Clinical trials are well-structured systems dating back hundreds of years that are still considered the foundation of regulatory requirements for drug approval. They involve trailing new medications and examining their effects, which helps improve healthcare and medicines for more effective results.
Numerous advancements have occurred in this field, with the most significant changes happening over recent years.
The Criticism of Clinical Trials
Clinical trials have been criticized for the lack of inclusion of women and other minorities, often underrepresenting and overlooking them. One of the main contributors to the lack of representation is the complicated exclusion and inclusion criteria involved in conducting a specified clinical trial.
Recently, more efforts have been pushing for more representation and inclusion of these groups in trials.
The United States National Institute of Health (NIH) revised its guidelines in 2017. The changes state that all clinical research projects funded by the organization must be done in a way that includes information from various genders, sexes, and racial groups.
While it does not specify the quantity or ratio of the representation, it is a huge step in ensuring more research organizations have diverse samples.
Transparency is crucial in clinical trials because it helps promote integrity within the process. Transparency also helps develop trust in society, increasing patient participation in trials. Numerous efforts have been implemented to encourage transparency in all operations, including the 2004 WHO initiative requiring global clinical trial registration.
The last decade has seen an exponential increase in registered clinical trials available to the public. Registering the trials in international and national databases ensures nobody duplicates the research and others build it for continuity.
There has also been a significant development in the quality of the trials through mandatory training of all project personnel. In 2017, the NIH required all staff to have proper clinical practice training for NIH-sponsored projects.
Researchers and organizations are also implementing GCP, an international scientific and ethical standard for all trials regarding conducting, auditing, monitoring, and reporting. It is essential to ensure integrity, safety, and research quality.
Covid-19 has been a massive contributor to clinical trial advancements. The pandemic saw people register clinical trials at a speed never seen before, promoting researchers to adapt the trial processes for convenience and efficiency. Researchers used online follow-up meetings, online participant recruitment, and remote participant monitoring during this time. These have been monumental in the development of clinical trials.
Data sharing had risen before the pandemic after the International Committee of Medical Journal Editors passed a policy requiring researchers to submit clinical trial manuscripts with data-sharing statements in 2018.
The data-sharing statements indicated whether the researchers will share the data, what they will share, and how they will share it.
However, the pandemic highlighted issues with collaboration and coordination in clinical trials. It also emphasized the importance of sharing data to ensure nobody replicates existing research.
Why Choose Altus?
Clinical trials are among the most essential research projects. Ensuring they attain the highest standards is vital.
Altus Research is a privately owned clinical research firm based in Lake Worth, FL. It has a diverse team of researchers experienced in Phases I, II, III, and IV of clinical trials. They specialize in numerous trials covering women’s studies, dermatology, urology, aesthetic medicine, vaccines, pediatrics, internal medicine, and rheumatology.
Fill out the Altus Research online contact form to speak to a specialist or book a consultation appointment.