I would rather be surprised , if it still comes as a startling fact to people that it takes more than a decade to have a medicine or therapy reach the market. Well, the process is inclusive of ideation, choice of key ingredients, formulation and then several rounds of clinical testing amongst animals and humans. Clinical trials plays a super critical role in the last leg of the process, and therefore would be of great importance for everyone.
Read on to know some basics around clinical trials.
What are Clinical Trials?
Clinical trials are the study in which people voluntarily participate to get new drugs or therapies or devices tested. For an experimental theory that has successfully worked in the lab, needs to be tested amongst humans as well to be made available. Every clinical trial is designed to determine and answer certain scientific questions and therefore helps to plan the treatment regime.
How do I know If I am eligible to participate in a Clinical Trials?
If you wish to participate in a clinical trial, it is best advised to check for the participation eligibility for the specific clinical trial. Every clinical trial that is planned and takes place, specifies its own eligibility criteria with specific factors such as age, disease status and also previous medical history. Your current doctor, considering the stage of your disease will suggest the bets standard treatment available and the possibility of you participating in a clinical trial. Your details are reviewed and the final decision to participate in a clinical trial resides with you.
What are the benefits of participating in a clinical trial?
- If a new treatment is successful, the patients are amongst the first ones to enjoy the benefits.
- As a clinical trial is a voluntary participation to get a therapy or medicine tested, it definitely saves the patient and the healthcare system a lot of money.
- The patients enrolled are monitored on a regular basis.
- The patients enrolled and participating are free to withdraw from the treatment regime as and when desired.
- Participation in the clinical trial, provides the patients the access to a wide network of doctors, nurses and researchers. This alone helps with the trust building between the caregivers and patients.
What are the disadvantages of participating in a clinical trial?
- As the treatment is novel therapy and the patients are the first ones to try it, it can be beneficial or fatal.
- Depending on the type of the study, it is not necessary that the patients would know if they are receiving the novel treatment or a previously existing one. Such a study is called a blinded study. Therefore, the patient should be prepared for that as well.
- The patient should be emotionally and mentally be prepared for unanticipated side-effects and risks.
- The patients can be required to present for several tests and investigations while the clinical trial is on.
Did you know?
- Because a patient voluntarily participates in a clinical trial, you are made to sign an informed consent which clearly explains that the treatment plan along with all possible benefits and risks.
- The clinical research is federally regulated with built in safeguards to protect patients. While the clinical trial is on, the patients are carefully monitored and as applicable follow ups are planned as per individual protocol requirements.
- Each protocol is approved by a Research Ethics Board that reviews the details.
- The patient is free to step out of the clinical study at any point in time.
In order to enroll in clinical trial run for cancer novel treatment, the patient has to undergo a detailed molecular testing such as broad next generation sequencing which will determine the eligibility of the patient for that particular clinical trial. Few common examples of large clinical trials are MOST PLUS, TAPUR, NCI-MATCH trial where molecular profiling is important to get enrolled.