Centring around its mission station of “powering smarter treatment and healthier people”, Medidata’s Rave platform supports companies and researchers throughout the entire clinical development process.

Co-founder and president Glen de Vries emphasised the importance of having a unified platform to facilitate innovative clinical development during his keynote at Medidata NEXT in London at the end of May. He stated that “the fragmentation of roles, departments and processes has led to the fragmentation of clinical trial systems”, which leads to an ineffectual piecemeal approach to clinical development.

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De Vries describes Medidata’s platform as an “agile” approach where “you look at what you are doing and you adapt your processes as you see opportunities”.

“We need to think about a platform…inclusive of technology and people, that allow us to work through this. This is really what we are trying to bring to the world with the Rave platform.”

Virtualising trials to advance clinical development

De Vries sees centralisation of clinical development as crucial as the industry looks towards virtualising aspects of clinical trials, with the final aim of virtualising the entire process.

In explaining why virtual clinical trials will be part of the future of clinical development, de Vries notes that there has already been a “paradigm shift” in healthcare where people and companies are connected to patients in a much more virtual manner.

Therefore, companies require new tools and approaches to achieve “continuous connectivity to patients…and continuous exchange of data.”

A more virtual clinical trial approach is convenient for both patients and life science companies, but de Vries believes it can also potentially transform evidence generation from trials.

Currently, two units of patient participation lead to one unit of evidence per clinical trial because of the need for a placebo or standard of care group. However, the personalisation of medicine makes it harder to find patients, so there is an emerging need to reconsider data sources for drug development.

De Vries suggests standardising patient data to initiate a virtual placebo approach, saying: “We don’t have to treat patients on standard of care, [either] because they have already been in clinical trials or we can use data from real-world sources.”

Medidata’s other co-founder, chairman and CEO Tarik Sherif, explains that the company’s platform can “create a huge amount of value for patients and our customers,” for example creating these “synthetic controls, or helping to target sites or patients better.”

Moving towards a patient-centric approach

A crucial aspect of a virtual trial is that it relies on better engagement with patients. De Vries states it makes drug developers “more dependent on the patient than on the healthcare provider” and so providing new tools for companies to help them better engage and connect with patients is part of Medidata’s virtual trials strategy.

Sherif notes that Medidata has “dedicated resources over the past five years to say how do we actually provide our customers with more value, more aligned with their patient-centric view…what do we do that ultimately reduces patient burden or helps target patients in a better way given what we do for the industry.”

The company has created a department working across all of its activities, focusing on patients. De Vries explains: “We bring patients, patient advocates, people from academia and industry who had a patient perspective into our offices to look at what does good look like for patients.”

Medidata crucially ensures its customers are compliant with data privacy legislation, such as GDPR, as they engage more with patients and their medical records.

Medidata case study: Adaptable, the aspirin trial

The company is currently testing its platform on a fully virtual trial in the Adaptable aspirin study. This is a three-year study with 14,600 patients currently enrolled, comparing the effectiveness of two daily doses of aspirin to find out which better prevents heart attacks and strokes in people with heart disease.

It is a so-called pragmatic trial, meaning it attempts to replicate real-world medical care by embedding it into the patient’s current healthcare setting and leveraging a wide range of healthcare data.

Patients are encouraged to engage and input information at every step of the trial – starting from consent design and ending with dissemination of final study results – through an efficient and interactive clinical trial model.

All data from the study will be collected in a secure database where each patient will be anonymised – however, a master list will be kept for researchers to keep in touch with patients.

Although Medidata vice-president of mobile health Anthony Costello noted in his presentation at the NEXT conference that this is a particularly straightforward trial to use as a case study, there is a lot to be learned from the platform’s first attempt at powering a fully virtual trial.