Thirty years ago, patient recruitment was a challenge for pharma companies. Today the patient participation rate in trials still hovers around five percent and is not expected to improve anytime soon. Patient recruitment remains a challenge that pharma must work to overcome.
In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”
Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.
Developing new, innovative pharmaceutical agents to address global health needs is becoming more complex, challenging, and costly. As the industry attempts to adapt and gain value for patients, healthcare providers, and other stakeholders, technologies, digitization, real-world data, immediate access to clinical trial data, and the adoption of wearable devices provide both opportunities and challenges. Disparate attempts to incorporate these capabilities across pharma, biotech, contract research organizations (CROs), regulators, and investigative sites create confusion and frustration while frequently adding unintended costs and quality issues.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
For biopharmaceutical sponsors, clinical trial data are both the greatest organizational asset and the greatest challenge. This paper discusses the principles of data governance and how they are used to build a business intelligence framework that advances data quality, acquisition, and integration to deliver actionable information for use across the drug development enterprise.
How can researchers identify participants’ overall level of suggestibility and then focus on the minimization of this characteristic to solve the issue of suggestibility in clinical trial?
Genetic testing is making it easier to identify patients for clinical trials. However, genetic testing in the context of clinical trials raises raise important ethical issues, including ones related to informed consent and disclosure of results. Genetic counselors can play a crucial role in helping sponsors address these operational and ethical issues, making trials more efficient, more patient-centered and, ultimately, more successful.
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Good recruitment and retention is critical to the success of clinical trials. Get it right, and a trial will likely achieve its primary objective; get it wrong, and the time, effort, expense, and any patient participation is likely wasted. This article discusses how a new national approach to involving patients and the public in the U.K. is helping life sciences companies get it right the first time.
There has been an increasing and requisite focus on the needs of individuals affected by chronic or life-limiting disease, which has in turn resulted in a focus on the development of possible interventions and how they are administered. The success of participation and retention of these patients in clinical research, advancement of the drug development process, and adherence post-commercialization require the involvement of another critical expert — the caregiver.
Every biopharma company talks about putting the patient at the center of everything they do, incorporating the voice of the patient and being patient-centric. However, very few companies are actually doing it. Why is it so hard to conduct clinical development in a patient-centric manner? What actions can we take in 2019?
The current limitations on the use of immunotherapy drugs could be swept away thanks to the development of immune checkpoint inhibitors. They block disruptive proteins that limit the body’s natural immune response and stop T-Cells from destroying cancer cells. Some of the biggest factors stopping the more widespread use of these drugs are the limitations of current standards in effectively measuring how well they work. Read how improvements in the methods used for immuno-oncology drug trials could benefit both researchers and patients.
Deep-learning algorithms have shown significant promise as applications in natural language understanding, decision making, and speech and image recognition. These algorithms are now being applied in bioinformatics applications within the biopharma industry to manage the increasing amounts of data from high-throughput techniques. Read more about recent applications of these algorithms to predict a variety of biological processes and interactions, particularly with respect to proteins.
Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial, clinical and technology roles within the biopharmaceutical industry and shares his insights on the primary considerations for sponsors when implementing an ePRO solution.
We’re at the cusp of a new era for medical device research regulations. What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.
