Clinical Trials – Safety, Risks and Benefits

Clinical Trials – Safety, Risks and Benefits

As a patient with an autoimmune condition it is likely that at some point in your care you have been asked to consider joining a clinical research trial or have investigated the possibility on your own.  There is absolutely no requirement for a patient to take part in a clinical study but for some it is something they may consider worthwhile, feeling that research is the best hope for improved treatment or a cure. Indeed, without participants in these trials none of us would have our current medications or treatment options.

On the other hand, it would be completely normal to question why you should try something that as yet has no proven track record and that researchers are not yet sure will work. This article addresses the safety concerns, as well as both the potential benefits and risks, associated with being a participant in a clinical trial. We hope that by giving some insights any of our readers considering this will be able to make a more informed decision.

Safety First

The history of clinical trials has led to many patients being understandably hesitant to sign up. It’s important to note that as with many other areas much has been done so that there are now strict rules in place to ensure participants safety, health and privacy are not jeopardized. Congress has passed a number of laws to protect participants. These safeguards are nowadays considered to be absolutely essential. Each and every trial must be approved by the FDA, this is the first step in insuring a high degree of protection for participants.

Every clinical investigator is required to monitor each participant extremely closely to ensure their safety. Each trial has a set protocol that describes in great deal what the researchers will be doing, the principal investigator is responsible for making sure that this protocol is strictly adhered to. This protocol has to be approved by an Institutional Review Board (IRB). Significantly the IRB includes not only consist of doctors and scientists who are dedicated to ensuring patients are not exposed to unnecessary risks but lay people as well that can offer a more patient centred perspective. The IRB meets regularly to review the study, its results and the impact on the participants.

In addition to the IRB, trials are supervised by a Data and Safety Monitoring Committee, made up of experts in the field relating to your condition. If it is found that the experimental treatment is not working or is harmful in any way, they will halt the trial immediately. Lastly, the informed consent process allows potential participants to ask questions and be fully informed before signing on. Anyone, who does decide to join, can leave the trial at any time and for any reason, without being judged or feeling as if they are in a difficult position regarding the medical care they will receive thereafter.

Taking Care of the Concerns

Of course, for most of us fear of the unknown would be a key factor when considering participating in a clinical trial. It can be helpful to remember that much investigation has already been done in the laboratory before any drug is passed on to human trials.

The treatment being trialled may be uncomfortable and could have side effects not yet known. The novel treatment may not be any better or could be worse than current treatment options. There is a chance that you will not receive the potential new treatment but are assigned to a control group which could receive the standard treatment or a no-treatment placebo. This would be extremely disappointing for someone that had high hopes of a new treatment yielding a great improvement in their symptoms and how they deal with their condition. In addition to your usual medical appointments it is likely that a clinical trial will require more frequent visits and monitoring, increasing the amount of time you need to dedicate to your condition and care, which can be an inconvenience.

The Benefits After the Doubts

One of the emotions many patients feel after a chronic condition diagnosis is loss of control. It is almost as if you relinquish control of so many aspects of your life to your condition or those that are treating your condition. The list of things you should or shouldn’t do after diagnosis can be extensive. A clinical trial can allow patients to be proactive rather than reactive regarding their condition. This can help to give participants back an element of control which can have a positive psychological impact.

Patients that are not responding well to traditional treatments have the opportunity to access a treatment not currently available to other patients.

Although you may need to dedicate more time to your medical appointments this is not necessarily a bad thing. Patients that have taken part in a trial have expressed that they feel as if they receive a greater degree of attention and care while in a clinical trial, as there are frequent designated evaluation points over and above those they receive during standard clinical assessments. Better monitoring can lead to better treatment and earlier intervention should it be necessary.

Depending on how the trial has been set up, as a participant you may have the opportunity to interact with others that are in a similar situation. Through this you may gain information about resources and support that you were previously unaware of. A chronic condition can be isolating and talking with others that can really understand and empathise can help patients to feel less alone.

Lastly, and perhaps most importantly as a participant you are helping to pioneer new treatment options not just for yourself but for others who may require them in the future as well.

Something to consider if you are still unsure of whether you would contemplate joining a trial is to look at the option of joining an observational trial. In these studies, the patient is minimally affected in terms of time and level of uncertainty. These studies can be extremely beneficial as participants are able to add to the knowledge base regarding their condition with little inconvenience to themselves. While this type of study is unlikely to offer direct benefit to your own treatment, which remains unchanged, the information gathered could be used to develop new therapies that improve survival or quality of life for yourself or others in the long term.

Taking the Next Step

If after considering the pros and cons and doing your own research, you feel that you would benefit from joining a clinical trial the first step will be to discuss the possibility with your primary care physician. Usually joining a trial is only possible if you have been referred by your doctor. Your doctor, being well acquainted with your medical history and current treatment protocol, will also be the best person to determine which trials you may be suitable for. Most trials have strict criteria regarding eligibility and only your doctor will be able to state whether you meet them.

Each patient will need to weigh up the potential negatives and positives associated with joining a clinical research trial. Your doctor will be able to answer questions and guide you but at the end of the day only you can decide whether being involved in a trial is the right choice for you.

 


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ANRF
Article Author
Arthritis National Research Foundation
arthritisresearch@curearthritis.org

The Arthritis National Research Foundation's mission is to provide initial research funding to brilliant, investigative scientists with new ideas to cure arthritis and related autoimmune diseases. Writing articles about the patients affected and the science being done to find a cure shows why we need to come together to #CureArthritis!

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