News

By: Ed Miseta, Chief Editor, Clinical Leader

How pervasive is the adoption of new technologies in clinical trials? DrugDev recently surveyed 572 clinical trial investigators from 11 countries to try and answer that very question. Their results are good news for technology vendors, clinical personnel hoping for greater efficiencies provided by emerging technologies, and sponsors hoping to cut the time and cost of trials.

As noted in the report, the pharma industry is often accused of being outdated and old-fashioned for its resistance to adopting new technologies. In fact, the industry’s continued reliance on paper, especially in clinical trials, is blamed for the high cost and long timelines of clinical studies. Thankfully, that trend may be reversing as several technologies that improve the efficiency of the entire clinical trials process are finally gaining solid footholds.

But first, a little about the survey. The data was gathered between February 17th and April 14th, 2015 from a 27-question online survey that was emailed to almost 11,000 randomly selected investigators in the DrugDev network. The highest number of responses was received from the U.S., South Africa, Brazil, France, the U.K., Australia, and India. Most respondents (over 50 percent) had experience on more than 10 studies. The top therapy areas were metabolic/endocrine, cardiovascular, oncology, and neuroscience.

Greater Access To Technology

The survey found 80% of respondents reported their staff had access to a computer for clinical data collection. The range of responses went from a high of 89 percent in Australia to a low of 66 percent in India. The primary device for collecting the data, by an overwhelming majority of respondents, was a desktop computer (85 percent), followed by laptop PC (38 percent), Apple or Android Tablet (23 percent), and Mac-compatible laptop (7 percent). Most respondents (92 percent) reported having access to Wi-Fi/Internet at their sites, while 83 percent also reported having that access in rooms where patient exams were conducted.

The next section of the survey asked respondents to rate eight different clinical trial technologies and applications on two different scales: The likelihood that it would become the ‘gold standard’ in the next three years, and the likelihood it will reduce the administrative burden for investigators. The technologies respondents were asked to rate are:

• e-Signatures
• Electronic Medical Records (EMR) to recruit patients
• e-Source (trial data source records from EMR)
• 100% Paperless Trials
• Risk-Based Monitoring (RBM)
• Electronic Patient Informed Consent
• Electronic drug adherence solutions
• In-home patient biometric monitoring for trials

When it comes to becoming the ‘gold standard’, e-signatures (70 percent) and EMR to recruit patients (64 percent) lead the pack as being extremely likely or very likely. E-Source, paperless trials, and RBM all scored between 50 and 60 percent. The other three technologies/applications all scored in the 40 to 50 percent range.

The next chart showed the likelihood that these technologies/applications would reduce the administrative burden for investigators. On this chart there was a little bit of a rearranging of the results. E-signatures still held the top spot at 69 percent. Paperless trials moved up to the second spot at 64 percent while e-source fell to number three at 58 percent. EMR came in number four at 57 percent while electronic drug adherence rated 53 percent. The final three solutions all scored around 48 percent.

Does Experience Factor In?

One section of the survey asked respondents to note the amount of experience they had with trials, denoting whether they had experience working on less than five trials versus five or more trials. This then enabled DrugDev to analyze investigator responses based on level of experience. When it came to the question on technologies extremely or very likely to decrease investigator burden, the more experienced investigators gave a lower ranking to the likelihood of technologies reducing their burden on all technologies other than e-signatures. On the likelihood of becoming the gold standard in three years, the same trend held, with investigators having more experience rating all technologies other than e-signatures lower than those with less experience.

Two final charts provide some insight into access to EMR by country and the interest in using them for clinical research. The access to EMR varied greatly across countries, with the highest numbers being in the U.S (67 percent), U.K. (61 percent), France (56 percent), and Australia (51 percent). The countries with the lowest numbers include Argentina (38 percent), India (36 percent), and South Africa (21 percent).

The final chart showed a very clear trend of interest by investigators in using EMR for clinical research. The most interest (again, extremely or very interested) came from using flags in the EMR system to alert site staff that a patient is a potential candidate for a study (74 percent). There was also substantial interest in using EMR data to identify potential patients (73 percent), Flags in the EMR system to alert staff that a patient is already in a study (73 percent), and the use of EMR data as supporting documentation for CRFs (71 percent). Sixty-nine percent were interested in using EMR data to provide study-level protocol feasibility information and also an automated population of CRFs based on EMR data.

Less experienced investigators had a slightly higher amount of interest in using EMR in clinical trials, but approximately two-thirds of both groups were extremely or very interested in all of the options.

What Does This Mean For Technology?

The report does draw some interesting conclusions from the data. The first is that some upgrading of technology at clinical sites is in order. Eight out of 10 sites have access to a computer for data collection, but at 85 percent of those sites, the device is a desktop computer, which is not in every room and is not very mobile. Tablets and iPads, which are much more mobile, are available at only 23 percent of sites, and getting them in more settings will clearly require additional capital expense. And, since many sites still do not have Wi-Fi in patient rooms, the report notes training patients on the use of home technologies will grow in importance as more hand-held and mobile technologies become available.

The use of electronic signatures will clearly be a growth area moving forward. Respondents rated this technology both as likely to become the gold standard in three years (70 percent) and likely to reduce investigator administrative burden (69 percent). Advancing the use of both electronic and digital signatures should be a priority for the industry.

Finally, for all the excitement and coverage that we seem to see on risk-based monitoring and in-home biometric monitoring for trials, these two technologies did not rate very high amongst participants in this survey. A 2015 report produced by Eye For Pharma noted 58 percent of companies were planning RBM studies in the next two years. Yet in this survey, only 48 percent of respondents felt the technology was extremely or very likely to decrease their burden. It is interesting to note that most of the respondents in the Eye For Pharma report indicated they were contemplating RBM to reduce cost and improve quality, not to lessen their burden.

And for all the hoopla we hear about the gathering of data from in-home patients, that technology appears to still have a ways to go before investigators will see it as a true burden reducer and a gold standard to the industry.

The complete survey results are posted on the Drug Information Association (DIA) website, and can be seen here.