per the document its overarching goal is to “enhance human subject protection and the quality of clinical trial data”. However, it clarifies on the strict interpretation that the industry has assumed long back and has spent billions in monitoring the sites. While this is draft guidance it is more than likely that this will end up in establishing the guiding principles for central monitoring of clinical trials, as such is the intent.

Risk Based Source Document Verification:

Primary activity of site monitoring is the source document verification and as was the case in site monitoring, industry has been mostly using the strict interpretation of source document verification. This resulted in 100% of source documents (patient eCRFs) being verified by the site monitors. However, the industry has realized that “law of diminishing returns” applies to this process as well and has been reducing the percentage of documents verified by the monitors. Medidata’s Insights “Targeted Site Monitoring Trend Snapshot” published in Applied Clinical Trials website confirms this trend.  According to this report the SDV percentage has reduced from 85% in 2007 to 67% in 2010.

Virtual Clinical Trials:

Another key trend that is slowly evolving in this context is complete virtualization of clinical trials. Pfizer is taking the lead in this space. While Pfizer’s REMOTE program is ongoing, an interim feedback from the program is provided by Mr. Craig Lipset, Head of Clinical Innovation at Pfizer is provided by Applied Clinical Trials in their article titled “Pfizer’s REMOTE Virtual Experience”. As highlighted in the article, they are going through the roadblocks of an early adopter.

Adoption of Enterprise Collaboration and Content Management:

Electronic communication and collaboration:

The above trends indicate that it is just a matter of time that total virtualization of clinical trials is accomplished. The key question that needs to be addressed is “How will the human interactions be virtualized?” The answer is “to adopt electronic communication and collaboration channels”. The channels can range from adopting systems to capture and manage clinical data, electronic source document verification to seamless communication and collaboration tools. The unique constraint with respect to clinical trials though is to ensure that the tools used adhere to “Good Clinical Practices” as well as other regulatory requirements like 21 CFR Part 11, HIPAA etc.

Enterprise Collaboration and Content Management Systems:

Systems for Electronic data capture (EDC), Clinical Data Management (CDM), Clinical Trial Management System (CTM), Adverse Event Management etc. are already available in the market. The key tool that would make it easier to seamlessly transition from human interactions to virtual interactions, in my view, is an Enterprise Collaboration and Content Management tool. Tools like Microsoft’s SharePoint, as highlighted in one of my previous blog posts, will help organizations make this transition fast and cost-effective. While it is always easier said than done, from real world experiences that we already have, it is relatively easy to adopt these tools in a GxP environment, meet all the regulatory compliance requirements and also accomplish the degree of flexibility required to easily communicate and collaborate.

Social Media and Mobility:

A couple more initiatives that could complement in the process are Social Media and Mobility. The need for a social media outreach program to increase the patient recruitment is highlighted by the channels Pfizer’s REMOTE program has adopted.  On similar lines, social media “like” features can be enabled on the collaboration and communication platform to be adopted. This can increase the accessibility and improve the response times from the patients. On similar lines, if the collaboration and communication platform can be made available over mobile devices like smart phones, tablets etc. the patient compliance and response times will improve considerably. Tools like Microsoft SharePoint make it easy to enable the social features and also deliver content to mobile devices.

Conclusion

Overall the ability of a sponsor or CRO organization increases tremendously to virtualize their clinical trial process by leveraging collaboration and content management tools. The overall “Risk-Based” approach to site monitoring and source document verification will also be “made easy” through these tools.  As noted in my previous posts, leveraging a tool like SharePoint for such purpose will improve the Return on Investment (ROI) and reduce the Total Cost of Ownership (TCO) of these tools.

As always, your feedback and comments are welcome.

Update, 20-Mar-2012:

This post has been picked up by www.AppliedClinicalTrialsOnline.com and published on their website.

Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite(BPMS)

It is essential that all new products developed and marketed by bio-pharma and device companies are safe to use and fulfill their efficacy requirements. However, it has been our practical experience over many decades that in most cases there are certain unwanted side effects. Hence, to ensure that the benefits outweigh the risks, regulators have been approving certain drugs under strict risk management assurances from the license holders.

In the US, the Federal Drug Administration (FDA) has been trying to address this through various regulations for over five years through Risk Management Action Plans (RiskMAP) and Risk Evaluation and Mitigation Strategies (REMS). The most recent guidance on this subject was issued in September 2009 through “Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”. In this guidance one of the important REMS elements that may be required is “Elements to Assure Safe Use”.

As part of this requirement the NDA/BLA applicants have to take measures to provide safe access for patients to drugs with known serious risks that would otherwise be unavailable. If a product is assessed to fulfill ETASU requirements then the sponsors are required to train and certify health care providers, pharmacies, patients and drugs. The drugs may be released to patients in a controlled manner only upon receiving evidence of their lab results. The sponsors may also have to register the patients and might subject them to certain monitoring as well. In a few cases the sponsor may be asked to extend the certification process to wholesalers, distributers etc. as well.

In order to fulfill the above mentioned requirements sponsors typically set out to build new IT systems. This is a challenging task as there is a possibility that these requirements could change over time and also there aren’t any commercial off the shelf products available in the market to address the specific REMS ETASU requirements.

To overcome this challenge, sponsors can look up to a Business Process Management System (BPMS) that is precisely built to handle such scenarios. Many other industries have successfully used BPMS to meet their ever changing requirements and priorities by integrating their business processes based on rules. Many commercially available BPMS systems typically include a process engine, Business Analytics, Content Management and Collaboration tools. These BPMS system building blocks can be effectively leveraged to fulfill the ETASU requirements by effectively providing features like Rules management, Content Management, Training Management, Patient/Provider/Pharmacy Registries, Collaboration Portal/Website, IVR/IWR, 21 CFR Part 11 compliance, Audits and integration with other enterprise applications.

Update: 01-17-2012

My Article on the same topic is published on “Drug Safety Directions” Website. You can access the article here: “Implementing FDA REMS Elements to Assure Safe Use (ETASU) Requirements using a Business Process Management Suite“.

%d bloggers like this: