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  • How Important is to Maintain Clinical Trial Transparency?

    How Important is to Maintain Clinical Trial Transparency?

    Clinical trials lay the foundation for the biomedical research enterprise. They not only assess the applicability of innovative laboratory findings in humans, but also generate robust evidence on treatments and/or preventive interventions in routine clinical care. Clinical trials also directly engage human participants, who trust the investigators to maintain utmost scientific as well as ethical knowledge. Although clinical trials continue to evolve and produce advanced evidence on diagnosis and treatment, the industry is posed with quite some challenges. As a result, significant changes are essential in order to reflect improved efficiency, accountability, and transparency in clinical research. (1)

    Clinical Trial Disclosure is a complicated challenge faced by nearly all the clinical trial sponsors worldwide. Along with the intricate task of managing vigorous clinical trial data and working with ever-changing global regulatory requirements, the sheer quantity of trials being conducted today only amplifies the difficulty of this task. Moreover, clinical trial transparency has gained importance to have a premeditated and operational impact on a sponsor organization, and eventually healthcare providers and patients. (2)

    Regardless of countless efforts to address the issues like inconsistent or selective reporting of biases, about half of all clinical trials conducted and completed during past few decades have reportedly never had their results published. This lack of transparency can certainly lead to serious implications for patients, providers, and health systems. Despite failed efforts, latest initiatives in the United States as well as other developed countries offer new prospects to address unresolved issues. The recent past has witnessed an explosion of trial disclosure requirements and expectations around the world. (3)

    Additionally, these requirements to maintain clinical trial transparency continue to evolve and expand. Consequently, these ever-changing requirements invite new challenges, generating added opportunities for knowledge-sharing and requiring more interaction with peers. (4) To cite an example, regulatory authorities along with researchers and the AllTrials clinical trial data transparency campaign (among others) are pressurizing the life sciences industry to willingly provide access to patient-level data and results from clinical trials to base the regulatory decisions on. Although data sharing is gaining momentum, if ignored, regulatory authorities may require complete public disclosure of the information from clinical trials information; which, in a way, provides wide access to researchers conducting valid scientific inquiry. Such instances pose a concern of disclosure of proprietary information to competitors. Clinical trial data transparency enables qualified researchers to validate clinical trial results, improve the effectiveness of clinical trials and make progress in the medical knowledge. Furthermore, data sharing can potentially improve public health, while also increasing public trust in clinical research and the healthcare industry. (5)

    Having said that, the aspect of clinical trial disclosure is gaining importance owing to the risks associated with non-compliance. It goes without saying that non-compliance will have serious consequences, such as penalties in the form of withheld grants, public warnings as well as fines issued by the FDA, rejection of manuscripts by the ICJME, and so on. Transparency is certainly an important effort, which has calculated and functioning impact on a sponsor organization. Therefore, sponsors as well as the related stakeholders must pledge to monitor emerging regulations and registry requirements consistently by allocating resources, recognising roles and responsibilities, and developing training and communication programs that are in line with their disclosure and compliance objectives. A well-coordinated approach will typically require the implementation of technologies along with process changes; particularly those that help manage the resources, tasks, and content within one environment to help in order to centralize and optimize the disclosure processes. These measures can curtail the risk of non-compliance, thus ensuring consistency of publicly-available data as well as reducing the resource requirements for managing and tracking disclosure information. Ultimately, it will mainly impact healthcare providers and patients in the sense that new information will be available that might impact their care. Organizations must always acknowledge the public need for access to clinical trial information.2

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    References

    1. Hudson KL, Lauer MS, Collins FS. Toward a New Era of Trust and Transparency in Clinical Trials. Jama 2016; 316(13):1353-1354.
    2. Wicks T. Clinical Trial Transparency: The Stepping Stones To Disclosure. June, 2015.
    3. Richardson E. Transparency in clinical research. January, 2016.
    4. Drug Information Association- DIA.
    5. SAS. Increase Transparency for Clinical Trials to Improve Public Trust.

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  • What are the Strategies for Effective Retention in Clinical Trials?

    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.

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  • Generating Scientific Evidence (Efficacy/Safety/Cost Data) from India

    Generating Scientific Evidence (Efficacy/Safety/Cost Data) from India

    Every country exercises strict control on medicines’ market access. Typically, this requires successful completion and adequate presentation of results from phase I through phase III clinical trials, bringing forward the findings of medicine’s safety and efficacy. The USFDA approves approximately 40 new medicines for the US market each year through this process. (1) In India, this number is more than 100 new medicines annually; however, there is not enough published evidence on submitted applications or summaries of approved medicines. Therefore, concerns are being raised about the safety and efficacy around medicine approvals in India in the absence of appropriate clinical trials. (2,3)

    For instance, a recent study, which evaluated the clinical evidence on the safety and efficacy of the most common metformin fixed dose combinations (FDCs) for T2DM in India, has highlighted the growing national and international concerns about the Indian drug regulatory system. Findings from this study further show high numbers of unapproved medicines and their irrational combinations floating in the market. This study has assessed the basis of efficacy and safety of top-selling metformin FDCs in India against four WHO criteria from clinical trial guidelines for the approval of FDCs. In India, only five FDCs have been approved by the Central Drugs Standard Control Organization (CDSCO); while, in reality, the Indian FDC-diabetes market contributes to the two-third of all diabetes medicine sales. (4) Furthermore, evaluation of published and unpublished clinical trials of these approved FDCs seemed to show underpowered and poor quality evidence of safety and efficacy for the treatment of T2DM. (5)

    The overall lack of available India-specific evidence heightens the need for its generation by publishing the unpublished trial results with Indian patients. India has in place the only required registration with Clinical Trials Registry – India, the national clinical trials database, since 2009. Moreover, the unpublished trials listed in this registry merely provide basic trial information with no results or outcomes reported. The lack of trials on Indian patients, in particular, is of concern, considering CDSCO’s guidelines for drug approvals acknowledge the importance of conducting trials on the Indian population to determine safety and efficacy.4

    Additionally, the Government, with an aim to achieve Universal Health Coverage (UHC) in order to reduce huge out-of-pocket (OOP) health expenditure and ensure affordable access to essential health care for the entire population, has identified a key priority of ensuring value for money in the health budget. This requires a systematic process for generating policy-relevant evidence that can inform policy decisions regarding health resource allocation, i.e. clinical effectiveness studies, cost-effectiveness studies, budget impact studies, along with ethical, social and political feasibility studies. (6) Needless to say that the healthcare payers, regulatory authorities, and health technology assessment (HTA) agencies also make decisions on relative efficacy of the new products based on evidence generated from clinical trials. (7)

    In most western countries along with the United States, the consumer rarely pays for the product—the payer is generally a third-party private or governmental insurer. Before approving a new medical entity (medicines/medical technologies) for reimbursement, private and governmental payers analyze clinical and economic data to determine the clinical value and cost-effectiveness of the new product as compared with currently available treatments. (8) Indian health system, on the other hand, is characterized by a vast but under-utilized public health infrastructure and a largely unregulated private market catering to greater need for curative action; where high OOP health expenditures hinder access to healthcare. (9)

    We believe it is high time even insurance companies start asking for robust evidence in order to provide reimbursement of better healthcare technologies and easier access to care. India needs to bring about a major reform in its health insurance policies, wherein a keen eye for detail is given to the published trial data on safety and efficacy of a drug or relevant evidence about a medical technology.

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    References:

    1. U.S. Food and Drug Administation. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products.
    2. Ministry of Health and Family Welfare, Department of Health and Family Welfare. Gazette of India, 10 March 2016. New Delhi, 2016.
    3. McGettigan P, et al. Regulatory upheaval and irrational medicines in India: a study of fixed-dose combination drugs. PLoS Med 2015; 12:e1001826.
    4. Evans V, et al. Adequacy of clinical trial evidence of metformin fixed-dose combinations for the treatment of type 2 diabetes mellitus in India. BMJ Glob Health 2018; 3:e000263.
    5. Shimpi RD, et al. Comparison of effect of metformin in combination with glimepiride and glibenclamide on glycaemic control in patient with Type 2 diabetes mellitus. Int J PharmTech Res 2009; 1:50–61
    6. Prinja S, et al. Health Technology Assessment for Policy Making in India: Current Scenario and Way Forward. Pharmacoecon Open 2018; 2(1):1-3. 
    7. Dang A, et al. Real world evidence: An Indian perspective. Perspect Clin Res 2016; 7:156:160.
    8. Gold M. Getting reimbursement for your product in the United States. June, 2003. 
    9. Prinja S, et al. Universal Health Insurance in India: Ensuring Equity, Efficiency, and Quality. Indian Journal of Community Medicine : Official Publication of Indian Association of Preventive & Social Medicine. 2012; 37(3):142-149.

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  • Is There Any Dogma Regarding Informed Consent in the Conduct of Pragmatic Trials?

    Is There Any Dogma Regarding Informed Consent in the Conduct of Pragmatic Trials?

    Clinical trials are instrumental for health science community to test and evaluate interventions. Trials can be broadly categorized in two classes, i.e. pragmatic and explanatory; where the former are designed to evaluate the efficacy of interventions in real-life routine practice conditions, whereas the latter aim to test whether an intervention works under optimal situations. Outcomes from pragmatic trials can be generalized and applied in routine practice settings. Since most of the findings of exploratory trials cannot be broadly generalizable, the “pragmatic design” has gained significant importance. (1)

    However, researchers hypothesize that there may be a tension between the goals of pragmatic randomized controlled trials (RCTs) and the traditional ethical rules governing RCTs. The main challenge then is the traditional regulatory informed consent process (referred to as “regulatory consent”), (2) which usually requires lengthy consent forms and procedures that significantly alter the routine workflow of “real-world” clinical settings, thus compromising the pragmatic nature of the trial. (3) Therefore, some have argued that in some types of pragmatic RCTs where the risks are very low and patient expectations are not violated, the regulatory procedures for obtaining informed consent could be altered or even waived. (4)

    The principle of informed consent makes the foundation for ethics in clinical research. This process provides crucial trial information to potential participants in order for them to make a rational and informed decision about participation. However, advancements in medical research have generated complex medical protocols resulting in elaborate and complicated information to be conveyed during the informed consent process. The complexity of consent documents also stems from the fact that sponsors as well as investigators view it as a legal and symbolic document of participant’s agreement to participate in the research study. This results in an informed consent process that is legally right, but often inadequate in terms of simplicity and ease of understanding for the study participants. (5)

    Pragmatic trials are typically associated with standard-of-care comparisons, and yet their value is not limited to treatments already used in clinical practice. Early pragmatic trials (EPTs) generate real-world effectiveness data by comparing new interventions with existing standards. This data can be valuable to health care decision makers even at the time of regulatory approval. Currently, ways to facilitate the design and conduct of EPTs to bridge the “efficacy-effectiveness gap” are being extensively explored. In this context, EPTs can study unapproved treatments in the pre-market phase (premarket EPTs) as well as newly approved treatments in the early post-market phase (post-market EPTs). (6)

    On the other hand, there is no well-established ethical framework for interpreting the criteria and little specific guidance on how to interpret them. This lack of guidance is evidenced by the fact that, as recently as 2008, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommended the Office for Human Research Protections to issue specific guidance on the topic. (7) Lack of guidance is especially acute in applying the waiver criteria to pragmatic RCTs, because historically these criteria have been applied to medical records research or to studies with special research designs (such as, experiments requiring deception). Thus, pragmatic RCTs, which compare individual medical interventions, are a novel setting for waivers or alterations of regulatory consent. (8)

    The most important reason for an ethical framework for waiver and alteration of informed consent is that the regulations lump together waivers and alterations, making important ethical distinctions ambiguous. Altering regulatory consent by leaving out a single consent element (e.g., whom to contact for information) is ethically quite different from waiving consent to RCT participation, which could involve actively concealing from someone that he is enrolled in a RCT; yet the regulations require the application of the same criteria for these two ethically different departures from regulatory consent. This is problematic, as it opens the door to over-regulation (unnecessarily prohibiting ethically acceptable alterations by holding them to the same standard as for a complete waiver) as well as to under-regulation (erroneously permitting unethical waivers by holding them to the same standard as for a minor alteration). Clearly, a principled ethical framework is necessary to prevent such mistakes. (8)

    Evidence suggests that the increased interest in standard-of-care pragmatic trials has led to the debate between if and how traditional regulatory consent can be ethically modified- either waived entirely or altered in some way to ethically achieve the goals of pragmatic trials. Indeed, some changes in certain research regulations explicitly accommodate “simplified” procedures for obtaining consent for some types of pragmatic clinical trials. However, there are many factors that necessitate the modification of informed consent process, such as research risks, impracticability of the regulatory consent, and ensuring non-violation of patients’ rights and interests.

    In the end, we would like to sum up our observations as follows: No pre-market EPT can be conducted with either a waiver of or an alteration to regulatory consent. Although no post-market EPT can be conducted with a waiver of regulatory consent, some may be conducted ethically with an alteration to the regulatory procedure. To add to this, thinking about EPTs can help further pinpoint morally relevant issues in pragmatic trials across the different stages of a drug’s life cycle.

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    References

    1. Patsopoulos NA. A pragmatic view on pragmatic trials. Dialogues in Clinical Neuroscience. 2011; 13(2):217-224.
    2. Kim SY, Miller FG. Waivers and alterations to consent in pragmatic clinical trials: respecting the principle of respect for persons. IRB 2016; 38:1–5
    3. McKinney RE Jr., Beskow LM, Ford DE, et al. Use of altered informed consent in pragmatic clinical research. Clin Trials 2015; 12:494–502.
    4. Faden R, Kass N, Whicher D, et al. Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data. Med Care 2013; 51(Suppl 3):S53–7.
    5. Sreenivasan G. Does informed consent to research require comprehension? Lancet 2003; 362:2016-8.
    6. Kalkman S, Kim SY, van Thiel GJMW, et al. Ethics of informed consent for pragmatic trials with new interventions. Value Health 2017; 20:902-908.
    7. Secretary’s Advisory Committee on Human Research Protections (SACHRP). Recommendations related to waiver of informed consent. 2008.
    8. Kim SY, Miller F. Waivers and alterations to consent in pragmatic clinical trials: Respecting the principle of respect for persons. IRB. 2016; 38(1):1-5

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  • How Strong is the Evidence for Drugs Receiving FDA Accelerated Approval?

    How Strong is the Evidence for Drugs Receiving FDA Accelerated Approval?

    A recently published study by Dyer O (2017) exposed major drawbacks in the accelerated approval process of some drugs available to the American patients without any stringent clinical evidence of their benefits. (1) Drugs receiving fast track approvals from the US Food and Drug Administration (FDA) often rest on a weak evidence base, says research that examined over 7000 clinical studies conducted with more than 37 drugs that received such approvals between 2000 and 2013. Researchers from the London School of Economics and Political Science (LSE) and the United States say that many US patients with serious illnesses are being treated by drugs which have questionable data. (1,2)

    Although, drugs eligible for accelerated approval are assessed for their probable clinical benefits, the slab for their market entry is far lower than those receiving regular approval. The potentially promising drugs can receive marketing authorization based on surrogate measures that are easy to obtain, rather than clinically meaningful outcomes, with the help of FDA’s accelerated approval process. The aforementioned study1 is the first of its kind worldwide that systematically evaluated more than 7000 clinical studies on drugs receiving accelerated approval by the FDA; and the shortcomings were due to the FDA introducing more flexibility to its evidence standards over the past three decades. The evidence ultimately accrued on the drugs getting ‘accelerated approval’ has major flaws and is inadequate to address the information needs of patients and doctors, and other decision makers in healthcare systems. (3)

    The key findings of this study include: (1)

    • Randomized trials, the gold standard of evaluating clinical effectiveness, comprised only a small minority of existing evidence;
    • The FDA approval excluded the therapeutic areas in about one-third of randomized trials; out of these, less than half evaluated the therapeutic benefits of these drugs but used them instead as common backbone treatments;
    • Drugs receiving faster approval were frequently tested simultaneously in different therapeutic areas;
    • Most drugs did not show substantial time lag that was apparent between the average start date of trials evaluating their effectiveness and their use as background therapy;

    However, on a flip side, some in the industry believe that this is not news. Post-marketing studies are conducted in only two-thirds of cases and are usually followed with a median delay of 4 years. Accelerated approval is often associated with unjustifiable delays in market withdrawal, and even in drug-related deaths. (4) For lack of efficacy, the process is even slower; for instance, drotrecogin alpha was not withdrawn for 10 years after initial approval and bevacizumab was approved for metastatic breast cancer in February 2008 under the FDA accelerated program and the license was not withdrawn until November 2011. (5) No one can justify this delay by the system for being wrong for so long. FDA along with the European Agency (EU) approves the drugs as quickly as they are slow for withdrawal. (6)

    Collective evidence on drugs receiving accelerated approvals has major limitations. The majority of clinical studies with these drugs are small and non-randomized, and about one third are performed in disapproved areas, typically alongside those conducted in approved areas. Most randomized trials that include such drugs eligible for accelerated approval are not proposed to directly evaluate their clinical benefits but, in fact, to incorporate them as standard treatment. (2)

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    References

    1. Dyer O. Drugs with FDA accelerated approval often have weak evidence, study finds. BMJ 2017 Jun 14; 357:j2905.
    2. Naci H, Wouters OJ, Gupta R, et al. Timing and characteristics of cumulative evidence available on novel therapeutic agents receiving Food and Drug Administration accelerated approval. Milbank 2017; 95(2):261-90.
    3. Major flaws in US drugs with ‘accelerated’ approval, research suggests. June 2017.
    4. Braillon A, Menkes DB. Balancing accelerated approval for drugs with accelerated withdrawal. JAMA Intern Med 2016; 176:566-7.
    5. Accelerated approval of drug on weak evidence is not the worst. BMJ News. June 2017. Accessed on 29th January, 2018.
    6. Bolland MJ, Grey A. Ten years too long: strontium ranelate, cardiac events, and the European Medicines Agency. BMJ 2016;354:i5109.

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  • How the Future of Clinical Trials in India Looks Like?

    How the Future of Clinical Trials in India Looks Like?

    According to the data from clinicaltrials.gov, 1.4% of global clinical trials are done in India, when the country has 16% of the world’s population and carries 20% disease burden in the world. However, the number of clinical trials in India is expected to rise by 2018-19 as a result of more stable and predictable regulations for clinical trials in India.

    In 2010, more than 500 clinical trials were done in India, and later the number dropped to less than 200 per year because there were said to be many uncertainties and ambiguities and regulations were not conducive to conduct clinical researches, with which the companies did not want to deal. In 2013, new regulations were introduced due to which major changes took place and clinical trials nosedived. This drop in clinical research in India was reported on account of regulatory uncertainty, judicial and social activism and some media sensationalism. This made the clinical research fraternity apprehensive and concerned over how this would translate into delayed access to new therapies for Indian patients. Over the last year and a half, the Ministry of Health and Family Welfare has taken steps to address the challenges posed by regulatory uncertainty and take on board concerns voiced by stakeholder. Regulations were amended and further guidance was given on existing ones. These were significant movements forward and a reiteration of the regulator’s commitment to clinical research in the country.

    The changes that began in 2014 now need to be sustained. The inclusive approach adopted by Indian regulators in which multi-stakeholder feedback has been actively sought and acted upon in many cases, continue. Industry personnel recommend stress upon the need to build on an emerging regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society. These developments will send out a strong signal to the global clinical research community that Indian clinical research industry is committed to a robust regulatory environment with a focus on collaboration, transparency and, most importantly, patient safety and protection.

    As a result of these regulatory and operational reforms, the timeline for the approval of clinical trials research has been reduced to six months by the Central Drugs Standard Control Organization (CDSCO). Initially, it used to take 12 months for any proposed clinical trials research to get approved, and as a result, by the time the trials body used to get the approval to conduct clinical research in India, globally similar trials had already been conducted in that time period resulting in India losing out its competitive edge. Since the timelines are defined now, this will help in introducing new trials and if they become successful, those molecules then subsequently can be introduced for Indian patients.

    Another development that happened is the scaling down of three levels of approval to only one, as now the approval process is done by a Subject Expert Committee (SEC), which consists of 25 panels of experts for various therapeutic areas, as per recommendations from The Ministry of Health and Family Welfare, Government of India. They evaluate the various categories of applications received for clinical trials, new drugs and new medical devices. In strengthening the SECs, the Ministry has addressed an industry concern that the SECs were not run as efficiently as envisaged because of an inadequate representation of subject matter expertise and the lack of availability of members for meetings. Feedback from the industry is that this has resulted in reduced approval timelines which are averaging six to seven months from submission to final approval as compared to 18 months earlier. Lot of work has been done in the last one to two years to set the expectations right in terms of the scope of SECs.

    Clearly the value of clinical research in India is being appreciated more but its full potential has yet to be realized. Several limitations still exist that either delay clinical research or curb its scope. One of our greatest challenges is to instill confidence and trust amongst global stakeholders about the evolving and more scientific regulatory environment in India and the fact that there is now a more conducive environment for clinical research in the country. We feel that there is a need for investment by the regulators in capacity building and infrastructure to ensure better governance and management of clinical research in the country. We hope that the proposed accreditation of Clinical Research Sites, Investigators and Ethics Committees will come into place soon and the cap limit for investigator initiated trials lifted vesting the final decision with the Ethics Committees. We also hope that Indian authorities will continue to play a proactive role in encouraging local research and innovation. We have made good progress and should continue this momentum. Millions of patients are waiting in the hope of better and more effective treatment. If we have to find better and more cost effective cures for existing and new diseases, we need to make clinical trials work in our country.

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  • How Important is to take Ethics Approval for Survey Research?

    How Important is to take Ethics Approval for Survey Research?

    Ethics are the moral principles that distinguish between right and wrong. In research, they differentiate between acceptable and unacceptable behaviours on the part of the researcher. Ethical considerations in research form the basis of adherence for the integrity, reliability and validity of the research findings. Some form of ethical review of human research is prevalent in some countries. However, important features of regulations governing the ethical review practice vary significantly. These features include the composition of ethics review committee, protocol review processes, procedures to determine which activity requires what type of review, and so on. As a result, academic journals receive manuscripts with similar types of research having received different levels of ethical reviews. Sometimes some publications get a waiver on the ethical review and journals are responsible for questioning the appropriateness of such wavers or alternative review processes in order to decide whether or not to accept this research.

    One type of research where such variation in ethical review is prevalent is ‘survey research’. It is defined as research in which a sample of participants is drawn from a larger population and is asked a series of questions related to a topic about which they should have some knowledge or attitude. In healthcare, survey research is conducted for a lot of reasons, viz. research to understand markets, public opinions, hypothetical preferences, or satisfaction with a particular service, to gain insights into the health status of different subgroups of the population or to make conclusions about health-related behaviours, such as diet or exercise, in a community. Surveys may also be used to collect data as part of a clinical trial designed to evaluate the impact of an intervention or interventions on individuals. However, because participants in clinical trials generally receive some form of intervention, this would not be classified as survey research. Rather, in survey research, the only form of intervention or data collection is through questionnaires or interviews, which, in some cases, may provide participants with information they need to understand a topic related to the questions being asked.

    Why the ‘ethics review’? The answer is straightforward: because research involving human subjects puts people at risk. The risks may be physical, psychological, social, economic, legal, or dignitary; a single study may also pose more than one type of risk to subjects. Of course, people are exposed to risks all the time, whether it is at work, in the doctor’s office, or driving a car. The difference in research is that people are exposed to risk in large part for the benefit of others, be they other patients, the health system, or society at large. It is this feature of research that drives the need for independent ethics review. While the integrity of researchers remains an important protection for research subjects, researchers themselves may not be in a good position to make the best judgment regarding the ethical acceptability of a research study. Ethics committees ensure that the liberty and welfare interests of research subjects are protected, and that national and international ethical and legal requirements are upheld.

    Ethical issues exist in all types of research and they need to be tackled. The most important ethical principles in survey research are protection of research participants (the respondents) and the guiding foundation of “no harm”. Most institutions and organisations have an Institutional Review Board (IRB), which is a panel of people ensuring the safety of human subjects in research, while also making sure the non-violation of human rights. Some common issues in survey research include voluntary participation and informed consent. These principles are followed to guarantee that all respondents are opting to participate in the survey of their own free will and that they are fully informed regarding the procedures of the research project and any potential risks. This is not a major problem in survey research since a cover letter or introductory statement is used to introduce the survey and provide any other information regarding the purpose, sponsorships, potential use of data, and methods of collecting it. Issues of confidentiality are also typically covered in this statement.

    Confidentiality and anonymity of the subjects is protected by applying ethical standards. This is the primary ethical issue in survey research, especially if the survey contains sensitive questions. Researchers should not share information between participants and should have procedures in place to protect the data and names of participants. If the research protocol calls for follow up with reminders or additional surveys at a later date, true anonymity may not be possible. However, if possible, identifying information should not even be recorded. Use of encryption technology for internet surveys and numbering of respondent data can help to reduce possible breaches with respect to confidentiality.

    Survey research does not deliver any intervention to research participants; thus, there is no risk of physical harm to participating individuals. Thus, we feel that such type of studies should get an ethics review waiver. However, there can be cases where a risk of informational or psychological harms are unavoidable. The situations with greater than minimal risk of informational or psychological harms necessitate institutional ethics overview of the survey research. Furthermore, survey research projects with vulnerable individuals having diminished autonomy should also receive institutional ethics overview. Additionally, the protocol of the research must ensure confidentiality of participant’s personal information along with the data they provide.

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