Developing Protocols For Patient-Centricity
Patient-centricity has become an increasingly important focus for clinical researchers in recent years. Creating a research experience that addresses patient-expressed needs and wants is an important part of recruiting and retaining sufficient numbers of qualified patients.
And it’s not enough to add a couple of features broadly considered to be what patients want, such as use of telehealth or home visits to reduce the number of site visits required for a study. The only sure way to ensure that sponsors can ensure their clinical trials are truly patient-centric is to design that focus into the protocol from the start, using a protocol optimization method such as Pro-ficiency’s Pro-Active Protocol solution.
In essence, patient-centricity marks a shift from the traditional disease-focused approach of conducting clinical trials to a philosophy that puts the well-being of patients enrolled in clinical studies first and treats them as “informed collaborators whose participation is crucial for the success of the research.”
Patient centricity has been at the forefront of the collective industry mind for the last several years. For instance, in 2016, the Drug Information Assn. (DIA) reported that a survey of pharma and biotech companies conducted in partnership with Tufts University showed that 65% of those firms had invested in patient-centric initiatives as part of their drug development programs.
By 2019, a SCOPE conference seemed to indicate widespread dedication to patient-centric trials, with representatives from various sponsors, CROs and other companies discussing how to incorporate more patient-centric aspects into research.
[three_fourth]
The FDA has also highlighted the importance of patient-centricity, as well, developing a series of four patient-focused drug development guidance documents to address various ways of collecting and using patient experience data to support clinical research:
- Patient-Focused Drug Development: Collecting Comprehensive and Representative Input, a final guidance issued in June 2020;
- Patient-Focused Drug Development: Methods to Identify What Is Important to Patients, a final guidance issued in February 2022;
- Patient-Focused Drug Development: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments, a draft guidance issued in June 2022; and
- Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making, a yet-to-be-issued draft guidance.
Why is patient-centricity important?
One of the driving forces behind the move to more patient-centric studies is concern over patient enrollment and retention. About 80% of clinical trials struggle with enrollment, and some studies estimate that up to 30% of patients drop out before a clinical trial concludes, according to a March 2022 Antidote blog.
“When product-centric trials neglect patient needs, dropout rates are high and the integrity of the data becomes compromised,” the MD Group agreed in a 2020 blog. Conversely, patient-centric approaches to clinical trial design can result in higher patient recruitment and retention rates.
And speaking at the 2019 SCOPE conference, Beth Zaharoff, senior director for patient-focused engagement and partnership at TESARO noted at the conference that enhanced convenience for the patient and focus on unmet needs expressed by the target patient population can help boost enrollment and ensure that patients remain in the trial for its entirety. Additionally, patient centricity can improve trial speed and efficiency by helping to ensure the protocol is simple to administer for the patient, she said.
[three_fourth]
What constitutes a patient-centric approach to research? Schedule flexibility and use of decentralized features are factors that are often touted as means of making research participation more attractive to patients. Other options are also popular among sponsors, such as these steps recommended by the MD Group in its 2020 blog:
- Make information accessible;
- Involve patient associations;
- Ensure that patients feel valued;
- Reduce inconvenience wherever possible; and
- Empower patients through technology.
[three_fourth]
But the answer doesn’t lie in randomly selecting features with the label “patient-centric” and attaching them to all clinical trials. Speaking at the SCOPE conference, Melanie Goodman, Pfizer director of patient recruitment programs, emphasized that patient-centricity must permeate every aspect of a clinical trial, from the protocol to the site, to be effective.
In other words, patient-centricity must be built into the protocol from inception. And that means that protocols must be optimized with an eye toward real-life patient needs and preferences. Pro-ficiency’s proprietary optimization methodology, Pro-Active Protocol, launched last month, can help achieve this goal by applying simulation to visually represent the operational flow of a clinical study. The service aims to shed light on protocol inconsistencies and gaps so sponsors and researchers can adjust and revise before a study begins.
A critical part of the service is gaining patient insight—along with opinions from study teams and regulatory agencies—about how easy or difficult it would be for target patients to participate in a study.
The only way to make sure that the protocol is written in a way that is feasible for the target patient population is to get those patients involved in the early stages of study design. This can be done via workshops that involve researchers, patient advocates and the patients themselves, for instance.
Logistical issues that don’t even register with sponsors during protocol design can have a large impact on a study’s ability to recruit and retain participants. For example, patients with long-term or serious conditions that cause fatigue may lack energy to travel at certain times. And patients whose condition causes dexterity problems may struggle to operate some devices or open certain types of drug containers.
The Pro-Active Protocol solution can “help to visualize and animate the patient journey through the study,” Beth Harper, Pro-ficiency Chief Learning Officer, explained. “This helps to set expectations for how involved the study participant will be and to help potential patients understand their commitment prior to participation; they will see how long the study will be and how involved from a procedure and time perspective.”
Having this information available makes it easier for sponsors to get feedback from patients on how likely they would be to participate in a clinical trial, including potential barriers to participation and opportunities to further simplify the study design and schedule of events.
Pro-Active Protocol can serve as an invaluable resource, whether used as a stand-alone resource or integrated with Pro-ficiency’s existing simulation-based protocol modules to boost site and study team understanding of the protocol requirements upon start-up of the clinical trial.
Site feasibility also supported
But ensuring that the protocol is truly designed with the target patient group in mind is just one of two critical areas that loom large for protocol optimization efforts. The second, and equally important, key area is ensuring that the protocol is clear and understandable for the research sites that will be implementing it.
“The most patient-centric thing sponsors can do is to make the protocol easy, or easier, to implement,” Harper said. “The easier it is to implement, the less change of errors (deviations), both on the part of the sites and the patients.”
Aidan Gannon, Advarra director of client services and innovation, agreed in a 2021 blog that there is a close relationship between patient-centricity and site-centricity, as well.
“One could argue patient centricity is not possible without site centricity, as sites deliver the patient experience in clinical trials,” he wrote. “The best intentions of any sponsor or contract research organization (CRO) make little difference if sites fail to engage with participants.”
Sponsors should listen to site experiences and suggestions for improvements, as these often have very practical implications to how well a clinical trial is conducted, he suggested. Sponsors should also offer process improvements and other support to help address any challenges that sites report.
These types of improvements can help sites run clinical trials more smoothly, efficiently and accurately. When not struggling with study-specific challenges, sites can turn more time, attention and resources to ensuring a patient-centric experience.
For example, Advarra noted one large pharma sponsor conducted a Phase 3 breast cancer study involving a short timeline and small patient population in 16 countries. The company provided custom training, engagement options and guided visits, among other things, which reduced screen failures by 50% and protocol deviations by 21%.
The better sites understand the protocol, the more confidence they will have in explaining it to patients, Harper said. In this way, clarity for sites ties back into patient needs, by providing sites with the intimate knowledge about how a protocol will really work so that their staff can communicate that information clearly to patients.
With this growing focus on improved patient-centricity, it is critical that sponsors provide protocols that address real-world patient needs, constraints and priorities. And they must make sure that the research sites they select to carry out their studies both understand and are able to implement the protocols in the most patient-focused way possible.
But many sponsors lack the tools in-house to develop the necessary insight to implement these types of changes to their protocol development process. This is where resources like Pro-Active Protocol come in. By pairing industry expertise with effective simulation techniques, this product can help sponsors ensure deep understanding of patient needs that can be incorporated into their protocols and communicated with crystal clarity to sites. The end result: well-written protocols that account for real-world patient experiences and are easy to implement correctly.
Click here to learn more about our Pro-Active Protocol solution: http://proficiency1.wpenginepowered.com/pro-active-protocol/
Michael Lang brings more than 25 years of healthcare experience to Pro-ficiency, including 20 years of senior leadership. While scaling, delivering revenue growth and managing change have been hallmarks of his career, Michael is most proud of the impact his high-integrity approach has had on patients. Ultimately, his commercial operations were focused on achieving excellence by developing an intimate understanding of his client’s needs rather than quota which ultimately benefited the patient. As he leads Pro-ficiency through their most recent growth and expansion strategy, the “client-centric” approach is already evident in the high-quality experience clients receive.
azithromycin 500 price
reputable online pharmacy no prescription
tadalafil canada price
online pharmacy delivery usa
brand name prednisone
levothyroxine synthroid
capsule online pharmacy
tadalafil 40 mg daily
tadalafil mexico
pharmacy wholesalers canada
reputable online pharmacy uk
azithromycin generic over the counter
how to get zithromax online
prednisone best price
canadian pharmaceutical happy family stores
azithromycin 4 tablets
prednisone generic cost
metformin 850 mg india
metformin price in india
happy family drugstore
valtrex online no prescription
cost of prinivil
canadien pharmacies
lisinopril pills
cialis daily cost
cheap scripts pharmacy
lisinopril 2.5
non prescription medicine pharmacy
order valtrex from canada
viagra vs cialis
buy metformin india
safe reliable canadian pharmacy
over the counter valtrex
synthroid from india
buy azithromycin 1000mg
valtrex 1000mg tablet
metformin 1000 mg generic
good value pharmacy
cost of synthroid 88 mcg
buy valtrex on line
canadian pharmacy 24 com
valtrex rx cost
tadalafil prescription cost
Wow, wonderful blog layout! How lengthy have you been running a
blog for? you made running a blog glance easy. The total glance of your website is excellent, let alone the content!
You can see similar here sklep internetowy
happy family store
cost of metformin in us
zithromax prescription
gold pharmacy online
online pharmacies that use paypal
tadalafil generic usa
cialis buy
cialis online us
metformin 1500
online pharmacy ed
happy family store
synthroid 62.5 mcg
how to get azithromycin
azithromycin pills
prednisone buy canada
synthroid canada price
where to buy synthroid online
cost of prednisone 5mg tablets
valtrex daily use
price of metformin 500 mg
online pharmacy birth control pills
glucophage cost in usa
which online pharmacy is reliable
azithromycin script
sure save pharmacy
express scripts com pharmacies
where can i buy valtrex online
Empower Your Farm with Bwer Pipes’ Irrigation Solutions: Bwer Pipes offers a comprehensive range of irrigation products designed to empower farmers in Iraq. From efficient sprinkler systems to durable pipes, our solutions are engineered to enhance water distribution, promote crop growth, and maximize yields, ensuring agricultural success. Visit Bwer Pipes
glucophage mexico
prednisone 5mg price in india
canadian pharmacy no scripts
cheapest prescription pharmacy
online pharmacy australia free delivery
cialis daily online pharmacy
how can i get valtrex
prednisone prescription
where can i purchase zithromax
azithromycin 500 mg tablets
safe online pharmacies
100 mg lisinopril
azithromycin 2019
glucophage 850 mg tablets
canadian pharmacy world coupon
6 prednisone
cheap cialis prescription
pharmacy canadian superstore
cougarsbkjersey.com
この実用的な記事のおかげで、多くのことを学べました。ありがとうございます。
tadalafil coupon
austria pharmacy online
canadian pharmacy antibiotics
pharmacy online 365 discount code
generic tadalafil paypal
where can i buy zithromax online
Siente la emocion de los casinos en linea en Peru con solo un clic
mejor casino online peru online casino games peru .
best rogue online pharmacy
synthroid 25 mg daily
internet pharmacy manitoba
valtrex price without insurance
?Experimenta la emocion de los casinos en linea en Peru!
mejor casino online peru mejor casino online peru .
generic tadalafil usa
zithromax 500 tablet
mail order pharmacy no prescription
buy metformin online nz
synthroid 50 mcg tab
cheap valtrex online
137 mg synthroid
buy metformin 500
metformin how to buy
where to buy glucophage online
valtrex prices generic
prednisone 2018
lisinopril 30 mg daily
metformin for sale
where to purchase tadalafil
prednisone 5mg tablets
legitimate online pharmacy
no script pharmacy
how much is lisinopril 40 mg
valtrex 500mg
zestril 5 mg tablets
synthroid 75 mcg price canada
online shopping pharmacy india
online pharmacy
where to buy metformin tablets
animehangover.com
아버지가 정상이면 항상 그렇지 않습니까?
which online pharmacy is the best
zestoretic drug
rxpharmacycoupons
order tadalafil canada
synthroid 125 mcg tablet
Почему важен рейтинг букмекера
лучшие букмекерские конторы в беларуси букмекерская контора бетвиннер .
azithromycin 500mg canada
good value pharmacy
where to buy zithromax over the counter
buy valtrex online cheap australia
prinivil 20 mg cost
url lisinopril hctz prescription
canada pharmacy happy family store pharmacy
glucophage brand cost
non prescription prednisone 20mg
buy prednisone no prescription pharmacy
metformin 1000 mg
tadalafil 40 mg online india
zithromax 500
buy synthroid online
canada pharmacy online
cheapest pharmacy for prescriptions
worldwide pharmacy online
buy synthroid in canada
order prednisone with mastercard debit
synthroid cost comparison
rate online pharmacies
synthroid cost comparison
where to buy zithromax
qiyezp.com
Zhu Houzhao는 황실 의자에 앉아 주위를 둘러 보았고 그의 마음은 영웅으로 가득 차있었습니다.
good online mexican pharmacy
cost of synthroid 75 mcg
Как попасть в рейтинг букмекеров
рейтинг рейтинг букмекеров .
web pharmacy
zithromax price
ordering tadalafil
valtrex generic price
mexican pharmacy online
zestril 10 mg price
metformin singapore pharmacy
where to get synthroid
metformin buy canada
indian pharmacies safe
valtrex 40 mg
tadalafil india price
pharmacy canadian superstore
good online mexican pharmacy
mail order pharmacy
zithromax 1500 mg
mail order pharmacy no prescription
azithromycin tabs 250 mg
lisinopril online uk
buy metformin online mexico
online prednisone 5mg
can i buy valtrex without prescription
cialis tab 10mg
onlinecanadianpharmacy 24
lisinopril 40 mg pill
prednisone 2 mg tablets
can you buy zithromax over the counter
buy lisinopril mexico
how to order metform onlline
zithromax for sale cheap
prednisone for cheap
metformin price in mexico
Hi friends, fastidious piece of writing and pleasant urging commented here, I am actually enjoying
by these.
synthroid 125 pill
valtrex 1000 mg tablet purchase
zithromax 1g
azithromycin medicine
buy valtrex online uk
prednisone buy online uk
buy tadalafil 20mg uk
pharmacy online shopping usa
preddisone no
tadalafil 5mg price uk
prednisone 10 mg tablet
prednisone 6 mg
20 mg cialis for daily use
metformin 1000 mg pill
Які новинки в тактичних рюкзаках
Секрети вибору
тактичні рюкзак https://ryukzakivijskovibpjgl.kiev.ua/ .
valtrex canada
synthroid capsules
lisinopril 40 mg
cougarsbkjersey.com
素敵な記事をありがとうございます。いつも楽しみにしています。
best lisinopril brand
legit non prescription pharmacies
metformin without a script
synthroid 1.25 mg
lisinopril 80mg tablet
valtrex 500 price
canadian pharmacy meds
medical pharmacy west
mikaspa.com
“차팔고 차팔고 국화차, 더위를 씻는다.”
valtrex price uk
zestril 5mg
synthroid pill 88mg
cialis india pharmacy
azithromycin buy over the counter uk
buy azithromycin online fast shipping
tadalafil generic coupon
prednisone
zestoretic 20 mg
canadian pharmacies not requiring prescription
order valtrex online canada
pharmacy com
tadalafil online pharmacy india
lisinopril 10 mg coupon
buy lisinopril without prescription
zithromax otc
synthroid mexico
80 mg prednisone daily
lisinopril 40 mg prices
lisinopril 10 12.5 mg
cost of synthroid
tadalafil soft gel capsule 20mg
cialis genuine buy
canadian pharmacies comparison
best canadian online pharmacy
lisinopril 25 mg
valtrex online prescription
generic zestoretic
valtrex 2 mg
daily prednisone
tadalafil 5mg india
best price for prednisone
prednisone steroids
online pharmacy no rx
cheapest valtrex generic
online pharmacy same day delivery
internet pharmacy manitoba
synthroid no prescription pharmacy
canadian pharmaceutical drugstore
buy tadalafil
online pharmacy pain
how to get metformin
online pharmacy indonesia
canadianpharmacyworld com
escrow pharmacy online
buy metformin online usa
cheapest generic tadalafil online
mexican online mail order pharmacy
tadalafil 5mg cost
canadian pharmacy discount coupon
pharmacy online shopping usa
synthroid pharmacy in canada
azithromycin cost india
synthroid 75 mcg
canadian pharmacy azithromycin buy online
buy synthroid without prescription
tadalafil paypal
tadalafil 7.5 mg
canada happy family store
synthroid 132 mg
valtrex online australia
buy tadalafil 20mg online
can you buy azithromycin over the counter nz
canadian mail order pharmacy
buy valtrex canada
valtrex for sale canada
lisinopril 5mg buy
cost of brand name metformin
lisinopril coupon
lisinopril 419
metformin hcl 1000mg
azithromycin 1000mg buy
lowest price tadalafil tablets 20 mg
lisinopril india price
legal online pharmacies in the us
lisinopril 2.5 mg price
how to get azithromycin online
buy synthroid online usa
where can i buy lisinopril
cialis daily cheap
prednisone 5mg coupon
synthroid 112 mcg canada
metformin 500 mg price in india
zithromax 50mg
valtrex cream
synthroid online paypal
azithromycin 4 tablets
metformin cheapest price
mexican pharmacy what to buy
sterapred ds
rx lisinopril 10mg
lacolinaecuador.com
Fang Jifan은 옳았을뿐만 아니라 큰 고통을 겪었습니다.
azithromycin cheapest price in india
valtrex 1000 mg tablet
metformin 800
cheapest pharmacy to get prescriptions filled
prednisone 5 mg buy online
canadian pharmacies not requiring prescription
synthroid 20
azithromycin price in usa
gold pharmacy online
predisone no rx
buy valtrex online usa
happy family store
buy generic tadalafil uk
zestril 10 mg price
prednisone uk buy
tadalafil cialis
metformin 101
azithromycin for sale online
happy family med store
canadian pharmacy tadalafil online
canada cialis over the counter
purchase prednisone for dogs online without a prescription
online pharmacy birth control pills
valtrex order
exprimegranada.com
素晴らしい洞察力!いつも勉強になります。
where to buy metformin in south africa
cost of brand name synthroid
tadalafil 20mg canadian
indianpharmacy com
best european online pharmacy
where to buy tadalafil
happy family drugstore
azithromycin buy us
zithromax online usa no prescription
synthroid 150 mg
lisinopril generic price
valtrex over the counter usa
valtrex 1500 mg
prinivil price
synthroid tablet 125 mcg cost
sandyterrace.com
당신은 문학에 대해 아무것도 배우지 않았습니다.
lisinopril metoprolol
purchase cialis online canada
tadalafil online sale
mexico pharmacy order online
prednisone 500 mg
zithromax medicine
2 lisinopril
valtrex where to buy canada
30 mg cialis
metformin 750 mg price
buy valtrex without get a prescription online
prednisone for dogs
cyprus online pharmacy
azithromycin medicine over the counter
Real Money Earning Games in Kenya
best online casino games kenya casino games online for real money .
where to buy prednisone 20mg
price of synthroid 75 mcg
where to buy zithromax in canada
tadalafil 5mg tablets india
prednisone 1 tablet
buy cialis 40 mg
synthroid purchase online
reliable rx pharmacy
zestril 5 mg tablets
Earn Real Cash Playing Mobile Games in Kenya
best online casino games kenya best online casino games kenya .
synthroid 37.5 mg
lisinopril 20mg pill
prednisone 50mg cost
tadalafil online canada
synthroid 250 mcg tablet
where to buy azithromycin online
cost of prednisone pills
best price for tadalafil tablets
zovirax valtrex
synthroid 12.5 mcg order online
prinivil 10 mg
prednisone 60 mg tablets
valtrex 500 mg generic
buy tadalafil tablets
prednisone generic brand name
where to buy zithromax
azithromycin tablets 500g
rxpharmacycoupons
cost less pharmacy
where to buy cialis online canada
prednisone 5
happy family store in canada
canadian pharmacy generic viagra
buy cialis 100mg
largestcatbreed.com
Hongzhi 황제는 “아, 알겠습니다. “라고 고개를 저었습니다.
where can i buy valtrex online
In the bustling wonderful of music and sports, staying in the hoop with the latest news and developments is required inasmuch as fans and enthusiasts alike. Our blog provides a concise yet captivating stage where you can examine rousing updates from these dynamic realms – https://notes.io/wst68. Affect’s delve into what makes our blog a must-visit journey’s end championing those passionate here music and sports.
When it comes to music, we’ve got you covered with the freshest releases, artist spotlights, and unshared experience coverage. Lay eyes on unripe albums and singles across various genres, ensuring you’re forever in tune with the latest beats. Traverse the creative journeys and influences of emerging talents and established artists from one end to the other our insightful artist highlights. From loving performances to first-rate music festivals, our persevere incident coverage brings you front-row access to the most electrifying music experiences worldwide. Saloon into the music industry’s trends and technologies with our behind-the-scenes insights, oblation a deeper settlement of this vital field.
On the sports bearing, relive the shudder of critical games, tournaments, and championships toe our comprehensive game highlights and adept commentary. Learn about the notable stories behind your favorite athletes, from their rise to stardom to their moments of triumph and challenge. Running backstay educated give player transfers, trades, and band strategies with our timely updates on shift news. Whether it’s the Wonderful Dish, the Have Cup, or the Olympics, our blog delivers pleasing previews and recaps of the most substantial sporting events, capturing the ado and stagecraft that define these spectacles.
What sets our blog apart is our commitment to providing extensive, propitious, and winsome content. Whether you’re a music aficionado or a sports freak, our blog caters to separate interests within these vibrant realms. Our span ensures that you’re every time up-to-date with the latest word and stories, presented in an engaging and educational style. Glue our community of like-minded individuals, cut your thoughts, and associate with gazabo enthusiasts as we laud the occult of euphony and the quiver of competition. Slow tuned for captivating satisfy that informs, entertains, and inspires you on your music and sports overseas!
cialis generic from mexico
buy cialis online no prescription
metformin with out a prescription
azithromycin 1200 mg
best tadalafil prices
buy cheap metformin online
025 mg synthroid
how to order generic valtrex
buy metformin online india
cheap valtrex uk
buy metformin from mexico
cialis soft tabs canada
lisinopril brand name uk
lisinopril for sale
synthroid 1.5