Aptiv Solutions is a full service international Clinical Research Organization for all phases of development, with a particular expertise for biopharma and medical device companies. Aptiv Solutions is a pioneer in the design and implementation of adaptive clinical trials, which use accumulated data from an on-going study to modify critical aspects of the study.
A study that utilizes an adaptive design is more flexible, allowing the sponsor to implement one or more pre-planned adaptation (e.g. the number of subjects, the duration of the study, the duration of particular treatments), depending on the data that’s collected for an interim analysis.
The subsectors of life sciences and medical devices receiving the most buzz in the regulatory world are health information technology and mobile health apps.
Current products in development are pioneering clinical trial strategies, as the culture of the industry changes following the FDA and Congress’ pledges to provide proper guidelines and mandates.
OneMedRadio spoke with Cynthia Nolte, Director, Medical Device Regulatory Services for Aptiv Solutions, about the state of mobile health/health information technology regulatory issues, clinical trial design for mobile health technology, and what we can expect from future guidelines. The conclusions about regulating a rapidly evolving space — and the case studies that have pioneered this process — are intriguing, and indeed promising.
Dr. Nolte as well looked to other factors — including globalization and limiting cost — have shaped new clinical trial design strategy in medical device and biotech.
Click to listen to the interview, and read the transcript below.
Matt Margolis: OneMedRadio welcomes Cynthia Nolte, Director of Medical Device Regulatory Services with Aptiv Solutions. Aptiv Solutions will be a sponsor for the upcoming OneMedForum NY 2013, taking place at the Metropolis Club June 26th and June 27th. Today we will be discussing the regulatory landscape, globalization and drug development, and the novel technology that is driving new strategies for clinical trial implementation. Thank you for joining us, Cynthia.
Cynthia Nolte: Thank you very much, Matt.
Matt Margolis: What kind of services does Aptiv Solutions provide and who are your clients?
CN: Aptiv Solutions is a full service CRO. Over the years Aptiv has proven expertise at supporting and developing projects for buyer pharmaceuticals and medical device companies. Our involvement spans all of the development life cycle, from feasibility all the way through regulatory approval. We have 850 professionals all over the globe that are proud to call themselves Aptiv Solutions employees.
Our clients are both small and large companies. We enjoy working with small companies, helping to develop their new and cutting edge technology. We also have a number of clients who are established market leaders; helping them manage their workload and supporting their exploration into new markets. I’m in my 18th year in Aptiv Solutions. I spent my entire career in regulatory affairs at Aptiv Solutions climbing the ladder in the medical device regulatory industry.
Like many Aptiv Solution’s consultants, I come from the regulatoin industry. I think it’s very beneficial that we are able to apply a very broad breath of technical expertise and understanding of best practices when it comes to scientific research of our consulting projects.
MM: Going into detail about what an adaptive clinical trial is. What are some essential concepts for success?
CN: Aptiv Solutions is a world leader in the use of adaptive design to run smarter, more efficient clinical trials. Adaptive design is just what the name implies: using accumulated data from an on-going study to modify critical aspects of the study. When this is done properly the validity and integrity of the study is maintained. So a study that utilizes an adaptive design is more flexible. It allows the sponsor to implement one or more pre-planned adaptation depending on the data that’s collected for an interim analysis.
So some examples of this pre-planned adaptations could be the number of subjects, the duration of the study, the duration of particular treatments, something like that.
MM: So I want to shift gears a little bit, talk about the mobile health space. Firstly, how have the FDA certified plans for mobile health at regulations changed.
CN: Well, what you heard FDA say is that they’ve been regulating mobile health or pre -cursors of the current mobile for some time. I’m seeing FDA as responding to the mobile health industry by attempting to put in place a consistent and predictable and scientifically rigorous approach to the regulation of medical devices. In the mobile health application industry, innovation is accelerating at a rapid pace. The basic frame work for medical device regulations has existed since 1970’s. The FDA is now helping – or trying to help – the mobile health application industry understand how the rules created in the 1970’s apply to their industry.
MM: Do you believe that the FDA guidelines for health IT and mobile health apps reflect what positions in hospitals want to see?
CN: The FDA’s perspective on the situation is a bit different compared to that of a physician or hospital because the FDA sees their mission as being to protect the public health. The physician being in a hospital in which their goal is to introduce a particular application with features that physicians and hospitals would like to use. When application is truly a medical device, the FDA’s job is to make sure that that application can be safely and effectively used by patients.
So it’s a little bit different perspective. Someone submitting an application to the FDA for a particular mobile health app, will put forward the claim that they know the hospital and physicians and would like to see their particular products. Then its FDA’s goal to make sure this can be done safely and effectively.
MM: How are trials from mobile health tools actually designed, and how is it different from bio-tech and traditional pharma?
CN: At the core, I don’t think that a clinical trial designed for a mobile health application would be any different compared to a bio-tech or traditional pharma tool. Good clinical practices are adopted by all sponsors of all sorts of clinical studies. However, it is true that new safety and effectiveness issues arise from mobile health applications. The issues of patient accessibility of information, integrity, security and the ability of users to properly operate a mobile health tool in conjunction with interpreting the information coming from the application are different than the issues that arise with something like a syringe or a pill.
MM: There has been a lot of criticism of the FDA taking a hard line against these mobile health apps, that they are over-regulating. Do you think that there may be a chilling effect for this industry?
CN: I think the FDAs guidelines will continue to frustrate those moving forward in the mobile medical space, where the sponsors or the developers of these applications don’t understand the applicable medical device regulations. The FDA is not saying, ‘We won’t allow any mobile medical applications to reach the market.’ They are saying, ‘If your product is actually a medical device then it will need to be regulated under the same framework of regulations that any other medical device software medical device is regulated.’
I think once the industry becomes more familiar with the guidelines and there are more examples of companies who have successfully navigated the FDA road map, we are going to see the concerns abate eventually. I do think that the excess amount of time the FDA is taking to finalize the guidance adds fuel to the fire. I think everybody agrees that the best thing the FDA could do, is to expedite the finalization of the guidance. All industries are frustrated by the lengthy period of time it is taking the FDA to introduce a new guidance.
MM: How much globalization of clinical trials is affected by the regulatory side?
CN: In 2001, the FDA issued a guidance focusing on how they intend to handle and how they currently handle foreign clinical data and I think that guidance still generally applies. Currently, the challenges that regulators face continue to be ensuring the patient’s privacy and safety is protected. It is critical that the data is being collected in a scientific and a rigorous as well as an unbiased manner. As more and more countries are being involved in the clinical trial process, the mandate to maintain patient’s privacy and safety are more of a challenge for the sponsors of clinical trial to ensure.
MM: So how does Aptiv Solutions assist in health care companies that are seeking to perform clinical trials abroad?
CN: We benefit from the fact that we have boots and heels on the ground in a number of different countries across the globe and we have a very excellent team approach to projects. So we have a broad expertise in a large variety of pharmaceuticals, combination products and medical device.
MM: What case studies can you point to a successful health information technology that has navigated the FDA?
CN: Well, if we are talking about devices like mobile medical help apps that are so popular today, I have seen throughout my career many pre-market clearances – meaning they reached the market via FDA 5-10K process – for a multi-component medical device system. An important question to ask is where and how the different components which exchange information communicate with each other and the outside world? Some of these are what we call in 2008, telehealth systems. They collect information from different medical monitoring devices, display this information and communicate that data to the outside world.
In the case of devices categorized as a mobile medical app, a figure of more than 75 has been touted in the press. Many of these involve managing chronic disease, like some sort of digital log book for tracking your glucose monitoring data. There has been a lot of work in this space for ECG devices where folks will wear their halter monitor, collect data on an electoral patch and then that data is transmitted out to a remote monitoring station.
There are also a lot of apps monitoring vital signs as well as imaging apps that have reached FDA via the 5-10K process. Aptiv Solutions have participated in a number of these projects. One of the most recent clearances, which Aptive Solutions can claim, and frankly, is a very innovative product, is something called my vision track. This is a hand-held prescription-only medical device provided as an app for iPhone, that received clearance in March of 2013. It’s marketed as an at home method for monitoring the progression of degenerative eye disease.
In regards to software differences, clinical studies are required for difference platforms, be it an iPhone or android. The FDA would expect to see the evaluation separately. I don’t think that means you have to go all the way back to the clinic, but I do think that it means every platform the FDA would consider a separate medical device and you would have to do your due diligence in terms of looking at the ability of this mobile platform to support the software.
This approach from my vision is no different than the approach the FDA has applied to any other type of medical device that is making claims for a conjunctive monitoring of disease progression.
MM: That was Cynthia Nolte, Director of Medical Device Regulatory Services with Aptiv Solutions offering perspective on the state of regulatory for mobile health and clinical guidelines. With OneMedRadio this is Matt Margolis signing off.