Do you ever wonder how prescription medications make their way to your local pharmacy? Clinical trials and health research play a vital role in maintaining the world population’s health on a regular basis. Without the proper research and clinical trials, many patients would still be suffering from ailments that are easily cured with medications now.
Patients aren’t the only ones to benefit from the health research and clinical trials that are routinely performed. Research experience is an important part of the overall development of a medical student and boosts the attractiveness on a residency application. Most of the competitive residency programs have the luxury of selecting from applicants who have all the desired elements, and this has created an over-the-top rush for med students wishing to get into research.
In some cases, researchers discover hidden benefits of some drugs that were created for one purpose but also end up being used to treat alternative ailments as well.
The 2007 Ig Nobel Prize in Aviation went to Patricia Agostino, Santiago Plano and Diego Golombek of Universidad Nacional de Quilmes in Argentina. Their research led to the discovery that sildenafil helps treat jet lag in hamsters. No one has understood why treating jet lag in hamsters is important.
What may be even more amazing is that someone actually did a clinical investigation to see if sildenafil would benefit the hamsters. For anyone that doesn’t know already, Sildenafil is the fancy, medical term for Viagra.
The public at large who are regularly patients can benefit from better understanding the clinical trial process. Knowledge is power and if everyone is more knowledgeable about the research behind their current treatments, everyone will benefit.
What is A Clinical Study?
A clinical study is a procedure involving research on human volunteers or participants; that is meant to increase the growing body of medical understanding. There are two main types of clinical studies: interventional studies and observational studies. As indicated by the names, in an observational study, the researchers simply observe the clinical trial participants without any changes or modifications. During an interventional study, the clinical trial participants may receive medications or behaviour modifications.
In interventional clinical trials, individuals get precise interventions in line with the protocol designed by the researchers. These interventions might be pharmaceutical products — drugs and devices; methods; or modifications to the participant’s behavior — such as food intake. Clinical studies may match a fresh therapeutic advance to one already available. Some cases relate interventions, previously available, to each other. When a new product is studied, it is not typically known if it will be effective, dangerous or whether any difference will be noticed. The researchers attempt to find out the safety levels as well as the efficiency of the new intercession.
In observational studies, researchers review health results in a group of participating in a pre-determine research protocol. Participants might get interventions which include medications or equipment, or methods as part of their routine and regular medical care. Regardless, members are not specified to the precise methodology by the researcher as they are in a clinical trial.
These are two of the most popular types of clinical trials, but there are other types of clinical trials that can be classified by their purpose:
- Prevention Trials
- Screening Trials
- Diagnostic Trials
- Quality of Life Trials
- Compassionate Use Trials
Yet another way of classifying the different types of trials is based on the data accumulated during the trial:
- Fixed Trials
- Adaptive Clinical Trials
- Location of Studies
Clinical studies take place in many locales including hospitals, universities, and physician offices. The location depends largely on who is doing the study. Geographical locations vary and are sometimes handled by a CRO. For example: George Clinical is one of the largest CROs in the Asia–Pacific region.
Length of Study
The length of a study will vary. It all depends on what is being studied. Despite the variation, participants are always told how long the study will last before they join.
Who Can Join?
Studies have outlines and standards concerning who can take part. Called eligibility criteria, the standards are found in the protocol. While some studies look for associates who have the afflictions that will be explored, others seek strong and stable participants. Still, some are limited to a planned group of people.
“Inclusion criteria” is the term which refers to the factors that allow someone to participate. Inclusion criteria are also the items that may disqualify someone. The criteria are based on characteristics including age, gender and type affliction as well as the stage of a disease.
Consideration for Being Included
Participating in a particular research helps to expand medical information. The studies’ results may produce a variation in the treatment of subjects by providing data about the benefits and risks of preventative, or diagnostic, products or interventions.
Clinical trials provide the foundation for developing and selling of new products, drugs, and devices. Often, the safety and the efficiency of the method or technique may not be fully known at the time of the test. Some trials often provide participants with the chance of getting medical benefits and other studies do not. Most studies include a level of risk of injury, though it may not be higher than the risk associated with conventional medicinal care.
Numerous trials expect participants to go through examinations and evaluations which are determined by the study’s protocol. The requirements are outlined in the informed consent documents, and any potential participation should also review the concerns with research team members.
Questions to Ask
What if you are asked to participate in a clinical trial or study? You should do your research and be prepared to ask plenty of questions before making a decision. Some questions to ask during the discussion include:
- What is being studied?
- Why to the study leaders feel the intervention being tested may be effective?
- How will the interventions received be determined?
- What will be required?
- What procedures are required?
- What is the length of the study?
- Who pays for participation?
- What if you are injured during the study?
Not for Everyone
Participation in clinical trials is not for everyone. Some people have work commitments that preclude active participation; others have child care issues. But for people who fit a particular trial’s criteria, it can be a great way to pick up a few dollars while helping push medical knowledge forward.