Clinical trials are a fundamental stage of the drug and treatment development process. They’re used to evaluate the effectiveness and safety of new medicines, devices, and interventions while monitoring the impacts on human health and well-being. Done right, these sorts of tests can take us one step closer to preventing and defeating many of the illnesses that trouble society.
If you’re planning to run some clinical trials, there are several legalities you must be aware of and adhere to. In this article, we discuss these and some of the other important factors you should consider.
Ethical and Regulatory Issues
The first step of any clinical trial is to ensure it meets the UK’s strict ethical and regulatory standards. A government agency called MHRA (Medicines and Healthcare products Regulatory Agency) must review and authorise any clinical trial before it takes place.
Other organisations such as the HRA (Health Research Authority) strive to protect patients and members of the public in health research. Understanding your legal and ethical responsibilities when conducting clinical trials is key, so consulting life science law specialists can help to ensure you’re well informed.
Cost and funding
Clinical trials are typically expensive to run, which can be a major downfall for smaller research organisations. The cost of treatments and tests, research staff, technology, administrative costs, and patient expenses all add up.
Securing funding may have already been a priority for you, but if you need more, it can often be sourced from private sponsors, charities, drug companies, international organisations, and the government.
Patient Recruitment
Finding the right people to participate in clinical trials is essential to achieve the desired research outcomes. Whether you need patients with certain medical conditions and characteristics or a general sample of the population, applying effective recruitment methods takes planning, time, and patience.
Some may be attracted by earning money, others by helping to solve some of society’s biggest health problems. Find what people are invested in and use it to attract a broad enough sample.
Scientific Rigour
It should go without saying, but following the appropriate research principles and standards is a must for any clinical trial. Public and patient health should always be at the centre of any testing process but the methods you use, the analysis you conduct, and your interpretations should always be unbiased and clinically robust.
Discoveries and conclusions from clinical trials could change the world as we know it. Maintaining scientific rigour can help to ensure any results can be shared confidently with all the relevant stakeholders.