Misconceptions People Have About Working in Clinical Trials
The Power of Clinical Trials: A Gateway to Medical Breakthroughs
In the ever-evolving landscape of healthcare, clinical trials stand as a cornerstone of progress. These meticulously designed studies evaluate the safety and effectiveness of new medical interventions, paving the way for groundbreaking treatments that were once unimaginable.
But what exactly are clinical trials, and why are they crucial for medical advancement? This blog post delves into the world of clinical trials, dispelling common myths and highlighting the significant role they play in shaping the future of medicine.
The Importance of Clinical Research Associates (CRAs):
Often referred to as the guardians of the research process, Clinical Research Associates (CRAs) meticulously monitor every step of a clinical trial. Their role encompasses ensuring participant safety, data accuracy, and adherence to strict protocols. Aspiring CRAs can learn more through this CRA course.
Benefits of Participating in a Clinical Trial:
Access to Cutting-Edge Treatments: Clinical trials offer the opportunity to receive potentially life-saving interventions before they become widely available. Interested in coordinating such trials? Consider the Clinical Research Coordinator course.
Superior Care and Monitoring: Participants benefit from close supervision by medical professionals throughout the trial duration. Those looking to support these functions can check out the Clinical Trials Assistant Training.
Contributing to Medical Knowledge: The data collected from clinical trials is instrumental in advancing medical understanding and improving patient care for generations to come.
Debunking Common Misconceptions:
Myth: Placebo is Used Extensively in Trials. While placebos may be used in some trials, participants are always fully informed about the possibility of receiving a placebo beforehand.
Myth: Clinical Trials are a Last Resort. Contrary to this belief, participation in a clinical trial can be a proactive approach to managing a health condition and gaining access to potentially superior treatments.
Myth: Time Commitment is Excessive. The time commitment for trials varies, and efforts are made to minimize inconvenience for participants, including transportation assistance and comprehensive support.
Myth: Researchers Withhold Information. Transparency is paramount in clinical research. All trial results, positive or negative, are published for the betterment of medical knowledge. In the United States, public access to trial information is ensured through ClinicalTrials.gov.
Safeguarding Participant Well-being:
Rigorous regulations and meticulous oversight guarantee the safety and well-being of participants in clinical trials. Stringent protocols and multi-layered checks and verifications are implemented to minimize risks and ensure ethical conduct throughout the research process. Explore more about these regulations with the ICH-GCP course.
Advanced Roles in Clinical Trials:
For those interested in advanced roles such as managing complex clinical research projects, consider the Advanced Clinical Research Project Manager Certification.
Physicians aiming to lead clinical trials can benefit from the Advanced Principal Investigator Physician Certification.
Additionally, the Medical Monitor Certification offers insights into overseeing the safety aspects of clinical research.
The Future of Medical Progress:
Clinical trials are the driving force behind medical innovation. By fostering collaboration between researchers, healthcare professionals, and patients, these studies pave the way for a healthier future for all.
Are you interested in learning more about clinical trials or finding one that might be a good fit for you? Numerous resources are available online, including ClinicalTrials.gov. Embrace the opportunity to be a part of medical progress. Consider participating in a clinical trial and contribute to shaping a healthier tomorrow!
References:
Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR. Clinical trials and medical care: defining the therapeutic misconception. PLoS Med. 2007 Nov 27;4(11):e324. doi: 10.1371/journal.pmed.0040324. PMID: 18044980; PMCID: PMC2082641.
Lawrence DJ. The therapeutic misconception: not just for patients. J Can Chiropr Assoc. 2008 Aug;52(3):139-42. PMID: 18769564; PMCID: PMC2528258.
Lidz CW, Albert K, Appelbaum P, Dunn LB, Overton E, Pivovarova E. Why is therapeutic misconception so prevalent? Camb Q Healthc Ethics. 2015 Apr;24(2):231-41. doi: 10.1017/S096318011400053X. PMID: 25719358; PMCID: PMC9067606.
Clinical Research Associate vs Coordinator (CRA vs CRC)
What is a CRA/CRC?
Use this guide to get a detailed side-by-side comparison of two similar acronyms with 2 very different roles.
The clinical research coordinator or CRC helps conduct the trial as one specific site and will archive all the documents at the site when the verification by CRA is complete.
The clinical research associate or CRA will review and verify documents from multiple sites conducting the same trial and do multiple visits to ensure quality and ethical conduct of the clinical trial.
CRA vs CRC (Clinical Research Coordinator vs Associate)
Clinical Research Associate vs Coordinator
Difference between clinical research associate and coordinator:
A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a research professional with a minimum of a bachelors degree (usually nurses!) who works under contracts or hired by sponsors, CROs, or freelancing (by biopharma and research institutes) to perform roles listed in ICH GCP guidelines for monitoring clinical trials.
Who makes up the research team?
A CRA ensures compliance with ICH GCP and the clinical trial protocol by checking clinical site activities, making on-site visits (selection, initiation, routine, close-out), verifying “trial” case report forms (CRFs) are accurate by comparing to medical records, and speaking with the site’s CRC.
CRAs protect the ethical safety of human subjects and ensure the scientific integrity of the data collected through these processes.
Difference between clinical research coordinator and clinical research associate:
When a PI (principal investigator, i.e. often a busy, working physician running a trial on the side) is chosen to conduct a trial at their site, clinical research coordinators often take over part of the essential responsibilities of PI. This includes making sure the trial is 1) conducted and 2) in compliance with the protocol and federal or international regulations.
Site (CRC) vs. Sponsor (CRA)
CRC vs CRA: CRC responsibilities include writing the IRB/Ethics Committee application (specific to each site unless trial is under a single IRB/sIRB), making/performing informed consent (IC) process, developing a budget for the site, subject recruitment, patient care, adverse event reporting (a CRA simply audits and ensures that no AEs were missed!), preparing the case report form (CRF) for the CRA to review against medical records, and submitting tons of data and records to the CRA/Sponsor at each site visit.
Roles of a CRA
CRA interactions with other fields
Roles of a CRC
CRC interactions with other fields
Clinical Research Associate vs Coordinator Salary
Because CRAs manage multiple trial sites at one time, have a bachelors degree (minimum), and produce outcomes that are cost-effective for improving the efficiency of a trial; clinical research associates usually get paid more than coordinators. Unfortunately, clinical research coordinators are really doing the brunt of the “front-line” work and are the reason the trial occurs at that site all together. CRCs take a huge responsibility in both starting the trial and then presenting the trial documents to the CRAs as well as being the “middle-man” of the entire Site vs. Sponsor/CRO communication line. While CRCs deserve to get paid more, of course, it is not cost-effective as there are usually multiple sites and thus budgets are not capable of expanding upon the CRC’s pay-range. Luckily, CRC’s with experience can bridge to becoming a CRA through certifications and exams.
List of Relevant Courses:
Clinical Research Coordinator Certification: Enroll Here
Pharmacovigilance Certification: Enroll Here
Clinical Research Associate (CRA) Certification: Enroll Here
ICH-GCP Certification: Enroll Here
Clinical Trials Assistant Training: Enroll Here
Advanced Clinical Research Project Manager Certification: Enroll Here
Advanced Principal Investigator Physician Certification: Enroll Here
Medical Monitor Certification: Enroll Here
CRC to CRA bridge program
You can bridge into being a CRA in your own company or apply for jobs to be a CRA by completing CRA certification and trying to get experience with any on-site “in house” CRAs your site may have. CCRPS provides advanced “senior”-level CRA certification for CRCs so that:
1) on resumes you can prove knowledge competency of CRA tasks up to an advanced level (easier for in-job promotion)
2) during interviews you can prove your application of knowledge
3) during the job itself you can be efficient and diligent in preventing errors.