Are patients being excluded from clinical trials?
Clinical trials form an essential part of medical research, treatments and prevention. Companies and organisations investing in trials are looking for medical breakthroughs that can help patients worldwide and they rely on patient participation to carry out their vital work.
For a patient to take part in a clinical trial, they need to meet the strict criteria relevant to the particular study, such as ensuring the trial won’t interfere with their current treatment or give inaccurate results because of any drugs they may already be taking. While patient safety is paramount, many are being excluded from taking part in trials that could potentially save or prolong their lives.
BBC presenter Rachael Bland recently revealed she is relying on clinical trials to treat her breast cancer.
Reasons for exclusion can include having had a previous condition that has been successfully treated. This applies even if the patient is no longer suffering from the illness or receiving treatment; for example, a patient with a new cancer diagnosis may have previously been diagnosed with a different type of cancer or other medical condition, which can prevent them taking part in trials and testing new treatments for their type of cancer.
Companies are using adaptive phase 1 clinical studies to ensure a phased approach to clinical trials. In the US, campaigners have been trying to get the criteria for who can and can’t participate in trials simplified; however, a study conducted at UT Southwestern in 2017 found that the criteria for lung cancer trials has seen a 50 per cent increase in the eligibility criteria over the past 30 years.
Participants for trials are selected by medical researchers and sponsors working within strict guidelines. Many willing participants are restricted from taking part because of a failure to be able to remove criteria that are no longer relevant to them, such as in cases where patients have had a pre-existing autoimmune diseases where their white blood cell, haemoglobin and platelet counts were previously not at a satisfactory level.
As a result of of the exclusions these strict criteria are creating, the pool of available candidates is shrinking. All this information is cleverly kept in Membership Management Systems to keep track of who is offered trials and who isn’t which could be located with companies such as Ofec. This is causing delays in new drug development; however, patients who have had a pre-existing condition represent the population. By removing the eligibility restrictions, they and others could benefit.
Infographic provided by The Emmes Company, a clinical research organization