Preamble
In recent years, the healthcare industry, like every other sector, was taken by surprises that called for sudden transformations and adoptions of more viable options. The pandemic came as a blow to healthcare providers, nurses, paramedics, and researchers. The role of researchers was a very crucial one. However, since most of the traditional clinical research was site-based and had not been furthered in terms of technology. Entering the third year of COVID-19 pandemic, the WCG shares annual insights report mentioning shifts, priorities, trends, and development prevailing in the clinical trials. Most of the experts are talking about the many advancements, some of which we have discussed below.
Decentralised Clinical Trials (DCTs)
One of the major flaws surrounding traditional on-site clinical trials is that they can have a slow pace. Now the research studies, specifically clinical trials, have become agile, meaning thereby that they are hybrid in nature employing technologies that enables DCTs. These are more patient-centric, therefore make it easier for the patients to participate in the trials. Patient-centricity is also one of the focuses of the newer developments that are being brought in every domain of the healthcare sector.
Remote DCTs have been successful in fast enrolment, better patient experience, and higher rates of retention. Though some of the trials require on-site presence, most of the biopharma-focused organisation have adopted for decentralised trial elements such as telemedicine, remote sites, remote patient monitoring, and eConsent.
RWE/RWD Drug Development
The FDA informs that the use of mobile phones and gadgets like wearables in order to gather data for healthcare is increasing rapidly. Thanks to technological developments, these improved analytical capabilities will allow precise data analysis and application over the medical product manufacture, approval, and reimbursement. All this has the potential to conduct clinical trials in a setting in the was earlier considered unviable and answer questions that seemed impossible to answer. Another important trend is the increase in focus of Real-World Evidence (RWE) and Real-World Evidence (RWD) to produce evidence for decision-making for biological products in Europe as well as the US.
Regulation of Privacy
As technology has started invading clinical trials, privacy regulations are evolving day by day. While privacy regulations are being implemented, these are supposed to be balanced in a way that clinical trials are documented properly. Likewise, data sharing among countries is still a challenge, especially to the countries of the European Union, since local laws concerning privacy exist. This administrative challenge, however, is being addressed in the clinical trials because this remains at the heart of the domain.
AI in Research
The employment of Artificial Intelligence (AI) in the healthcare industry is a rapidly increasing trend, despite the concerns surrounding it. Though AI is providing facilities, it poses various challenges for medical research. The trends/concerns that experts expect are going to be addressed this year are the use of AI, ethical issues surrounding it, and implementing the rules that Office of Human Research Protection (OHRP) has laid bare. Institutional Review Board (IRB) expects the institutes to weigh out the risks and benefits that are expected from AI. However, the organisations expect to make the best use of AI without compromising the rights of the human subjects.
