Out-Law Analysis | 26 Mar 2020 | 3:59 pm | 4 min. read
The clinical trials process is a core step in the development of new medicines. It ensures that a product is both safe and effective before it is rolled out for widespread use.
It can commonly take drugs manufacturers several years to complete the various phases of clinical trials testing to get new medicines to the point where they are ready to be granted marketing authorisation. However, with medical researchers around the world working on developing treatments for coronavirus, officially Covid-19, public health officials are cautiously optimistic that a vaccine may be found by the end of 2020 and that wider use may be seen by this time next year.
Medicines regulators have an important role to play in enabling this effort. Many have already announced a willingness to streamline regulatory processes to help manufacturers get a vaccine to market quicker.
Once this crisis has passed, consideration should be given to whether best practices we are seeing emerge can be adopted permanently and help cut the drug discovery and development process for all new medicines.
In Europe, the European Medicines Agency (EMA) has called on researchers from across the EU to "prioritise large randomised controlled studies" since these are "most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of Covid-19".
A randomised controlled trial is already underway in the US, where the Food and Drug Administration (FDA) has confirmed that it is working closely with product sponsors to speed the development of Covid-19 treatments. The FDA has said it has cut the usual 30 day waiting period that it usually takes sponsors to get the go-ahead to initiate trials.
A more collaborative, aligned approach of mutual recognition means that, during such times of crisis where everyone must pull in the same direction, there is less red tape to navigate. This is a blueprint for the future for when this crisis is over.
The EMA's Committee for Medicinal Products for Human Use (CHMP) has said it is concerned about small-scale clinical trial studies already being undertaken or being explored in isolation. It feels those studies "are unlikely to be able to generate the required level of evidence to allow clear-cut recommendations" and that they "would not be in the best interests of patients". Instead, it advocates greater collaboration.
The CHMP said: "Randomised controlled studies with a control arm without antivirals or other experimental agents, as none yet has proven efficacy, would allow generation of data that could lead to timely regulatory decisions and could promptly guide clinicians in defining best treatment options for Covid-19. Such studies need to be prioritised, considering that they would allow the best use of available supply of investigational agents.
"Multi-arm clinical trials investigating different agents simultaneously have the potential to deliver results as rapidly as possible across a range of therapeutic options according to the same evaluation criteria," it said. "This concept has been developed for Covid-19 by institutions in the EU and by WHO (World Health Organisation) and is generally supported. It would be important that all EU countries are considered for inclusion in such trials."
Such an approach could provide results rapidly and would allow for comparative assessments against the different agents investigated. The EMA is pushing for all EU countries to be involved in such trials. To generate statistically robust data, clinical trials must be sufficient in size, as a concern of multiple small sites carrying out individual studies is that this body of data is unlikely to be generated. A coordinated pan-European approach is therefore required.
In the UK, the legislation that governs clinical trials of human medicines is the Medicines for Human Use (Clinical Trial) Regulations 2004. Those regulations stem from the EU's Clinical Trials Directive of 2001. The regulations provide stringent requirements regarding clinical trial authorisation and the ethical approvals and conduct of approved trials.
Before placing a medicinal product on the market, a manufacturer must obtain marketing authorisation. The regulatory processes required to obtain the necessary approvals to test, manufacture and then bring a medicinal product to market can be lengthy. Ordinarily, applicants need to ensure that: the highest quality data is generated to demonstrate the safety and efficacy of the product; and the highest quality assessment of that data to ensure that it demonstrates a positive risk-benefit ratio for patients. A health technology assessment might also be required to ensure that the product will be reimbursed.
Perhaps with this in mind, the EMA has indicated that it stands ready to support those seeking to develop medicinal products, with all available regulatory tools, "to advance and expedite the development of effective measures to fight and prevent the spread of Covid-19".
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has similarly indicated that it has procedures for rapid scientific advice, reviews and approvals. Reflecting the collaborative approach called for by the EMA, the MHRA has also indicated that it stands ready to support researchers, manufacturers and other regulators to develop medicinal products to fight and prevent the spread of COVID-19.
There are reports of progress being made in all corners of the world in the race to develop a Covid-19 vaccine, as well as of new and improved diagnostic testing products and of existing medicinal products which may show some efficacy in treating the symptoms caused by the virus.
There is also a pressing need for access to real-world data on the disease, its history, risk and treatment models, as well as on the supply chain. Artificial intelligence is being used to model Covid-19 and is fundamental to the speed of drug development, clinical trials and testing.
Collaboration and coordination in the creation, analysis and sharing of data is essential to the current efforts. A more collaborative, aligned approach of mutual recognition means that, during such times of crisis where everyone must pull in the same direction, there is less red tape to navigate. This is a blueprint for the future for when this crisis is over.
When time allows, industry and regulators should reflect on the efforts made to expedite clinical trials testing and other steps in the development of new medicines during this crisis, and consider how best practices can be adopted when business as usual returns.
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