From The Editor | November 3, 2017

Clinical News Roundup: New Alzheimer's Drugs Reach Clinical Trials

Ed Miseta

By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical

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There are 126 drugs in clinical development for Alzheimer's disease and every single one represents hope. That is the conclusion of a new report titled Closing in on a Cure: 2017 Alzheimer's Clinical Trials Report. The report, released by the Alzheimer's Drug Discovery Foundation (ADDF), identifies the drugs for Alzheimer's that have reached human clinical trials.

"Alzheimer's has too often been a story of failure," says Howard Fillit, chief science officer at the ADDF. "But this report shows a diverse group of promising drugs are nearing the finish line. The first disease-modifying treatment for Alzheimer's is likely in clinical trials right now. We are closing in."

While drugs targeting beta-amyloid (a protein that comprises the plaques common in Alzheimer's) remain the most prevalent, other drug targets such as inflammation, mitochondria, and neuroprotection are gaining ground. This broadening of targets is due in part to the efforts of the ADDF, which funds new approaches to treating Alzheimer's. Nearly 20 percent of the drugs now in clinical stages have received ADDF support.

In addition to the emergence of innovative targets to treat Alzheimer's, the report highlights other aspects of the current clinical pipeline. This includes the relatively small number of repurposed drugs being tested, the shift toward trials with earlier-stage patients, and persistent challenges such as recruitment and the relative lack of validated biomarkers for innovative targets. It also defines a path forward for the field, specifically the need for experimental trial designs and combination therapy approaches.

Clinical Monitoring Salaries & Turnover Continue To Rise

A 2017 compensation study has found that employee turnover in clinical monitoring jobs outside the U.S. increased significantly in 2016. The 19th annual CRO Industry Global Compensation and Turnover Survey, conducted by HR+Survey Solutions, noted that turnover in the clinical monitoring job function, which monitors participants’ health during a clinical trial, jumped from 16.4 percent in 2015 to 22.9 percent in 2016, an increase of 40 percent.

In the U.S., turnover for clinical monitoring jobs at CROs remained high at 25.8 percent, an increase of 2.7 percent from the prior year. That number is much higher than the estimates of overall U.S. professional turnover, which stands at 17.8 percent.

The increase in turnover was matched, not surprisingly, by increases in salaries for those positions. While salaries in professional, non-managerial clinical research positions were expected to increase by 3 percent due to annual merit increases, actual salaries increased by an average of 8.3 percent.

Overall turnover (all positions) at CROs in the U.S increased only slightly from 2015, but remains high at 21 percent, compared to a turnover rate of 18.7 percent outside the U.S. All countries outside the U.S. which were covered in the survey experienced turnover of 10 percent or higher while half the countries (20 out of 40) had average turnover of over 20 percent. One-third of the countries had turnover of more than 25 percent.

KoNECT-DIA Conference Emphasizes Patient-Centric Trials

The 2017 KoNECT-DIA International Conference on Clinical Trials opened its third annual conference to discuss a wide range of topics from clinical development to the future of clinical trials in Seoul. The first session of the conference emphasized the importance of patient-centric clinical development.

Clinical trials are often the first interaction between patients and sponsor companies. However, some trials can get sidetracked after failing to remember whom the clinical trial is intended. Therefore, matching the needs of the patients to the genuine scientific needs of clinical trials is still demanding.

“The definition of patient centricity can be defined as putting the patient first in an open and sustained engagement of the patient and to respectfully and compassionately achieve the best experience for that patient and their family,” said Trish Caruana, CEO of Rare Disease Solutions. “The important thing is to think of the patient and the family as one.”

Caruana added that with the patient population now familiar with patient-centric policies, patients want an ongoing relationship with pharmaceutical companies and have come to expect patient-centric strategies. Although patient centricity is a challenging model for pharma to incorporate, it is the model that will allow the industry to measure, define, implement, and access its goals.

Mariah Baltezegar, executive director and rare disease consortium co-lead at INC Research/Inventive Health, notes strategies need to focus on the patient to make a successful patient-centric recruitment strategy. “Focusing on the patient involves engagement and support, minimizing protocol complexity, gaining the patient’s trust, and identifying the patients and creating sites around them,” she said.

GDPR Compliance Findings Raise Concerns

The CGOC (Compliance, Governance and Oversight Council) has released the results of a survey that reveals most enterprises are not ready to comply with the EU’s General Data Protection Regulation (GDPR). The new regulation goes into effect on May 25, 2018. According to Top Corporate Data Protection Challenges, a survey of 132 compliance officers from organizations around the world and across multiple industries, only 6 percent of respondents feel their organizations are currently compliant with the upcoming regulation. The results also indicate most organizations are concerned about their poor data disposal practices and ability to demonstrate compliance, key elements of GDPR readiness. Organization size had no significant impact on readiness levels.

For years before the passage of the GDPR, the CGOC focused on advice and resources to help organizations adhere to the European Data Protection Directive. Because the Directive created only a minimum standard, many countries implemented higher and different standards, leading to confusion. The GDPR now harmonizes all of the data protection laws in the EU to protect the personal information of its citizens and residents. GDPR readiness compels organizations to know the type, value, and location of the information they store, and to delete, change, or provide information as required by the regulation. Successful readiness is also aided by the regular and automatic defensible disposal of information that has no legal, regulatory, or business value, a practice that can significantly reduce the burden on information asset managers to remain GDPR-compliant.

“A comprehensive and unified governance program is one of the main pillars of GDPR readiness because it ensures the involvement of all information stakeholders in the program, provides a single, centralized view of all information across the enterprise, and automates critical processes such as defensible disposal,” said Heidi Maher, CGOC Executive Director. “As organizations build momentum for their GDPR-readiness programs, CGOC can be a helpful resource for implementing information governance strategies and practices.”