Patient Centricity Archives - Marksman Healthcare

Patient-Centric Medical Affairs: Empowering Healthcare through Patient Engagement
The field of medical affairs is witnessing notable changes, with an increasing focus on enhancing the patient experience. Traditionally, medical affairs focused primarily on scientific communication and product promotion to healthcare professionals. However, there is now a notable shift towards becoming more patient-centric. This evolution prioritizes understanding patient needs, experiences, and outcomes, with the ultimate goal of improving the value proposition of both new and existing therapies.[1]

Several factors have contributed to the rise of patient-centricity in medical affairs. Patients today are increasingly informed and engaged in their healthcare decisions. They actively seek information online and participate in patient advocacy groups, necessitating effective communication channels to address their needs and concerns. Additionally, healthcare systems are transitioning towards value-based care models, where treatment effectiveness and patient outcomes play a more significant role in reimbursement decisions. Consequently, demonstrating the real-world value of therapy from a patient’s perspective becomes crucial. Regulatory agencies like the USFDA are also encouraging the inclusion of patient perspectives in drug development through programs like patient-centered drug development.[2]

Integrating patient-centricity into medical affairs offers several advantages. Understanding patient needs early in the development process allows for the design of more targeted and relevant clinical trials. It can also help identify unmet medical needs and guide research priorities. By incorporating patient perspectives into regulatory submissions, companies can strengthen their applications and potentially expedite approval timelines. Patient-centric medical affairs help build a compelling value story for a drug by demonstrating its real-world benefits and impact on patient lives. This can be particularly crucial in negotiations with payers for coverage and reimbursement. Addressing patient concerns and ensuring they understand the treatment options available can facilitate better access to new medications. Additionally, patient-centric programs can improve medication adherence and optimize treatment outcomes. By demonstrating a commitment to patient well-being, pharmaceutical companies can build stronger relationships with patients and healthcare professionals, fostering trust and brand loyalty.[3]

However, the transition towards patient-centric medical affairs presents several challenges that need to be addressed. One significant challenge is data privacy and security. Safeguarding patient data is critical to maintaining trust and compliance with regulations. Robust data governance processes and adherence to stringent privacy protocols are essential to protect patient confidentiality while leveraging data for insights. Another challenge is engaging representative patient populations. Ensuring diverse representation in research and advocacy activities is crucial for capturing comprehensive patient perspectives. Overcoming barriers such as language, culture, and socioeconomic status requires innovative approaches to recruitment and engagement.[4, 5]

Resource allocation poses another challenge. Adopting a patient-centric approach often requires additional investments in patient engagement initiatives and skill development within medical affairs teams. Balancing competing priorities and budget constraints requires strategic planning and alignment with organizational objectives. Regulatory compliance and ethical considerations also present challenges. Health Insurance Portability and Accountability Act (HIPAA) and the General Data Protection Regulation (GDPR) are imperative to protect patient rights and mitigate legal risks. Moreover, the digital divide and accessibility issues must be addressed. Ensuring that patient-centric initiatives are accessible to all patients, regardless of their digital literacy or access to technology, requires inclusive design and alternative communication channels.[4]

To overcome these challenges, several solutions can be implemented. Robust data governance frameworks and privacy protocols can safeguard patient data while enabling meaningful insights. Innovative recruitment strategies, such as community partnerships and targeted outreach, can enhance the representation of diverse patient populations. Strategic resource allocation, guided by clear priorities and organizational objectives, ensures effective implementation of patient-centric initiatives. Collaboration with regulatory experts and adherence to ethical guidelines ensure compliance and uphold patient rights. Moreover, adopting inclusive design principles and leveraging diverse communication channels can enhance accessibility and address the digital divide.[4]

In conclusion, while the transition towards patient-centric medical affairs presents challenges, addressing these hurdles through strategic planning, collaboration, and innovation can unlock the full potential of patient engagement. By overcoming these challenges and implementing effective solutions, pharmaceutical companies can truly empower patients, improve healthcare outcomes, and drive meaningful change in the medical affairs landscape.

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References
1. Ashkenazy R. Building the case for developing a medical affairs patient-centric framework collaboratively. Drug Discovery Today. 2020 Mar 1;25(3):475-9.
2. Robbins DA, Curro FA, Fox CH. Defining Patient-Centricity: Opportunities, Challenges, and Implications for Clinical Care and Research. Ther Innov Regul Sci. 2013 May;47(3):349-355. doi: 10.1177/2168479013484159. PMID: 30231434.
3. Yeoman G, Furlong P, Seres M, Binder H, Chung H, Garzya V, Jones RR. Defining patient centricity with patients for patients and caregivers: a collaborative endeavour. BMJ Innov. 2017 Apr;3(2):76-83.
4. Pharma Medical affairs and patient-centric outcomes. ZS [Internet]. Available from: https://www.zs.com/insights/medical-affairs-drive-patient-centric-outcomes-experience-journey.
5. Amin D, Vandenbroucke P. Advancing patient-centricity in medical affairs: a survey of patients and patient organizations. Drug Discovery Today. 2023 May 2:103604.
MarksMan Healthcare

March 28, 2024

Healthcare Transformation, Medical Affairs, Patient Centricity, Patient Engagement, Value-Based Care
Innovation in Rare Disease Research through Integration of Real-World Evidence in HTA
For individuals grappling with rare diseases, finding effective treatment options can be an overwhelming challenge. The conventional pathways of drug development, tailored for larger patient cohorts, encounter numerous obstacles in the context of rare diseases. This leads to delays in innovation and impedes access to potentially life-changing therapies. Fortunately, the emergence of real-world evidence (RWE) offers a promising solution to overcome these challenges and reshape the landscape of innovation in rare diseases.[1]

The term “rare disease” encompasses a diverse array of conditions affecting a limited number of individuals. This small patient population presents a substantial hurdle for traditional clinical trial design, which relies on large cohorts to establish statistically significant efficacy and safety. Recruiting an adequate number of participants for rare disease trials is a time-consuming and expensive process, often necessitating international collaboration and specialized expertise. Additionally, the heterogeneity of rare diseases, with their varied presentations and disease trajectories, further complicates the development process.[1]

The traditional HTA process relies heavily on data generated from controlled clinical trials, which may not adequately capture the complexities and variabilities associated with rare diseases. Moreover, the rarity of these conditions often means that traditional clinical trials include a limited number of patients, making it challenging to generate statistically significant results. This limitation not only hampers the regulatory approval of new drugs but also affects the subsequent HTA evaluations.[2]

RWE offers a powerful tool to address these challenges and accelerate innovation in rare disease research and development. RWE encompasses data collected outside of traditional clinical trials, including electronic health records, claims databases, patient registries, and wearable devices. RWE empowers regulatory agencies and HTA bodies, offering the potential to streamline the approval and reimbursement processes for innovative drugs in rare diseases.[2,3]

RWE can be used to quantify the unmet medical need by providing valuable insights into the prevalence, burden, and impact of rare diseases. This data not only highlights the necessity for new treatment options but also informs cost-effectiveness analyses, estimating the costs associated with rare disease management and potential cost savings from innovative treatments. Additionally, RWE contributes to evaluating the long-term value of therapies, offering insights into their impact on patient outcomes and healthcare utilization. This comprehensive approach aids HTA bodies in assessing the overall value proposition of new therapies, ultimately expediting access to effective treatments for patients in need.[3]

RWE significantly drives innovation for rare diseases, offering diverse benefits. Firstly, RWE can be used to identify and recruit patients who meet specific inclusion criteria, even for geographically dispersed populations, leading to faster and more efficient trial completion. Additionally, RWE supports adaptive pathways that align with personalized medicine. This approach allows continuous learning and adaptation based on real-world experiences, tailoring treatments to individual patient characteristics and needs.[3,4]

The integration of RWE into HTA processes brings forth a range of advantages, yet it is not without its challenges. Notably, the quality and standardization of real-world data emerge as critical considerations, demanding continuous efforts to establish common standards and enhance data quality for credible HTA evaluations. Additionally, the reliance on patient data from real-world settings in RWE necessitates a delicate balance between data access and patient confidentiality, highlighting the ongoing challenge of addressing privacy and ethical concerns.[3]

Education and adoption present another layer of complexity, with stakeholders such as regulatory agencies, HTA bodies, healthcare professionals, and pharmaceutical companies requiring comprehensive awareness of the benefits and limitations of RWE. This underscores the need for active promotion and facilitation of RWE adoption in decision-making processes. In the context of rare diseases, these challenges are amplified, prompting innovative approaches to evidence generation.[3]

To fully harness the potential of RWE in rare disease research and HTA, the establishment of a robust infrastructure is imperative. This involves standardizing and harmonizing data collection, analysis, and reporting across different sources to ensure reliable and comparable evidence. Investment in technologies that facilitate data sharing and integration from diverse sources is essential for enhanced data capture. Building trust in RWE necessitates transparency in data sources, methodologies, and limitations, requiring open dialogue with patients, researchers, and HTA bodies. Additionally, clear regulatory guidelines and frameworks for utilizing RWE in HTA decisions are crucial, providing developers and researchers with the necessary clarity and fostering greater use of RWE.[4,5]

The integration of RWE into HTA has the potential to reshape the landscape of rare disease innovation. By providing a more comprehensive understanding of treatment effectiveness, safety, and cost-effectiveness in real-world settings, RWE can address the limitations of traditional clinical trials and expedite the development and access to innovative therapies for rare diseases.

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References
1. Dang A. Real-World Evidence: A Primer. Pharmaceut Med. 2023 Jan;37(1):25-36.
2. Graili P, Guertin JR, Chan KKW, Tadrous M. Integration of real-world evidence from different data sources in health technology assessment. J Pharm Pharm Sci. 2023 Jul 17;26:11460.
3. Hampson G, Towse A, Dreitlein WB, et al. Real-world evidence for coverage decisions: opportunities and challenges. Journal of comparative effectiveness research. 2018 Dec;7(12):1133-43.
4. Field MJ, Boat TF. Development of new therapeutic drugs and biologics for rare diseases. InRare Diseases and Orphan Products: Accelerating Research and Development 2010. National Academies Press (US).
5. Boat TF, Field MJ, editors. Rare diseases and orphan products: accelerating research and development. National Academies Press; 2011 Apr 3.
MarksMan Healthcare

January 12, 2024

HTA, Patient Centricity, Rare Disease, RWE
The Role of Medical Affairs in Precision Medicine Advancements
The healthcare landscape is undergoing a substantial transformation propelled by precision medicine. This change has necessitated Medical Affairs (MA) to pivot towards personalized healthcare, departing from the conventional product-centric approach. As a result, patients become the focal point, positioning MA as a key player in navigating the intricacies of precision medicine.[1]

The integration of artificial intelligence provides healthcare professionals with unparalleled capabilities. Medical Affairs (MA) teams, equipped with advanced analytics tools, not only decipher intricate landscapes but also actively engage with patients. This patient-centric strategy transforms MA from mere ‘product promoters’ to ‘strategic partners,’ fostering a more rewarding and impactful healthcare journey. The success of precision medicine relies on MA forging robust partnerships with diverse stakeholders. MA’s active involvement in co-creation workstreams with patients and collaboration with advocacy groups proves instrumental, shedding light on unique challenges and contributing to early diagnosis and improved outcomes.[2]

Despite the immense promise, precision medicine encounters challenges such as ethical considerations, data privacy, and healthcare disparities. Here, technology emerges as a guiding force. Data encryption safeguards patient information, while telemedicine and digital communication tools bridge geographical gaps, ensuring accessibility to specialized care. The economic implications of precision medicine, including potential cost savings, necessitate a strategic evolution in reimbursement models. MA’s role becomes pivotal in navigating this terrain, ensuring financial sustainability for both providers and patients. This places MA at the forefront of shaping the economic landscape of precision medicine.[3]

Crafting a strategic vision for MA organizations within the context of precision medicine demands a comprehensive approach based on key pillars of excellence. This evolution in the healthcare landscape, driven by precision medicine, necessitates reevaluating MA’s role in bridging the gap between internal R&D and the commercial organization. In the era of value-based care, MA demonstrates therapeutic value throughout a product’s lifecycle, by generating evidence-based value indicators, shaping treatment protocols, and collaborating with health economics and outcomes research (HEOR) groups. Aligning R&D efforts with unmet clinical needs becomes paramount through a patient-centric development strategy. As the conduit for influencing early-stage R&D, MA transforms patient data into actionable insights, driving innovation.[4]

MA is responsible for coordinating medical and scientific exchange, becoming a central player in engaging with key thought leaders, disseminating educational information, and supporting investigator-led research initiatives. Moreover, MA assumes a lead role in managing the benefit-risk ratio, shaping corporate risk tolerance, focusing on proactive initiatives, and communicating risks transparently. This strategic shift positions MA as a guardian of the industry’s commitment to driving health rather than merely profits.[4]

The cornerstone of a transformative MA organization resides in its ability to generate compelling evidence. This involves harnessing data and analytics advancements to exert influence across various crucial aspects, including development, commercialization, and treatment paradigms. In essence, evidence generation within MA entails the systematic collection, analysis, and interpretation of data to produce valuable insights. The impact of evidence generation extends to the developmental phase of medical interventions. MA leverages robust evidence to inform and shape the trajectory of research and development efforts. This involves identifying patient needs, understanding treatment efficacy, and delineating the potential economic and clinical impact of novel medical solutions.[5]

MA facilitates a strategic shift towards scientific exchange, emphasizing understanding and solving patient problems rather than traditional marketing approaches, both internally and externally. Leveraging technology, MA ensures the delivery of relevant and accurate information, anticipating the needs of each stakeholder group. This shift promises a future where every patient receives the most effective treatment tailored to their unique needs, leading to a healthier and more equitable healthcare system.

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References
1. Ginsburg GS, Phillips KA. Precision medicine: from science to value. Health affairs. 2018 May 1;37(5):694-701.
2. Weil AR. Precision medicine. Health Affairs. 2018 May 1;37(5):687-.
3. Yang H, Khatry DB. Reinventing Medical Affairs in the Era of Big Data and Analytics. InData Science, AI, and Machine Learning in Drug Development 2022 Oct 3 (pp. 245-263).
4. Shepard KV, Kremer C, Sundem G, editors. Medical Affairs: The Roles, Value and Practice of Medical Affairs in the Biopharmaceutical and Medical Technology Industries. CRC Press; 2024 Jan 30.
5. Farrington AD, Frøstrup AG, Dahl P. The Value and Deliverables of Medical Affairs: Affiliate Perspectives and Future Expectations. Pharmaceutical Medicine. 2023 Nov;37(6):417-24.
MarksMan Healthcare

January 11, 2024

Healthcare Transformation, Medical Affairs, Patient Centricity, Precision Medicine
How Innovative Alternate Payment Models Are Bringing Change In Healthcare?
Drug prices in the US are the highest in the world, which necessitate new or alternate payment approaches. For instance, the new treatments for hepatitis C virus (HCV) infection are highly effective and very expensive at the same time, at least from the view of many payers, physicians, and patients. Even 5 years after these drugs were introduced, only 15% of the estimated population of more than 3 million HCV patients in the US have been treated. This can also be due to budgetary constraints of the state Medicaid programs. (1)

In the example stated above, the ideal way to treat the HCV infection would be at the population level, treating every patient possible, at a possible speed. Since the medicine is shifting towards value-based care day by day, it is essential for patients and physicians to have flexible, innovative, and practical payment models that would facilitate better outcomes. As a result, many industry stakeholders are predicting the introduction of new alternate payment models (APMs) that are in being developed currently and will possibly be rolled out later this year. Moreover, the Centers for Medicare and Medicaid Innovation (CMMI) is responsible for the assessment of alternative payment models (APMs), such as bundled payment models that would reduce program expenditures under Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) in order to increase quality and efficiency. (2) In addition, with the support of increasing evidence and momentum, APMs are the precise solution to today’s cost and quality challenge in healthcare. They promise to bend the healthcare cost curve to achieve a sustainable, long-standing future for Medicare and reasonably priced private coverage. (3)

Having said that, Medicaid programs in several US states have limited access to treatment. For instance, Louisiana State only treated 384 HCV patients last year (2017-18) out of an estimated 35,000 Medicaid beneficiaries carrying the virus. Consequently, the Centers for Medicare and Medicaid Services (CMS) warned the states about possible violation of statutory Medicaid requirements owing to restricted access to hepatitis C treatments. (4)

However, as a solution, Louisiana State is soon adopting the ‘Netflix Model’ that involves a licensing deal, to expand access to treatment. As per this model, instead of paying for each prescription individually, the State would pay the drug company a subscription fee for medication for several years in exchange for unlimited access to treatment, just like the consumers paying a monthly fee to stream unlimited television shows and movies. (4,5) This ‘Netflix Model’, when applied to health care, makes a lot of sense. This is because the pharmaceuticals R&D costs can be high, but the manufacturing costs, much like software, are often low. Netflix content is essentially purchased through a monthly license, where the consumers are not charged a fee every time to view a show. The basic idea here is to incentivise the content creator, not limiting the ability to watch since marginal costs are low. (4)

Similar to the ‘Netflix Model’, researchers have also proposed drug-licensing models for health care that promise increased drug use without altering patients’ out-of-pocket spending, health plans’ costs, or drug companies’ profits. These models are based on an idea of buying annual drug licenses to ensure unrestricted access to a clinically optimal number of prescriptions over the course of a year. (6) Furthermore, new efforts are in progress in Massachusetts to figure out ways to pay for the potential million dollar price tag for an experimental one-time therapy designed to treat the devastating, rare disease of spinal muscular atrophy and its underlying genetic cause. Even in this case, similar to the ‘Netflix Model’, the health insurers are considering to pay for the treatment over several years, which if succeeded, could hopefully prove to be a viable model for the entire US. (7) Here, Novartis’s AveXis unit, the manufacturer of the gene therapy Zolgensma, has suggested a price tag of up to $5 million, and is in talks to participate.

Evidence from literature has shown such subscription models to improve outcomes and save money at the same time. Subscriptions can better balance the public health interest in gaining rapid, extensive and inexpensive access to these drugs than traditional fee-per-dose reimbursement. This can further ensure that manufacturers’ generate enough revenues to justify the drugs’ development costs. (4-6)

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References
1. Trusheim MR, Cassidy WM, Bach PB. Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model”. JAMA 2018; 320(19):1977-1978.
2. Landi H. Are New APMs from CMMI Coming Soon? Industry Stakeholders Forecast Bold Moves from the CMS Innovation Center in 2019.
3. Leavitt MO. Alternative payment models in healthcare are a must. January, 2017.
4. Goldman DP. When we find a cure, price it like Netflix to ensure access. September, 2018.
5. Johnson CY. Louisiana adopts ‘Netflix’ model to pay for hepatitis C drugs. January, 2019.
6. Goldman DP, Jena AB, Philipson T, et al. Drug licenses: A new model for pharmaceutical pricing. Health Affairs 2008; 27(1).
7. Court E. A revolutionary drug that could treat a rare and devastating disease is prohibitively expensive. But one state has a plan to pay for its potential $5 million price tag. January, 2019.
Written by – Ms. Tanvi Laghate
MarksMan Healthcare

January 18, 2019

Affordable Medicines, Drug pricing, Market Access, Patient Centricity, Value Based Healthcare
How Well are we Able to Quantify ROI from Patient Centric Activities?
In recent years, patient-centric initiatives are becoming key factors among healthcare companies, as they are increasingly becoming aware of the fact that the key to growing business and improving customer health is to better focus on the needs and concerns of the patient, rather than attending to just the product approval. The objective behind patient-centric drug development and other associated initiatives is to involve patients and the healthcare community as partners in order to bring about a sense of ownership in the success of new medical treatments. (1,2) There are four core principles that frame the growing arsenal of patient centric initiatives: (3)
1. Relevance: Unmet medical needs identified in collaboration with and based on input from patients and their healthcare support network
2. Pragmatism: Agendas and clinical trial designs recognised and accommodated in real-life patient and healthcare community needs and experiences
3. Feasibility: The burden of study participation minimised and supported by initiatives that improve convenience
4. Interactivity/Participation: Patient’s voice responded with the support from patient community, and giving the patient community an opportunity to be actively involved throughout the research process by amplified planning and execution
Adherence to the above principles facilitate patient-centric drug development to encourage the sharing of important information and drug development risk among a broader community of external partners e.g., academic and basic research groups, co-development sponsors, development operations alliances, and patient advocacy groups. (3)

A growing number of researchers are adapting to patient-centric initiatives across multiple studies, which can eventually be used while centrally monitoring and coordinating activities. This can further promote harmonization and can also better assist in communicating lessons learned from earlier implementations and from peer companies. Such activities can also help in deriving consensus metrics to evaluate the impact of various initiatives on organizational and study-level processes and performance. (3,4)

Return on investment (ROI) expectations are required to consider a reasonably long-term view. This is because researchers need enough time to collect experience with patient-centric initiatives, learn from mistakes while continuously processing their use. Ideally, target measures from multiple representative studies should be gathered two to three years prior to and after the implementation of initiatives. Stakeholders use some key implementation and ROI metrics to measure three broad areas, viz. reach; patient/study volunteer feedback; and performance. (3)
- Reach measures (e.g., number of pilot initiatives, number of planned initiatives, etc.) are usually quantitative, having an aim to assess the extent of adoption and usage within organisations, along with the number of patients and study volunteers who have participated in a given initiative.
- Patient/study volunteer feedback measures (such as ratings, etc.) are more often qualitative in nature; however, several organisations do implement a few quantitative feedback measures as well. Qualitative measures examine the subjective reports of satisfaction; sense of involvement in a given study or in association with a specific initiative, and the perceived relevance of specific clinical trials; while quantitative measures determine efficiency of patient/study volunteer participation in facilitating change. (3,4)
- Performance measures (viz. screen failure rates, number of procedures per visit or protocol amendments, etc.) are quantitative and they largely compare studies, whether or not they include the usage of patient-centric initiatives or not. (3)
We feel that it is too early to conclude on this aspect, as there is inadequate data demonstrating the extent and impact of patient-centric initiatives, across the industry. Needless to mention that patient-centricity movement is certainly inspiring the drug development enterprise to challenge and transform the traditional drug development prototype by putting the patient at its core.

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References
1. Lopez Kunz B. Trial Return On Engagement: Quantifying Benefits Of Patient-Centric Initiatives. Clinical leader. June, 2017.
2. A patient-centric approach: Patient-centric initiatives in drug development. March, 2017.
3. Getz KA. ROI for patient-centric drug development. Applied Clinical Trials. August, 2015.
4. Gets K. The transformative promise of patient centric R&D. May, 2015.
5. Markowitz FE. Involvement in mental health self-help groups and recovery. Health sociology review : the journal of the Health Section of the Australian Sociological Association 2015; 24(2):199-212.
MarksMan Healthcare

July 3, 2018

Patient Advocacy, Patient Centricity, Patient Outcomes, Patient Reported Outcomes
What are the Strategies for Effective Retention in Clinical Trials?
The most recent evidence shows patient recruitment and retention issues to be a persistent problem in clinical trials. Also, it is almost certain that this problem will only continue to grow as the years go on. (1,2) Missing data is often due to patients being lost to follow-up or withdrawing before data collection time points, difficulties in measuring and recording outcomes for patients who are retained, incomplete or missing patient reported outcomes (PRO), or exclusion of data from randomized patients from the analysis population. Loss of participants during trial follow-up leads to bias, thus reducing power that affects the generalizability, validity and reliability of results. While losses fewer than 5% may lead to minimum bias, 20% loss can threaten trial validity. (3,4)

Findings from a recent Delphi survey showed that identifying methods to improve recruitment was a top methodological research priority, whereas methods to minimize attrition and the development of core outcome sets came second. (5) These priorities are set with an aim to minimize waste in research, ensuring robust and cost-effective trials. This can primarily achieved by maximizing the retention of all recruited patients in the study as well as the collection, analysis and reporting of a complete set of outcomes. (6)

Insufficient recruitment considerably impacts the scientific and financial viability of an RCT. The possibility of leading to a type 2 error (incorrect conclusion, with no significant difference between treatment groups) increases if the estimated sample size target is not met. Sufficient patient enrolment accounts for a base for projected retention of patients, which further helps in evaluation of patient data, thereby resulting in extension of trial period and increase in the study cost. This may lead to a level of uncertainty about the treatment efficacy, while also resulting in delay for a potentially effective therapy. Slowly gathering trial evidence may impact the financial investment of the funding agency, thus making a way for lesser reliability but more rapid approach to evaluation. (1,4)

For effective conduct of RCTs, the barriers to recruitment must be identified and potential strategies should be devised to improve the same in clinical trials. Consequently, trial researchers assume various strategies for improving patient retention and generating maximum data return or compliance to follow-up procedures. These strategies are often implemented to motivate and keep participants or site clinicians engaged in a trial. Few global studies determining the retention-related issues suggest strategies, such as piloting the recruitment process, financial and educational incentives for clinicians as well as patients, newsletters and reminders for patients, open- versus placebo-controlled trials, assistance with patient travel, and networking with various healthcare professionals. (7,8)

Some trial researchers have opined for increasing retention in trials. One such suggestion is good monitoring process for data collection in order to identify and address any problem that might facilitate retention, e.g. telephonic reminders. Training and working with local research site staff to minimize missing data is strongly recommended. (8)

Additionally, one of the oldest and largest problems faced by patient recruitment is the extent of awareness among general public about clinical trials. Thus, the more aware clinical trial patients are about the study, the more inclination they show towards signing up for it. It’s ethically wrong to directly encourage a patient to commit to a clinical trial, which is why the emphasis should be on education and not persuasion. Also, just the basic information has been shown to increase the likelihood of participation. Furthermore, doctors can play an important role in generating awareness, as they are at the front line of care and are trusted to provide the best care possible, which clinical trials often represent. Moreover, a common practice by the pharmaceutical industry to educate as many people as possible, by casting a broad net, would also help increasing the patient retention. (8,9)

The common cure for retention challenges is interaction with patients. The buzzword that is making rounds throughout the industry since last few years, when it comes to underlining patient communication and comfort, is ‘patient centricity’. It’s a contested term as to its actual application, but it implies for whatever method successfully involves the patient to a greater extent within the trial. (9)

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References
1. Kadam RA, et al. Challenges in recruitment and retention of clinical trial subjects. Perspectives in Clinical Research 2016; 7(3):137-143.
2. Toerien M, et al. A review of reporting of participant recruitment and retention in RCTs in six major journals. Trials 2009; 10:52.
3. Dettori JR. Loss to follow-up. Evidence-Based Spine-Care Journal 2011; 2(1):7-10.
4. Kearney A, et al. Identifying research priorities for effective retention strategies in clinical trials. Trials 2017; 18:406.
5. Tudur Smith C, et al. The trials methodological research agenda: results from a priority setting exercise. Trials 2014; 15(1):32.
6. Salman RA-S, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383(9912):176–85.
7. Robinson KA, et al. Systematic review identifies number of strategies important for retaining study participants. J Clin Epidemiol 2007; 60:757.
8. Brueton VC, et al. Strategies to improve retention in randomized trials: a Cochrane systematic review and meta-analysis. BMJ Open 2014; 4:e003821.
9. Clinical trials and their patients: The rising costs and how to stem the loss. Pharmafile, 2016.
MarksMan Healthcare

May 6, 2018

Clinical Research, Clinical Trials, Patient Centricity
Is India Gearing up for Patient Centric Healthcare Model?
Following the recent announcement by PM Narendra Modi hinting at a legal framework for doctors to prescribe generic medicines cheaper than equivalent branded generic drugs, doctors appeared to welcome the move and opined that it will benefit patients as the life-saving drugs could be obtained at much cheaper rates. (1,2)

In reality, India being the largest supplier of generic medicines globally (20% of global export volume); the quality of the generics should not be an issue. Generic drugs dominate India’s pharmaceutical space, wherein generics account for about 70% of the market. Also, India accounts for approximately 30% (by volume) and about 10% (value) in the US$ 70-80 billion US generics market. Therefore, quality of the manufacturing has got nothing to do with branding. It is purely a manufacturer’s decision and ability enforced by law which is paid for by the customer. (3)

However, PM Modi did attract the wrath of many following the announcement. This is because a lot of doctors questioned the accessibility and quality of the generic drugs. However, many feel this to be just an excuse, as doctors fear that this move would upset their nexus with the drug companies. (4,5) Furthermore, industry associations reaching out to the health ministry, hoping to approach the PMO to prevent the law from being passed, were opposing proposal on the grounds that the onus of decision-making (what patients should consume) would shift from doctors to chemists. This group further pointed out that the chemists are unregulated and have no ethical or commercial obligation on what they sell patients. However, the Ministry of Health and Family Welfare announced to seek only qualified candidates in the workforce. (6)

Consequently, the health ministry has made bio-equivalence (BE) studies mandatory for all drug manufacturers before launching any generics in the market. This is primarily to guarantee the same quality and efficacy of generics as their branded counterparts. The health ministry has also issued a gazette notification to this effect. (7)

Frankly, this move is worth applauding for, since it will ensure the quality as well as appropriate distribution of the generic drugs. This is because most of the doctors have been avoiding generic prescriptions in the name of lack of quality; while actually focusing on the incentives from the pharma marketing.^iv On the other hand, in reality, prescribing generics would only benefit the patient in terms of both quality and affordability. But going by certain decisions the government has made since last couple of years, we can surely say that India has started accepting the patient-centric healthcare model.

Big pharma players and even the smaller (generic manufacturers) ones need to think of ways to rebrand themselves. Certainly, not every company can manufacture a drug for every possible disease condition; however, the future of pharma business is predicted to go by branding based on robust ’therapy area’ leadership. For instance, Mylan Pharmaceuticals, the biggest generic drug manufacturers globally, has been manufacturing more Parkinson’s medicines than any other company in the world. (8) Furthermore, small players will have to invest money in proper and ethical ways of marketing, i.e. publishing results from BA/BE studies to prove the similar efficacy of generics with reference to their branded counterparts. (9)

It has always been a patient-centric approach. The solution to all these complications is ‘patient empowerment’. Doctors primarily make diagnosis; they cannot polarize patients to earn their own incentives from the pharma players. Also, learned chemists/pharmacists should hopefully provide patients with cheaper generics. In the end, it is patients who must choose what is right for them.

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References
1. Chatterji S. Modi says govt will bring law to push doctors to prescribe generic medicines. Hindustan Times. April, 2017.
2. PTI. PM Narendra Modi Hints At Rules For Doctors To Prescribe Generic Drugs. NDTV India. April, 2017.
3. Pharmaceutical Exports From India. India Brand Equity Foundation (IBEF). October, 2017.
4. Pardasani S. Health for all: Not just Prime Minister’s call. Mumbai Mirror. April, 2017. Available at:
5. Kaul R. Doctors welcome move to prescribe generic drugs, say accessibility may be an issue. Hindustan Times. April, 2017.
6. Rajagopal D. `Chemists, and Not Doctors, Could Decide Brand of Drug Use’. The Economic Times. April, 2017.
7. Thacker T. Health ministry warns on rushed implementation of generics plan. livemint. August, 2017.
8. Mylan Receives FDA Approval for Generic Version of Parkinson’s Treatment Parcopa® ODT.
9. Phukan RS. Generic drugs in India: More awareness required. November, 2014.
MarksMan Healthcare

April 25, 2017

Affordable Medicines, Healthcare Policy, Patient Access, Patient Centricity