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In the past decade, the healthcare sector has witnessed major advances and breakthroughs in the different therapeutic areas. One of the biggest sector that targeted by the discovery of new medications is that of clinical trials, as for any drugs to be approved for the use and commercially available, major regulatory bodies across the globe have stringent regulations and processes, clinical trials being one and a key step of the process. The emerging healthcare reforms have led to the changing competitive landscape for the pharmaceutical and biotechnology companies. New developments, rising mergers, and acquisitions, opportunities created by many blockbuster drugs going off patent, rising potential and healthcare budget in developing countries have created a great growth potential for the pharmaceutical industries. With the emerging pharmaceutical and biotechnology industries, the clinical trial industry is both changing and growing at a significant rate. To remain competitive, the company also need to make their approach for conducting trials such that it can be carried out with better efficiency and agility. Clinical research is an important sub-process in pharmaceutical R&D and emerging trends in the clinical research not only ensures quicker returns on investments made by the pharma company but also drives access to better and safer patient care.
Growing investments in R&D and a growing number of clinical trials along with automated solutions are changing the face of clinical trials across the globe. Thanks to technological developments such as mobile devices and apps, artificial intelligence, and more, clinical research is more streamlined than ever before, while simultaneously creating a less expensive, more effective, and more standardized research environment. The rising costs of drug development and R&D activities have pushed pharmaceutical companies to seek for better, cost-effective and smarter options and led to the outsourcing of the clinical research activities leading to the rise of clinical research organizations (CROs). Solutions have also been developed to enable participation of the patients beyond the clinical research site. The recent example is Apple’s ResearchKit platform that allows information to be gathered on daily basis, providing researchers with data as and when required, and patients will not have to travel all the way to study sites fill out questionnaires or tell about any improvements or adverse reactions if any. AI and robotic process automation have also played major roles to improve clinical trials productivity and analysis. Shifting of clinical research towards the low-cost areas as a response to cost pressures have led to the rapid adoption and implementation of technology and sponsor/CRO service teams that has helped simplify trials while providing valuable transparency and resources along with quick results.
To meet the demand of the changing drug development landscape, emergence of new technologies and services such as eCOA, EDC, eSource, eConsent, EHR, telehealth will play a key role and change the way clinical research is done by rising the efficiency in data integration. The trend to go paperless and have quick and anytime and anywhere access to the data have led to a further rise of these technologies in the clinical trial industry. Adopting the technology will also allow the better collaboration among various stakeholders involved in the process. This adoption of the e-way has not only reduced the inherent cost burdens related to production, storage, and destruction but also the logistical burden of necessitating that all hard-copy records receive the designation of a certified copy. Nextrials' clinical trial management platform, Prism uses its own familiar interface without the need to learn the tool for a coordinator, allows faster and accurate data collection and therefore can be used in merged clinical trial/healthcare settings. These digitally enhanced products not only provide the researchers with the real world data that guide them to predict and design the right protocol, mitigate risks associated with patient enrolment and compliance and enhance the patient experience during the trials as well as post-approval period. Furthermore, the flexibility of these platforms speeds up the time of trial completion as compared to standard ways.
Despite the above trends, partnership and transparency instead of working in silos along with the proper and timely clinical research supplies continue to be critical for the success of the trial. With GDPR legislation that came into effect in May 2018, partnership and transparency across sponsors and CROs have become the topic of paramount importance. There is a long-term goal and benefits sponsors as well clinical trial organizations seek along with the goal to simplify safety and clinical data reconciliation and post-marketing analysis & the meta-analysis while considering the impact this would have on bringing the drug to the marked safety, quickly and cost-effectively. With the rise in worldwide pharmaceutical R&D spending, the rise in the number of clinical trials is also expected and obvious. With more stringent regulations regarding the patient, companies are also seeking to adopt the technology that can help them with their research plans and can by executed quickly, safety and without increasing cost burden. Thus, the emerging trends in clinical research indicate a shift from efficiency centric approach to a broad-based effectiveness oriented approach changing the face of the clinical trial industry and impacting it in a positive way.