Clinical trials are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people. With the current Covid-19 pandemic, clinical trials are needed now more than ever. But what are they, how do they work, what are the risks and how can these risks be mitigated?
What is a clinical trial?
A clinical trial is a research study performed in people that are aimed at evaluating a medical, surgical, or behavioural intervention. They’re used to determine whether new drugs, diagnostics or treatments are both safe and effective.1 And help improve and advance medical care.
Many different companies conduct clinical trials. For clinical research, this is typically pharmaceutical and biotech companies, CROs (contract research organisations), public sector including the NHS, Academia and not-for-profit/charities (often in collaboration with private sector), medical device and technology companies.2
How do clinical trials work?
Clinical trials of drugs are governed by strict regulation and are typically divided into different three phases:
Clinical trials phase one
The first time a new treatment is tested in humans. It will usually be given to a small group of healthy volunteers to investigate the safety of a drug and the side effects it may cause.3
Clinical trials phase two
Phase two trials involve a larger group of people and will usually include patients who have the condition the potential drug is targeting. The aim is to establish the effectiveness in treating the condition, the effectiveness in preventing the condition
Clinical trials phase three
Phase three trials are often much larger trials, involving hundreds, possibly thousands of participants and can last several years. Here, the objective is to; demonstrate the safety and effectiveness of the new drug, confirm effective dosing levels, identify side effects and compare results against any currently achieved by existing treatments.4 If this stage completes positive results, regulatory approval is then sought.
What are the risks with clinical trials?
There are multiple risks with clinical trials, both from a health and safety (possible side effects) and business risk perspective. As experts in insurance, we’re here to talk about the risk to business. And with businesses in the sector racing to respond to Covid-19, there are many emerging risks that need to be considered and potentially mitigated.
Covid-19 clinical trial risks
As of early August, 2,906 trials targeting Covid-19 were happening around the world.5 With the scientific and medical communities throwing everything at Covid-19, and regulators creating greater flexibility around clinical trials, trade-offs are being made between best practice and pragmatism. This is creating an evolving risk environment.
A report by Chubb identifies:5
- A bit of everything is being thrown at the problem, from diabetes drugs to anti-fungals. Chubb have seen up to 200 trials with something in the order of 40 different molecules being looked at, which is really unparalleled.
- There’s a danger the boundaries between the normal clinical setting and the research setting can merge and overlap. This proposes the risk of giving drugs to research subjects that could otherwise be excluded.
- Changing of endpoints- the factors measured as the primary criteria for success introduces bias into the research.
- Research is being circulated publicly before it has been through the peer review process. This can potentially hinder the integrity of the community should there be a sudden mass of research.
- Companies have to be careful when marketing to either doctors or the public that they can give their drug a go.
- Fast-tracking drugs and vaccines leads to the potential for more unknown adverse reactions to these drugs when they are on the market late down the line. For example, the anti-inflammatory drug Vioxx that was pulled from the market after 5 years in 2004 due to increased cardiovascular risk.6
The frenzy of clinical trial activity in response to Covid-19 has created a magnitude of risk implications for the researchers running trials, but also for product owners whose drugs are being tested against the disease. While the regulatory environment is allowing for fast-tracked trials and greater leniency, the trade-offs being made are creating long-term risks that someone could be held liable for and must be managed accordingly.
Minimising risk in clinical trials
Risk identification and mitigation are the primary defence against trial interruption. Here’s some top tips:6
- Beware of the increase in scrutiny of GCP regulations.
- Meticulous planning is essential.
- Engage early with regulators.
- Embody quality in every step, go beyond the letter of GCP regulation.
- Be aware of the key cost drivers and where overruns could occur.
- Simplify the process to avoid unnecessary errors.
- Take an “evidence-based” approach when selecting optimal trial locations.
- Ask difficult questions when choosing your contractual partners.
- Work collaboratively with your partners, building in regular and effective communication.
- Periodically re-evaluate strategies and practicalities.
Reviewing existing insurance arrangements to ensure clinical trials risks are adequately covered is also encouraged. A robust internal audit programme can help organisations resolve risks before they become an issue.
Clinical trial insurance
Life science companies are vulnerable to a number of unique liability exposures. It’s important to seek the right clinical trials insurance to help protect you from possible claims that arise from clinical trials. The potential reputational and financial damage can be devastating.
If you have any enquiries regarding clinical trials liability insurance, from single trial policies to all embracing annual covers, contact your nearest life science insurance expert today.
3, 4. uk.gsk.com/en-gb/research/trials-in-people/clinical-trial-phases/