Top 9 Key Aspects of the Clinical Research Process

Dustin Reynolds

clinical research

Medical breakthroughs hold great promise to improve human health. But developing and testing new medications requires extensive research.

Successful drug development programs involve four phases that test the safety and effectiveness of medication. One key aspect of this process is selecting patients to participate in trials.

1. Precision Medicine

Precision medicine seeks to personalize diagnosis and treatment more precisely and predictably; moving away from traditional, one-size-fits-all approaches that rely on nonspecific physical symptoms as indicators.

Precision medicine uses data about an individual’s genes, environment, and lifestyle to determine which disease prevention or treatment strategies will best benefit them. At present, much precision medicine research focuses on genetics; however, its scope could expand into areas like metabolomics (the chemical composition of one’s body), microbes, environmental exposure, or personal devices. The National Institutes of Health has initiated the All of Us Research Program that involves gathering this type of data with one million volunteer cohort study members enrolled; eventually, precision medicine will allow doctors to predict what will happen even before entering an office!

2. Big Data

Big data in healthcare offers immense potential for breakthroughs in drug discovery, personalized medicine, and optimal patient care. But its sheer volume necessitates sophisticated tools and technologies to manage it effectively.

Big data analytics in healthcare offers many advantages, including reduced healthcare costs and faster diagnosis/prevention/cure rates for diseases; providing physicians with vital insights; as well as providing patients with more informed treatment decisions and improved outcomes. 

Medical facilities could see positive results as well, such as decreased unnecessary hospitalizations/stays. To see these changes take effect, however, financial incentives must exist for organizations to adopt and implement data-driven processes successfully.

3. Patient-Centred Research

PCORI merit review meetings provide a space where scientists and patients come together as part of the decision-making process for funding studies. This ensures that PCORI’s five criteria – impact on health care outcomes, potential for accelerating implementation, technical merit, and patient-centeredness — are taken into consideration during funding decisions.

Utilizing patient perspectives in research studies can enhance the choice of outcomes or comparators and increase the likelihood of meaningful final results for patients, but its effect on more distant issues like health system design or policy research findings remains less clear.

4. Global Collaboration

Many health-related issues are global in scope and require global collaboration for solutions to be found. Collaboration across borders is especially essential when treating infectious diseases that have no territorial boundaries to respect.

International trial collaboration is made easier thanks to email, social media, and web-based systems for clinical data capture. Enrolling patients from multiple regions accelerate trial processes, reduces costs, and can provide more comprehensive judgments that generalize trial results more accurately. Recruiting from diverse geographic regions also enables the inclusion of rare tumor types that might not have enough cases diagnosed in one area for adequate trial recruitment purposes.

Cooperative trial groups play a critical role in leading international investigator-initiated, noncommercial collaborative trials and support CRNs by providing the infrastructure and resources necessary for these trials to take place. Unfortunately, however, our survey shows that despite having high commitment levels towards international collaboration many CRNs lack dedicated staff or management structures that facilitate effective international cooperation.

5. Regulatory Complexity

Clinical trials involve testing new medical approaches with human participants, such as drugs, cells or biological products; surgical procedures; radiological procedures; devices; behavioral treatments, dietary supplements or preventive healthcare methods – with ethical committee approval as a condition. They must ensure participant rights and safety.

These requirements are dictated by international regulations such as the Good Clinical Practice guidelines of the International Conference on Harmonisation and federal patient privacy laws as well as local ethical review processes. Unfortunately, these regulations can be difficult to interpret and implement correctly (especially if supervisors can exercise discretion), leading to potentially inconsistent effects for different forms of risk.

Complex regulations create unnecessary confusion for those tasked with complying. However, computer programming lessons may offer solutions for reducing unnecessary regulatory complexity and increasing efficiency for healthcare organizations.

6. Recruitment Hurdles

Research can have profound national and even global ramifications, making it crucial that only appropriate people participate in medical research studies. Quality data depends heavily on participants sourced and vetted according to strict protocols; properly chosen research subjects provide the highest qualitative and quantitative insights.

Workshop participants noted that academic investigators often lack support for their trials, leaving them to design them on their own and find necessary resources on their own. Furthermore, academic investigators are underpaid which disincentivizes physicians from referring patients for clinical trials.

Complex hiring and onboarding processes may deter qualified candidates from accepting job offers, negatively affecting healthcare recruitment and leading to high turnover rates. Implementing a comprehensive recruiting software solution may streamline and standardize hiring practices across departments for improved candidate experience and increased recruitment efficiency.

7. Data Security Concerns

Even as digital healthcare services advance, hackers continue to focus on healthcare organizations as the target of cyber attacks for various reasons, including the high commercial value of medical data and hacktivism.

Therefore, healthcare breaches cost more than those occurring elsewhere and have affected hundreds of thousands of patients.

Breaches of security can be divided into various categories, such as hacking incidents and unauthorized internal disclosures. Hacking incidents mainly involve theft of patient personal data and its exposure, while mismanagement of confidential information in organizations leads to leakage of sensitive material. To combat these problems, researchers have devised telemonitoring technologies that enable patients to monitor their health from home or other locations via remote devices connected directly to medical records or central databases.

8. Financial Constraints

Producing and testing new drugs can be an expensive endeavor; on average, trials typically cost $1 million per patient enrolled and this figure could rise should the drug fail in its clinical testing stage.

Conducting clinical trials can be financially prohibitive for physicians. Physicians must strike a balance between patient care and research activities, investing time and money to obtain the training required to participate in clinical research studies.

At an ASCO roundtable held recently, experts discussed the significance of eliminating financial barriers to clinical trial participation. Researchers must better characterize patient-related financial burdens associated with clinical trials and devise tools to alleviate them.

Additionally, researchers must find ways to streamline the budgeting process for clinical trials. Although hospitals usually provide budget tools to assist them with this task, often these resources are insufficient. Finally, more incentives need to be offered for patients enrolling in trials; though this remains controversial from an ethical standpoint; appropriate financial compensation may help boost participation rates and make trials more accessible across diverse populations.

9. Publication Bias

Failing to publish results of studies that don’t demonstrate the efficacy or safety of medications or therapies is known as publication bias and presents clinicians with incomplete knowledge of the benefits and harms of treatments. This can leave them unprepared to make informed decisions when treating their patients.

There can be various reasons for why some research does not get published, including competing commitments, low or no interest from editors and reviewers, perceived or real conflicts of interest, and the desire to present a favorable image of a drug or therapy. Studies that report more positive findings tend to be cited more frequently in academic journals.

Researchers can strive to limit publication bias by gathering data from sources other than Medline indexing. This includes trial registries and regulatory documents as well as by reaching out directly to research teams involved with conducting trials. Furthermore, funding agencies can incentivize authors who report both negative and positive findings by rewarding those authors who do so.

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