My friend and colleague Les Jordan has recently added a new posting to his MSDN Blog called CTMS & EDC: A system to do both – and more. Lately, I have been thinking a lot about Clinical Trials as well, so I wanted to add my own perspective to his excellent posting.
I think Clinical Trials are another area within the Life Sciences industry that are incredibly balkanized. Most of large pharmaceutical companies I have worked with have between 20 and 25 clinical systems that need to work together. The effort and expense to make all this function is simply mind-numbing! A partner just sent me some presentations from a recent CTMS conference, and I just could not believe the incredible pain and expense companies have to go through to make these systems work together. They have no idea how much easier their lives could be by considering some alternative approaches. And it is scary to think they actually believe they are doing cutting edge stuff. Well, in a way they are doing cutting edge – by pouring money and resources into legacy systems which they believe to be ‘best-of-breed’. They are literally spending millions (or even tens of millions) annually to keep these systems running and working together. However, the reality is that nobody can afford these approaches any more, and things will have to change drastically in the Clinical Trials space, just like in all the other facets of the life sciences industry.
If I had to start from scratch, I would build a system on the following elements of the Microsoft stack: MOSS, SQL Server, Project Server, and Dynamics CRM. These are just four ‘moving parts’, but they are designed to work together, and work with a single integrated development environment in Visual Studio.
When I think about it, it is mostly about collaboration and business process management around data and documents. Let’s consider a simple overview of Clinical Trials, without going into too much detail, and consider what systems need to be in place. It is a complex, convoluted process, and I would like to show that most can be done with just four ‘moving parts’.
- First, the Clinical Trial needs to be designed. There are a number of specialized tools that are used for this, but no doubt collaboration plays a key role. How can this collaboration take place: MOSS, of course!
- Then, a Clinical Protocol needs to be written. This is usually a complex, and highly structured document which lends itself well to automation. We are currently working on using the Intelligent Content Framework and DITA-Maps (don’t be scared of the specialized term: think of a DITA-Map as a Table of contents and a set of rules to build a document) and to make this process as automated as possible. The same approach also applies to Clinical Investigator Brochure.
- The Clinical Protocol needs to be reviewed and approved by an Institutional Review Board or an Ethics Committee. Again, this is a collaborative process. The best tools for this are MOSS, in combination with Unified Communications.
- Once the trial has been approved, the sponsor (i.e. the pharmaceutical company, or the CRO who they have contracted – as an aside, MOSS is a great platform for managing contracts between the sponsor and the CRO) has to select the Clinical Sites (these are mainly hospitals or research centers) where the trial will be conducted. There is a lot of business process management and collaboration that has to take place during the so-called Site Initiation Process, and other documentation needs to be managed, such as Patient Consent Forms, Investigator Brochure etc. Most of this is very document and forms-centric. Our partner NextDocs has built a great module to do this – on MOSS! There is also the need to manage all Training Records for Clinical Investigators and Research Associates, and to manage the published Clinical Investigator Brochures. NextDocs has this Clinical module built out, too. In fact, I am even aware of a free SharePoint Services 3.0 Application Template for Clinical Trial Initiation and Management.
- In order to conduct the Clinical Trial, the sponsor or the CRO usually puts up a Clinical Investigator Portal, where investigators log in to get all the information about the particular trial, and protocol, and can upload all their pertinent information, such as CV, completed Statement of Investigator (also known as 1572 form), etc. MOSS is ideal for this application. Of course, Dynamics CRM can also work in conjunction with this to serve as an Investigator Database (which needs some CRM capabilities)
- Sponsors have to recruit patients who are interested and willing, and qualified to participate in the trial: they often put up a Patient Recruitment Portal for this application. Again, MOSS is ideal for this application. Our partner Quilogy has built some very impressive applications in this space (both for Patient and for Investigator Recruitment). And of course, Dynamics CRM can also supplement the Patient Recruitment Portal application as well. Dynamics CRM is also an ideal platform for Investigator Grant Management, another area that is ripe for a major technology upgrade – most companies are still using antiquated technologies for this application.
- Sponsors also have to track payments and disbursements to investigators, have to track clinical supplies, etc. This is also often referred to as a CTMS application. There is an excellent solution for this by our partner TranSenda. We have been collaborating closely with them on their Office-Smart Clinical Trial Manager, and they have posted an excellent White Paper about SharePoint in Clinical Trials. We are also doing some very innovative and forward-thinking work with them around managing Clinical Trial process data, which is not an area that is covered by the Clinical Data Interchange Standard Consortium (CDISC). See here for a great article that covers the problem space that we are addressing with Cortex™ . The part about the Clinical Trials Interchange Platform (CTIP) is especially relevant! The Veterans Health Administration have also built their own CTMS system on MOSS technologies. They have the same requirements as the biopharma industry, but a fraction of the budget, so they have to be innovative and forward-thinking. However, shouldn’t that be the business paradigm for everyone these days? I have uploaded some materials of their solution here. To quote Dave Rose, Chief Architect of VA’s CTMS/EDC solution set: “The system leverages current investments, scales and is absorptive of future technologies. Imagine managing your clinical trials on the same platform you use to manage the enterprise….” In fact, there is now also a commercial version of the application available: http://infopathedc.com/ And of course Dynamics CRM is an excellent development platform for this, too. I posted some White Papers on the latter here.
- Now we come to the conduct of the trial. There are many Project-related activities related to this, and of course Project Server can be the tool of choice. The beauty of this application is that it is built on the same foundation as MOSS, so that Project data can easily be surfaced in the Portal, and even managed from there.
- Once trials are up and running, there is a ton of data being generated related, which is made up of patient data and process data. Increasingly, companies are moving to Electronic Data Capture to achieve this. This data is then fed to Clinical Databases (SQL Server is used by several partners of ours for this purpose). Once again, InfoPath and Forms Services, part of the MOSS stack, are ideal for this. Here is a great application from Qdabra that can seamlessly connect forms to databases. It has great potential for EDC applications. The problem I see all too often that there is a lot of legacy technology that has been built, and vendors are very reluctant to cannibalize their old legacy EDC tools. It is such a shame, because InfoPath and Forms Services are built on XML, and are ideal for this ‘smart form’ application. However, there are already several applications out there that leverage this capability. There are our friends at the VA, there is Tenalea, and there is also InferMed.
- I do not see paper going away completely for a while as a means to collect data via Case Report Forms. Imaging and Capture applications are also needed to get Data into the the system. Among the solutions I have seen out there, I am a particular fan of KnowledgeLake, as a capture system for CRF data.
- During the conduct of Clinical Trials, sponsors also need to track and manage Adverse Events data, which is fed into an Adverse Events Report System, which is essentially a specialized database. The biggest problems many companies face are how to capture and process this data, prior feeding it into the Adverse Events Report System. Once again, InfoPath and Forms Services, in combination with a capture and imaging system, driven by business process management in the back end an ideal solution.
- All the EDC and scanned Case Report Forms have to be published into a Casebook, which then are collected as part of a Trial Master file. MOSS is an ideal platform as an Electronic Trial Master File. I just read an interesting article about this recently. However, the NextDocs Clinical module does this, too. There is also the issue of making sure all documentation is properly tagged and uploaded into the system to form the Trial Master file. We have a great Case Study on the subject, where I closely collaborated with the customer and the partner who built the solution – on MOSS!
- There is a lot of interest in Secure Document Exchange for Clinical Trials these days. It is mindboggling to consider how much paper is still being processed, huge bills being paid to shipping and logistics companies to manage all this paper, and the interpretation of ‘electronic’ in many cases is still data burnt on a CD or DVD, and then shipped via a courier service. In fact, the excellent article from 2002 titled ‘Tortured by Paper’ is still very much current. Not too much progress in 7 years….. However, as it happens, MOSS is a solution for this problem, too – and the NextDocs Clinical module is built with this purpose in mind. I have no doubt that they will be very successful with this application. Certainly, paper will not disappear entirely for a long time – but there are some excellent Capture solutions build for MOSS that can help reduce or eliminate the ‘torture by paper’ part: KnowledgeLake, BlueThread and Clearview are the ones I usually recommend.
By no means is the above a complete listing of all the intricacies and details of Clinical Trials, and I have stayed away from specialty areas such as randomization, IVR, biostatistics, pharmacokinetics, etc. However, I wanted to provide a high-level overview of some of the main clinical systems and processes, and also emphasize again that it is mostly about collaboration and business process management around data and documents. The latest Microsoft software stack is ideal for this, and it is time people realized that they can simply no longer afford the balkanized approaches of taking all these so-called ‘best-of-breed’ solutions and try to make it all work together smoothly (even if some of them still believe that Web Services will be a panacea to fix all of this). Best-of-breed can a misnomer, too – because the Microsoft software platform is mature and powerful enough to be able to build any of the systems mentioned above, and to deliver a superior solution at far lower cost. Why not build a best-of-breed suite on a platform that was designed to work together from the ground up?
Update February 2, 2010: we just released a brand new Case Study that I sponsored, and I am really proud of: http://www.microsoft.com/casestudies/Case_Study_Detail.aspx?CaseStudyID=4000006256 What a great success story for SharePoint being used at a CRO, helping them lower costs and run their business more efficiently!