As soon as the global pandemic hit, it was action stations for a lot of research labs around the world. Medical research is usually a very long and drawn out process, however drug development companies were forced to expedite the process and try to come up with a vaccine for this brand new virus in months, not years. The average time for a new drug to be put through clinical trials is around 10 years, and pharmaceutical companies were expected to find a viable vaccine in just 12 months, which is a huge undertaking. Thankfully we have technology on our side, and there are a number of systems that have been created over the past few years that have drastically reduced the time it takes to conduct clinical trials. Read on to learn more.
What Are Clinical Trials?
Clinical trials are medical or food-related studies or experiments done on human subjects usually under the supervision of medical doctors or staff. Such prospective behavioural or clinical research on human subjects are usually undertaken to answer certain basic questions relating to the subject of how does a new drug work, how can we detect and treat any disease and more. These medical trials also aim at gathering more data and understanding the effects of the treatment method applied by doctors to patients. In USA, all clinical trials must be approved by the FDA (Food and Drug Administration) in order to be rolled out into the consumer market. However, clinical trials that are done privately by individuals without FDA approval may not meet the standards of protection given by the FDA. Therefore, there are certain laws that governed clinical trials and all clinical trials should be reported to FDA once any research is done.
Following Protocol is Crucial
One of the most important aspects of clinical trials is the importance of following protocol. Protocols are necessary for a number of reasons, such as the protection of the identity of the patients involved in the study, proper conduct of the study, data collection and analysis and even the right of any participant to withdraw from the trial at any time without prior notice. The protocol must be adopted by the clinical trial coordinator so that all participant follow the study properly and that the data collected in the study is used appropriately. It is very important for the investigators to have a shared view of the entire plan from the beginning to the end because only this will ensure that all the participants get the proper treatment and the results of the clinical trials are reliable.
Another big part in the success of clinical trials is the post-registration process. This should be done carefully and thoroughly. All the details of all the procedures and the results of the clinical trials will have to be registered so that it will be clear for the researchers and the patients about what exactly happened. Registration means everything related to the registration of the clinical trials including the control group, the post-registration protocol, the regulatory approval and the post-trial monitoring. All the details and results of each participant who takes part in the trial must be submitted when the drug or vaccine goes for approval, and this is usually collected on special software designed for clinical trials.
Clinical trials in oncology involve taking different types of cancer drugs. The type of cancer drug can be decided after analyzing the response of patients in the various phases of the treatment and the effectiveness of the new drug. For example, if the new drug is effective against leukaemia but has little effect in patients who are in phase I or II of the illness, then it is not suitable for these patients.
Interventional clinical trials usually concentrate on a single drug or a combination of drugs. It is very rare for clinical trials to combine two drugs that have different mechanisms of action. Most often, one drug is administered in a phase I clinical trial and another in a phase II clinical trial. However, the combination trials may also occur. A combination of two drugs is usually used for the treatment of a single symptom or disorder in order to determine whether the drugs can be used interchangeably in the future. In general, it is very difficult to conduct clinical trials.