I recently visited the DIA EuroMeeting to have a look at the latest and greatest in patient centric research and what patient-facing technologies are available today. I found the show well organized and the meeting venue in RAI Amsterdam was very good. Helping vendor and sponsor interaction, the exhibit hall was just one big space and seemed to be relatively lively compared to some of the previous EuroMeetings.
One of the highlights for me was the opportunity to interview the new DIA President, Dr. Ling Su. Here’s a summary of our discussion:
Me: Is the same patient-centric research trend also seen in China?
Dr. Su: Not to the extent that we see in Europe, which is probably the most advanced, followed by the US. There is some movement in Japan. In other parts of Asia, it’s not as organized.
Me: Do patients in Asia have similar access to clinical trials than in the west?
Dr. Su: I don’t think trials are as accessible. There is also a bit of a ‘guinea pig mentality’. Adverse events, etc are negatively publicized in the media and people don’t have a balanced view. They don’t understand what the safeguards put in place are and how risks are minimized. More public education is needed.
Me: Almost half of the Internet users come from Asia, but the penetration is still only around 27%. Are people in Asia using online health resources routinely?
Dr. Su: The younger population certainly uses mobile a lot, but the elderly much less. There are a lot of health resources available in the Chinese language, but I don’t have the statistics of their popularity. China is a big country and the use of the Internet probably varies a lot by region.
Me: What about attitudes towards online tools for clinical research. Like EDC and resources for patients.
Dr. Su: EDC is used a lot in China, but it depends on the Sponsor. Most of the multinational companies conducting research in China use EDC and some of the local Chinese companies use it as well, but many still use paper.
Me: Does the DIA have special initiatives focused on the patient? At least the patient groups are well represented at the EuroMeeting.
Dr. Su: Patients are certainly a critical component of drug development and that’s what the DIA’s mission is about. In Europe, USA and also in Japan there is now a lot more patient group involvement in the meetings. While we don’t yet have online resources available directly for patients, we do want to hear from them so that we can better serve their needs in the future. We have also decided to allocate one seat in the DIA board for patient representatives.
Me: You must have heard about the Pfizer virtual REMOTE trial. Do you think this model would be successful in China?
Dr. Su: I have heard about it. I’m not sure about China. You need several prerequisites for such a model, first of all, you need a robust healthcare system across the region and the standard of care needs to be consistent. The investigators and patients need to have a good understanding of trials and GCP. In China, I think this will still take a long time before it will happen. You need to establish a foundation for success first.
Me: One of the motivations for doing these virtual trials is to reduce the burden for the patient and the site. My understanding is that this might be less of an issue in China as patients are generally very compliant and actually like going to visit their doctor.
Dr. Su: Exactly. In China, many people think that if they don’t see their doctor, they’re not being appropriately cared for. This is the cultural reality. For example, people also like to get injections rather than oral medication as that seems as a more potent way of getting treatment. In China people also typically want to always go to the best available hospitals, even for trivial treatments that could easily be taken care of in the community clinic.
Me: What big trends do you see in Asia?
Dr. Su: Clinical trials certainly are increasing a lot in the region. From the industry point of view, the sponsors need to pick the best pathway for getting their products to the market and this can be quite complicated. You need to consider the disease, the product and existing medical practice. Regulatory approval times, differences in populations and also other regulators like the EMA have their own regulations about what kind of data they can accept outside of the EU. China is also getting richer and healthcare is becoming a priority. At the same time, the need for training for Investigator and Sponsors is increasing and the public perception of clinical research needs to be strengthened. The DIA is providing some of this training, for example, we’re conducting ethics committee training for the third time in two years time.
Me: What kind of support is available for global companies interested in doing research in China? You mentioned you work in an advisory role?
Dr. Su: Let me talk about my background a bit. I have studied in both China and the USA and worked at regulatory agency in China as well as the FDA. I’ve been working as an epidemiologist and heading development for many industry companies in China and Asia, including working as a Senior VP for Novartis as the Head of Development for China where I was responsible for the development of complete pharma products. Having worked on all side of the fence has given me the insight required to be able to advise clients on strategic issues. I currently work for a law company as a Strategic Advisor advising clients on regulatory and product development issues as well as teaching at universities.
China is complicated and evolving. Many small to mid-sized companies from the industry work with CRO’s in China, but currently CRO’s strengths in China are in execution, not strategy. There are only a handful of people that are advisors in this matter, but I believe their numbers will increase in the future. It is very important to have good disease insight through the Key Opinion Leaders (KOL) as well as a good regulatory strategy. Even the big Sponsors that have local presence often want a second opinion for their programs and this is generally a good idea.
Me: Thank you Dr Su for your insight, and for support such a interesting EuroDIA.
In terms of patient-facing technologies, there were a couple of interesting products:
1) Vitaphone, a telemedicine provider had some very interesting products on display. I was especially impressed with their Vitaphone RemosEKG product, which is an ECG meter that offers the kind of patient usability I’m looking for. Basically, it’s a remote ECG device, which you simply hold to your chest and press one button to start recording your ECG, which the device then automatically sends to a central server where it can be reviewed by a medical professional. In a clinical study setting, this device can help eliminate unnecessary visits and make life a little bit easier for both the patient and the site personnel.
2) ePRO technology has seen some advances. PHT has released their ‘ePRO App’, which is a long-awaited opener from one of the major players that allows patients to complete electronic diaries using their own smartphones. It’s a good principle that will have nice potential in many parts of the developed world. Japan, for example, has 100% 3G coverage already so this kind of technology is accessible to many people. CRF Health has done some nice work on their user interfaces, especially their tablet devices which are turning out really nice. ePRO in general, is a really nice example of technology that has several benefits, from helping patients keep track of what they need to do to also reducing site burden and of course helping sponsors collect high quality data.
There was also an interesting poster about PRO’s being used for pharmacovigilance. Is this going to become a new trend? We’ll see.