Empowering Patients: A Clear and Comprehensive Guide to Understanding Clinical Trials

Clinical research is the main area of focus and development of new medical technologies that can improve patient treatment options and save lives. During clinical research, pharmaceutical and medical device companies center their studies on determining various medical treatments' safety, efficacy, and overall impact. Since clinical research began in 1948 , when the infamous trial for pulmonary tuberculosis medication, known as Streptomycin , occurred, clinical trials have become the foundation of medical research and is the primary method for determining whether a new intervention is safe for patients [1]. This post explores the relevance of clinical trials in advancing innovation in healthcare, the advantages of clinical trials, the potential risks that can be expected while participating in a trial, and how clinical trials are typically conducted. 

In order to ensure that a new treatment is safe and scientifically sound, researchers complete a series of extensive trials before any medication is released for the marketplace. These trials typically are conducted in several phases (phases 0-3), with each phase designed to answer specific research questions that are based on the primary learnings from the previous phase.

 

In addition to advancing treatment options for patients, clinical trials are also essential to any research process: playing a vital role in shaping how we diagnose, treat, and prevent diseases. An elaborate and complex clinical research trial can lead to additional support or rebuttal of previously conducted studies. [2] [3]

 

If you are interested in participating in a clinical trial or want to learn more about the general overview of clinical research and clinical trials in medicine click here [4]. 

Clinical trials are an essential component of any research process as they test the safety, efficacy, and potential side effects of new medical treatments. They play a principal role in shaping how we diagnose, treat, and prevent these diseases. They support scientific data collection by researching the benefits and risks of new procedures. 

There are several advantages of conducting clinical trials:

Clinical trials provide an opportunity to test new treatments and therapies, which can lead to improved healthcare outcomes for patients. They are necessary for new medications, medical devices, and medicines to procure regulatory approval from a group of experts, particularly the IRB (Institutional Review Board). The IRB decides whether a treatment is safe and efficient enough to be licensed for the use of the public. In addition to that, trials can help identify new drugs or procedures that can cure or ease illnesses and improve the overall quality of life for patients. Participants may get early access to productive treatments or medicine.

2.   Safety of the participants

Clinical trials evaluate and render justification of the safety and effectiveness of novel treatments. They give researchers time to determine the potential adverse effects of these treatments and evaluate their success. Before a trial can begin, it must undergo a rigorous approval process that considers both the perils and benefits of the proposed intervention.

3.   Scientific knowledge

Clinical trials help advance scientific knowledge by providing data on the effectiveness of new treatments and procedures. They help expand our understanding of the field of medicine. The information gathered from medical research can improve or develop new therapies and can also do the following: [5]

4.   Patient empowerment

Clinical trials offer patients an opportunity to take an active role in their healthcare. Participants have access to advanced treatments, expert medical care, and a team of healthcare professionals dedicated to their well-being. 

5.   Economic benefits

Clinical trials can have a positive economic impact on the healthcare industry by creating new jobs and generating revenue for companies involved in developing new treatments and therapies. Successful clinical trials can lead to increased funding for research and development. 

Clinical trials are carefully designed and monitored by a team of experts and healthcare professionals to minimize the risk of potential risk of adverse effects. However, there are still potential risks that may come along, including:

     1. Bias

Clinical trials can be influenced by bias, which can affect the study’s results. Bias can arise from various factors such as the trial’s design, selection of participants, and involvement of researchers. There may be side effects compared to the conventional treatment, and results may vary from one individual to another.

     2. Limited sample size

Typically, clinical trials will be conducted on a few participants, which may not accurately reflect the wider population. Doing this can limit the generalizability of the trial’s results.

     3. Cost

Clinical trials are expensive to conduct, which can limit the number of studies and delay the development of new treatments. This may also directly impact the participants considering that they will travel for trial visits. Patients may find the cures and frequent trips to be demanding, as well. [6]

     4. Ethical Concerns and Risks to Participants

Clinical trials must adhere to ethical standards, such as obtaining informed consent from participants and ensuring their safety. However, some studies may raise ethical concerns, such as the use of placebo treatments or including vulnerable populations. In addition, specific clinical trials can carry potential risks and side effects.

When it comes to a typical clinical trial, a group of researchers and medical professionals collaborate to guide participants throughout the entire procedure to ensure that the clinical trial is performed safely, ethically, and that the objectives of the clinical trial are met. Here are the most common ways that a clinical trial is carried out:

The trial team designs a study in order to align with the needs of the participants and the target market. Trial designs encompass research questions, determining the study design, selecting an adequate study population, and ascertaining the objectives, limitations, and outcome measures. 

The trial team aims to reach an adequate participant population within the range of the research trial limitation. Participant recruitment is often performed through social media platforms, emails, and advertisements. As soon as a certain number of qualified participants is reached, participants are oriented about what to expect, and the proper disclosure of advantages and potential harm is done. Before conducting a clinical trial, regulatory and ethical approvals must be secured first. This includes support from the relevant regulatory authority, ethics committee, or Institutional Review Board (IRB). 

Participants may ask questions about the trial and be allowed to decide whether they want to join. Upon decision, informed consent forms are to be handed out to the participants. Signing the form allows the team of experts to include them in the clinical trial. Consent forms and the participants’ personal information are to be treated confidentially. [7]

This involves administering the intervention or treatment, gathering data, and monitoring the participants for adverse effects. Participants are to be assigned to a control or treatment group, and procedures are to be followed. A good deal of research site visits may vary. During these visits, the participants may ask questions to the trial team or report any issues and consternations to the researchers. [8]

After completion of the clinical trial, the trial team will proceed with data management and analysis. The data are to be analyzed, and the results are to be gathered and presented afterward.

By participating in a clinical trial, you are gaining access to innovative treatments and therapies, contributing to medical research advancement, and potentially helping future generations.  At ClinConnect, our mission is to empower and support you through your clinical trial journey by providing the tools and resources you need to connect with new medical treatments. Our digital platform is designed with patients at the heart of its development, connecting you with other patients to build a community, bespoke notifications to alert you of new trial developments, and a helping hand to guide you through trial enrollment and participation. 

Additionally, our post-trial engagement feature will enable users to stay connected with researchers and other participants after the trial ends. You can share your experiences, ask questions, and provide feedback to improve future trials. This engagement can help build an additional sense of community and support, which can be advantageous as far as your overall well-being.

 

If you are interested in learning more or would like to connect with a member of our team please visit us at  ClinConnect. We will strive to expand your options to every FDA-approved clinical trial, with over 500,000 clinical trials available, and provide a supportive and inclusive community for all our users.

We understand that undergoing clinical treatment can be a daunting endeavor, and we believe that connecting with others through similar experiences can be invaluable. Join the thousands of users who have already found success through ClinConnect. Start your journey to improved health and a better future today!