Clinical Data Collection: Best Practices And Latest Trends

Collecting clinical trial data can prove to be a demanding endeavor, but it is arguably the most crucial part of the study process. And to do it well, clinical data managers must master every aspect of the data collection and management journey, including determining what type of data to collect, deciding how to collect it, and determining how to store and analyze it.

Regulatory Readiness: Best Practices For Clinical Trial Compliance

Let’s face it: Clinical trials and, to some extent, their sponsoring companies can live and die by decisions made by the FDA. And while regulatory matters simultaneously motivate and strike fear in the folks working in regulatory and compliance roles, clinical research professionals across functional areas are best served when they too stay abreast of the FDA’s every move.

Strengthening The Sponsor-Site Relationship In Clinical Trials

The past several years, due in part to the impacts of the COVID-19 pandemic, have been particularly challenging to clinical sites. From adopting new operating models and myriad technologies emanating from decentralized clinical trials (DCTs) to mitigating the financial impacts of inflation to managing ever-increasing responsibilities amid staffing shortages, sites have been tasked at nearly every turn.

Overcome The Challenge Of CRO Selection

When I speak to clinical executives from large pharma companies, they always seem to be interested in the trending topics of the day. Those topics might include AI and machine learning, blockchain, real-world evidence, adaptive trials, and more. When I speak to executives from small pharma and biotech companies, the conversations are very different. Their interests lie in what you might call the basics of clinical trials. Those basics include selecting and overseeing sites, CRO oversight, and patient recruitment. One of the greatest challenges for those companies always seems to be CRO selection. The articles in this e-book all relate to the challenge of CRO selection. I hope you enjoy them and learn from the insights contained in them. I wish you the best of luck in selecting your next outsourcing partner.

Hybrid & Decentralized Trials

Hybrid and decentralized approaches have the potential to revolutionize clinical trials. These new technologies have existed for years, but the COVID-19 pandemic in 2020 hastened their adoption by drug developers.

Real-World Evidence

The data gathered by researchers during a clinical trial might be sufficient to garner a regulatory approval, but it does not provide sponsor companies with a holistic view of how the drug will perform when made available to the general public. The small number of patients participating in trials, coupled with the lack of diversity present in those populations, makes it difficult to understand the full effect a treatment might have in patients.

Patient Diversity in Clinical Trials: What Progress Has Been Made?

In November 2020, the FDA released guidance on enhancing diversity in clinical trials. The guidance, first issued as a draft in 2019, provides the agency’s thinking on steps to broaden eligibility criteria in clinical trials. Although patient diversity is a concern for pharma and biotech companies, the solutions to recruiting more diverse patient populations are not easy to come by. It seems clear, however, that recruiting minority patients will involve education, building trust, a different type of outreach, and engaging with new site partners.

AI Will Bring Needed Changes To Clinical Trials

Clinical trials are expensive to conduct and are very time consuming. The cost of developing a new drug is then reflected in the prices that must be paid by patients and insurers. One aspect of trials that drives up the cost of research is the number of clinical failures. Reducing failures would mean cutting costs, shortening timelines, and getting needed medicines to patients faster. That is where artificial intelligence (AI) and machine learning enter the picture.

COVID-19 Creates A Rush For Virtual Trials

COVID-19 has had an extreme negative impact on countries around the world. Businesses were closed, economies were damaged, employees were forced to work form home, and everyone had to get used to wearing a mask and other practices considered to be the "new normal.” One industry that was not spared the wrath of COVID-19 was clinical trials.

Clinical Trials and a Pandemic: Managing Studies And The Impact of COVID-19

Conducting clinical trials is always a challenge. From protocol development to patient recruitment, the gathering of accurate and reliable data, and the regulatory oversight, trials are a lengthy and expensive process.

How Patient-Centricity is Changing Clinical Trials

 

 In this eBook, we present the stories of four companies attempting to overcome these challenges and bring effective therapies to patients in need. Dr. Brian Schwartz, CMO for ArQule, discusses the challenges of an ultra-rare disease trial; Dr. Pushkal Garg, Chief Medical Officer at Alnylam Pharmaceuticals, discusses new approaches to patient-centric drug development; Mallory Factor, chairman of IntraBio discusses what government can do to help promote orphan disease research, and a panel of experts discuss what progress is being made to bring treatments to rare disease patients.

Study Start Up

Learn how technology investments can help with study start-up, how you can ensure a smooth start-up in a gene-therapy trial, and what companies are doing to overcome these challenges. I hope these articles help you to better navigate all of your trial start-ups.

CRO Partnering & Collaboration

While CRO selection and partnering may not be a hot and trending topic for some companies, the executives I talk to from the small- and mid-sized companies often list it as one of their biggest challenges. Finding the right CRO, putting the right contract in place, and becoming valued partners for each other is never easy. For everyone who deals with CRO selection and collaboration, we have produced this eBook. The articles included will provide you with the information you need to make better selections,  avoid outsourcing mistakes, be a sponsor of choice, and make any partnership work better. I hope you enjoy them.

CRA Hiring and Fraud

Learn how to find and hire competent CRAs in this free collection of articles highlighting CRA turnover as well as how to spot fraudulent resumes and counterfeit degrees. 

The Challenges Posed By Orphan & Rare Disease Trials

As chief editor for Clinical Leader, I speak to a lot of executives at companies working in the rare disease space. Clinical trials always present challenges to sponsor companies. Those challenges can be magnified greatly when dealing with rare and orphan diseases. The lack of a natural history of the disease is the first hurdle many companies have to navigate, but patient recruitment, data collection, and trial design can also present additional challenges that must be overcome. In this eBook, we present the stories of four companies attempting to overcome these challenges and bring effective therapies to patients in need.

Real World Evidence

The data gathered by researchers during a clinical trial might be sufficient to garner a regulatory approval, but it does not provide sponsor companies with a holistic view of how the drug will perform when made available to the general public. The small number of patients participating in trials, coupled with the lack of diversity present in those populations, makes it difficult to understand all of the effects a treatment will have in patients. For that reason, real-world evidence (RWE) has been gaining in popularity. In this eBook, we take a close look at RWE. What is it, how is it being used, why all the hype over it, and how the use of RWE is bringing together the worlds of pharma R&D and healthcare.

Digital Health and Wearables In Clinical Trials

Clinical trials are changing. Companies continue to struggle with patient recruitment and the high cost and lengthy timelines of conducting clinical trials. Even once we recruit patients, keeping them engaged with the study can be a challenge. The lack of real-time monitoring of patients participating in trials also prevents researchers from having the quality data they need. This has led many in the industry to realize that we can’t conduct trials of the future using technologies of the past. One of the emerging trends that will enable trials of the future and make them better for patients is the emergence of digital health and wearable devices. In this eBook, we present seven articles showing the potential of these technologies to reform clinical trials.