Abstract
With the recent emphasis and focus by federal agencies in funding clinical research we come to understand its importance in establishing evidence based medicine and healthcare reform. Clinical research and drug trials aid in establishing a wide-ranging and extensive array of therapies which add value to healthcare, to the individual and society at large. In spite of the enormous benefits of conducting clinical trials they can also have potential for causing risks to the participants of the clinical trials. There can be harm caused to participants because of the flaws due to biased information obtained during these clinical trials. A well designed clinical trial may appear pretty simple and straightforward but it has also to be established on sound and rigorous methods and should be governed by ethical principles. In this article we provide an overview of what drug trials and clinical research means, the types of clinical trials available, why these clinical trials are important to healthcare, how they work, how these trials are organized, who can participate in these trials and such other issues that are critical for our understanding and for the entrepreneur who may wish to make a foray into clinical research and drug trials.
What do we understand by the term “Clinical Research?”
This is a branch of healthcare science that enables determination of the safety as well as effectiveness of devices, medication, treatments, diagnostic products which are all necessary for human use. These can be useful in prevention, diagnosis, treatment or even in relieving symptoms of any disease. “Clinical research” refers to the study or trials that are conducted on people and as the developers design the study and its outcome they take into account the various clinical research phases and what they plan to accomplish for each of the different research phases. They will later begin the Investigational New Drug Process (IND) a process that is required before they can start the clinical research.
Drug Trials or Clinical Trials can be explained as research studies that explore the possibility of a certain medical strategy or treatment and its effectiveness and safety on human beings. These drug trials can also predict which of the many medical approaches will work best for illness of a certain kind for certain groups of people.
While preclinical research generally serves as an answer to many basic questions regarding a drug’s safety etc., it does not become a substitute for studying ways and manner in which the drug interacts with the human body.
What are the many areas of clinical research and trials that one should be aware of and how is this achieved
● Clinical trials are separated into the following types: Treatment, prevention, supportive care, screening, and health services research, diagnostic, as well as basic science.
● In order to ensure participant safety, clinical trials are first initiated with smaller groups to ensure that the new method does not affect the participant in any manner and does not cause any unnecessary side effects.
● Clinical trials are most needed when one wishes to find out if a certain treatment will benefit people suffering from a particular illness and if that is the best course of action i.e. if the new approach works effectively in humans and if it is safe.
● The designs of the clinical trials could be either “experimental” or “observational” in nature and can include study types such as case cohort, control, systematic review and randomized controlled trials.
● The research team that is involved in the clinical trials may be a team of doctors, social workers, healthcare professionals, data managers, scientists, nurses and clinical trial coordinators.
● The participants of a clinical trial would have to meet certain eligibility criteria and ensure they are suitable for the same.
● There are both risk factors as well as benefits to the participants of a clinical trial. There is an “informed consent”
document that the participant is asked to sign before he is ready and included in the clinical trial. Risks to participants are both monitored and controlled. There may be rare instances where the risks are unavoidable due to medical research studies.
● The clinical drug trials are divided into 4 phases in order to examine the safety of a new drug and compare the same with treatments that are already in practice and use.
What’s in it for entrepreneurs and providers? What should they bear in mind before entering this field?
● The implementation of clinical trials requires an approach founded on rigor and scientific methods with statistical, ethical and legal deliberations and reflections. Hence it is essential that health care providers understand the principles and guidelines on which well-performed clinical tests depend. This will help the providers in retaining a good partnership with the industry and patients in quest of the most competent, safe, resourceful and effective treatments and remedies.
● Providers need to be aware of the key areas and concepts along with the issues that they may encounter in the fruitful design and execution of a clinical trial. The health care providers may also partner with regulatory bodies and pharma industries in order to compare the treatment methods and therapies. This will enable everyone concerned in meeting the common goals of health care reform.
● While these clinical studies and trials are most needed in the development of new treatment methods for serious illnesses like cancer, they are also vital in studying all aspects of medicine. All new treatment methods and drugs as well as medical devices would have to go through these clinical trials and have to seek and obtain the approval of FDA.
Who can take part in these clinical trials and what age group should the participants be?
While people of all ages can take part in the clinical trials, there are steps that one needs to take in order to be part of any study.
1. For instance for a child to be enrolled in a clinical study the parents or guardians should first decide if they wish to involve the child in the study.
2. Once the parents give their permission the older children should be asked if they are willingly taking part in the study and they have to provide their individual consent to take part in the clinical study. This process is termed as consent.
3. The child has a right to refuse taking part in the trial even if the parents are willing to permit it.
4. One may ask what the uncertainty in the trail can be. Doctors who are in charge of the clinical trial are themselves not sure of the results of the trial ahead of time. If they did have any idea of what the result would be, then there would be no need for the trial in the first place.
5. One has to bear in mind that there is bound to be an element of uncertainty in any clinical study and hence the need to be well informed of all consequences before entering the trial.
6. There is no simple answer to the query “should I take part in a clinical trial”. The common man does not usually pay much attention to a clinical trial until he has a serious illness.
7. We don’t hear about clinical trials in every day conversation and these get reported in the news only when something goes wrong with the clinical trials themselves and someone is seriously affected by a drug trial.
8. Medical breakthroughs which are the result of clinical trials on the other hand get reported in the news. What we do not hear about is the millions who are benefitted by taking part in the clinical trials and the several others who are benefitted by others participating in the clinical trials.
What are the definable and actual benefits of clinical trials?
1. Clinical trials show us what works and what does not in healthcare and medicine. They are the best means of knowing what works in treating diseases like cancer.
2. They can answer two important questions – does the new treatment work on humans and if it does, are the doctors looking at how well the treatment works. Also, is it better than the current treatment for that particular disease? If the new treatment is not better than the existing one, then does it atleast have lesser side effects or does it work on certain people for whom other drugs have proved ineffective in treatment?
3. The clinical trials can also tell us if the new treatment is safe and if it is entirely without risk. Or atleast does the new treatment balance the possible risks?
4. Clinical Studies are all not just meant to study treatments. They are also useful in studying new ways to diagnose, detect, or learn the extent of disease.
What are the safeguards that are employed in order to make these clinical trials and drug trials safe for the participants? Why does the process of approvals take long?
1. The first step is to answer the questions listed above and exposing lesser people to the unknown treatment.
2. This would require several different clinical trials which are normally grouped into phases and in each phase they are meant to test every new treatment method before it can be considered safe and effective. Thus every new treatment has to pass several tests before being deemed fit for public usage.
3. Clinical Trials are only a small part of the research that go into the development of the new treatment. New drugs that are discovered or created have to undergo a process of purification and then have to be tested in laboratories ( in cell as well as animal studies) before even reaching the human clinical trial stage. Among those drugs that are tested in the early stages, very few are seen to be worthy of clinical trials on humans. For example, in the case of a new cancer drug entering the clinical trial stage, there are major bottlenecks before the drug is made available for human consumption. It takes on an average around 8 years from the time a cancer drug enters the clinical trial stage to get approval from FDA.
4. Why does it take such a long time for approvals? This is to ensure that the drug is absolutely safe and effective. Also, only a certain people are deemed eligible to take part in each clinical trial. It takes months if not years to see if a certain drug works on any one person.
5. Next, finding out if the drug increases the chances of survival is another long process and the greatest barrier to this is finding enough people to take part in every stage of the drug trial. Among those of the adult population, affected by cancer, less than 5% would be willing to take part in the clinical trials. In fact clinical trials are used more in the treatment of children with cancer. 60% of children under the age of 15 participate in clinical trials, this being the reason for survival rates of children with cancer being higher in the last few decades.