Multiple Sclerosis (MS) Clinical Trials Explained
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Clinical trials are research studies used to evaluate if a new drug or a new medical intervention is safe and effective. Before a drug is offered on the market, it needs to be properly assessed in various research phases to confirm its effectiveness, both alone and in comparison to other available drugs for the same clinical condition. These trials also evaluate the safety profile of new interventions and are important because they can lead to a better understanding of diseases, as well as to the use of newer, more effective methods for treating them.
Clinical trials have been instrumental in the development of new drugs for patients with multiple sclerosis (MS). Participating in a trial helps both current and future patients dealing with the same disease, thus making it an essential step forward in increasing the range of treatment options.
Some clinical trial studies involve the use of drugs that are currently available and already approved by the FDA or other regulatory authorities. Other trials involve the use of new, potentially beneficial medications which are under review to evaluate their benefits, as well as their safety profiles.
Why do people participate in clinical trials?
The benefit of participating in clinical trials is not just for the greater good. The two most common reasons why patients volunteer to participate in research are: access to cutting-edge treatments, and the quality care they receive while participating in the trial and beyond.
Other reasons for participating in a trial may include the inability to tolerate certain medications due to various side effects or being unable to continue with intravenous (IV) treatment administrations and being willing to try oral formulations.
In most instances, you cannot take part in a clinical trial if you have not previously received the standard treatment and care available for your disease. It is also important to consider the known and unknown health risks that could be associated with a specific trial before enrolling into one, which can be achieved by discussing the risks and benefits involved with the researchers leading the trial.
What does eligibility entail?
Patients who are eligible for a clinical trial need to fulfil a list of required eligibility criteria. These may vary according to the cohort of patients being investigated (disease type and status), and the drug type under scrutiny. All participants are required to sign a consent form voluntarily, which can only be done after they receive a detailed explanation of the potential benefits, risks and possible side effects that may occur within that specific clinical trial. There is no restriction or penalty if a volunteer decides to cease participation in the middle of the trial.
Of course, the final decision to become involved with a research protocol is personal, and patients are encouraged to consult with their treating doctors.
The evolution of MS clinical trials
The advances in MS treatment over the past 20 years reflect the success of the numerous clinical trials that have identified those beneficial medications. Current ongoing clinical trials continue to offer MS patients the ability to help advance scientific research into this disease, while also providing a unique opportunity to try new medications not yet available on the market.
Clinical trials in multiple sclerosis do not only seek to treat the disease. Some trials are aimed at treating the most difficult symptoms which are part and parcel of the disease, such as pain and spasticity, which is the stiffening of muscles that prevents normal movement. Most MS patients will experience spasticity at some point during their disease development. This symptom can lead to difficulty in walking and increase the risk of falls with severe consequences and complications. Additionally, new ongoing clinical trials focus on areas of physical therapy exercises and the use of devices to stimulate muscle usage. Specific medications are also being trialled to improve patient symptoms and reduce further complications.
How do I find an MS clinical trial?
The sheer volume of available clinical trials for MS can prove overwhelming for many physicians and patients. Even well-informed patients face challenges with the technical language used and the very granular nature of the inclusion and exclusion criteria. Physicians may understand the language but are not always aware of all clinical trials available. In the best cases, they are aware of those that take place in their own hospital or clinic. This leaves many potential patients unaware of the trials that could be their best hope for a cure or remission and a high number of trials critically under-enrolled.
In addition, MS patients often face another hurdle. Some of them find it hard to concentrate over time, and many of them experience some cognitive difficulties (AKA “cog fog” among MS patients), making it tough to digest the vast amount of information found within the clinical trials databases.
One of the resources that can be used to find MS clinical trials is ClinicalTrials.gov. This is a searchable registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. The website gives a listing of all clinical trials available for a specific diagnosis, but it is not a personalized resource. You can find information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from healthcare professionals.
Other resources, such as MS community apps that offer clinical trial matching services, incorporate AI and machine learning (ML) to digest the huge volume of data in the clinical trial database. The AI algorithms match patients’ profiles and treatment history to clinical trial catalogs and refine the list to find the trials most relevant to them, making the results personalized to the patient’s particular characteristics and condition.
While the AI does 95% of the heavy lifting, some apps provide clinical trial coordinators to make sure the data entered is accurate and complete, review preliminary results, consult with patients and develop the final short list that meets the individual’s preferences and needs, such as inability to travel significant distances.
The coordinator discusses the results with patients, allowing them to understand all their options. Sometimes, that leads to a second round of matching. The program returns the results of the search to patients directly but encourages them to discuss them with their physician. If desired, the coordinators connect patients with the trial site. The clinical trial coordinators also play a critical role in keeping the data clean and improving the algorithm by validating the appropriateness of the matched trials and correcting errors so that the system does not repeat the same mistake twice.
Before participating in any clinical trial, it’s very important to speak to your physician and learn about the potential risks and benefits.
The current achievements in the treatment of MS are mainly based on the outcomes of clinical trials that demonstrated beneficial and quantifiable results in treating a disease which has an unpredictable course. Since the mid-20th century, a lot has changed. Important scientific and technological advancements have enabled better diagnosis of the disease and monitoring of its progression, together with better support from ancillary studies. As treatment options for MS broaden, future clinical trials will continue to incorporate new strategies to identify novel therapies and pathways of intervention, for the betterment of the MS community.
About the author:
Dr Daniel Vorobiof is the Medical Director of Belong.Life, developer of social network and navigator apps for patients, caregivers, and medical professionals, with apps currently available for cancer, multiple sclerosis and IBD. Dr Vorobiof has published more than 120 peer-reviewed articles in international medical journals.