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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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Mobility – HTML 5 vs. Native Apps

Building native applications for mobile devices is like building a ‘Client-Server’ application which was popularized in the 90’s and 00’s with the explosion of personal computers. While this trend leveraged the fact that an application can use the computing power of the client device and provide better user experience and performance. However, from a maintenance perspective this was a nightmare. I still remember the “DLL Compatibility” issues driving me and my team crazy when we were deploying these applications in an enterprise environment and having to update/upgrade the application frequently. It generated a lot of call volume to the support teams. Combine that with the lack of good collaboration tools and you have a perfect storm whenever there is a new release.

The reason I bring this up is that the web has changed this whole ‘Client-Server’ paradigm and drove the application development model to adopt web-based architectures. With respect to Mobile Application Development we are looking at another such paradigm shift where there should be more and more applications built using ‘HTML5’ based app development for mobile devices. Just as in the case of Client-Server apps, ‘Native Apps’ for mobile devices provide a lot of power for developers to build apps that provide better user experience and performance, but it is a maintenance nightmare and also tend to increase the deployment cycles. A ‘HTML5’ application that follows the “80-20” rule and uses 20% native code will provide greater flexibility by delivering almost all the advantages that a ‘Native App’ would. Plus, it also fits into the “Build Once Deploy Anywhere” model where the app can be deployed to multiple mobile devices (iOS, Andriod, Blackberry, Windows Mobile etc.) with minimal changes (to the 20%) of the native code (all the HTML5 code doesn’t need any platform specific changes).

This approach is being recommended by many analysts, thought leaders and vendors. It would be interesting to see how many developers adopt this approach and accelerate the shift in Mobile Application Development paradigm.

Patient Reported Outcomes and Mobile Solutions

As stated in some of my previous posts, I have been working in the Life Sciences industry for over 8 years now. That amounts to a little bit over half my career till date. It has been a good journey with appreciation towards the greater good that this industry does in making people’s lives better. I agree that there is an image problem due to multiple incidents that compromised patients’ safety for profits or other trade-offs. However, all in all I personally think that there is much more good done than harm.

One thing that Life Sciences industry is not is “being technologically savvy”. Even this statement, if applied with in an organization, the degree of applicability changes from one business unit to the other. More than that, it has to be stated that the units that are “more regulated” are much behind in new technology adoption. The units that I have been working with the most is Research & Development (R&D). Even within this unit, the Research Teams, specifically Drug Discovery teams are more open to adopting new and advanced technology compared to the Drug Development teams.

As part of my day job, one of my goals is to continuously monitor new technology trends, specifically within the Life Sciences realm and help our teams develop new solutions and services. Identifying the solutions to be developed is not an easy job considering the economic constraints under which most companies are working in this “New Economy”. Luckily for me, another goal of my job is to find the right partners who would help us develop these new solutions and services so we can go to market faster.

One such partnerships is with a company that developed a Mobile Solution to enable Patient Reported Outcomes (PRO). I did a joint Webinar with them today titled “Maximizing Patient Reported Outcome (PRO) compliance in Clinical Trials – Leveraging Mobile Solutions“. While trying to put together a presentation that highlight the trends in Mobility adoption in general and adoption in Life Sciences and specifically Clinical Trials, I found out some surprising facts that the Mobile industry will be growing at a CAGR of 15.6% for the next 5 years (IDC Press Release).Also, according to another IDC report, Smart Phones will out sell the Netbooks, Desktops, Laptops and such combined in the next couple of years.

Patient Reported Outcomes (PRO) is all about getting information directly from the patients, without any interpretation  by specialists. In fact, FDA defines this as “A measurement based on a report that comes directly from the patient (i.e., study subject) about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. A PRO can be measured by self-report or by interview provided that the interviewer records only the patient’s response“. In my opinion, it looks obvious that leveraging the Mobile devices to run PRO trials improves the overall quality of data as well as the response time, not to mention the compliance to a large extent. The key is the coverage of last mile, i.e. enabling the patients to be reminded of any delays in submission of assessments. This will also open up a more personal service channel that can be leveraged to build a closer relationship with the patients.

As with adoption of many other disruptive technologies like Social Media, Cloud Computing etc. the regulatory compliance questions need to be addressed for any solutions developed to be used on Mobile devices. You can refer to my previous post titled “iPads, iPhones, Androids, Windows Mobile Phones, Life Sciences and Compliance” on what are the regulatory compliance requirements (specifically, guidance by FDA) to be considered in this context. The key is to ensure that the patient data collected is secure and the solution works in situations where the patient does not have connectivity. Also, the overall cost of the trial would come down considerably if the protocol permits ‘Bring Your Own Device (BYOD)” model for patients participating in the trial. Of course, this depends on the nature of the protocol and the trial design.

All in all, with the phenomenal up tick in Smart Phone sales, more so in ‘Pharmerging” markets like India and China which are also becoming the “Hubs” of future growth for Life Sciences companies, it is essential that Mobile solutions be developed and used to cover the last mile i.e. for the user touch points like Physicians, Patients and Pharmacies.

As always, your feedback and comments are welcome. I also encourage you to share Pros and Cons of the adoption based on your practical experience. I will be even more interested in any technological challenges you may have come across in the adoption process.

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.

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