Clinical research is a competitive but growing field and provides rewarding career opportunities if you have qualifications or experience in life sciences. 

There are a variety of ways to progress a career in the clinical research field with Contract Research Organizations (CROs) offering opportunities for healthcare professionals

Clinical Trial Management 

Usually in charge of managing, coordinating, and supervising various aspects of the trial. Supervising staff, implementing study tools and documents, overseeing trial budgets, and providing strategic input into trials are typical responsibilities. 

Clinical Team Management 

Responsible for acting as the associates’ direct line manager. Clinical team managers will manage and support team members, ensure effective staff training, assess the effectiveness of business processes, and plan professional development activities. 

Clinical Project Management 

They are involved in the planning and direction of clinical trials, as well as the evaluation of clinical data. Day-to-day responsibilities include keeping study records, ensuring activities are completed on time and within budget, interpreting study data, and developing trial plans. 

Here, we will look at what it takes to have a successful career in clinical research, as well as the most common career paths: 

Clinical studies are used in different circumstances depending on what is known and what isn’t. Scientists may even study the same research question using different kinds of studies and different demographics

Let’s share an overview of different studies:

Observational Studies: An observational study is a study in which the researcher simply observes the subjects without interfering. It helps the researchers understand a situation and come up with hypotheses that can be put to the test in clinical trials.

Case Study/Case Series: A detailed description of one or more patients. By documenting new and unusual cases, researchers start to generate hypotheses about causes or risk factors.

Epidemiological Study: In epidemiology, researchers are interested in measuring or assessing the relationship of exposure with a disease or an outcome. A detailed description of one or more patients. By documenting new and unusual cases, researchers start to generate hypotheses about causes or risk factors.

Cross-Sectional Study: Compares the rate of a disease or condition for groups of people, such as towns in different climates or with different average incomes.

Case-Control Study: A snapshot of many people at one moment in time. These studies can show how common a condition is and help identify factors associated with it.

Cohort Study: A large group of people is observed over time. Some eventually develop a disease or condition. Researchers can learn how often the condition occurs and find possible causes or risk factors.

Clinical Trials: In these studies, researchers test new ways to prevent, detect, or treat disease. Treatments might be new drugs or combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Clinical trials can also test other aspects of care, such as ways to improve the quality of life for people with chronic illnesses. A well-designed clinical trial is a gold standard for proving that a treatment or medical approach works, but clinical trials can’t always be used.

In the order of effectiveness clinical trial is found to be more reliable, why? Well, because clinical trials are known to be the gold standard for medical research and preferred for investigating the efficacy of new interventions. Many authors and editors believe that the design of the clinical trials always surpasses other research designs. The main advantage of clinical trials is that it provides better control over possible bias through randomization and blinding. In other words, the great strength of clinical trials is their high internal validity.

Clinical trial statistics: what are they? In case you are wondering, they give us the insights we need to come up with better solutions for the future! Now there must be a research body that would conduct all these clinical trials, right? This is where Xcene Research comes into play.

We take these data points, exhaust all forms of examinations and tests on these data points, and provide them to institutions, hospitals, labs, organizations, etc. Now, these institutions make use of this examined data to produce results for human consumption, like drugs, medical write-ups, etc.

So, thanks to technology, there has been a shift in the medical research world. Perception and insights are just like checks and balances. Due to the increasing use of technology, these two variables put all the data in check. Basically, they are the constant variables to be on the lookout for when studying the trends that are occurring in the medical world today. Allow me, ladies, and gentlemen, to break down these trends.

1. Patient recruitment and enrollment in clinical trials: Researchers now are being creative with the way they gather data. How do they do this?

Simple, by trading traditional processes for virtual or decentralized opportunities. The introduction of technology into the medical world has resulted in an overall positive clinical trial experience. As the saying goes, numbers don’t lie, right? Did you know that in 2019, 15% of respondents mentioned that smartphone apps for study data collection were used during their clinical research study? And in 2021, the numbers went up by a whopping 24%! Wow! 47% of respondents mentioned that wearable devices were used during their study, while 19% mentioned it in 2021, with 40% indicating that they were very helpful for the study. Technology like apps and wearables helps researchers by providing real-time data. However, the experience is different when it involves the physical presence of the researcher. This is the downside to one-on-one contact. Yeah, the researcher gets access to a small window provided by the patient, and to be honest, we live in a world where humans let you know what they only wanted you to know, right? And this isn’t sufficient when we are dealing with human lives. Don’t you agree? One honest response can save thousands of lives.

2. The second trend! Potential clinical trial participants are learning about study opportunities. In other words, everyone is a potential clinical respondent, and we are all learning. A horror movie in 2020. We can attest that it was the scariest year ever!!! The whole world stopped!!! Technology, being a superhero, came to our rescue. It was our only source of survival information. One very important benefit of digital patient recruitment is the ability to reach patients online whenever and wherever, especially on social media platforms like Facebook, Twitter, Instagram, Pinterest, and TikTok, as well as search platforms like Google and Microsoft. How cool is that?

Statistics from CISCRP’s 2021 survey (The Center for Information and Study on Clinical Research Participation) showed that social media is now one of the top avenues where clinical trial participants learn about research studies. According to statistics, social media, which was 15%, came second, just right under local advertisements like newspapers, radios, TVs, etc. Fun fact alert! 16% of participants learned about studies through their PCP […]

Orphan drugs are medicinal products intended for the diagnosis, prevention, or treatment of life-threatening or very serious diseases or disorders that are rare. A disease or disorder is defined as rare when it affects less than 1 in 2,000 citizens, some rare diseases include Moebius syndrome, Stoneman syndrome, alkaptonuria.

These drugs are called “orphans” because, under normal market conditions, the pharmaceutical industry has little interest in developing and marketing products intended for only a small number of patients. For drug companies, the extremely high cost of bringing a medicinal product to market would not be recovered by the expected sales of the product.

As a result, the potential market for new drug treatment is also small and the drug companies’ industry would incur a financial loss.

Therefore, governments and rare disease patient organizations advocate for economic incentives to encourage drug companies to develop and market medicines for rare disease treatment.

The lack of scientific knowledge and quality information on the disease often results in a delay in diagnosis. Also, the need for appropriate quality health care engenders inequalities and difficulties in access to treatment and care. This often results in heavy social and financial burdens on patients.

As mentioned, due to the broad diversity of disorders and relatively common symptoms which can hide underlying rare diseases, initial misdiagnosis is common. In addition, symptoms differ not only from disease to disease but also from patient-to-patient suffering from the same disease.

Due to the rarity and diversity of rare diseases, there is a need to ensure that experts, researchers, and clinicians are connected, that clinical trials are multinational, and that patients can benefit from the pooling of resources across borders. Initiatives such as the European Reference Networks (networks of centers of expertise and healthcare providers that facilitate cross-border research and healthcare), the International Rare Disease Research Consortium , and the EU Framework Programme for Research and Innovation Horizon 2020 support international, connected research.

Positive Action

There is an increased call for more stakeholders to become involved in raising awareness for these conditions and doing more in terms of research to develop medicines and treatments for people living with […]

A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. Clinical trials are done to determine whether new drugs or treatments are safe and effective. They are usually part of a long, careful process that may take many years to complete.  Clinical trials are conducted in four phases:

• Phase 1 – Tests carried out using an experimental drug or treatment on a small group, typically between 20 to 100 people, to evaluate the treatment for factors including identification of a safe dosage range, patient safety, and detection of side-effects.
• Phase 2 – Experimental drug or treatment is given to a larger group of 100 to 300 people to evaluate its safety and to determine the drug’s efficacy.
• Phase 3 – Testing of drug on a larger group of 300 to 3000 people to assess efficacy, effectiveness and safety.
• Phase 4 – Post-marketing studies commence after treatment approvals by the approved regulatory body for drugs, e.g., the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria and the Food and Drug Administration (FDA) in the US.

 Clinical Research

Clinical research is the study of health and illness in people. It is a more encompassing discipline investigating how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigations. Simply put, it involves human participants and helps translate basic research carried out in laboratories into new information and treatments to benefit patients. There are different types of clinical research including treatment research, epidemiological studies, diagnostic research, and others.

Critical Contribution to Healthcare

Clinical research, therefore, includes the processes of clinical trials, epidemiological research, and health services. It also covers education, outcome management, and mental health services for participating individuals. These elements are all vital for medical innovation.

Clinical trials will not be a success without volunteers and participants. However, volunteers and participants must be informed of the risks and benefits of a successful clinical trial.

Volunteers who participate in these studies may benefit from accessing highly-effective treatments that could be deployed for debilitating illnesses. A volunteer can also gain full access to new medical treatments before they are widely available.

Without a doubt, the year 2020 presented many challenges to the healthcare industry–the COVID-19 pandemic ranking as the global antagonist. Those challenges are yet to be completely eliminated even in 2021, but they have brought endless opportunities to improve clinical trial processes across the world.

At Xcene Research, we continue to work at supporting clinical sites and sponsors in creating more efficient, decentralized processes with the patient always top of mind. Bringing care directly to patients is what we do best and we are excited to be part of this new frontier.

One major innovation in the management of sickle cell disease came in the 1980s with the discovery that a drug called hydroxyurea could reduce pain for people living with it by 50%.  Other efforts have been focused mostly on prevention through health education to raise awareness for people already living with the disease and the public.

Hydroxyurea was first tested in a person with sickle cell disease in 1984 and was found to decrease the rate of acute chest syndrome (ACS) episodes and blood transfusions by about 50% in adults. Initially developed as an anticancer drug, it has since been used to treat myeloproliferative syndromes such as leukemia, melanoma, and ovarian cancer. Although it presents certain side effects such as neutropenia, bone marrow suppression, the elevation of hepatic enzymes, anorexia, nausea, vomiting, and infertility, the US Food and Drug Agency (FDA) in adults due to its efficacy at improving the quality of life when applied to SCD patients.

The Future: Gene Therapy

A new wave of innovation is bringing hope to people living with sickle cell disease. Novartis and the Bill and Melinda Gates Foundation are collaborating to develop a single-shot gene therapy that would cure sickle cell disease without the need to engineer cells outside the body. If gene-based cures do materialize, they could significantly change the lives of patients with the disease. We can be confident that in the coming years the therapeutic landscape for SCD will change due to a combination of advances in genetics and genomics.

Xcene Research is playing an active role in the very first steps toward fulfilling this vision by facilitating SCD-focused clinical trials in sub-Saharan Africa.

The world’s first clinical trial is recorded in the “Book of Daniel” in The Bible.1 This experiment resembling a clinical trial was not conducted by medical personnel, but by King Nebuchadnezzar a resourceful military leader.1 During his rule in Babylon, Nebuchadnezzar ordered his people to eat only meat and drink only wine, a diet he believed would keep them in sound physical condition.1 But several young men of royal blood, who preferred to eat vegetables, objected. The king allowed the rebels to follow a diet of legumes and water — but only for 10 days. When Nebuchadnezzar’s experiment ended, the vegetarians appeared better nourished than the meat-eaters, so the king permitted the legume lovers to continue their diet.1 This probably was one of the first times in the evolution of the human species that an open uncontrolled human experiment guided a decision about public health.

Avicenna (1025 AD) in his encyclopedic Canon of Medicine describes some interesting rules for the testing of drugs. 2 He suggests that in a clinical trial a remedy should be used in its natural state in disease without complications. He recommends that two cases of contrary types are studied and that study be made of the time of action and of the reproducibility of the effects.2 These rules suggest a contemporary approach for clinical trials. However, there seems to be no record of the application of these principles in practice.

The first clinical trial of a novel therapy was conducted accidentally by the famous surgeon Ambroise Pare in 1537.1,3 In 1537 while serving with the Mareschal de Motegni he was responsible for the treatment of the battlefield wounded soldiers. As the number of wounded was high and the supply of conventional treatment – oil was not adequate to treat all the wounded, he had to resort to unconventional treatment. Here is an excerpt in his own words:

My oil lacked and I was constrained to apply in its place a digestive made of yolks of eggs, oil of roses and turpentine. That night I could not sleep at any ease, fearing that by lack of cauterization I would find the wounded upon which I had not used the said oil dead from the poison. I raised myself early to visit them when beyond my hope I found those to whom I had applied the digestive medicament feeling but little pain, their wounds neither swollen nor inflamed, and having slept through the night. The others to whom I had applied the boiling oil were feverish with much pain and swelling about their wounds. Then I determined never again to burn thus so cruelly the poor wounded by arquebuses’.2

However, it would take another 200 years before a planned controlled trial would be organized. James Lind is considered the first physician to have conducted a controlled clinical […]

Read more: https://www.worldpharmanews.com/research/5353-researchers-design-and-test-protein-that-may-lead-to-covid-19-therapeutic