How Covid-19 could lead to pharma to examine and change how clinical trials operate.
In light of the global pandemic, Pharma is having to strategically re-evaluate their R&D pipelines and decide whether or not planned clinical trials can go ahead in existing timeframes and if existing trials can continue in their current scope of work, due to in-country restrictions globally. For sponsors conducting Covid-19 studies, they need to decide whether to re-prioritize and change over existing studies and if so, they have to set up with accelerated timelines, due to the urgent need to establish drug efficacy in the prevention or treatment of the virus.
To ensure the continuation of certain trials during the pandemic, both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) relaxed clinical trial regulations in March and stressed that patient monitoring, patient consultations, and confirming patient consent can all now be accomplished remotely.
Already we are seeing significant developments. Science 37 recently partnered with AiCure, Medable partnered with MRN, and Bioclinica has joined forces with VivaLNK to develop better remote trial offerings that will support trial sponsors throughout the pandemic.
This wider adoption of remote trials will achieve: 1) greater efficiency for trial sponsors, 2) a more diversified pool, and 3) continual monitoring.
Greater efficiency for trial sponsors
A move from in-person to clinical trials will save substantial costs for trial sponsors. Currently, CRAs who travel to trial sites must be reimbursed for transportation, housing, and meals. These costs add up quickly and, consequently, onsite monitoring of clinical trials costs up to 30% of the entire clinical trial costs, according to FDA data. Moving to remote trials will be of great benefit to sponsors as it will make it easier for them to launch new trials and to invest in additional drug research and development.
A more diversified pool
Remote trials can also eliminate geographic barriers, making it easier to recruit a diversified participant pool with greater representation of minority and rural participants. Achieving diversity in clinical trials is extremely important as it gives crucial data about the potential effects of a given drug on individuals of different populations. Access to such a large population of participants through remote trials also aids in trial recruitment and retention, leading to better results.
With remote trial capabilities, participants are now able to consent to treatment electronically and receive medication and monitoring equipment from pharmaceutical companies through the mail. In time, trials may also utilize smartwatches and other wearable devices to continually monitor trial participants and check-in with them virtually in a timely manner whenever issues arise. Aside from saving time, this can also limit the risk of infection.
However, the recent shift to remote trials will not completely eliminate in-person pharmaceutical trials. Predominantly remote trials will likely require occasional in-person check-ins or monitoring visits. Also, certain high-risk trials, such as those in oncology, will continue to necessitate more frequent in-person interactions.
Remote pharma trials will also face some potential difficulties. Certain participants may feel anxious about rarely meeting with researchers face-to-face, or they may not take their trial as seriously when it is conducted remotely. Further, pharmaceutical companies will have to ensure that they are in full regulatory compliance during remote clinical trials. This might prove challenging initially, as much of the remote trial infrastructure is still being developed.
Nonetheless, a greater emphasis on remote trials in response to Covid-19 will bring permanent change, with it the potential to make many types of trials faster, more efficient, and more successful than before.
The change in how clinical trials have been conducted in the past few decades has been significant. Complex therapeutic areas, globalization of clinical trials and the increase in regulatory requirements to name but a few mean sponsors must continue to evolve their operations to keep pace with new demands. Covid-19 represents an extension of this evolution, as sponsors recognize the restrictions siloed supply chains have on their ability to respond with speed and precision to urgent demand and effectively manage risk.