A guide to starting up clinical trials

17 April 2016 (Last Updated January 31st, 2020 13:52)

Clinical trials are notorious for their complexity, typically taking many years to reach completion and costing millions of dollars. What can drugs companies do to streamline the process and save money in the process? Abi Millar finds out.

A guide to starting up clinical trials

clinical trial

Getting a clinical trial underway is no simple task. From patient recruitment to study completion, the drug maker must undertake a wide array of complex, and closely monitored operations, complying with regulations all the way.

However, given the increasing pressure to cut costs and slash timelines, what worked 15 years ago may not seem so practicable in today's business climate. This is particularly the case as trials become more global, patient groups more targeted, and investigator sites more widespread.

With these challenges widely acknowledged, there is a clear gap in the market for solutions. How best to streamline their trial, without sacrificing quality or rigour, is an abiding conundrum for any drugs company or CRO.

It is no surprise, therefore, that we are starting to see a number of new solutions that promise to do just that, bringing trial frameworks squarely into 2016. Claiming to improve efficiency, accelerate timeframes, and cut costs for the sponsor company, these services are particularly pertinent to smaller organisations, which would otherwise struggle to meet the operational challenges.

Some of these services are intended to cover the duration of the trial, through digitising manual processes. Others are designed to help at particularly critical junctures, such as with patient recruitment, site activation, or data collection. Many are cloud-based, and therefore suitable for clinicians working across multiple sites.

Site activation with Veeva

In November 2015, the software company Veeva unveiled Veeva Vault Study Start-Up, a complete solution for life sciences companies looking to embark on a clinical trial. Unusually for a solution of this kind, it covers both start-up documentation and site initiation data.

"The life sciences industry has long struggled with manual and inefficient processes for study start-up," said Kathryn King, vice president of Vault Clinical at Veeva. "Existing solutions managed either documents or start-up activities, but never both together. This created significant challenges in identifying and addressing issues during start-up, resulting in longer study durations and impacting overall time to market."

"The life sciences industry has long struggled with manual and inefficient processes for study start-up."

According to researchers from the Tufts Center for the Study of Drug Development, site initiation typically takes a full 17 months to complete. This is due in part to inefficient methods of site engagement, in which a number of incompatible, and often manual, approaches are used.

The Veeva solution, by contrast, brings all relevant pieces of the puzzle together. It is also fully interoperable with Veeva Vault eTMF, which is an attractive selling point for drugs companies looking to bring their paper-based trial master file (TMF) solutions processes into the digital age. While eTMF solutions are regarded as an important way to expedite study start-up - allowing users to create, exchange and update all their trial documents within a single application - there can still be a time lag if site activation is managed separately.

The new Veeva solution, which has been available since December 2015, allows all relevant parties (investigational sites, sponsors and CROs) to access the same clinical information. It has been billed as improving visibility into study milestones, automating global workflows and slashing the time before the first patient is enrolled. Early customers include a top 20 pharma company and a top 10 global CRO.

Digital signing with SureClinical

Software provider SureClinical is on a mission - to help pharmaceutical companies step away from paper. The company provides cloud based health sciences applications that automate business solutions, and can accelerate clinical trials in the process. Its eTMF cloud, which is purpose-built for trials, negates the need either for paper processes or for costly on-premise software.

It also includes an integrated digital signing capability, meaning there is no need to print, sign, scan and upload study documents - clinicians can simply capture their signature on a tablet or smartphone. This capability, unprecedented in the market, came about thanks to a collaboration with Thales, a world leader in cybersecurity.

"The adoption of this technology would be out of the question if it didn't meet the trust and security requirements mandated by regulatory agencies and the industry. Thales was the only company that was able to provide the assurance and strong cryptographic technology that met both the needs of the pharmaceutical companies as well as the regulatory standards of the FDA and the European Commission," said SureClinical president Zack Schmidt, president of SureClinical.

Through incorporating Thales nShield hardware security modules (HSMs), SureClinical's digital signing solution meets the strictest standards of security and privacy. This makes it the first of its kind to receive FDA approval for use in clinical trials - with the potential to save time and money for pharma companies, without exposing them to the risk of fraud.

End-to-end trial management with Parexel

At the end of 2015, the US-based CRO Parexel launched its new IMPACT Express cClinical tTrial Mmanagement sSystem (CTMS), which is designed to simplify trial management and monitoring. Quick to implement, cost-effective and highly scalable, it promises to help pharma companies start managing their trials within as little as four weeks.

"IMPACT Express does not require any technical infrastructure or resources."

A 'lightweight' solution targeted at small to mid-sized biopharma companies, IMPACT Express does not require any technical infrastructure or resources. It includes trial oversight, trial tracking, site monitoring, investigator management and selection and payment management, and can be used all the way from start-up to trial completion.

"By applying a process-driven approach to trial management and monitoring, biopharma companies will be better able to save time - and money - while simplifying their drug development journey," said Patrick Nadolny, vice president of product management, data and analytics services at PAREXEL Informatics.

Patient-centric solutions

On a somewhat different note, a number of drugs companies are looking to incorporate solutions that help their trials become more patient-centric. This approach has been billed as leading to higher recruitment and better retention rates, therefore streamlining the process.

For example, we are seeing the emergence of technologies designed to improve the convenience of data collection. These include wearable devices, sensors, and smart pill technology ('ingestibles') that can monitor a patient in real time, without requiring them to visit their clinician. Google X is developing a wrist-worn health sensor for this purpose, and Proteus Digital has joined forced with Oracle to track patient medication adherence.

Some of these changes have to do with the changing nature of trials themselves. As medicine becomes more personalised, better-targeted patient recruitment will be essential, meaning we will see a greater need for technologies that help match the appropriate patients with each trial. Various CROs, such as Quintiles, have set up digital portals to connect the two, making it easier for patients to find studies and vice versa.

As clinical trials continue to evolve, drugs companies will no longer be able to rely on existing, tried-and-tested methods for success. Luckily, with a wide array of new solutions arriving on the market, there is great scope to shake up existing frameworks, utilising emerging technologies to meet the challenges that lie ahead.