The cost of bringing a new drug to market is estimated to be over a billion dollars, and while we normally associate high development costs and long timelines with large pharmaceutical companies, there is an increasing number of small to mid-size pharma and biotech companies pulling the load.
Over the years, trial Sponsors have turned to eClinical tools and digital strategies to streamline clinical trials. However, at the same time, regulatory authorities have implemented legislation and guidelines to increase patient safety that often require additional data collection and analysis and sometimes even additional trials.
Implementing new software or digital platforms is not always cost-efficient. Large pharma companies may have the budgets to experiment with eClinical tools, but how can the SMEs select the right tools to comply with regulations and guidelines while improving trial efficiency?
SMEs – or SMBs – are small to mid-size organizations usually classified in terms of annual turnover and number of employees. For example, the European Medicines Agency identifies SMEs as companies with less than €20 million in annual turnover and less than 250 employees. The EMA had 1,853 registered SMEs as of November 2017 within the 28 EU countries.
While the vast majority of Sponsors are now using Electronic Data Capture (EDC), it still presents many challenges which may hit SMEs harder than large pharma. According to a recent survey by the Tufts Center, there is an average of 60 days between submitting a protocol and FPFV, but there are significant delays due to the fact that “the clinical trial database is a slow, inflexible process, which has remained largely unchanged over the past 20 years”.
SMEs can strategically select an EDC system and provider that allows for independent study build and management with minimal training efforts. There is no real guidance from regulatory authorities on how to evaluate the many EDC systems available. The availability of cost-effective, open source or proprietary EDC applications have the potential to improve clinical and research activities. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major benefits.
Selecting the best EDC system for study needs is an important first step for SMEs.
This selection will then help SMEs implement a risk-based data analytics solution. Why should SMEs be thinking about data analytics?
There are many regulatory changes affecting the clinical trials landscape going into 2018. One of the biggest changes is the ICH GCP E6(R2) addendum to the guidelines – the biggest change in over 20 years. The addendum focuses heavily on a risk-based approach to data to ensure patient safety and complete trial oversight on behalf of the Sponsor.
These guidelines can become a heavy burden for SMEs if they are not well prepared. SME Sponsors should consider clinical analytics solutions to manage their biometrics. These are tools such as centralized statistical intelligence and risk management metrics using data visualization technology. Biometrics oversight is no longer a “nice to have” but a “must have” in order to comply with regulations and standards. SMEs can prepare by mapping out a plan with their service provider on selecting an EDC system and determining which metrics need to be analyzed.
More importantly, as SMEs approach marketing authorization, they need to consider solutions for data de-identification and anonymization. The Clinical Trial Regulation 536 and the General Data Protection Regulation (GDPR) – both EU initiatives – are aiming to better protect patient information and increase safety. Clinical data will be made available in a publicly accessible portal and Sponsors need to be prepared. Large pharma have been champions of publicly accessible data for years because they have the budget to fund projects.
According to recent studies, less than 10 percent of the pharmaceutical industry is prepared for GDPR. The GDPR protects citizen data and information and health care data plays a significant role in this new directive. SMEs can’t afford to not be prepared. The fines are severe: 4 percent of total global revenue or €20 million, whichever is greater.
SMEs should sit down with their service providers to understand how to move strategically in 2018. The EMA SME office aims to promote innovation and the development of new medicines for human and veterinary use by SMEs and supports as a single contact point. The SME office of the EMA can assist with:
- Assignment of SME status
- Regulatory assistance & SME briefing meetings
- Fee incentives
- Translation assistance
- Training and awareness
- Partnering and Networking
As a registered SME with the EMA, CROS NT can support Sponsor SMEs with their eClinical technology needs by understanding regulatory requirements and putting together a solution that works based on study and budget requirements.
CROS NT can offer the following eClinical solutions for SMEs:
- A portfolio of EDC systems based on study size and budget (including Medidata RaveX, DATATRAK and a proprietary EDC system)
- CROScheck: a clinical analytics solution which combines leading statistical methodology with easy-to-follow E6(R2) workflow
- Data anonymization compliance with up to Level 3 data privacy protection