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Leveraging Technology to Improve Patient Recruitment for Clinical Trials

I was asked to respond to a costumer inquiry recently to help them with providing a solution to improve their patient recruitment in clinical trials. Initially, I thought this must be a question to one of our experts in our CRO. However, I kept thinking about it and realized there isn’t a silver bullet that would solve this problem. There is no commercial off-the-shelf solution to fix this problem. Sponsors, CROs, Site Coordinators, PIs and other stakeholders involved in the clinical research have been struggling to address this situation but it is still a challenge and is the root cause of delays in clinical trials which will result in increased and lower Returns on Investment (ROI).

Discovery and development of medical products take a long time and consume lot of resources (Effort & Cost) from sponsors from molecule to patient. This involves discovery of the molecule to pre-clinical and clinical development to marketing & sales. A lot of these resources are typically spent in late stage (Phase III) of clinical trials. One of the root causes for delays in clinical trials in phase III is delay in recruiting the patients that meet the inclusion criteria of the protocol. Another key concern is patient drop out during the course of the trial. These issues not only delay the trial but also force the sponsors and CROs to consider changes to the protocol or force them to take alternative steps to ensure the necessary patient population is recruited to continue the trial.

Adherence rates across the duration of therapy

Adherence rates across the duration of therapy

According to a report on Patient Adherence by Capgemini consulting [1], “Patient adherence levels vary between 50% for depression to 63% for enlarged prostate. On average, adherence levels drop over the course of the patient journey from 69% of patients filling their first prescription to 43% continuing their treatment as prescribed after 6 months.”

Also, if you notice in the attached diagram, 31% of the patients recruited will not last until they fill their prescription. Further, by the sixth month almost 57% patients do not show up for their refills. At this rate, in order to continue the trial, the sponsor has to continue to recruit patients during the course of the trial. This recruitment due to a drop out comes at a cost. The report has also identified that the cost of recruiting a new patient is 6 times the cost spent by sponsors to retain an existing patient.

So, what are the sponsors/CROs doing to improve the patient recruitment and reduce the drop outs? The key to fixing any problem is identifying the root cause. For this problem, there are multiple areas of failure and hence requires a comprehensive, multi-pronged strategy to fix the problems.  Some of the best practices being adopted by sponsors and/or CROs include:

  • Comprehensive and incremental approach to integrated solutions rather than silos  by leveraging :

–          Patient registries

–          Better communication between patients and clinicians

–          Electronic records

–          Better engagement of physicians

  • Refine Site selection

–          Analysis to select better performing sites

  • Patient centric recruitment process

–          Simplify informed consent process (move to informed choice)

  • Collaborative approach to Protocol design

–          Engaging Principal Investigators (PIs) in protocol design by research coordinators

  • Improve patient retention

–          Better follow-up systems to increase adherence

–          Enhanced post-trial engagement

In order to implement these best practices sponsors can adopt technology solutions like:

  1. Create strategy to improve the recruitment process by leveraging technology solutions
  2. Analyze site performance and select high performing sites and drop out non-performing sites
  3. Patient Recruitment Systems to search and match protocol eligibility criteria with patient’s available Electronic Health Records (EMRs, Narratives, Health Insurance and Claims Documents)
  4. Social Media tools to target patient communities to identify potential subjects from the available patient population
  5. Social Media tools to gauge trial buzz in patient and physician community
  6. Study & Investigator Portals to enhance engagement and collaboration between study coordinators and Principal Investigators
  7. Mobile Trial Adherence Systems to alert and notify patients of visits and other trial compliance activities to reduce drop outs
  8. Key Opinion Leader portals to better engage physicians
  9. Analytics to identify potential subjects, site initiation process and performance, patient recruitment effectiveness, patient drop out alerts etc.
  10. Advanced analytics to simulate recruitment performance based on historical data and thus tailoring recruitment strategy based on sites and other factors

Despite all these best practices and solutions, will be able to help the sponsors and CROs in:

  • Collecting historical and real time operational and scientific data
  • Performing objective analysis of data
  • Visualization of such performance
  • Identifying the bottlenecks and root causes for the problems
  • Helping in making decisions to select the right sites, recruit the right patients, avoid costly drop outs and improve the collaboration and communication among Patients, Primary Investigators and other stakeholders.

I will be writing about each solution in my “Top 10” list above. As I mentioned in the beginning of this post, there is no silver bullet for this problem. A strategic and integrated approach to create solutions that will aid in collecting, analyzing and decision making is the only way to solve this problem.

As always, please let me know your feedback. If you have more insights into the problem or solutions, I will be more than glad to discuss with you and also post some of the inferences in a subsequent post, as promised. Happy Reading!!!

References:

  1. “Patient Adherence: The Next Frontier in Patient Care – Vision & Reality, 9th Edition Global Research Report”  by Capgemini Consulting
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SharePoint is not your problem, It probably is your People and Process

In a meeting with my colleague recently we were discussing about some of the challenges faced by customers who bring in certain tools that are easy to use and are adopted multiple groups in the organization in a frenzy and before you know it there is no method to that madness.

Yes, I am talking about SharePoint.

It was developed primary as a tool to make it easy on IT teams to be able to put together websites (Intranet / Extranet / Internet) quickly as well as implement collaboration better with necessary plumbing pre-built. However, the ease of use drove the adoption. The subsequent releases added features like Document & Records Management, Social Media, Insights and even capability to integrate business data from other existing enterprise applications. The problem with such growth is that people use these tools in ways that they were not originally designed for. Once the product teams realize these new ways of using it, they will tweak the design or redesign the tool to fulfill such requirements. This cycle goes on and leads to the evolution of the product.

Any way, coming back to the challenges of adoption without a strategy and governance leads to chaos. As one of my good friends, a SharePoint Architect, puts it “SharePoint is like a Virus !!!” and it needs to be stopped. While we can argue if comparing it with virus is the right way to describe it, his intention is to say that the adoption rate in organizations is phenomenal. If not controlled, this will spin out of control and in no time will lead to people blaming SharePoint for all the problems. To be honest, this is the case pretty much across the board wherever it is adopted without proper strategy and governance.

To derive the maximum benefit out of the SharePoint implementation, one needs:

  • A Good Strategy before you bring in SharePoint to ensure it serves the business purpose
  • A proper Information Architecture to implement and configure it the right way,
  • A good Application Life Cycle Management Process to ensure the applications are created and managed the right way and more importantly retired, once their purpose is served
  • A good process to increase the adoption within the organization
  • A good training process to ensure that the IT and End User community is trained to use the tool is used the way it ought to be used and
  • Last but not least, a good Governance Process to keep it all in check

While the above points would be true for new adoptions, the same goes to organizations struggling with some of the problems as a result of unplanned adoption. They should take a step back and view at the problems they are facing. More often than not they are because they have not followed one or more things from the list above. While it could take a huge effort to clean up the mess that is already created, it is never too late to start adopting some best practices that would steer them in the right direction over a period of time.

A good resource to start with is provided by Microsoft as part of their Tech Net Resource Center. Good Luck with your efforts and do let me know if I can help in any way.

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.

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