Reimagining Clinical Research Trials

Mayank Agarwal
Associate Consultant - Business Consulting

In this first of a two-part series, we will look at emerging trends and the challenges that clinical trials bring to the life sciences industry. In the forthcoming part, we will look at how life sciences enterprises can effectively respond to those challenges in a way that not only saves costs but also creates a competitive advantage for them in the market.

Clinical trials – Changing landscape

Ever increasing complexity of clinical trials, highly complex and varying regulatory guidelines, high patient drop-out rates, increasingly remote teams with fast-evolving roles and responsibilities, and rapid technological breakthroughs are putting enormous pressure on the life sciences industry. According to a research report on top challenges faced by clinical trials (available at knect365), top challenges in the life sciences industry are:

Top Challenges in Clinical Trials % of Respondents
Designing a trial that gives right answers in the most simple and unobtrusive way for patients 21%
Spiraling costs 15%
Patient recruitment and retention 12%
Some of the other challenges mentioned such as governance and oversight, staff roles and responsibilities, technology and new drugs. < 10 %

Many new players, powered by modern technology, are already responding to these challenges with their innovative offerings. Take for example ePatientFinder, a start-up that provides clinical trial exchange platform. It claims that a recent chronic conditions trial accepted 78% of the participants through its platform compared to just 3% enrolled through traditional, direct-to-consumer marketing methods. VCT, another start-up, developed a worldwide database to prevent dual enrollment. Icertis helps streamline contracts and other documentation required for a clinical trial that allows the user to access and analyze documents for risk reports, obligation tracking, etc. VitalTrax provides search, eligibility identification, application, reminders, messages and alerts, electronic diary and various other services that significantly improve patient experience*.

These along with other pressures such as decreasing autonomy of physicians, increasing consumerism and consolidation in the healthcare market are bringing to life sciences that many other industries are already experiencing – an urgent need to redefine the way business is conducted.

Unfortunately, the industry’s response to these challenges, until now, can be described only as lackluster and halfhearted, at best.  The industry did take a few initiatives such as digitizing information streams in the form of electronic outcome assessments, electronically informed consents, and few patient engagement apps. However, these initiatives did not really make life easier for patients as much as was expected mainly because patient journeys continue to stay fragmented within a swathe of poorly integrated processes. Patients continue to face challenges such as –

  • Anxiety due to weird symptoms ( or adverse events)
  • Inaccessibility to right support group at the right time
  • Fear of being randomized into a control group
  • Delay in getting answers to queries ranging from enrolment, payment, drug interactions, next steps etc.

Even the industry itself has not been able to significantly reduce its operating cost as essentially there were no improvements at a process level. Furthermore, the industry is yet to properly leverage the high-value insights present in diverse new and high-quality data sources such as wearables and sensors, social media and other data platforms leading to missed opportunities.

A company that provides mediocre experiences to its customer cannot survive for long in today’s highly consumerized market. It is high time for the life sciences industry to rethink the way business is conducted and to come up with solutions that not only significantly reduce operating costs but also create highly fulfilling and meaningful relationships with patients.

Stay tuned for our forthcoming article in this series. We will delve into a multi-dimensional solution that can solve a $300 bn problem!

* Any companies, referred to in this article, are named for illustrative purposes only.

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