Who Can Handle And Conduct Clinical Trials?
Clinical Research trials are observations or experimental studies conducted on a specific number of test subjects to determine the safety profile of a new drug, medical device, or treatment designed for a particular disease. These studies generate data on the efficacy of a drug or treatment and are performed by the associates that are given the best clinical research training. As these studies are experimental, they have many risks associated with them.
Clinical trials are only conducted after the treatment or medication has tested positively on other organisms. The participants for these clinical trials are generally volunteers to test the medical interventions, including cells, drugs, surgical procedures, radiological procedures, preventative care, behavioral treatments, and other biological products.
Clinical trials are very carefully designed in an orderly manner, reviewed, and completed. These have to be approved by the respective authorities before they can start. Based on the type of treatment, age groups are chosen to take part in these trials. These trials have to strictly adhere to protocol and with excellent patient counseling to achieve the expected outcomes.
There are four phases in every clinical trial. These phases are:
- Phase I: This includes the studies of the test conducted by the new drugs for the first time on a very small group of individuals. It is done to evaluate the safety profile, and dosage ranges, and the adverse effects of the drug.
- Phase II: This phase studies the test treatments that were found to be safe in Phase I. This phase includes a larger group of test subjects to monitor them with respect to the adverse effects of the drug.
- Phase III: The studies of this phase are conducted on a large population in different regions of different countries. It is often considered to be the actual first step in drug or treatment approval.
- Phase IV: These studies are generally conducted after country approvals, and there is a strong need for further testing in larger or wider populations. It is done in a larger time-frame on a mass population.
Who participates in clinical trials?
The set protocols determine who can take part in clinical trials. Every clinical trial has set protocols set based on certain criteria. This criterion is solely based on the objectives of the clinical trial. The possible criteria may include the possible illness or condition and being healthy without the specific condition. The exclusion criteria are the factors that restrict people from taking part in the trial.
There are several non-specific reasons for a participant to participate in a clinical trial. Being a part of a clinical research trial enables the participants to try new treatments before they are widely available. After a participant signs the consent form, they shall be screened by the clinical staff and professionals to verify if that participant meets all the required criteria to be an active part of the clinical research trial. This form of screening generally involves cognitive and physical tests.
A large volume of participants is screened to find enough people meeting all the requirements for the trial. As the eligibility criterion varies from trial to trial, exclusion from one trial does not exclude other trials.
All clinical trials must have a diverse group of participants. The participants are generally a group of individuals of different ethnicities, ages, races, and sexes. If a particular trial is conducted on similar people, the treatment or drug may not benefit everyone.
Who conducts clinical trials?
Clinical studies and clinical research trials are generally conducted by a principal investigator who is generally a medical professional. These studies are generally led by a research team that includes doctors, nurses, social workers, volunteers, and other healthcare professionals.
Clinical Research Courses are sponsored or funded by academic medical centers, pharmaceutical companies, government organizations, volunteer organizations, etc. These clinical research studies can occur in many locations, including hospitals, universities, community clinics, etc. It is dependent on who is conducting and sponsoring the trial.
The FDA and other concerned authorities are committed to protecting the participants of the clinical trials. They also provide reliable information to those willing to participate as test subjects in these trials. The concerned authorities ensure that all the protocols are rigid and are complied with to make sure that no harm comes to the test subjects of the trial. Any form of unethical behavior results in complete shut-down with strict actions taken toward the clinical trial hosts.
Although they are made to minimize the risk associated with clinical trials, some risks are completely unavoidable. It is because these trials are experimental and may have unexpected reactions. All the test subjects need to understand the procedure and protocols and the expected side-effects and situations of unsayable circumstances before deciding to take part in these trials.
There are several ways to find out about on-going clinical research trials. Your doctors and healthcare providers can give you information regarding on-going trials. One takes an active role in their healthcare by taking part in these trials. They also contribute to the betterment of the overall health of the world by taking part in these trials. These trials are certainly beneficial to all of mankind as they help eradicate illnesses one step at a time.