TECHNOLOGICAL INNOVATIONS SURVEY REPORT

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OVERVIEWThroughout medical history, advancements in technology have allowed caregivers to better diagnose and treat their patients. The continuous development of technology in the medical field has enabled countless lives to be saved and the overall quality of human life to improve over time. From innovations like the stethoscope, X-ray and antibiotics, to MRI machines, artificial organs and robotic prosthetic limbs, technology continues to drive the field of medicine forward.

Medical innovation today is a broad field encompassing biotechnology, pharmaceuticals, digital technology and medical devices that were unimaginable even a few decades ago. The creation and development of innovative technologies and their adoption by academic and research organizations as well as by health care practitioners are different sides of the same coin. Technological innovation represents change that brings varying levels of acceptance, accompanying concerns and a range of perspectives.

Understanding how innovation and new technology advancements work in the real world provides especially valuable insight for companies in the drug development services sector of the health care market.

SCORR Marketing, in partnership with Applied Clinical Trials, conducted a number of surveys in 2016 that dealt with issues both directly and indirectly related to technological innovation. These include surveys related to mHealth wearables, paperless clinical trials, innovation and big data. This report details some of the findings and common themes that should be considered as the industry continues to wrestle with technological innovation in clinical trials.

In this report, we provide inter-survey information about:

• Acceptance and resistance to technology, innovation and change

• Cost and data quality as concerns

• How opinions of a company vary based on perspective and context

• Optimism regarding mHealth wearables and paperless processes

• The presence (or lack thereof) of structures that encourage innovation or collaboration

• How innovation and big data facilitate risk-based monitoring

• How innovation and big data don’t facilitate patient recruitment

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SURVEY PARTICIPANTS

To be eligible, survey participants were required to be employed and experienced in at least one aspect of the drug development services market sector. The companies and organizations represented in this summary include academic institutions; pharmaceutical, biotechnology and medical device companies; contract research organizations; clinical research sites; consultants and third-party service providers.

Job areas of participants include corporate, data and project management; clinical research associates and directors; research and development; medical and regulatory affairs; and strategy and planning.

Geographically, the majority of respondents were in North America and Europe, although Asia, South America, Australia and Africa were also represented.

What type of company or organization do you work for?

22%

23%

13%

11%

10%

8%

7%

3% 3%

Research Site

Service Provider

Med Device Company

Biotech Company

Consultancy

Other

Academic Institution

Pharmaceutical Company

CRO

What is your job title?

0% 5% 10% 15% 20%

Medical A�airs

BusinessDevelopment/Sales

Regulatory

ProjectManagement

CRA

QA/QC

DataManagement

Strategy/Planning

CorporateManagement

Other

ClinicalDirector

R&D

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SURVEY PARTICIPANTS (CONT)In which therapeutic areas has your company conducted clinical trials?

Where are you based?

Where does your company currently conduct trials?

77%

27%31% 35%3

30%

35%

54%

22%

32%

63%

29%

5%

1%2% 1%

Africa

Australia

South America

Asia

Europe

North America

0% 10% 20% 30% 40% 50% 60%

Opththalmology

Musculoskeletal

Dermatology

Gastroenterology

Hematology

Neurology

CNS

Infectious Diseases

Immunology &Inflammation

Respiratory

Endocrine

Cardiovascular

Oncology

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THREE MAIN POINTS:Acceptance of innovative technologiesOf the groups included in multiple surveys, CROs proved to be the most willing to accept new processes or technologies. CROs were ranked first or second in three surveys dealing with innovative processes for clinical trials, the shift to a paperless format for trial conduct, and the adoption of big data for use in clinical trials.

At the other end of the spectrum are those on the front lines of implementing new processes: clinical sites. Investigators and their staff were least accepting of big data and innovative processes in clinical trials, and the second most resistant group to paperless trials and the use of wearable mHealth technologies.

Pharmaceutical companies were considered by far the most resistant group to wearables, but the second most accepting of innovative processes for clinical trials, and in the middle of the pack for acceptance of technologies promoting paperless trials and the use of big data in clinical trials. Third-party service providers were most agreeable to the use of big data in clinical trials, but ambivalent in terms of paperless clinical trials and other innovative processes for clinical trials.

mHealth Wearables

Paperless Clinical Trials

Innovative Practices

Big Data

CROs n/a 1st 1st 2nd

Third-Party Service Providers

n/a 3rd 4th 1st

Laboratories 1st 2nd 5th 4th

Pharmaceutical Companies

4th 4th 2nd 3rd

Patients 2nd 6th 3rd 5th

Clinical Sites 3rd 5th 6th 6th

Key barriers to acceptance Cost and skepticism about data quality are the leading barriers to acceptance of innovative technologies. Cost was cited as the major concern regarding implementation of wearable data collection devices and was most frequently mentioned as the reason for the slow adoption of paperless and other innovative processes in clinical trials. Data integrity was the biggest concern about the use of big data in clinical trials and the second most cited misgiving regarding paperless processes.

Asked if a lack of interest in technology hampered its acceptance, all groups said no. Instead, fear of change and the reluctance to give up tried-and-true, if cumbersome, processes were among the top responses to why companies are slow to adopt paperless and other innovative clinical trial processes.

Concerns About

mHealth Wearables

Hindrances to Paperless

Clinical Trials

Problems Stemming

From Paperless Clinical Trials

Hindrances to Innovative

Practices

Concerns About Big

Data

Cost 1st 1st n/a 1st n/a

Data Integrity/Quality

n/a n/a 2nd n/a 1st

Data Security 3rd n/a 1st n/a 2nd

Fear of Change n/a 2nd n/a 2nd (Tie) n/a

Lack of Interest/Low Priority

n/a 5th n/a 5th n/a

Lack of Internal Support/Training

n/a 3rd n/a 2nd (Tie) n/a

Patient Compliance

2nd n/a 4th n/a n/a

Regulatory Requirements

n/a 4th n/a 4th n/a

Worse Collaboration

n/a n/a 3rd n/a n/a

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THREE MAIN POINTS (CONT):Variations in how respondents view their companiesHow respondents view their companies varies depending on to what their companies are being compared. Compared to the industry as a whole, respondents felt their own company was more likely to adopt the paperless standard (42 percent vs. 32 percent). Conversely, they also believe it’s more important for industry to accept big data technologies in clinical trials than for their own company to do so (58 percent vs. 32 percent).

Respondents also viewed themselves as more open to innovative processes than their companies are, with an average rating of 4.29 versus an average rating of only 3.78 for their companies. When competitors are drawn into the context, participants viewed their own companies even more harshly, giving them an average rating of only 3.33.

0% 20% 40% 60% 80% 100%

Personal

AVERAGE RATING

4.29

3.33

Company

Company(when compared

to its competitors)

3.78

Very Negative Neutral Positive Very PositiveNegative

How accepting are you and your company to innovative processes?

7

Lack of structure to facilitate innovation or collaborationMany companies still lack organizational structures that would tend to facilitate innovation and collaboration. One-half of respondents say their company doesn’t have an innovations department or infrastructure, and only about a third participate in a database network to share (and gain access to) a larger set of clinical trial data.

Presence of Innovations Department or Infrastructure

to Initiate and Execute Innovative Pilot Programs?

Participation in a Database Network to Share Clinical

Trial Data and to Gain Access to a Larger Set of Data?

Yes 50% 36%

No 50% 64%

Risk-based monitoring biggest innovationWhen asked which areas of clinical trials companies had already implemented new technologies, half cited risk-based monitoring (RBM) and 22 percent believe RBM will be the new standard in five years.

Ambivalence regarding patient recruitmentHow big data and other innovations may affect patient recruitment for clinical trials is still an open question for respondents. Patient recruitment was third of six areas where companies had already implemented new technologies, and when presented with a series of seven statements regarding the impact of technology, just 4 percent of respondents selected as most likely, “Patient recruitment rates will be significantly better.”

OTHER KEY TAKEAWAYS:Positives outweigh negativesThe ultimate adoption of paperless processes in clinical trials and wearable technology for patient data collection seems assured. When asked if they thought the positives outweighed the negatives, 91 percent said yes for paperless processes while 95 percent said yes for wearable tech.

95%Wearable

Technology

91%Adoption

of Paperless Processes

YES

Optimism about the futureMore than nine in 10 respondents believe their company will be utilizing wearable technology in clinical trials more in three years than they are now. Twenty-two percent report that 75 percent or more of their company’s clinical trials are currently conducted using paperless processes; 42 percent think 75 percent or more of their company’s clinical trials will be paperless in three years.

Data quality primary benefitAlthough data quality and integrity is a significant concern, it is also the most cited benefit realized from the adoption of paperless processes (46 percent) and the most identified benefit realized by technological advances.

Concerns about data securityRespondents said that data security, though not always one of their biggest qualms, is still a concern. It is the most identified problem resulting from company’s adoption of paperless processes and the second most identified concern coming from company’s use of big data.