Clinical Trials: Discovering Drugs
Today one can say that clinical trials have become increasingly costly initiatives, adding to largely the cost of developing a drug and, eventually, the price that patients pay for those drugs. Today bigger pharma companies and small biotech firms are looking for pioneering ways to develop trial outcomes and, also at the same time lower trial costs — this means increasing the effectiveness in which they recruit patients, monitoring more closely how drugs are supplied and being lither about trial design. Through technology, a lot of tools are assisting these organizations to optimize clinical trials today.
It is not new that technology has been very much present in the clinical trials sector for years. Technologies like Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) and Patient Recorded Outcomes (PRO) have transformed into a rule; however, technology is now playing an essential role in the overall clinical study strategy. IT giants who are Google, Apple and Amazon, are also looking for a large piece of the clinical trial sector by increasing technologies that center on patient centricity. Market leaders such as Oracle, Medidata and Veeva are enduring to increase extensive technology platforms for clinical trials.
Higher quality standards:
Regulations are focusing on enhancing patient safety and raising the bar when it comes to Quality Management Systems and on the whole quality assurance practices. The ICH GCP E6 (R2) regulations intimate taking a risk-based approach to quality assurance by following ISO norms and execute best practices. Organizations will be looking for specialist and niche providers in this sector.
Data privacy and transparency alongside anonymization:
This year has been all about safeguarding citizen privacy. The European Union has adopted significant measures to guarantee data privacy via the General Data Protection Regulation (GDPR) which is applicable to all companies managing data in the EU. The European Union is also set to execute Clinical Trial Regulation 536/2014 which calls for an EU portal printing clinical study results once a Marketing Authorization Application (MAA) has been submitted. This calls for the elimination of patient identifiers and the de-identification of data.
Understanding regulatory requirements:
There are numerous other significant regulations, apart from GDPR and Clinical Trial Regulation 536/2014 that sets to give results especially in the areas of clinical data management, regulatory submissions, pharmacovigilance reporting, and medical device trials. Fines are said to be made severe for non-compliance, and therefore budget for the extra regulatory support should be in mind.
Data Analytics is Necessary:
Centralized analytical monitoring is being discussed more often as Sponsors look to assist risk-based monitoring with real-time, accurate metrics. Data analytics has started playing an even greater role in these critical strategic decisions for Sponsors. The ICH GCP E6 (R2) regulations place a massive emphasis on oversight and lay the accountability of clinical trial conduct on the Sponsor.
Pharmacovigilance outsourcing (PVO):
Pharmacovigilance Outsourcing has started getting its own acronym and attention of late. The management and reporting of unfavorable events are becoming a complex business, and new regulations are making it trickier for Sponsors to work without support from specific experts. In Europe, for example, there are new developments to the Eudravigilance system for the reporting of complex events.
Medical Device regulations:
EMA and FDA have examined the medical equipment trials in the past year, and the FDA is looking at the conduit for medical device approvals. The EU has set forth a new framework for medical device trials together with an EU-wide coordinated procedure for multi-centre investigations and superior transparency. Medical device firms need to appear at how they are managing data. Alongside Biotechs which now have multiple outsourcing models available including Functional Service Provision to allow them to continue developing their product and this may lead to an enhanced clinical trial procedure.