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European Pharmaceutical Contractor

The Digital Age of Pharma

Patient recruitment is a very important key to unlocking drug franchise success; sponsors must adapt to the way patients themselves communicate, using mobile devices and social media to get their attention.

Whether you call them new media, digital technologies, or social media, in the patient recruitment industry we call them game changers. From online, patient-driven communities to centralised and actionable data sources to mobile devices, digital media is transforming the way clinical research is accomplished – especially when it comes to franchise-level clinical R&D.To stay competitive, pharmaceutical companies are relying increasingly on a new array of technology solutions for successful rollout of global research programmes.

This article will explore some of the most innovative solutions that are making the biggest impact on the bottom line in terms of ramped-up enrolment for clinical trials, more precise feasibility data, as well as improved communications with study staff and participants.

There is no substitute for a wellconsidered therapy backed by a sound research strategy for ensuring a successful drug franchise.While these five digital keys cannot guarantee franchise success for a given clinical compound, they are each load-bearing pillars of competitive clinical research in the digital age. 


Mobile Devices

At no other time in recent history have consumer electronics and healthcarerelated information sources been so powerful and influential as to affect drug development and the way medical information is disseminated. In some ways, the personal electronic devices of the average consumer outgun the resources available to the average clinical research coordinator who is managing multiple trials via email, data entry systems and spreadsheets from a desktop computer. In contrast, study participants expect appointment reminders by text messaging and the ability to enter patient-reported diary information via their Smartphones.“Can we do the appointment via Skype?” one study volunteer recently asked a coordinator in the UK.

One more example is a new role for the ever-increasing presence of the Apple iPad®: a product that has garnered global attention for the way it has revolutionised the multimedia communications and the web platform, first established through the iPhone®. On the pharmaceutical sales side, the iPad accompanies representatives from Otsuka, Novartis and AstraZeneca to name a few. Within clinical R&D, market familiarity with the iPad has now reached a level of utility that can transmit into major cost savings for pharmaceutical sponsors.

“Imagine a typical study binder that gets produced for the investigators’ meetings for a global clinical trial”, said Matthew Stumm, Director of Agency320, a creative consultancy and media solutions agency that specialises in patient recruitment for clinical trials.“Sponsors spend tens of thousands of Euros creating these massive binders of the protocol and a spectrum of various charts, checklists The Digital Age of Pharma Patient recruitment is a very important key to unlocking drug franchise success; sponsors must adapt to the way patients themselves communicate, using mobile devices and social media to get their attention. and diagnostic scales... and I can’t tell you how many of them I’ve seen left behind in the meeting hall.”

As an innovative approach to centralising the mountain of documentation and other study-related materials and information that accompany a typical clinical research protocol, Stumm’s company has developed a number of applications that leverage iPad technology into a virtual study binder.

“The Franchise e-BinderSM supports study start-up by making it possible to instantly distribute, store and retrieve information and data with the tap of a finger”, Stumm said.“Our application of this new and accessible technology skilfully supports clinical research professionals as they work to manage the avalanche of information surrounding clinical trial particulars.”

Not only are investigators’ meetings made simple, but the variety of Agency320’s Franchise e-BinderSM iPad applications offers principle investigators and research coordinators one-stop access to critical study forms, such as the protocol and patient recruitment materials. On the data-gathering frontier, study coordinators can use the device during patient screenings and procedures, and have data instantly uploaded to the given information management system for the study and/or site. Clinical study managers and monitors can avail themselves of this hand-held portal to site administration resources – including training, study contact listings, sponsor documentation, clinical assessment tools, and more. As well, top-level study data and analytics is sourced centrally and easily retrieved by clinical operations managers.

Social Media: Not Just a Fad

In the competitive drug development marketplace, clinical trials run the risk of stalling if they can’t keep up with the way patients are used to communicating and receiving information. On the social media frontier, today’s market research tools allow sponsors to target, observe and record much of the incredible activity taking place on social media portals. Information gleaned by ‘listening’ to these portals indicates where patients meet online, what they talk about, as well as the words and phrases they use to discuss their health. These findings can be used to direct, refine and target the content and call to action of traditional advertising and outreach. With basic knowledge of patients’ social media use, adverts and outreach can be served directly to those patients via specific portals – and with unprecedented precision.

“Sponsors can establish a sophisticated and elaborate web presence for recruiting patients for a given study, but if the messaging is off, then nobody will be the wiser and the opportunity will be lost,” said Jennifer Tomosivitch, Director of Marketing, European Donor & Plasma Division, for Swiss-based Haemonetics SA.“The patient recruitment opportunity presented through social media venues is really unprecedented – and it provides a means of ensuring that outreach messaging is as targeted and cost-effective as possible,” she added, citing opportunities to significantly reduce costs of patient outreach through better performance.

To help ensure that media messaging is on target (and to mitigate the challenge of culturally adapting patient outreach for global studies) social media ‘listening’ projects can pinpoint where, when and how a particular patient population is accessing and utilising medical information for a given condition. It can help to provide insight as to how specific patient populations relate with each other to share information and learn more about their particular condition, and even to provide support and encouragement along the difficult path of diagnosis and treatment.

Understanding the way patients communicate and relate with each other is one key to knowing how to reach them at the precise moment in time when they are likely to consider participation in a clinical research study. Of course patient needs will vary widely from diabetes to depression studies or late-stage cancer trials, but knowing exactly what those needs are and being able to respond to them in an impactful way through precision outreach messaging means clinical operations managers can better predict and deliver on study enrolment timelines.

Patient-Driven, Online Communities

The competitive demands of global patient recruitment for clinical trials have driven the advent of online patient communities as a major factor for helping sponsors raise awareness and support study enrolment. Patients across a wide spectrum of diseases are leveraging the internet in record numbers to not only access health information, but to connect with and learn from others who share their condition – or empathise over the impact a given illness has had on their families.

Online patient communities present the most dynamic use of social media by delivering study messaging in a ‘place’ where patients interact with one another and often search for new treatment approaches including clinical research studies. Some research sponsors have incorporated blogs, message boards, e-mail lists, or social media pages dedicated to a particular study into their online patient relationship-building efforts.

These communities may be started by patient advocacy organisations, pharmaceutical companies, or more organically, by a small group of sufferers who find one another online. In the past decade, a number of companies have been formed around the idea of matching patients with diseases to physicians involved in research studies with varying degrees of success – no more so than in oncology. However, simply matching services does not a community make, so there is room for further innovation in this arena.

Founded in 2004 by three MIT engineers in Boston,Massachusetts, PatientsLikeMe® is a privately funded company dedicated to making a difference in the lives of patients diagnosed with life-changing diseases. As a company, PatientsLikeMe was envisioned as a new system of medicine by patients for patients, based on the impact that amyotrophic lateral sclerosis (ALS) had on the families of its founders.

“The healthcare industry is in need of change and patients’ sharing of health information is the catalyst behind real improvement,” said Benjamin Heywood, Co-founder and President. “Patients are sharing meaningful data and creating new knowledge about disease, which is in turn being used to accelerate research and improve patient care. As an industry, there’s unparalleled power and opportunity to align our interests with the people who matter most – patients,” Heywood said.

With over 100,000 patients experiencing more than 500 conditions, PatientsLikeMe now supports recruitment of patients to clinical research studies by providing its members with information about, and invitations to explore actively recruiting clinical trials.

Evolution of Electronic Medical Records

Long considered a potential boon for improving the viability of protocol design, the matching of research centres to protocol requirements, and qualification of potential study participants, electronic health or medical records (EMRs) have yet to deliver all their promise. But don’t dismiss this evolving digital resource as EMR systems are rapidly gaining market penetration and sophisticating their data normalisation and related search functionality. If you’ve already crossed EMRs off your list, take a fresh look at this category as web-based, cloud computing models replace the frustrating, installed systems of the early players in the EMR market.

Still not convinced? Consider that Oracle, IBM, Google and Microsoft continue to invest in systems that are transforming data into actionable insights, and several niche companies are developing applications driven by the needs of clinical researchers. For example, Germany-based MEDEORA GmbH Medical Information developed a web-based system to assist medical researchers in Austria, Germany and Switzerland overcome data management difficulties that are inherent in some of the legacy formatting of EMR and information codes. The company’s flagship product transforms open text information into redefined and searchable data for analysis to support clinical research.

“The SAPPHIRE system opens up new opportunities for the interpretation of medical data,” said Andrej Woehrmann, MD, co-founder and CEO of MEDEORA. “You can benefit from all of the information advantages in only a matter of seconds, and this is possible because different data sources are gathered together, the data is saved in a uniform way, and the analysis is especially optimised for clinical and scientific research requirements,” Woehrmann said.

“The goal has been to bring some order and utility to a universe of data that will vary from hospital to hospital and medical university to medical university,”Woehrmann added. “We’re helping our clients interpret data that was simply not accessible to them before – whether the data was coming from standard formats, or from combing through vast amounts of data compiled by individual investigators.”

Data, Data Everywhere and Not the Time to Think

Online, digital data collection, query management, quality control, supply management, randomisation – the list is extensive and ever-growing. With more and more data points available to clinical operations managers, the opportunity to improve study planning and execution is right in front of us.Yet, the staffing infrastructure for study management has not evolved on a par with these technologies – especially within the realm of study start-up and recruitment.

In many instances,we rely on digital data to streamline personnel hours, eliminating wasted hours spent tracking down missing information or inaccurately entered notes on a case report form. Online randomisation systems have either replaced or acted as a supplement to telephone-based systems to further streamline study supply management and distribution. The electronic case report form and study submission processes certainly improve timelines and quality of clinical research information.

From a patient recruitment perspective, each of these systems contains insights that improve management of active studies and planning for future research. Yet few organisations know where to look for and what to do with the information right in front of them.

At TCN e-Systems, a global leader for patient recruitment data management, seamless data integration – regardless of the initial IVR, CTMS, or other data source – has been the goal for streamlining patient recruitment data analysis and facilitating timely and cost-saving programme management for its global clients. In the words of one senior CRO executive,“We see this information every day in nearly every report our systems generate, yet we’ve never looked at it this way to drive study management decisionmaking.” For example, knowing the answer to the query number of days since a research site has last screened a patient can prompt actions which are both congratulatory and corrective.Yet many study managers focus on the number of patients already enrolled – a data point not likely to improve future enrolment.

On the clinical study administrative frontier, actionable data from specific real-world experience with patient recruitment and clinical trial management across the various research phases for a given compound are key to ensuring timely progress from safety, to efficacy, to pivotal studies – especially if the data is housed in a secure, centralised source that is readily accessible to the study community atlarge. It is no longer enough to have a system for managing prospective participant inquiries and referrals to research centres.There are myriad more insights these data can deliver to improve study start-up and ongoing patient enrolment efforts.

The Road Ahead

Despite these many advances,patient recruitment remains that single greatest bottleneck for timely clinical study completion in the 21st century.And regardless of how well your Phase II trial enrolled, past performance will never be a reliable indicator for future success the digital age of clinical R&D.Global competition, the exponential growth of emerging markets, and the advent of personalised medicine demand predictability with respect to study execution timelines and the randomisation of highly targeted participants – individuals who are hammered by thousands of daily media messages and stimuli.

To compete for their attention, sponsors must adapt to the way patients now communicate – a paradigm shift that is as subtle as it is profound. Throughout the clinical research enterprise, digital technologies are delivering exponential opportunities to connect sponsors, investigators, monitors, patients and caregivers. At the same time, these same technologies have increased our expectations for customised communications that speak to each of us as individuals.

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Matt Kibby is the Global Operations Lead for BBK Worldwide and Director of the company’s European Headquarters in London, advising clients on country and site selection, enrolment feasibility analysis, site assessment, and patient and physician market research. He is frequently published in international industry publications and was recognised by PharmaVOICE as one of the 100 most inspiring people in the life sciences industry. Email:
Matt Kibby
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