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Home » Authors » Elizabeth Tilley Hinkle

Articles by Elizabeth Tilley Hinkle

New Skills

Novel Research Areas Require New Skills

January 31, 2023
Elizabeth Tilley Hinkle

From stem cells to psychedelics, novel areas of medicine are spurring change in the clinical research industry. New investigational areas — such as precision and personalized medicine, cell and gene therapy, regenerative medicine, nanomedicine and alternative therapies, such as cannabis — will require new techniques, technologies, trial designs and skills. 

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Change Management

Change Management: Why It Matters in Today’s Clinical Research Landscape

December 1, 2022
Elizabeth Tilley Hinkle
The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. With the clinical research industry being both highly risk-averse and in need of innovation, sites and sponsors can benefit from establishing strategies to take the sting out of change. Read More
Change Management

Effective Change Management Can Help Ease Transition and Speed Innovation

November 30, 2022
Elizabeth Tilley Hinkle
The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. And few industries are as risk-averse or as in need of innovation as the clinical trials field. Read More
Protocol and Procedures

Protocol Deviations: Characteristics and Consequences

November 30, 2022
Elizabeth Tilley Hinkle
Protocol deviations can pose serious risks to clinical trials, including regulatory troubles, study delays and, ultimately, failure to launch an approved investigational product. But despite the importance of following study protocols, deviations remain a consistent problem in the industry, regularly topping the list of problems found during FDA inspections of research sites. Recent figures indicate that the average phase 3 trial has 118.5 deviations per protocol that affect nearly 33 percent of enrolled participants. Read More
Contracts

Specific Points of Leverage in Contracts Can Help Sites Push Back Against Sponsors

September 30, 2022
Elizabeth Tilley Hinkle
Clinical trial agreements (CTA) are a leading cause of delays in study startup. Miscommunication, misunderstanding and mistrust can drag out a contract negotiation far beyond sponsors’ and sites’ original timelines. Read More
Informed Consent Form

Room for Change in Informed Consent? Addressing Length, Language and Reading Level

September 1, 2022
Elizabeth Tilley Hinkle
Sites, sponsors and IRBs all agree that informed consent forms (ICF) need to be shorter, less technical and more readable for the lay person, but there can be tradeoffs in any kind of change. Explaining medical terms in plain language requires more words, adding to the length of the document. Removing legalese can make ICFs shorter but may leave a sponsor open to liability issues. Read More
community-based

CBOs an Underutilized Source of Clinical Trial Support

July 29, 2022
Elizabeth Tilley Hinkle
Clinical research sites often turn to community-based organizations (CBO) when it’s time to identify and recruit patients from specific populations for clinical trials. And while those local connections are a great source for finding diverse participant pools and for publicizing new studies, CBOs can be a valuable, long-term resource for research sites in other ways, too. Read More
Diversity text

Addressing Bias in the Clinical Research Workplace

July 29, 2022
Elizabeth Tilley Hinkle
Regulatory agencies and the clinical research industry as a whole have put increasing emphasis on diversity among trial participants. But there’s much less urgency around building diverse research teams, even though evidence shows that doing so can benefit everything from participant recruitment to trial operations to innovation and collaboration. Read More
Recruitment-360x240.png

Site Spotlight: Award-Winning Site Shares Mobile Approach to Recruitment

July 25, 2022
Elizabeth Tilley Hinkle
Starting with a small fleet of buses retrofitted to provide mobile COVID-19 testing and vaccination in underserved communities, one Maryland site has leveraged this access to boost recruitment and diversity in its trials. Read More
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Cancer Trials Increasingly Using DCT Methods, Finding Solutions Despite Hurdles

June 6, 2022
Elizabeth Tilley Hinkle
Decentralized trial (DCT) approaches are often overlooked in oncology due to cancer research’s more stringent drug requirements and complex assessments, but experts say that, when deployed correctly, many DCT approaches can help break down barriers cancer trials have faced. Read More
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