Clinical trials are becoming increasingly important in society because they provide unbiased evidence about treatment effectiveness and assist in determining their cost-effectiveness. However, they face challenges, including the need for clearer communication of their benefits to the general public.
Despite these challenges, clinical trials are critical for evidence-based medicine and healthcare reform, and they must be conducted ethically. In public health emergencies, such as the COVID-19 pandemic, well-designed clinical trials are essential for discovering new diagnostic and management strategies, but they require a coordinated and collaborative approach.
In this post, we’ll be taking a look at clinical studies predicted to shake the public.
Alzheimer’s Disease
Alzheimer’s disease is a type of brain disease, just as coronary artery disease is a type of cardiovascular disease. It is also a degenerative disease, which means that it will worsen over time. Alzheimer’s disease is thought to begin 20 years or more before symptoms appear, with brain changes that are undetectable to the person affected.
Eventually, nerve cells in parts of the brain that allow a person to perform basic bodily functions like walking and swallowing are affected. Individuals become bedridden and need round-the-clock care. Alzheimer’s is ultimately fatal. Allan Levey, professor and chair of the Department of Neurology at Emory University School of Medicine, has been said to pick up Lecanemab, an Alzheimer’s drug that reduces the amount of beta-amyloid, a protein that clumps together in the spaces between neurons and forms distinct plaques in Alzheimer’s patients’ brains. His research found that lecanemab slightly reduced cognitive decline and has a moderate toxicity. On January 6, 2023, the FDA granted accelerated approval for the drug.
Two ongoing phase 2 clinical trials, namely VIVA-MIND and VIVIAD, are currently evaluating the safety, tolerability, and effectiveness of Varoglutamstat in participants with MCI and mild dementia due to Alzheimer’s Disease.
Stem Cell Therapy
Stem cell therapy, also known as regenerative medicine, uses stem cells or their derivatives to promote the repair of diseased, dysfunctional, or injured tissue. It is the next step in organ transplantation, using cells rather than donor organs, which are in short supply. Stem cells (SCs) have the ability to self-renew and differentiate in multiple directions.
Under certain conditions, they have the functional capacity of regenerating into various cells, tissues, organs, and human bodies. There are more than 5,000 registered clinical studies involving stem cell therapy for a variety of organs, including the liver, kidney, heart, and lung. The effectiveness and safety of these treatments have been the main focus of the great majority of stem cell clinical trials. The most successful stem cell therapy till date is the bone marrow transplant.
Mental Health Treatments
Mental, emotional, and psychological health have gained prominence as a major public health concern. Mental health encompasses not only the traditional emphasis on individual therapy interactions, but also emerging frameworks for addressing mental health at the population level.
Increased scale and speed in addressing mental illness are critical to meeting the Sustainable Development Goals (SDGs) of ensuring healthy lives and well-being for all people by 2030. Failure to do so could have devastating socioeconomic consequences. Funding mental health clinical studies yields substantial benefits for all parties involved.
Yale School of Medicine is currently carrying out a study on ‘Obsessions or ideations: First Person Suicide Images study in OCD’. The purpose of this research study is to examine the differences between suicidal obsessions and suicidal ideations in participants with OCD. The study focuses on individuals who have been diagnosed with or are suspected to have OCD and who have endorsed thoughts or obsessions of suicide.
Gene Editing
Luigi Naldini, professor of cell and tissue biology and gene and cell therapy at the San Raffaele University School of Medicine in Milan, chose gene-editing to treat transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD), both potentially life-threatening diseases caused by haemoglobin mutations. He specifically mentioned an ongoing multicenter, single-arm, open-label, single-dose phase 1/2/3 clinical trial in patients with severe SCD.
As welcome and significant as the medical breakthrough using gene editing appears to be, it raises concerns that too few people will be able to afford the therapy. There is also the issue of limited access and demands that come with the high-tech, intensive 3- to 6-month treatment, which will be offered, at least initially, by only a handful of health care providers. However, more research and studies are being done to fully harness the qualities of gene editing and making it easily accessible to all.
COVID-19 vaccination in HIV patients
COVID-19 had a negative impact on the entire global population. Despite the fact that there is a common goal that should be supported by unified resources and efforts, a disproportionately large number of clinical trials have been registered that are of poor methodological quality.
Glenda Grey, president and CEO of the South African Medical Research Council, described a clinical trial being conducted to “assess the efficacy of the mRNA-1273 (Moderna) vaccine against Covid-19 in adults infected with human immunodeficiency virus (HIV) or with other comorbidities that increase the risk of severe Covid-19. There is an urgent need to characterise infection and viral clearance in immunocompromised people, which will be investigated in further studies and research.
Antibiotic Resistance
Antimicrobial resistance (AMR), which is primarily caused by improper antibiotic use, has emerged as a global public health concern in both human and animal populations. Since its first report in the 1940s, it has been a growing source of concern. Many newer generation antimicrobials are no longer effective against previously susceptible organisms.
This is a massive challenge all over the world, exacerbated by the “discovery void” in the field of developing new antibiotics. If the necessary steps are not taken immediately, the looming fear of reaching a therapeutic dead end will become a reality. In a recent study, Japanese researchers have now compared bacteriophage-derived enzymes for combating drug-resistant bacteria.
Examination of T1-spanin revealed that it shows superior bactericidal activity against various strains, including E.coli. Phage-derived lytic enzymes is one such type of enzyme, which can break down and kill bacteria from the inside out. Harnessing the power of these enzymes through bacteriophage therapy, offer a promising approach for targeting drug-resistant pathogens with high precision and efficacy.
Cancer Immunotherapy
Immunotherapy is a type of cancer treatment that stimulates the immune system to fight cancer. The immune system defends your body against infections and other diseases. It is composed of white blood cells, as well as lymphatic organs and tissues. Immunotherapy, which aims to stimulate the immune system in order to eliminate malignant cells, is a significant advancement in cancer treatment.
Despite low response rates, immunotherapy has produced long-term clinical benefits for a variety of cancers. Several immunotherapies, including immune checkpoint inhibitors (ICIs), cancer vaccines, adoptive cell transfer (ACT), and oncolytic virus therapy (OVT), have produced encouraging results; however, all of these treatments in clinical practice have limitations.
Precision Medicine
Many health-care systems have disparities in who can access and use existing precision medicine technologies. These disparities may stem from a lack of access to health care due to cost, availability, geography, or awareness. They are also exacerbated by systemic racism, which excludes and denies access to racialized and indigenous peoples.
In addition to meeting increased demand by investing in new resources and infrastructure, there are opportunities to improve precision medicine capacity through efficiencies. Developing system capacity may include increasing the number of trained professionals, as well as streamlining workflows and investing in technology-enabled clinical care and new care models that provide genetically informed patient care.
Pain Management
Pain is a massive global problem. According to estimates, 20% of adults worldwide suffer from pain, and 10% of new chronic pain diagnoses are made each year. The prevalence, incidence, and widespread social and health consequences of global pain necessitate that closer attention is paid to pain management. The NIH HEAL Initiative has pledged support to new clinical research programs to evaluate innovative therapies for pain management. UCSF Medical Centre is proposing a trial on ‘Group-based Integrative Pain Management in Primary Care Safety Net Clinics’.
People from low-income backgrounds are more likely to experience chronic pain, which is made worse by factors like social exclusion, intersectional stigma, and differences in the availability of pain management services. Reducing the unequal burden of pain requires multidimensional, biopsychosocial therapies that are effective. In order to enhance pain treatment for low-income patients from a variety of racial and ethnic backgrounds, the suggested study will examine group-based integrative models of pain management in primary care safety net clinics.
AI in Healthcare
AI is a rapidly evolving tool that is transforming many aspects of healthcare. AI has been primarily used in medicine and healthcare administration. However, widespread use of AI in clinical research only recently began, with the arrival of COVID-19. However, the implementation of AI raises concerns that must be addressed in order to ensure equitable and ethical outcomes. To reduce the risk of exacerbating existing health disparities, AI-driven solutions must be transparent, fair, and inclusive of diverse populations.