Updated clinical trial common protocol templates aim to speed up research, align objectives & endpoints

common protocol templates clinical trial research stockThe NIH-FDA Joint Leadership Council and TransCelerate BioPharma released updated common protocol templates (CPT) last week to accelerate clinical development. An Outsourcing-Pharma.com article and interview with TransCelerate CEO, Dalvir Gill, details some of the key additions to the new templates and how they will help advance research.

First and foremost, both the FDA/NIH and TransCelerate BioPharma templates aim to increase efficiencies in clinical trial protocol development. The FDA/NIH template is intended for NIH-funded studies. Global, multi-center trials requirements are covered by the Transcelerate CPT. During the interview, Gill described the key principles needed in a Common Protocol Document. “Structure must be streamlined and consistent, it must enable common wording relevant for all phases, and… it must enable endpoints that map to objectives and support the use of [Clinical Data Interchange Standards Consortium] CDISC therapeutic area standards,” Gill explained. These requirements acted as the foundation on which Gill and his team built the new common protocol template.

Aligning objectives to endpoints

The CPT includes new elements that align objectives to endpoints. Most importantly, the newly established level 1 and 2 heading structure allows sites and regulator reviewers to easily find information. These structural changes appear in both the Transcelerate and NIH-FDA protocol templates. Additionally, “establishing common endpoints aligned to CDISC Therapeutic Area standards and common language when used consistently will speed the time to first draft and reduce human errors,” Gill stated.

The existence of a Common Protocol Template will ease protocol interpretation and review by sites, IRBs, and regulators. Protocols have increased in complexity as the number of new studies registered in Clinicaltrials.gov steadily increases year-by-year. Sponsors currently provide protocols in their own structure and sites spend more time deconstructing and interpreting protocols. That time could be spent more effectively, Gill lamented, which justified the need for a structural alignment between protocols. “[The] collaboration with NIH-FDA to align structures of CPT and their newly released protocol template will take harmonization and information sharing even further… a harmonized template will also enable review and even comparisons of studies by regulators.”

Next steps for the CPT initiative could include changes in automation, content reuse, and traceability. Gill hopes that these next steps could further reduce the time to study startup. Pearl IRB provides expedited and full board ICF/protocol reviews. Our efficient, experienced team delivers superior IRB services that effectively balance the needs of human subjects, sponsors, and institutions. Contact us today to discuss your clinical research needs.

Single IRB requirement intended to streamline multi-site clinical research

NIH national institutes of health logo single IRBBeginning September, 2017, the National Institutes of Health (NIH) will require that a single IRB (sIRB) of record be used in the ethical review for all NIH-funded non-exempt, multi-site human subjects research protocols in the United States (NOT-OD-16-094). The sIRB policy applies to all multi-site human subjects research regardless of the NIH funding mechanism (e.g., SBIR/STTR awards, grants, cooperative agreements, contracts or other mechanisms such as Cooperative Research and Development Agreements (CRADAs), and Interagency Agreements (IAA)).

The goal of this policy is to enhance and streamline the IRB review process, in the context of multi-site research, so that research can proceed as effectively and expeditiously as possible. In addition to streamlining some aspects of IRB reviews, the new sIRB policy presents an opportunity to harmonize the standards used in clinical research in the United States and streamline future administrative responsibilities.

The sIRB policy takes effect on September 25, 2017. This date is four months later than the effective date that appears in the sIRB policy document. NIH extended the effective date to allow additional time for successful implementation.

Finally, beginning in January 2020, the revised Common Rule will expand the studies to which this requirement will apply. The revised rule will require single IRB review for all multi-site studies conducted in the United States, rather than having each site’s IRB bear regulatory responsibilities. This had been a controversial provision of the NPRM, but became less so following the issuance of the NIH policy for research it funds.

Resources and guidance are available on the NIH Office of Science Policy website (http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinical-research-policy/models-irb-review). But for now, the question remains on whether the requirement for sIRB review will be equally protective of subject interests and actually demonstrate to be more effectual.

Pearl IRB will keep you updated on future developments impacting clinical research through our blog. For immediate updates, follow us on Twitter or send your inquiries to our experts directly.

21st Century Cures Act: potential impact on the clinical research landscape

clinical trialsThe historic 21st Century Cures Act, written into law last December, is a 362-page bill comprised of several initiatives impacting the life sciences industry. The allocation of $4.8 billion for the “Cancer Moonshot” portion of the bill won over most headlines during news cycles leading up to the bill’s signing, but several other sections will impact the clinical research ecosystem over the next several years. An article published in this month’s volume of the Journal of Clinical Research Best Practices outlines the major sections of the Cures Act that affect clinical trials.

The aforementioned Cancer Moonshot leads the bill, creating a $4.8B “NIH Innovation Account” that will allocate funds to the Precision Medicine Initiative, BRAIN Initiative, Cancer, and Adult Stem Cells research. Another $500M will be set aside for an “FDA Innovation Account.” The Eureka Prize Competition section allocates prize money for significant advancements in biomedical sciences and/or improving health outcomes in serious yet disproportionate research areas. Three sections address confidentiality of personal health information for study participants: Privacy Protection for Human Research Subjects, Protection of Identifiable and Sensitive Information, and Data Sharing.

To support emerging scientists, the NIH will develop and prioritize policies that promote opportunities for new researchers. The NIH also addresses Educational loan repayment addresses by increasing repayments from $35k to $50k in exchange for research work in the areas of basic science, AIDS, and emerging needs. This section also instructs the NIH to prioritize research conducted by professionals from disadvantaged backgrounds.

Reducing administrative burden for researchers also makes up a large section of the bill. Within two years, HHS is to “harmonize and eliminate duplicative Conflict of Interest reporting… [and] examine the varying minimum thresholds, consider allowing for just in time reporting, and consider redefining which investigators and sub-investigators need to report.” Several sections address the patient experience during clinical trial studies. The FDA will create guidance explaining the use and requirement of patient experience data such as data collected by non-clinicians (e.g. patients, family, etc.), the impact of disease and therapy on patient lives, and patient treatment preferences.

The bill would not be complete without detailing the penalties for violation of grants, contracts, and other agreements created under the 21st Century Cures Act. The bill outlines fines from $10k-$50k for each false statement or omission in addition to $10k-$15k fines per day for delays in the transfer of funds to HHS.

Do you need assistance with your NIH funded research? Please contact us at Pearl IRB.

Inclusion of women in clinical research still too small

The Government Accountability Office (GAO) recently released a report in regard to women in clinical research. While past efforts by the National Institutes of Health (NIH) have increased the number of women involved in research, further changes are still necessary. eNews Park Forest’s press release includes statements from Senators in support of the report. Since diseases and treatments impact men and women differently, it is important for the NIH to generate more data from women in order to develop effective solutions and scientific advances.

To get more details, check out eNews Park Forest’s press release here.

21st Century Cares Act gets passed by Congress

The 21st Century Cares Act was passed with an overwhelming majority on July 10th, 2015. This bill would increase the funding for both the NIH and FDA and instate a new framework for evaluating patience’s experience with drugs risks and benefits. Not only will the bill help the drug approval process, it also establishes a new national pediatrics research network and will be impacting CRO’s.

This bill will impact the pharmaceutical industry tremendously. Critics of the bill are worried how it will be paid for and how it will bring new cures to the market. Although the payment of the bill is not stated, many are looking forward to see how the bill will help the world.

To read more on Zachary Brennan’s article in outsourcing-pharma, click here.

Will NIH be the next to use smartphones for gathering data?

NIH may be the next to join Apple and Google in using technology (i.e. smartphones) to help gather information for clinical trials. This new step for the NIH came under the White House’s Precision Medicine Initiative (PMI). President Obama hopes the PMI will “bring us closer to curing diseases like cancer and diabetes — and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”

To find out more on the studies of using smartphones for clinical studies, continue reading Jonah Comstock’s article in Mobile Health News here.

NIH releases ClinRegs website to simplify global clinical trial regulations

clinregsThe National Institutes of Health’s (NIH) National Institute for Allergy and Infectious Diseases (NIAID) launched a new website, ClinRegs, designed to provide country-specific information on clinical trial regulations. The website contains a number of resources to help researchers keep up with the various regulatory requirements in each country. Through this new tool, NIH can provide reliable, up-to-date information, and site-by-side comparisons between countries with varying regulations.

Through the initial launch of ClinRegs, users can view information on 12 of the most common clinical research countries, with additional countries to be expected in the near future.

For more information on ClinRegs, read Alexander Gaffney’s article on raps.org.

NIH provides funding for rare disease studies

The National Institutes of Health (NIH) has recently awarded $29 million toward the advancement of clinical research and investigation of treatments for rare diseases. This is part of a collaborative effort to expand the Rare Diseases Clinical Research Network (RDCRN), lead by the National Center for Advancing Translational Sciences (NCATS).

The fund has helped to establish six new RDCRN consortia to add to the existing sixteen, which provide scientists with data to identify similarities among rare diseases and essentially deliver proper diagnosis, monitoring, and treatment options for patients with these diseases. According to the NIH’s announcement, “scientists at the 22 consortia will conduct a minimum of two multisite clinical studies, including one longitudinal natural history study for at least three related rare diseases.” In total, this award has provided researchers with funding to study over 200 rare diseases.

To learn more, read the NIH’s news release here.

I-Corps at NIH pilot program to bring biomedical innovations into the marketplace

The NSF Innovation Corps (I-Corps) has collaborated with the National Institutes of Health (NIH) to pilot a program that will help biomedical innovations advance into the marketplace. The I-Corps program provides biomedical researchers with the opportunity to work with experienced business instructors to seek potential markets for their innovations and learn how to integrate that into a successful business model.

The NIH has a number of institutes that plan to participate in the pilot program, which will add to the 300 teams that have already completed the I-Corps training. Michael Weingarten, director of the NCI SBIR Development Center, has witnessed the benefit of I-Corps, saying that the program “Will help teach NIH-funded start ups how to build scalable business models around new technologies they’re developing for the detection and treatment of disease.”

The collaboration with NIH and the introduction of this pilot program has greatly contributed to the development and efficacy of the I-Corps network. The National Science Foundation’s assistant director for engineering, Pramod Khargonekar, stated that with the program’s emphasis on life sciences, “We expect biomedical researchers will be better equipped to enter the business arena.”

To read the full news release on the NIH website, click here. Are you a start-up in need of regulatory, clinical, or product development support? Contact us at info@pearlirb.com.

NIH consolidates brain samples into one program

Cassandra Leger from bioresearchonline.com covered recent development regarding the National Institute of Health’s (NIH) plans to create a program to expedite research designed to treat brain disorders. The NIH is planning on turning their new biospecimens biorepository to a virtual open library for brain tissue specimens. The program is being modeled by one that already exists over in Europe for doctors all over the continent. The biobank will offer economies of scale, increase availability of biospecimens, establish a standardized system, and raise public awareness of the importance of human brain research. To read the full article click here.