Tag Archive | Life Sciences

Digital Clinical – Ushering in new technologies into Clinical Research

What is Digital Clinical?

I noticed this term used quite often in my conversations with customers, colleagues and industry analysts in the last couple of years. As is the case with many things in the past, the building blocks of “Digital Clinical” have been in the works for a long time now. At its core, in my opinion, it is all about various technology advances coming together to progress and enhance the clinical research. To name a few, the core technologies/developments include Mobility, Analytics, Social, Cloud Computing, Big Data, Semantic technologies. As mentioned while this is not a comprehensive list, it is a good start to understand how these are being leveraged to improve clinical research and the impact they are having on Heathcare & Life Sciences Industry, Patients and society at-large.

Areas of Focus:

The following are some of the focus areas across the R&D Value Chain being considered as Digital Clinical initiatives by various life sciences companies in the market space:

  • Mobile Data Collection in clinical trials, patient reported outcomes and general quality of life data
  • Data aggregation from Payer, Provider, Rx, Clinical and other Health Economic & Outcomes Research Data
  • Ontology based repositories, Master data management, meta data repositories and text analytics
  • Bio-Sensor and other wearable data capture, aggregation & analysis by leveraging cloud computing
  • Mining of data from EHR/EMR, Social Media and other data sources
  • Leverage OMOP, Sentinel and other such industry initiative outcomes to kick-start Real World Evidence/Real Life Evidence strategies

Business Use Cases being considered:

Some of the use cases being considered are:

  • Site selection and Patient Recruitment
  • Use wearable Bio-sensors in Clinical Trials
  • ePRO
  • Adverse Events in Social Media & Safety Surveillance
  • Protocol Validation : Inclusion/Exclusion criteria assessment

I hope this gives a high level overview of what Digital Clinical means, some of the technologies influencing and enabling it and practical use cases being considered by the industry to leverage these technologies and provide better quality of life to patients.

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Clinical Platforms on the Cloud

It is amazing to see how fast things change, when right technology comes along, picks up the willfully reluctant “legacy” way of doing things and takes them on a ride of their life time. Not too long ago paper based clinical trials was the norm, and still is in some countries. Then came the electronic data capture systems and technology. While that is, people used eCRFs same way as they did paper CRFs. Slowly that started to change with data validation, edit checks etc.

With the cloud revolution came the thought of having clinical data capture/management systems on the cloud and be managed by a third party while pharma companies controlled the protocol and trial design as well as data transformation, analysis and submission management. Off late we are seeing companies being more open to store and share clinical trial data on the cloud. I think the days of ‘Clinical Platforms on The Cloud’ as the norm will soon be a reality. These platforms will not be limited to Clinical Trial Data but will host systems that provide end-to-end clinical research process support capabilities. Not only that, they will also stretch the boundaries further, by accommodating social media, mobile, big data & analytics capabilities.

Future of technology companies that are pioneers in enabling this transformation is going to be interesting and bright with ample opportunities to take the lead and leap to the next orbit.

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.

SharePoint in Life Sciences Value Chain

I was putting together a presentation for a session on “Enterprise Collaboration and Content Management” earlier this week. As part of the exercise I was making a list of point solutions, in each phase of the Life Sciences value chain, that can be developed using SharePoint. This sources for this list are various articles and publications, customer requests, actual applications that I have seen or delivered to customers and last but not the least, from my own brain. I thought of sharing the list here so it could be useful for some of you and might trigger your imagination on leveraging your SharePoint investments.

SharePoint in Life Sciences Value Chain

SharePoint in Life Sciences Value Chain

My intention is neither to say SharePoint will be a sophisticated solution for all the business needs mentioned above  nor that this list is exhaustive. I would like to argue that using SharePoint will definitely be an upgrade from age-old manual and/or paper based process which is still the norm in many organizations. For those who are skeptical about SharePoint being compliant with regulatory requirements like 21 CFR Part 11, I want you to know that it can be  “Validated”.  May be, that is a topic for another blog post in the future.

As always, your comments and feedback are welcome.

Is Functional Knowledge for IT Teams Over Rated?

I have been in the IT Industry for over 13 years now. I started my career as a developer. At that time, all that I cared about was whether I remember the right syntax to ensure that all the programs I code, compile right and execute without crashing. After that it was time for me to build products and solutions that solve business problems, thus started my journey into verticals / LOBs.

While I understand the need for some functional knowledge for developers, testers and other members of an IT team that would eventually be responsible for successful development, testing and deployment of an IT solution for a specific functional requirement, I happened to think that the degree of knowledge required varies. In my career as a developer I have changed verticals at least 5 times in the span of  7 years. Even with in a vertical, as you can imagine, there would be multiple functional areas. So, for example if you are working as an IT consultant in Life Sciences industry, the functional areas covered would range from R&D to Manufacturing & Supply Chain to Sales & Marketing. So, even if you try to restrict or focus in a specific vertical, it would still be hard for IT staff to be able to know it all across multiple functional areas.

So, my point is, when it comes to the expectations of various stakeholders responsible for an IT project, ideally you would want all the members of your IT team understand the functional nuances extremely well. However, that would hardly be the case. Hence you should be prepared for some learning curve for these teams. In this world of multitasking, parallel processing and maximum reuse, while it is reasonable to expect an IT specialist to be also an expert in his or her chosen domain / vertical it would not e practical and just.

So, what should one expect?

In my opinion:

1)  You need Subject Matter Expert(s) (SME), be it a Business Analyst or a Product Manager, you need at least one person in the team that would act as a bridge between the business and IT teams.

2) You would also need at least one technology person with very good functional/domain knowledge. This person could be a Technical Architect / Lead or another role. He/She should be able to translate the functional requirements to technical specifications.

3) There should be an “on-boarding” process for the rest of the team, that would ensure appropriate functional training as per the training requirements identified as part of project planning.

So, in essence, while the stakeholders would long for IT teams with absolute knowledge of the functional areas, that is hardly the case. As long as there is reasonable planning and effort to ensure the teams are equipped with enough knowledge to build, test and deliver an IT system that meets the requirements of the business, AS A TEAM, one should be content with employing the services of teams that are more technology focused and either have the functional knowledge or imparted the knowledge as part of “on-boarding”.

As always, feedback and comments are welcome.

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