Drug trials can be the light at the end of the dark tunnel for many patients dealing with critical diseases
Leading a normal life, being physically active and eating right- everyone tries to follow these to stay healthy! But suddenly when a normal person discovers a lump, a cyst, or has a persistent cough, uncontrolled bleeding or any other major problem and finally comes to know about some critical disease he or she is diagnosed with their life just comes to a standstill!
Of course technology has grown by leaps and bounds and the latest treatments are available in the market for all different types of health problems, but still there are those few people who end up with a bug of a different kind and at times need a new drug to help them! The answer to their problems is clinical trials.
Clinical trial- a test or a solution
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A clinical trial is usually a study involving patients-usually known as the subject- to improve medical knowledge, to prove that certain drugs are successful and can be used to treat humans. Usually there are two types of studies- clinical trials and observational studies. Clinical trials involve the use of drugs or devices to see the safety and efficacy of the product and observational studies assess health outcomes in groups of people.
The two main purposes of a clinical trial are to know
- Does the new treatment work well on humans?
- Is the new treatment safe?
These trials go on in many phases and a clinical trial is only one small phase. Each drug goes through at least 6 years of study before it comes into a clinical trial. And on an average it takes about 8 years for a drug to pass a clinical trial and come into the market. During these trials the doctors have to work closely with the patient’s (subjects) to see the effect of the drugs on them. The biggest challenge of these trials is the fact that not many patients are willing to participate in these trials. According to the American cancer society less than 5% adults agree to take part in clinical trials involving cancer drugs whereas 60% children take part in trials that is why survival rates of childhood cancer have gone up well in the recent past.
THE PHASES INVOLVED
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Clinical trials are not simple procedures but involve a series of phases before they are considered successful and the product is ready to launch in the market. Drugs are tested for the first time on patients. It helps to decipher the dosage of drugs which the patients can tolerate.
- This phase includes pilot trials and final trials to evaluate the efficacy of drugs on the patients to see how it helps to treat or prevent the disease.
- Trials are demonstrated on patients who will eventually use this medicine prior to submission to NDA (National drug authority) and followed by a study post submission to NDA just before the launch in the market.
- The last phase involves studies on the medicine even after it is in the market to provide additional information on its efficacy and side effects. This is also known as post marketing surveillance.
CLINICAL TRIAL- A SECOND HOPE
Clinical trials not just provide new drugs and devices to the medical field but also give a second chance and ray of hope to people suffering from critical health problems. Critical health problems are life threatening and not having a right cure for it can be even more disheartening for the patients. But clinical trials have proven to help such patients as well and have given them a new lease of life.
Mary James an Afro American was diagnosed with breast cancer and she had a complicated form of cancer which needed multiple lines of treatment. She needed a lumpectomy, followed by chemotherapy and radiation. Just as she finished her line of treatment her oncologist suggested her for a clinical trial of accelerated partial breast radiation. This involves comparing the standard breast radiation which takes 6 weeks with accelerated partial breast radiation which confirms the radiation close to tumour cavity and lasts only 5 days. Mary felt that the trial she went through has not only improved her chances of living longer but has also given her an opportunity to do something to make the place a better world. The outcome of these trials definitely provide a better chance to people suffering from critical diseases towards a new hope of living.
Clinical trials provide solutions for other problems as well like osteoporosis, diabetes, Alzheimer’s to name a few. Osteoporosis is a metabolic bone disorder which involves thinning of the bone. A recent trial done at the Oregon Osteoporosis centre at Portland has shown that a drug called romosozumab, works well on osteoporosis by not just preventing further bone mass loss but also by promoting bone formation.
CLINICAL TRIALS- A FAILURE AT TIMES
A clinical trial is a test of a kind and so not always successful. A drug failing a clinical trial and not coming into the market is better than a drug coming into the market and adversely affecting patients. One such example is of a clinical trial failure of a breast cancer drug called Cadcyla by Roche as it failed to give results superior to existing drugs. Several anti-inflammatory drugs have been withdrawn from markets following side effects during clinical trials. A failure in a trial is like a red signal to the pharma company to stop it from launching in the market.
GRANDOPINION- YOUR GUIDE TO A CLINICAL TRIAL
A diagnosis of a critical disease, multiple lines of treatment and your doctor requesting you to be part of a clinical trial- leaves you rather confused. If you are wondering who can guide you at this point of time, then the simplest guide and friend you can find is GrandOpinion. If you are dealing with a life and death situation and Inspite of regular medication and treatment, you see no improvement in your disease, and your doctor sees no ray of hope for your living, you can consult GrandOpinion for that second trail to life i.e. for clinical trials.
- Has your doctor told you about clinical trials? If not our doctors on GrandOpinion will guide you and tell you more about clinical trials and how they can help you find a line of treatment for the critical disease you are suffering from.
- Has your doctor been asking you to through clinical trials? In this case, GrandOpinion will help let you know if there is any other line of treatment available or clinical trial is the last option.
Apart from these, the effects and side effects will also be clearly mentioned by our doctors.
A clinical trial is a good option for many as it not just helps your problems and increases your chances of living but having been part of a trial you provide a great path for the future generations to come.