Case studies:Clinical research associate: Donna Thompson

Donna graduated with a degree in biomedical science from Kingston University in 2006. She now works as a senior clinical research associate for ICON Clinical Research and has recently taken on the functional role of a lead clinical research associate…

When I graduated from university I wanted to get a lab-based job, ideally in medical microbiology. Competition was fierce, though, and so I took a lab job at the Veterinary Laboratory Agency (VLA). I left there after eight months, as I really wanted to be in the medical field.

My friend was working as a clinical research associate (CRA) for a contract research organisation (CRO) and thought it might be a role I would find interesting. So, after learning more about the CRO world and clinical trials in general, I went for an interview and was offered a job as a CR assistant (similar to an entry-level CRA).

I worked as a CR assistant for six months before being promoted to CRA I. I left the company eight months later to work for ICON Clinical Research as a CRA II. In September 2009 I was promoted to Senior CRA and in April 2010 I took on the functional role of a Lead CRA, managing six countries in a phase II trial.

A prerequisite for working as a CRA is a degree in a life science, and biomedical science in particular gave me a good foundation when it comes to understanding medical terminology, as well as disease, treatment and tests.

My day varies greatly. It could be a 12-hour day consisting of travelling to a site either by car, train or plane, depending on the hospital location; monitoring data and patient’s notes for the study; performing drug accountability; and meeting with the site staff to discuss any issues before travelling back home or checking in to a hotel.

Alternatively, my day can be spent in the office on the phone with CRAs across Europe, discussing study timelines and making sure we are on track to meet sponsor deadlines. The number of tasks to do over the course of a trial is endless. Every day is different from the last and this is one of the reasons that this job appeals to me.

The best thing about working in this role is the sense of working towards an end goal that will really make a difference; when deadlines are fast approaching and stress levels are high, it can be easy to forget the bigger picture; without the role of the CRA, new drugs would not be developed.

When working on a trial and hearing from the research nurse that their patients have really seen an improvement in their quality of life since being on the study, or from reading the patient satisfaction questionnaires, there is a sense of achievement that what we do as an individual, a company and an industry will inevitably make a difference.

If you would like to get into this career, research CROs and pharmaceutical companies, there are so many out there. Being a graduate looking for your first job can be difficult, every job requires experience it seems. But the qualities companies look for in a CRA are mainly good organisational skills and attention to detail, so being able to demonstrate these in any area would be a good start.

Read More»

Evaluation of knowledge regarding good clinical practice among faculties at a tertiary care teaching hospital

Ashna S. Pandya, Pavan J. Panchal, Bhaven C. Kataria, Mitul R. Parmar

Background: This study was aimed to assess the knowledge regarding basic aspects of conduct of clinical trial and associated regulatory as well as ethical issues before and after and educational intervention in form of a workshop on Good Clinical Practice (GCP).

Methods: One day workshop on “Good Clinical Practice” was planned which included important ethical and regulatory issues regarding clinical research. Various resource persons from industry and academia were chosen to address the workshop. Total 60 participants were enrolled for this one day workshop. Pre-workshop questionnaire of 15 questions were distributed before the actual topic started. Each participant had to fill the questionnaire form and return it within 15 minutes. Again at the end of workshop, post-workshop questionnaire containing the same questions were distributed and the participants were asked to fill the form. Sequence of questions was changed in post workshop questionnaire. Comparison between answers in pre and post workshop questionnaire was done. The primary outcome was knowledge, which was evaluated using the Wilcoxon signed rank test.

Results: In Pre workshop, out of 60, total 28 (46.66%) participants had answered all 15 questions, while 30 (50%) participants had skipped to answer one question “Define GCP.” 2 out of 6 (3.33%) participants had not answered 4 and 5 questions out of 15, respectively. Total 45 out of 60 (75%) participants in post workshop answered all questions. All 15 (100%) questions were answered correctly in post workshop as compared to 11 (73.3%) questions in pre workshop. So, in post-workshop, there were significant (P <0.005) gains in knowledge regarding all good clinical practice questions.

Conclusions: Good clinical practice knowledge improved markedly with a targeted education intervention in form of workshop. However, changes in behaviour and attitude were not studied by this questionnaire based study.

Read More»

Study: Clinical trial transparency improving

Transparency amongst industry-sponsored clinical trials continues to improve with results of 90% of trials on all new medicines approved by the EMA in 2012 disclosed within a 12-month timeframe, according to an Association of the British Pharmaceutical Industry (ABPI) study.The study, conducted by Livewire Editorial Communications on behalf of the ABPI, is a follow up to a 2013 study of disclosure rates. Together the results highlight that since 2009, the disclosure rate of industry-sponsored clinical trials at 12 months has steadily improved year-on-year from 71% in 2009, to 81% in 2010, 86% in 2011 and 90% in 2012, indicating that the pharmaceutical industry is achieving disclosure in a timely manner more consistently than ever before.Dr. Virginia Acha, ABPI’s executive director research, medical and innovation, said, “This study highlights an encouraging trend toward greater clinical trial transparency by industry and tangible evidence of the increased openness in relationships with all stakeholders, including patients and healthcare professionals. We do acknowledge, however, that there is more work to do and, alongside our European and international counterparts, we will continue to work with companies toward greater transparency across the industry globally.”

Key findings of the study show that of the 340 industry-sponsored trials (completed before the end of January 2014) associated with all 23 new medicines approved by the EMA in 2012:

• 307 or 90% had results disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion
• 312 or 92% had results disclosed by the end of the study at 31 July 2014.

The study also showed that disclosure rates for larger phase III trials were higher with 96% disclosure at 12 months and 97% at the end of the study.

“While we are not seeing disclosure rates at 100% yet, we are seeing a sustained trend toward improved disclosure of industry-sponsored trials associated with new medicines,” said Bryan Deane, co-author of the study.“Generally speaking, it is the older, smaller, earlier phase trials whose results remain undisclosed,” said Deane. “This is not surprising given that for this group of new medicines, many of the early phase trials were conducted around 10 years ago, before results could be posted on registries and at a time when few small phase I and II trials would have been published alone. Now that the registration and reporting of clinical trials has become routine, it is fair to expect that transparency associated with industry-sponsored trials will continue to improve.”

Read More»

Misinterpreting the concept of “FDA drug approval”: A study

According to a new study, many people believe that the safety and efficacy of those drugs approved by the FDA is higher, which is why they get an okay.

To cite a popular example, in 2004, Vioxx –a painkiller approved by the FDA – was withdrawn from the market consequent to an increased heart attack and stroke risk associated with the drug use, as determined by long-term evidence.

As per the results of a new web-based survey of 3,000 people in the US, nearly 25% believed that only those drugs without any serious side effects receive FDA approval, while 39% of the population was under the impression that only “extremely effective” drugs are approved.

One of the study authors from White River Junction VA Medical Center in Vermont, Dr. Steven Woloshin, said that in reality, approval “just means that the benefits are judged to be greater than the harms. It doesn’t mean that they’re big and important.”

Subsequently, it is just up to the doctors and patients to decide upon certain drugs for any indications.
During the survey, the researchers presented the participants with 2 scenarios to understand whether educating patients about drug options would transform their concept regarding which drugs are the safest and most effective.
In one of the scenarios presented, patients were asked to pick between a hypothetical cholesterol drug that was shown to lower cholesterol and another that actually reduced the risk of a heart attack. The authors said that keeping all other factors constant, choosing the drug with a clear effect on a “bad outcome” (heart attacks) should have been the approach. However, that choice was exercised by only 59 percent of the participants.

In the second scenario, participants had an option to pick one amongst a newer or older heartburn drug, both of which had the same side effects and were equally effective. However, only 34% made a choice to pick the older heartburn drug.
The participants were then informed by the authors that newer need not necessarily mean better because researchers may not have had adequate time to review and evaluate safety concerns.

Woloshin said, “New often just means we know less about it… because it takes time for a drug to establish its track record.”

As per the report in the Archives of Internal Medicine, researchers stated that on hearing this, participants had a change of mind and performed better. The cholesterol drug with clear clinical benefit was chosen by 71% of the participants and the older version of the heartburn drug was picked by 53% participants.

Woloshin said, “We were happy that these very simple statements had an effect.”

According to researchers, although a simple explanation brought about a tremendous improvement, this would not be convincing enough for all patients to take an informed decision.

Woloshin made a few suggestions to educate people. To begin with, a one-page fact sheet created by the FDA could clearly detail the risks and benefits associated with each drug, including a prompt “new is not necessarily better.” He added that those abbreviated reminders could be reiterated on all drug advertisements on drug labels for the public.

In an email, an FDA spokesperson said that the study was not reviewed by the agency and therefore refrained on a comment, but also said that the FDA has publicly available information on “new and emerging drug safety issues.”

A commentary accompanying the study was documented by San Francisco VA Medical Center’s Dr. Michael Steinman who went on to say that patients should not shy away from consulting their physicians about treatment options and must not feel frightened about voicing their concerns.

He said, “Doctors are well trained in knowing about the risks and benefits of different treatments, but patients know themselves better than anyone else.”

“It’s important for patients to be their own advocates, to keep track of what’s going on… to ensure that they are getting the highest quality care that suits their needs,” he said.

Read More»