The interest in clinical trials has grown exponentially since the beginning of the COVID-19 pandemic. The results from trials are awaited by scientific community and by common public. At the same time, it is also important to understand the process of clinical trials and the scientific approach behind them to finally come out with a successful drug, vaccine, or therapy.
Clinical trials basics
Clinical trials are a way to evaluate new tests and treatments and their outcomes on human health. They are standard processes to check if there are any side effects of the proposed therapy or drug as a part of the proposed trial. Clinical trial results provide the ability to make decisions on the approval of a drug or treatment. There are diverse ways of designing clinical trials. People take part in clinical trials voluntarily. The procedures are designed with care and scrutinized at every step. They need approval prior to the start of the trial. There are typically four phases in a clinical trial.
Who conducts clinical trials?
Every clinical trial is led by a medical doctor who is referred as the principal investigator (PI). The PI is supported by a research team including other medical and healthcare professionals. The trials can be conducted and sponsored by universities or medical institutions. They can also be partly or completely sponsored by private companies such as pharma or nonprofit organizations and voluntary groups.
Where are clinical trials held?
The trials are held in multiple locations. They can be multi-institutional in hospitals, universities, individual doctor’s clinic, and community clinics. The trial location can depend on the type and host of the trial.
Duration of clinical trials
The duration of clinical trials varies based on the type and length of the study. The duration of each trial is calculated based on the complexity of the study and is of course communicated to the participants. Until now, many trials have spanned years to conclude. However, vaccine trials for COVID-19 were conducted extremely quick and vaccines were subsequently approved worldwide.
Why do we need clinical trials?
Humans respond differently to illnesses based on a variety of factors such as age, gender, lifestyle, ethnicity and many more. It becomes necessary to scientifically evaluate usage of any treatment or drug and analyze it prior to making it a standard practice globally. The final outcomes of these trials add medical knowledge to the existing information.
Participation in clinical trials
Every clinical trial has a study protocol listing out the eligibility criteria for participation in the study. These criteria parameters would be published once the trial is approved to be conducted. This information would also include the length of the study, planned dosage or treatment procedures. The study protocol would also enlist the search for specific patients or healthy volunteers. Any known potential side effects may lead to exclusion of certain volunteers. After careful planning of the study design, the trial conducting groups publish ads inviting volunteers to participate in the study.
Data Protection
All participants are briefed on the trial guidelines and must sign a consent form. The consent form provides information on the potential risks and benefits of the trial. Anonymization of volunteer data protects patient data and is one of the key parts of the trial once it is published. Also, volunteers are free to withdraw from the trials at any given time.
Ethics and review committee
Each planned trial is supervised and monitored by a review committee including medical professionals, researchers and patient support groups. They carefully evaluate the study design and especially weigh in ethical balance of the trial. Their role is to ensure all volunteers are subjected and protected within the ethical guidelines at every time during the study. They focus on reviewing all aspects of the trial right from the design to ethics or data sharing.
Why consider participating in a clinical trial?
Clinical trials are a method to introduce new therapies and drugs for human benefit. There are risks associated with participation. However, careful planning and evaluation by the organizing and review committees help minimizing these risks effectively. There are also expected benefits published for participation in the trials. Volunteers can raise questions on every aspect of the study design by preparing well before participating in the trial. The final outcomes of the trial can help patients get a better treatment and even lead to new trials that can bring further improvement of medical treatment and therapy.
There are multiple resources available to understand and find out more information about clinical trials being conducted globally. Healex is committed to providing solutions that streamline clinical trials and enable efficient data sharing and management across clinical trial conducting organizations. We want to create true benefits for the patient by generating and transmitting real-time data that helps improving and accelerating diagnostics and medical care. If you are interested in our solutions, feel free to contact us anytime.
About Dr. Jubin Shah:
About Healex:
Connecting and accelerating medical research and treatment – with this goal Healex develops solutions that support and fasten clinical work and networked research, especially in the current Corona crisis.
Healex enables the transfer of information from various clinical and research systems as well as secure and usable storage of health information. The data can be used for prevention, up-to-date anamnesis, care, and science.
This enables fast, cross-site clinical trials and real-time data exchange between clinical research and care.