Digital Transformation in Clinical Trials

In the past decade, lifestyle-related diseases, an increase in aging population, and new treatments and technologies have encouraged a global growth in pharma research and development. At the same time, pharma companies have been under pressure to maintain their bottom line, owing to ever-increasing costs of doing research and constant changes in healthcare reforms by governments. This has caused fluctuations in budgets for pharma companies. The year 2016 proved to be a difficult year, similar to the last four to five years, for pharma companies due to low product approval, higher price variations of drugs and increasing competition.

Globally, pharma companies spend more than USD 140 billion in R&D. Clinical trial costs have soared over the past decade, with average cost per patient increasing by more than 150%. The major responsible factors are rapid increases in the drug pipeline along with growing concerns around cost reductions, increased patient compliance and patient-physician visibility, etc.

Out of all the clinical trials costs, patient recruitment costs are the highest, with a share of more than 30%. Late-phase clinical trials are a large contributing factor, where patient engagement and retention is the most crucial issue for the success of clinical trials.

Patient engagement in the trials begin with recruitment of the patients. More than 20% of the time, clinical trials end up running over their deadline due to ineffective recruitment methods. This in turn further adds to the cost of clinical trials.

To counter these issues, companies have shifted their focus to innovations in clinical trials. Internet portals like PatientsLikeMe and CISCRP have helped patients from across the world to interact with each other, create a space for themselves and educate each other about new treatments and trials. Members can find clinical trial recruitments happening for their conditions and around their location in these portals. Such portals increase the likelihood of getting patients with the required symptoms for trials. For instance, in October 2014, Roche Genentech entered into a five-year collaboration with PatientsLikeMe to get access to a global online patient network for real-world experience in clinical trials.

Social media platforms like Facebook and Google AdWords have features like advanced targeting options that help recruiters filter candidates. They have helped build a huge pool of patients, separated per the needs of recruiters across the globe. This in turn can reduce the burden on CROs and pharma companies by posting on such portals and getting access to interested patients.

Currently, patient retention is the bottleneck in the clinical trials process. This is mostly because of reduction in patient motivation as a study progresses, due to the frequent visits required to the clinical research center and any moderate-to-severe adverse effects of the drugs during the study. To address these issues related to better patient engagement and retention, frequent follow-ups and real-time interaction between physicians and patients are very important. Some companies have come up with digital tools such as mobile health apps and wearables to support continuous patient monitoring.

For instance, pharma companies Sanofi Genzyme BioVentures and others are investing in digital health space and novel initiatives like Mobile Clinical Trials offered by Science 37. This enables patient participation from their homes, which is useful for patient enrollment as well as patient retention by facilitating the clinical trials process with transformative digital techniques.

The process of continuously monitoring a patient’s heart beat and sleep is not only monotonous but also logistically difficult. Fitness trackers like FitBit and Apple watches are user friendly, capture real-time data on continuous basis and improve patient monitoring. Though the accuracy of wearables is questionable, we can expect them to improve over time.

So what does all this hold for the pharma industry? Pharma companies are looking for ways to speed up the process of getting their drugs approved and to market. For this, they need to get access to patients that have required symptoms for the trial. Above that, retaining the patients until the end of the study is a difficult task. With the support of various digital tools and platforms, pharma companies and CROs are accelerating the clinical development process through rapid and cost-effective patient enrollment and retention.

Summary:

To reduce overall costs associated with drugs, pharma companies must look for innovations in the pharma value chain and R&D, especially clinical trials, which represent a huge opportunity. GEP observes that, in this space, digital transformations like wearables, health apps and social media are being increasingly adopted by pharma companies and CROs alike, which will in turn improve the entire spectrum of patient recruitment, engagement and retention throughout the clinical trials study.