¶ … Technology in Managing Data in Clinical Trials TECHNOLOGY IN CLINICAL TRIALS

Incorporation of technology (electronic and digital technology that can utilize the internet or mobile devices) into the process of designing and executing studies in Clinical trials has been a slow process. Currently, individuals and various corporations have already incorporated such technology into their day-to-day lives and rely on electronic platforms. The aim of this paper is to provide a general overview of how e-technologies are used in clinical trials research, especially in the last ten years that have seen internet based-tools and mobile devices grow rapidly. The benefits and challenges that are associated with using e-technologies in collecting data, recruitment, and retention, delivering interventions and dissemination have been provided. The use of e-technologies for designing and implementing clinical trials has the ability to reach an extensive audience thus enhancing the efficiency of trials and reducing the cost: researchers should however be cautious in the adoption of these tools considering the numerous challenges that come with the use of new technologies and the threat to the confidentiality/privacy of the participants. Hence a description of how regulatory oversight of the use of e-technologies in clinical trials research is currently being conducted will also be provided. Careful planning, forethought, and useful partnerships can help overcome the challenges of new technologies. Smartphone and web-based applications have the role of expanding and increasing the use of these platforms by the scientists as well as the public thus making them significant tools that cannot be ignored.

Table of Contents

i. Abstract 2

1. Introduction 4

2. Literature review 4

3. Current e-technology trends in clinical trial design, execution and dissemination 6

3.1. Recruitment 7

3.2. Engagement and retention 7

3.3. Data collection 7

3.4. Using electronic platforms for recruitment, retention and data collection 7

3.4.1. Registries 7

3.4.2. Electronic health records 7

3.5. Dissemination of study results 8

4. Current status of regulatory guidelines for e-technology use, challenges and limitations 8

4.1. Institutional Review Board (IRB) review 8

4.2. Consent 8

5. Advantages and limitations of e-technologies in clinical trials research 9

5.1. Advantages 9

5.1.1. Improving efficiency 9

5.1.2. Lowering cost 9

5.1.3. Fostering research and development 9

5.2. Disadvantages 10

5.2.1. Privacy/confidentiality issues 10

5.2.2. Including a non-representative sample 10

5.2.3. Big data/accuracy of data 10

6. Future directions for the use of e-technologies in clinical research 10

7. Conclusion 11

8. References 13

1. Introduction

In the past, clinical trial activities (such as recruitment, delivery of interventions, retention, and collection of data) were conducted using the conventional "face-face" approach. For instance, radio or newspaper advertisements were used in the recruitment of participants; telephone calls or mail used to in conducting follow-up assessments interventions were personally delivered while paper and pencil instruments are used in data collection. Clinical trials have been reluctant to embrace e-technology in the designing and execution of their studies (Baker, Gustafson & Shah, 2014) and (Riley et al., 2013). They faced the challenge of keeping up with the rapid developments in technology. For instance, in the time taken for designing, implementation, and publication of research findings (around 6 years) the world transformed from playing interactive video games (Wii) to the use of voice activated personal assistants such as Siri (Riley et al., 2013). During this timeframe, about a million iPhone applications were added into Apples app store. Apart from the rate of change in digital technology advancement, the other reason that possibly caused the slow adoption of e-technology use include limited evidence based on whether e-technologies enhance or improve clinical trials design as well as the paucity of the regulatory policies and guidance especially where approval by FDA is required (Rosa et al., 2015). The aim of this paper is to provide a general overview of how e-technologies have been incorporated in clinical trials research particularly for past ten years. The aims of this paper are to:

(1) Present a summary of the current integration of e-technologies into the design, execution and dissemination of clinical trials;

(2) Present the status of regulatory guidelines regarding the use of e-technology, its limitations as well as challenges;

(3) Present a summary of the benefits and limitations of e-technologies in clinical trials studies; and (4) Outline future predictions of e-technology use in clinical trials research.

2. Literature review

Some researchers of clinical trials adopted e-technology early-on, by deploying the power of internet in recruitment of study participants and creation of internet...

Gradually, however, in the past two decades, researchers used Electronic tools in the development of protocols, communication with personnel involved in the study, randomization of participants, data collection and result analysis -- as a more mainstream application. Earlier on, there was limited communication with participants, and individuals were only directed to a website where they could find information concerning the study. For purposes of recruitment and retention, contact information was provided (Scholle et al., 2000). Websites were later used to distribute online questionnaires to collect data for purposes of consent and eligibility. In the recent past, social media (Twitter, Facebook) has been increasingly used for clinical trials. Blogs and text messages have also been incorporated for recruitment and enhancement of participant retention as well as meeting regulatory requirements of consulting the community. Mobile technologies (smartphones and tablets) are used for data collection (outcomes reported by patients, surveys) and monitoring study compliance. Other innovative approaches of collecting data such as the use of GPS (global positioning system), wearable gadgets, and apps are slowly being integrated as tools of investigation (Rosa et al., 2015).
In the last two decades, electronic systems have been incorporated for implementation procedures in clinical trials for example data entry and randomization. However, overall advancements in technology have been much faster and larger since then. On 9th March 2015, Apple's ResearchKit software, which was designed for health and medical research was introduced. By 30th March 2015, numerous iPhone applications had been created to be used in large-scale research of Parkinson's disease, breast cancer, asthma, diabetes and cardiovascular diseases (Apple Press Info, 2015). Google Inc. has also developed a tool that is intended to be a medical device that can be of assistance in clinical trials in the near future (HIT, 2015).

The industry of clinical trials is very late in incorporating and thereby improving its technology use and a there is pressure for transformation in the near future. The FDA has already taken leading strides by publishing social media use recommendations. Several companies have joined the movement. Pfizer and Abbvie are already using their Twitter accounts to engage the clinical community as well as the patients (Marwaha, Patil & Singh, 2007). However, only very few companies have managed to take the steps for transition from simple Twitter feeds into a media strategy that is comprehensive and engages the targeted audience.

Over the last ten years, pharmaceutical companies have introduced numerous initiatives to make clinical trials more productive. The introduction of Electronic Data Capture (EDC) systems is one of these initiatives. These systems allow researchers and patients to enter information regarding their trials directly, either in online systems or in electronic diaries. There are laudable efforts in adopting new scientific approaches, for example, the Bayesian techniques that allow pharmaceutical companies to refine the design of their trials stage by stage. Additionally, technological capabilities of companies, particularly connectivity, have been improved thus enabling trial managers to keep continuous tabs on patient retention and the progress of their trials. They have also increased their ability to conduct trials globally by extensively increasing their patients and researchers. They have also adopted more disciplined trial management procedures by borrowing techniques in some stages (including "stage gates," which allow strict deadlines to be set for data collection and refining the objectives of the next stages) from product design (Marwaha et al., 2007; Marks, Conlon & Ruberg, 2001).

For clinical trials, the fast growth of economic wearable health monitors meant for the consumers is a great platform where potential patients can be identified and large amounts of data collected throughout the patient's life. The ease of collecting data is the game changer- data is collected through wearables such as a wristband on or tagging onto clothing. Numerous new entrants have brought into the market, products that are highly functional, fashionable, and integrated fully with online portals for analysis and reporting. For example, Misfit Wearables delivered a tiny wearable disc attached on the user's clothing thus allowing the user to wear the device throughout the day. All the essential data required to create accurate mapping of exercise and activity are therefore captured. On the other hand, FitBit uses a very flexible wristband that is used to track the user's movements. Both gadgets offer numerous features in very small and convenient packages (Marwaha et al., 2007).

Mobile Health Monitoring is also an aspect of health-related explosion of data that could assist clinical research organizations to collect data without paying for the expensive cost of monitoring systems. For instance, recently, Apple was awarded a patent for the manufacturing of 'earbuds' that will have the ability of monitoring vital signs in the wearer. This will allow users to gather detailed data about their heart rate and other vital signs while working…