b'Medicine & ResearchClinical Trials What are they and how can they help the future of MS.Clinical trials. The words may seem daunting,The phases of clinical trials especially if you have never participated inClinical trials, particularly those testing new one. But if it werent for clinical trials, all thedrugs, go through the following phases: DMTs available today for newly and currently Phase I: A small group of healthy participants diagnosed people with MS would not exist.receivesthetreatmenttoevaluatesafety, There would not be any new research occurringdetermine dosage, and identify side effects. with options such as biosimilars, and patient Phase II: The treatment is tested on a small care would be diminished. Lets go through whatgroup of people with the goal to assess clinical trials are and some basic terminology.effectiveness while continuing to monitor By understanding the types of research andsafety. the steps involved, you may feel empowered Phase III: Larger groups, often across multiple to consider participating in one or helping tolocations, receive the treatment to conrm the educate others.effectiveness, monitor rare side effects, and From planning to participationcompare it to any existing treatments. Researchbeginsinaclinicaltrialwith Phase IV: After FDA approval, these studies carefullydetailedplanningtoensurethatcontinue to monitor the treatments long-term studies will gather meaningful and unbiasedeffectiveness and safety in a broader population information. Poorly designed studies can leadsuch as multiple countries. to bias and skew the results in one direction,Approval for use leading to inaccurate results. When research shows that a treatment is Beforestudiesinvolvinghumanbeingssafeandeffective,researchersdetermine can begin, experimental treatments undergowhether regulatory approval is needed. New extensive preclinical research in laboratories.drugs and certain medical devices require This stage often involves testing on living cellsapproval from the FDA. The review process andanimalstoevaluatethetreatmentscan take from six to 10 months but may potential benets and identify any risks. Anbe expedited for treatments that address an Institutional Review Board must approve theunmet need.study design. The IRB ensures the potentialWhy this matters benets outweigh the risks and that participantsEvery MS treatment available today started safety, and rights are protected.as an idea that was tested and rened through Once approved by an IRB, researchers shareresearch. Understanding this process highlights the inclusion and exclusion criteria to ndthe contributions of study participants and suitable participants. Those who meet theresearchers alike. Whether youre considering criteria are given detailed information aboutjoining a study or simply curious about how the study, including potential risks and benets.treatments come to market, knowing the journey This process is known as informed consent,behind every breakthrough is the rst step. whereparticipantsareencouragedtoaskThroughresearchandinnovation,wecan questions and must sign forms acknowledgingcontinue to move toward a future where MS their understanding of all risks and benets. is more manageable and, someday, curable. msfocusmagazine.org 23'