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International Clinical Trials

Data Based

Biopharmaceutical companies are intensely focused on efficiency and speeding market approval – yet the nature of clinical R&D continues to present obstacles to attaining these goals. Today’s trials are still far too costly, and study cycle times remain too long to achieve a recoverable time to market.

In response, many biopharma firms give priority to reducing study cycle time by pinpointing the right countries, sites and patients. In tandem, they are turning to insights from CROs to provide a comprehensive view of the competitive site landscape. Unfortunately, however, a lack of real-time standardised data still exists, causing serious issues such as user distrust of the data, an inability to analyse data across studies, and critical data-driven decisions that cannot be made in a timely manner.

eCROs – innovative CROs with a comprehensive in-house application services business – are addressing this deficiency with new offerings that deliver speed, simplicity and service above and beyond those of their traditional counterparts. In particular, the need for faster study start-up, along with optimised country and site identification, has created several approaches to data-driven feasibility through the use of advanced technology, utilising up-to-date data and analytics to aid in both patient- and site-centric feasibility.

In addition, after patient populations are located, a variety of technologies are being used to enhance recruitment and retention.

Data-Driven Feasibility

The value of patient data has always been recognised, but true patient-centric organisations must also appreciate the value of feedback from trial participants themselves. Social media is one route that has opened up a communication channel with patients.

However, although pharmaceutical companies may see the benefits of social media, they may resist its full potential because of uncertainty and an underlying fear about the legal risks – typically around privacy, adverse event (AE) reporting and unblinding. Regulatory guidance on use of social media is not yet fully developed, and it is therefore recommended that companies engage their risk management departments to ensure the data being collected has meaningful purpose.

Online Conversations

A recent study tracked 224 pharmaceutical brands and analysed more than 257,000 associated posts across social media sites during a 30-day period (1). Some of the key findings include:
  • Only 0.3% of all posts contained an AE experience
  • Of those, only 14% of the posts that contained an AE (0.04% overall) had an identifiable name and contact method
  • On average during the 30-day period, each brand received a total of three posts that met the requirements for AE reporting
These results suggest that benefits and opportunities from engaging in online conversations far outweigh the risk of an occasional AE that would require reporting.

Most communications involve one-way commercial promotion of a drug. Social media assists in study awareness, driving traffic to either a call centre or a study website where the potential patient can learn more or pre-screen before referral to a site. This still requires initiative by the individual to act.

New advancements in technology leverage web listening, which provides real-time analysis of publicly available social media to deliver insights into patient experiences, views and perceptions. Some eCROs can now analyse and assess social conversations, advise clients, engage patients and influencers, and understand sentiment.

Intelligence Landscape

A critical objective of site-centric feasibility is to provide a comprehensive overview of sites, primary investigators, centres and subjects by geographical regions, therapeutic areas, indications, performance and quality factors. In order to optimise a study, an eCRO needs to aggregate, master and analyse site data from both internal and external sources.

Disease prevalence and incidence data, demographic data, as well as prescription and claims data, need to be marshalled along with historical site experience to ensure predictable outcomes and clinical study success. In an environment as multifaceted as the clinical research enterprise, it can be difficult to identify the signals from the noise. The eCRO in command of the dashboard bringing this complex site intelligence landscape into focus will be able to generate the insights needed to deliver the study on time and within budget.

Site Performance

Most delays in clinical programmes occur at the site level. A big factor contributing to delay is the 'churn rate' among investigators. In some estimates, over 50% of investigators have only completed one study; therefore, the very basis of a successful trial – the research site environment – is in constant flux. Furthermore, undermining an ability to select the right trial site is a lack of coherent and compelling data.

The previous performance of the investigator is the vital piece of information helping companies make the best site selection decisions. However, such information is fragmented and dispersed throughout the industry. The task of collating this data and gleaning useful knowledge from it is a major technical challenge.

Another study, 'Selecting Sites: Using data to drive decisionmaking', examined which performance factors and site characteristics are correlated with enrolment (2). Findings from this analysis of over 38,500 global sites, with at least three trial instances in Phase 2-4, demonstrated that performance data and site characteristics are predictive of future success. Previous recruitment success, type of site and hours per week dedicated to clinical research are good indicators. As they continue to build out the complex landscape of site capabilities and performance, eCROs will find it increasingly difficult to identify the predictive signal from the noise.

Investigator Analysis

More advanced eCROs can provide a combination of dynamic and sophisticated analysis of site data with best-in-class visualisations to generate key insights to optimise country and site identification. Aggregating and mastering investigators across both in-house and third-party databases produces a more comprehensive and therefore clearer picture of what sites have achieved in terms of recruitment rates in comparable studies. Various sources of site data can be aggregated, including study pipeline, competitive landscape, performance data (for example, randomisation and enrolment metrics) and quality metrics. These can come from lab data, electronic data capture, medical imaging, and other central lab analyses such as electrocardiograms and clinical trial management systems.

eCROs that have created a complete view of site intelligence data are better positioned to understand site capabilities and, in turn, make more accurate data-driven decisions regarding country and site selection. A platform visualising the key drivers for country selection – medical, financial, regulatory, operational and clinical – allows for scenario-based selection in order to confirm the suitability of countries proposed by sponsors for any given study. This enables the magnification of countries at higher risk of underperforming – ensuring the study has an optimal mix of nations to deliver results on time and support a sponsor’s development strategy. Answers are rarely found in an algorithm; a detailed analysis reinforced with data will inform better decision-making.

eCRO Insights

Clinical trials may seek to answer an important scientific question, but to be executable they need buy-in from a number of constituencies: investigators, patients, family and friends of patients, and patient support groups. Understanding what might motivate these stakeholders to take part – or, conversely, what might cause them to reject the study – is an important aspect of determining the feasibility of a study. Web listening can reveal what patients and physicians really think about a therapy area, current treatments, a particular class of drugs, clinical research in general, or even the reputation of the sponsor company. Because it is passive listening rather than active questioning, it can often reveal far more than surveys.

The insights that result can significantly impact how to position the study to investigators and patients, how to support the study better at the site level, and how to adapt the study to better fit with a patient’s care pathway. This recognises the essential role investigators and patients play as active participants in the clinical trial process.

eCROs understand the patient profile in collaboration with internal patient recruitment, feasibility and therapeutic area experts. With the appropriate technology, they can define desirable criteria for country and site selection, and communicate it to the global clinical operations teams to execute. Once sites are selected, the patient recruitment group should re-engage with field operations to create a local site patient cohort. From there, rapid enrolment for the study begins through chart review or electronic medical records, if available. This approach can ultimately reduce the number of non-performing sites, increase the overall number of high enrolling ones and accelerate the enrolment period – reducing the overall study cost and cycle time.

Recruitment and Retention


It is equally beneficial to use technology to ensure study participants complete all necessary procedures and visits. Several considerations determine the best approach for technology in recruitment and retention strategies, including:
  • Are there regulations or legal requirements that prohibit the electronic tactics?
  • Have the ethical tactics previously been accepted?
  • Are the tactics acceptable from a cultural standpoint?
It is important to refine these strategies at a country level to better support patient enrolment, and it is critical to get input into which tactics will be most impactful and approved by ethics committees.

Use of pre-built study websites can cost-effectively maximise recruitment, minimise attrition and encourage compliance. Recruitment and pre-screening services, plus continual education throughout the course of the study, are used to engage and retain patients by developing a sense of community and extending study support. In addition, animation technology can improve education during the informed consent form process by increasing patient understanding of clinical trials and protocol requirements. It can include questions to evaluate patient comprehension. These best practices provide a consent process with the patient and family, regardless of literacy or prior medical knowledge.

Video communication is another technology that can help maintain patient contact. Webcams and videophones can be utilised to connect the patient with call centre technology to provide for remote dosing or to address concerns. With their focus on and experience in technology, eCROs should be well-equipped to create these solutions aimed at replacing expensive traditional site visits with efficient remote communication. Study data collected in this manner has been found to be more reliable and completed ahead of schedule.

There are also many options in the mHealth field which, through the use of mobile devices, can improve clinical study efficiencies in patient recruitment and retention. This includes the use of mobile applications for visit schedules, dosing, education, symptom tracking and reminders. Most people already use mobile devices in their daily lives, so extending study contact via mobile technology is a natural way to increase interaction with trial participants.

Combined Know-How

Advancements in clinical trial technology as a means to build competitive patient strategies will continue to drive investment in this area. As pharma companies continue to explore the latest available tools, there is a scale of adoption to be expected, whereby key components will be outsourced to the leading technology service providers. Unlike traditional CROs or functional service providers, eCROs arguably offer the most effective combination of technology, capability, and scientifi c and clinical knowledge within a single point of accountability.

References
1. Kmetz J, Adverse event reporting: What pharmaceutical companies need to know. Visit: www.cision.com/us/2013/12/adverse-eventreporting-pharma, 2013
2. Schultz J, Selecting Sites: Using data to drive decision-making, presentation at the DIA Annual Meeting, San Diego, 2009

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Paul Evans is Vice President and Global Head of Feasibility and Enrollment Solutions at PAREXEL, where he focuses on study strategy incorporating feasibility, site intelligence, patient recruitment and site alliances. He leads a global team of some 160 experts to identify the right countries, sites and patients for clinical studies. Paul has more than 25 years of industry experience in global CROs and site management organisations, during which he has established successful trial execution strategies in Phase 1-4. He gained a PhD in Biomedical Engineering from the University of London.

Xavier Flinois
is President of PAREXEL Informatics and a member of PAREXEL’s Business Review Committee, the company’s most senior leadership group. He has more than 20 years of experience in the technology and healthcare services sector, having previously served as Chief Executive Officer of Clinical Solutions, founded a consulting and investment business, Houat Partners, and held senior roles in two large international IT services companies. Xavier holds Master’s degrees in Science and Engineering from Ecole Polytechnique and Ecole des Ponts et Chaussees, respectively.
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Paul Evans
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Xavier Flinois
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