The Emergence of Wireless Technology for Capturing and Managing Clinical Trial Data at the Patient Point-of-Care
E-BUSINESS, E-R&D AND WIRELESS CASE STUDIES FROM PHARMA CHAIRPERSON: Kathryn R Miller, Vice President, Pharmaceutical Applications, Numoda Corporation 8.30 INTRODUCTION
By on May 23, 2001E-BUSINESS, E-R&D AND WIRELESS CASE STUDIES FROM PHARMA
CHAIRPERSON: Kathryn R Miller, Vice President, Pharmaceutical Applications, Numoda Corporation
8.30 INTRODUCTION
Kathryn R Miller, Vice President, Pharmaceutical Applications, Numoda Corporation
.which is located right here in Philadelphia and Numoda puts together wireless applications and software for hand held devices for the pharmaceutical industry, the finance industry and in several other verticals.
I am the chairperson for this morning and I will be introducing the speakers and chairing the panel after our break. I will also be filling in for one of our speakers who was not able to show up from AstraZeneca and ICM so I guess they had a long way to fly to get here from Finland or Sweden but we do have Timo Apopelto from CRF Box who did make it all the way from Finland via his US office in Boston as well and our third speaker will be Bengt Falk from Pharmacia. He will speak right after lunch and talk about his initiatives within Pharmacia putting in a wireless strategy for their CRM solutions.
With that I'sm just going to go right into telling you a little bit about the case studies that Numoda Corporation has done. We'sre sort of like CRF Box in that we have been around for about four years but like Timo's organization we have really been out there only for maybe the last nine months introducing ourselves to the pharmaceutical industry so I'sll be giving you some examples of things that we arewe have deployed and are in the midst of getting ready to design and deploy for various pharmaceutical companies and my area is just focused on the pharmaceutical sector not on the other verticals that we have.
A lot of my friends, when I started working at Numoda said Okay, Kathryn this is very interesting but why should be care about wireless, so tell me why wireless..what can it bring to the pharmaceutical industry? and in the Pharmaceutical Executive this last March there was a quote that said, market evolution may eventually make doctors so reliant on wireless technologies that they will be unable to practice medicine without them. Now I don'st know how much everyone believes that statement but certainly at Numoda we hope that's a true statement.
Pulling up information from Palm Technology the Gardiner Data Quest survey shows that the number of PDA's will be increasing over maybe three times as much by the year 2004 and if you think back over Christmas holidays and all the ads for all the different PDA's that were out there this last year you can see that we are being inundated by new technologies. How many of you actually first have a cellphone? So that's pretty much everybody, maybe the easier question is: Who does not yet have a cellphone? Believe it or not I actually presented to someone at a major pharmaceutical company lasta few weeks ago who was in charge of e-business strategies and she still did not believe in cellphone technology, so you can see what kind of obstacles we are going through to convince the pharmaceutical industry to move toward a wireless environment.
What I am going to try to cover and I will have to watch, since I am the chairperson and I'sm going to have to watch my own time, maybe I can get the front rows to tweak me when I go overtime. I am going to cover what we consider what the definition of wireless and talk about various case studies where we are employing wireless for various solutions, how we try to get the pharmaceutical companies to think out of the box and not just in terms of patient diaries. We will talk about the business rationales and technical issues, how we try to ensure more successful implementation and some of the lessons that we have learned and where we think, or where I think wireless technology is moving.
One of the things that we have come up against when we look at all of the vendors out there and some of our competition just trying to get a lay of the land, we are finding that the word wireless is being used rather indiscriminately and if you think about it, even paper is wireless. So paper, PDA's and cradles synced with their PC, anything to do with the internet, WAP, cellular technology and of course PDA's with a wireless modem. If you add the word mobile's then you can eliminate the PDA's in cradles, in PC's and if you add electronic data capture's then you eliminate paper.
So one of the first decisions that the pharmaceutical companies have to make in coming up with a solution for, and I'sm usually focused on the clinical trial process, is do you want to be wireless, do you want to use wire line or do you want a cradle. We can use any of those methods but it may be that wire lines are more cost effective in certain situations or even that wireless capabilities are not always available for each particular site, so you have to come up with a technology that is most appropriate for each site in that study.
I'sll talk about some of the various case studies that we have including our physician charge capture system that we are putting together for a hospital and that has been an interesting one because many times the pharmaceutical companies want to understand the level of acceptance within physicians. We'sll talk about chart reviews for Alcoms research, phase 2 dose ranging studies, phase 4 marketing data, patient diaries. We are actually we are also doing phase 3 studies and there is a unique project that we are doing where we are using wireless technology for screening and scoring patients to keep within a very strict time line and for one clinical trial we have also put together an opiod calculator which was a convenience for the physician.
So how do we get the pharmaceutical companies to think out of the box and not just think about a wireless technology or PDA's for .just for patient diaries. So we want them to start thinking about them for the entire clinical trial process for quality of life questionnaires, even for FAE's to come up with automated reports and to manage the whole process of the clinical trial, for drug inventories, for randomization, for lab specimen tracking and of course what everyone has been talking about, the salesforce, the SFA and CRM and as an addition, finance application, so where you are actually tracking the deliverables and letting finance be able to tap into the database to see which deliverables have been met and actually make payments through the wireless system.
So in each of our examples the same business rationale was used but each one had different priorities. Most important probably is that the wireless technologies seem to solve a problem that the paper or the web based systems either created or couldn'st solve for the sponsor. They are also looking at systems so when you are looking at vendors you want to know what kind of devices they use, whether they are device agnostic, kind of operating systems whether it's Palm based operating systems or Windows CE and which network carrier they are using. You may be interested in a two-way exchange of data so not just pushing data from the field but actually receiving information back from the database. You are looking at as well, user specific applications so you may want specific information going to different users and having different users have access to different kinds of reports.
Real-time access to data, that's not important to everyone but that is certainly one of the major benefits of wireless technologies, having real-time access to that information and being able to do something quickly with that information. Increasing your revenue stream - certainly that's what the physician charge capture systems was after. Shortening the life-cycle of the drug, demonstrating RLI's, one of the most important things that we'sre doing for the pharmaceutical companies is coming up with metrics to help convince their upper management that this is an important step and of course minimizing the workload either for the CRO or for the project management team.
So the kinds of problems that we are solving of course, the physician charge capture, trying to eliminate the loss of revenues from the lost orders or forgetting to bill for certain procedures. In the chart reviews that we have done, they were trying to make the whole process of capturing that data more efficient and decrease the cost of the operation.
In the Phase 4 marketing data that we have done, they of course wanted real-time access to data so that they could take that information very quickly and change their marketing and advertising strategy to increase their market share.
Patient diaries of course were interested in non-compliance issues, eliminating the non-compliance and knowing exactly when patients were actually completing the forms and as I mentioned the screening and scoring patients; they had a very tight time frame and that was one of the advantages of the wireless technology. They had actually done this project with paper and had so many problems with trying to keep on time and averaging the scores that it became a nightmare, and of course the opiod calender calculator was just for the physicians convenience.
So you are looking for, as I said, systems that are device agnostic; you want to look for systems that minimize the amount programming that is involved for creating the application because the more programming that is involved the longer it is going to take to actually create the application and usually by the time they have signed the contract they'sre behind schedule and they want that, those applications, created very quickly as we'sre painfully finding out. You want to know if their operating system, if they'sre agnostic in terms of which operating system they use and which wireless network so as long as you can use a system that can use any network carrier that's very critical for studies that are going to be global and I'sm sure Timo will describe the convenience doing studies in Scandinavia where 90% of the population uses wireless technology.
On the user specific access one of the things you want to be looking for is making sure, as I said before, that individual users within the clinical trial have access, ready access, to the information that they need rather than having to go through the project manager and try to phone up and getting answers to questions and hassling that person. You want the investigator to be able to go into the database and get just their information, you want the directors or CRA's to be able to go into the project and get their information, finance to get access to their information etc and you want a two-way exchange of information so you want to be able to push and pull information through the system.
Of course everyone is interested in the time and cost savings and this was one of the very early projects that Numoda had done, I think when they were actually testing out the technology. They managed to cut down the chart audit review process from twelve months down to two months and cut the cost by over 60% with a considerable ROI as you can see, in fact some times our returns on investment are so staggering that we stopped emphasizing them. It is not always true, it is going to be the bigger the study, the more sites, the more patients, the larger the ROI tends to be although that isn'st always the overriding concern for the pharmaceutical companies that are looking at this technology. Many times it is having real-time access to data and as described in that one study where they were screening patients and dosing them and they were on very tight time frames, that was the major consideration.
So you want to look at what the true costs are of the various situations and here I'sm just comparing wireless to not using wireless and when you think about wireless you have got to think about the costs of all the hand held devices and if we are talking about large patient studies for patient diaries, that is a lot of hand helds to be purchasing and what are you going to do with the hand helds at the end? Are you going to give them to the patients, are you going to reuse them, how many times can you reuse them? There is the cost of developing new SOP's and the cost, the huge cost of implementing change. One of our biggest obstacles is introducing this technology to nurses and physicians who go, Oh my gosh, I have to do something on this little device and I want my paper back. We have had projects where they didn'st want to give back the devices at the end because they loved using them at the end but you have got that whole image of having to change their mind, their whole view on how they have to collect this information. And then another big issue right now because this is such an evolving technology is the combination of the pharmaceutical company now is looking at getting different vendors to do different pieces of it and I think what you are going to see is that more vendors will form alliances and work together to make it more of a seamless process for the pharmaceutical company. But the disadvantages I think are still on the other side of the disadvantages and the costs of not using wireless. Of course you have got missing and illegible data, you have got more source of data verification for wherever you are using paper CRF's and in fact you are using paper CRF's probably for web based data collection because you'sre collecting the information on paper and then taking it to the PC and entering it into the PC. You still have to generate project reports and site management reports where that can be done automatically with wireless. You have the delay of investigative payments and the cost of their good will, the cost of computers, patient non-compliance, extra travel costs for monitors and you can even argue that the CRA turnover and job satisfaction issues tend to be minimized with a wireless technology.
Some other factors that will differentiate the various wireless vendors out there, the ability to deliver wireless whenever it is desirable. So again you are looking for vendors that can do any of those methods of delivery, whether it is wireless, or wire line or CD's, excuse me, cradles with PC's. You want to look and see what kind of patents they have, whether they are patented reports or it is patented technology and you want to be able to look at whether or not there are actually xxxxx the applications or whether they have some automated process for speeding up that process of creating the application. If they re using object oriented technology, what is the size of the object library, can they make changes on the fly; that's very critical in some cases where you are making changes. You don'st want to have to go and recall those devices if you are making a change in the questionnaires, you want to be able to change those, make those changes remotely and on the fly and deliver different applications to different sites, if depending on when their IB panel has met. You want to look at companies who have actually completed their validation on the core technology which is going to speed up the whole validation process, you want to look at how easily they can be integrated with your internal systems and you have to remember that the validation on the back end is the sponsor's responsibilities.
Some of the technical issues and I'sm not going to be able to have time to go over all of them but all of the studies will have issues with the technology. It is important for you to understand how each of those vendor's systems works so that you can evaluate your various options. Everyone is interested in the user acceptance, there is the issue of text entries, security, validation, their compliance with FDA regulations, the question of where is my source document now?'s Users are visual, they like their paper and that whole issue of getting them to change and give up that paper safety net has been an issue. The limited real estate, how big is that screen? If you have got a visual analogue scale and you are determined and very inwed to that ten centimeter visual analogue scale, that is going to be an issue, it is going to make an impact on the kind of device that you select. Unless you are a much more flexible company and you aren'st wedded to a ten centimeter scale. And you have to accept that there is going to be a lot more pre-planning on the part of the sponsor to make this work.
This is a little hard for you to read and my SVP suggested I not show this screen however it is important for one reason and that was, when we presented our particular solution to pharma companies they couldn'st get over the possibility that you could actually do a hundred page or a three hundred page CRF on a little PDA. How could you possibly fit that on a PDA and I thought that they were focused on their RLI's and the believability of the RLI's so the explanation in our case was that we had to come up and this is one of the obstacles that all of the wireless vendors have to come across, is how do you come up with a technology where you take up such a small footprint that you can actually still run all of the other applications or be able to do much more than just a patient diary and this slide is attempting to explain how we have solved the problem and it is basically, you'sve got, and I'sm going to give you a very layman's explanation: You have your objects which is the mini executables which could be things like here's a template for yes/no question's here's a template for a multiple question's and if you had all of your questions and your CRF in those two formats that's all the size that the program needs to be, all of your text gets slid into those same executables each time so you can store all of the text for your questions and the multiple choice answers and re-use those same objects over and over and over again on the PDA including incorporating your skip logic. In fact with that methodology you can actually, on a 2 meg device because when we started that is all the size of the PDA's were, you can actually load 65 000 questions on a PDA. So it is pretty mind boggling what you can do in fact now you can, you have got PDA's that can take 8 megabytes of memory and 16 megabytes so it is lot more memory and usage that you have on these PDA's. But aside from that, in our case the bulk of the application is really on the server, it is the server that performs all the queries and verifies who the user is and verifies the time on the PDA's so that you have got all of your sites synchronized at the same time. So those are just some of the reasons why you can actually handle a clinical trial on a PDA and aside from that you don'st have to because you have remote access, you don'st have to have all of those questions at the same time on a PDA, you only deliver the applications that are necessary for that day or that week.
I'sm getting the five minute warning on my presentation here. One of the issueswe did this survey last February at a DIA Conference forwith project managers and finance people and 60% of them had never even touched a PDA so we did this survey for them and it was all on project management and finance questions and at the end we asked them, Well, okay, so efficient was this process of using this PDA for this survey, did you like it, was it user friendly, how easy was it and how was the text entry? and you can see the issue that was most salient is the issue of text entry and so you have got to come up with: that's our problem, how do we come up with the method of capturing this data withoutand minimize the amount of text entry that is required?
So some of the solutions in fact this one project that I mentioned where we are screening the patients, they'sre actually using barcode scanners to scan in the patient's the screening ID for the patients and then when they qualify to scan the randomization number for that patient and that way they are keeping the timing going, they'sre not losing the timing for the dosing and all of the screening information has been fed into the system ahead of time. It is our job to minimize the amount of open text entry because you want to gather data that you can aggregate rather than depending on open text and having to analyze that. You do probably and this is up to each project, you may want to collect information on paper to capture any information that the judges may.any comments that the judges may want to make about, or the physicians may want to make on those patients so you can still have a hybrid of paper and wireless and again, even used the web based interface for the text entry as we'sre doing on this one project where we are entering the patient information in demographics over the web and then conducting the trial wirelessly. And of course there is the last option, there are actually detachable keyboards that actually fold up and are about the size of a PDA although no one yet has requested them, I guess they have gotten used to the graffiti mechanism for entering data but those options are available.
This is just an example of one of the ways that we get around text entry, you could use visuals and in this case they have a menu where the select whether it is bruises or lesions or masses and they can point and make markers on the body. We have also done a project where we have pictures of the mouth and arm but they can actually mark on the graphic whatever the comment is that they need to record.
One of the issues and I'sll try to end with this, are data more secure on wireless than on paper? Well I think certainly we believe it is far more secure. You have got electronic signatures that are unique and repeatable, we even capture the graphic signature which has no biometrics attached to it, it is like when you go and sign for your package from Federal Express or UPS but it gives the sponsor the assurance that they have got a signature signed as well as an electronic signature signed with that data collection. You have got an alterable audit trails with time and date stamps, you'sve got encryption of the data on the device. When you are transmitting the information as I showing you where you have the objects separate from the text, you also have the data separate from the text so that the data are being transmitted without the questions and anyone who might be able to intercept that information will have no idea what questions they were answering. And then of course the networks of course have wireless encryption during the transmission.
This is just an example of how we log in and maybe Timo will show exactly what kind of signature linkage that his system uses but you log in with your user ID and your password and then get access to the data. One of the issues here that we have to address is if they'sre not active on the PDA it will shut down and then they have to log in again, so that is part f our FDA regulatory process, so you may want to extend the amount of time that the PDA will stay active.
So the big issue here is, where are the source documents and I know Timo will have some comments to make about that as well. Electronic signatures appears to have been written with the belief that pharmaceutical manufacturers have an incentive to falsify electronic signatures, now of course those issues are there for web based systems a well. What you have to accept and what we are going through the process of convincing everyone is that the source document is now the actual database and that is assuming that the original data entry is occurring on the PDA and not being transcribed from paper and the audit trail occurs on the PDA so your source document is now your database and any paper copies of that data will have a later time and date stamp than what is in the audit trail for the data base. If you file a copy of that, if the investigator files a copy or gets a faxed copy of his data and that is filed in the binder or in the patient chart, that is going to have a later time and date stamp than what's in the database. Reports can be designed to accept additional physician comments and data regarding patient's wellbeing - that's an important part of the source document and now you are going to find the source data verification can be focused on more issues.on issues more related to consistency and logic.
I think with that I'sm going to allow you to ask any questions about how we have done wireless projects here at Numoda in the States and then I'sll introduce Timo to talk about CRF Box. Okay.