FSSAI (FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA) has published gazette to regulate the Advertising and Claims made by companies on the food products in India.
FSSAI (FOOD SAFETY AND STANDARDS AUTHORITY OF INDIA) has published gazette to regulate the Advertising and Claims made by companies on the food products in India.
Indian Society for Clinical Research (ISCR) in collaboration with Indraprastha Apollo Hospitals is organising a Workshop on “Exploring Future Trends in Clinical Research” on 30 Nov 2018. Here is the agenda for the meeting.
Nanotechnology is clearly a concept whose time has come. Five years ago, little was known about the technology outside specialist circles. Yet it is now being promoted in the scientific and popular press as a major technological breakthrough, heralding the next industrial revolution. Researchers and developers are talking about how nanotechnology might be used to develop lighter, stronger materials, better batteries and improved solar cells in the near-term (just a few of the many examples), with applications such as targeted cancer treatments, microscopic sensors and even life-mimicking devices in the mid to distant future. This enthusiasm is backed up by serious research and development funding from government and industry—estimated at nearly US$10 billion globally for 2005.
Born from the marriage of nanotechnology and medicine, nanomedicine is set to bring advantages in the fight against unmet diseases. The field is recognized as a global challenge, and countless worldwide research and business initiatives are in place to obtain a significant market position.
MARKET FOR NANOMEDICINE
In the field of nanomedicine research, the US accounts for one-third of all publications and half of patent filings. A comparison between Europe as a whole and the US shows that while Europe is at the forefront of research, the US leads in the number of patent filings. The strong patenting activity of US scientists and companies indicates a more advanced commercialization status.
According to BCC Research (www.bccresearch.com), the global market for nanoparticles in the life sciences is estimated at over $29.6 billion for 2014. This market is forecast to grow to more than $79.8 billion by 2019, to register a healthy compound annual growth rate (CAGR) of 22%. The biggest increase will come in the area of drug delivery systems.
As products complete clinical trials and gain US FDA market approval, the revenues from these products will grow at 23%. Basic biotechnology research revenues will increase due to the quest to find more nanoparticle applications, as more drugs become successfully delivered by these carrier systems. Drug development and formulation will show steady sustained growth at 20.7%. Nanoparticles for use in diagnostic imaging will continue to show healthy growth at 20.1%. This will result from the need to develop more definitive nanoparticle markets for disease diagnosis.
According to a research report from the Business Communications Company (BCC) Research, despite the catastrophic consequences of the 2008-2009 crisis on capital markets, the global nanomedicine sector, which was worth $53 billion in 2009, is projected to grow at a compound annual growth rate (CAGR) of 13.5%, surpassing $100 billion in 2014. One of the largest segments
of this market is represented by anticancer products. Valued about $20 billion in 2009, it is expected to reach $33 billion in 2014, growing at a CAGR of 11%.
Of the approximately 200 companies identified as active in nanomedicine worldwide, some three- quarters are startups and SMEs focusing on the development of nanotechnology-enhanced pharmaceuticals and medical devices.
Nano-enabled medical products began appearing on the market over a decade ago and some have become best-sellers in their therapeutic categories. The main areas in which nanomedical products have made an impact are cancer, CNS diseases, cardiovascular disease, and infection control.
At present, cancer is one of the largest therapeutic areas in which nano-enabled products have made major contributions; these include Abraxane, Depocyt, Oncospar, Doxil, and Neulasta. Cancer is a prime focus for nanopharmaceutical R&D, and companies with clinical-stage developments in this field include Celgene, Access, Camurus, and Cytimmune.
Treatments for CNS disorders including Alzheimer’s disease and stroke also feature prominently in nanotherapeutic research, seeking to build on achievements already posted by products such as Tysabri, Copazone, and Diprivan. According to BCC Research, this is a field hungry for successful therapeutic advances and annual growth from existing and advanced pipeline products is expected to reach 16% over the next 5 years.
Autoimmune-related inflammatory disease has an increasingly high profile, and nanotechnology has contributed to the success of products such as Remicade and Humira. Enzon is among companies vigorously pursuing new product development in this field, and new products are expected to add to the continuing market penetration of existing therapies, contributing to annual growth rates around 15%.
In addition, nanotechnology has contributed to a wide variety of anti-infective products, from PEGylated interferons used in viral disease to nanocrystalline silver used topically in wound infections. Biosanté and NanoBio are among companies actively involved in this field.
The US market is by far the largest in the global nanomedicine market, and is set to continue to dominate the world marketplace, but other national markets are expected to increase their shares over the next 5 years.
In 2007 investment in nanotechnology by VCs was US $702 million, involving 61 deals. 27% went to healthcare and life science, 31% to energy and environment, and 42% to electronics and IT. Two years later, nanotechnology market captured US $792 million from VCs. Of these, the largest share (51%) went to healthcare and life sciences, followed by energy and environment and electronics and IT, with 23% and 17%, respectively. Doubling the funds invested in the healthcare segment in just two years, the VC industry has demonstrated a clear interest in investment opportunities in the nanomedicine field
Not having a very explicit, legal and concise regulatory guidelines couple with long approval procedure and regulations make nanomedicine products different from those of other industries using nanotechnologies with no limitations due to regulatory bodies. As a consequence, the expenditure to bring a nanomedical product to the marketplace is so huge that pharmaceutical and biotechnology industries have no alternative but focus on the blockbusters that can please the stockholders. It is reasonable to presume that nanomaterials are “new for safety evaluations purposes”, and therefore they merit careful oversight by regulatory authorities both before and after entering the marketplace.
COMMERCIALIZED & FUTURE MARKETS
Apart from targeted cancer chemotherapy, nanotechnology is being used more widely in creating a new generation of drug delivery systems. A key factor in its adoption is that nanoscale particles have a greater surface-to-volume ratio than macroparticles. Thus, a drug-bearing nanoparticle can release a drug more quickly and more abundantly than larger particles. This is helpful when the drug poses problems with solubility and absorption, as is the case with a considerable proportion of new drugs.
(a) Global Nanomedicine Market Size
Already on the market in the US and elsewhere are wound dressings that exploit the antimicrobial properties of nanocrystalline silver. Ionic silver is a powerful antibacterial, effective even against problem organisms like MRSA, and nanotechnology offers a way to optimize its effect when incorporated in a wound dressing.
Within the anticancer products segment, Doxil and Abraxane are two main examples of success in the clinic. Sequus Pharmaceuticals was the first company to sell doxil, the liposomal formulation of Doxorubicin, a powerful but toxic chemotherapeutic, initially approved for treatment of Kaposi’s sarcoma in the USA in 1995. Sequus was then acquired in 1998 by ALZA Pharmaceutical for US $580 millions, which subsequently merged with Johnson and Johnson in 2001 in a US $12.3 billion deal. The other approved nanotherapeutic agent, Abraxane, instead, was originally sold by Abraxis Biosciences, which was acquired in June 2010 by Celgene Corporation for US $2.9 billions.
(b) Anticancer Products Market Size
Granted by the orphan drug designation in January 2005 by the FDA, this product consists of albumin nanoparticles containing paclitaxel, and is indicated for the treatment of breast cancer.
Conventional chemotherapies consist of injections of cytotoxic drug intravenously, which indiscriminately kill both healthy and tumor cells. The clinic success of Doxil and Abraxane was driven by their ability to concentrate preferentially in tumors, because of the gaps (otherwise called endothelial fenestrations) characterizing the blood vessels that supply the cancerous mass. Nanoparticles of the right size can penetrate these “gates” and passively diffuse into the tumors. Thanks to this generation of chemotherapies, patients are now benefiting from new treatment strategies for delivering drugs through nanotechnology carriers with lower systemic toxicity and improved therapeutic efficacy
Despite the issues nanomedicine still has to face, investments in this market are predicted to increase. New applications of nanomedicine have been demonstrated, and the resulting expansion of the potential market makes the risk more appealing. Ferocious financial collapse elevated sunk costs of the essential R&D process, tricky access to funds, uncertainty of expected returns, and the extremely meticulous, and lengthy FDA regulatory process has not deterred the investors’ community. On the other hand, the promises of great future potential developments in the different market segments and high returns connected to the high risk of the innovation investments make this market still considerably attractive. Compared to the 2007 benchmark, VCs in 2009 decided to double their investments in this sector, at the expenses of the information technology market. The fact that nanomedicine dominates the VC funding in the healthcare market is surely a good predictor of the bright future landscape of expansion of this promising area of research.
Tarun Pandotra is Vision-driven executive with 20 years of demonstrated leadership in the pharmaceuticals and CRO industry. Proven track record of driving bold initiatives and innovative partnerships across multiple channels, expanding business scope, productivity, and profitability. Extensive international experience, with commitment to delivering quality results, establishing ethical guidelines, and motivating staff for peak performance and program success. Tarun has authored various articles which was published in Biospectrum Asia, Pharmaphorum and so on.
12 NOVEMBER, 2018 [DELHI] Global Regulatory and Consumer Insights (GR-CIS), a leading provider of drug development consulting and regulatory services, is pleased to announce a strategic partnership with Global Contract Research Organization (CRO), George Clinical.
George Clinical is a leading CRO in the Asia Pacific, with over a decade’s experience running clinical trials in India. With major operations in fifteen countries worldwide, George Clinical provides the full range of clinical trial services to pharmaceutical, medical device and biotech customers, for all trial phases, registration and post-marketing trials. George Clinical combines scientific and clinical leadership with expert trial delivery capabilities to create a distinctive world-class service.
“This collaboration offers our clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions”, said Tarun Pandotra, Global Regulatory & Consumer Insights’ Founder & Director. “This approach, coupled with our expertise will provide our client, with the ability to accelerate the development of their products and stay ahead of the competition.”
“George Clinical welcomes the opportunity to partner with GR-CIS,” Vanaja Krishnan, Managing Director of George Clinical, India adds. “We have an extensive track record in the delivery of clinical trial services to the highest quality in India and around the world. This partnership will further our focus on the delivery of the best science, service and pragmatic trial solutions.”
About George Clinical
George Clinical is a leading independent Asia-Pacific based clinical research organisation (CRO) with global capabilities differentiated by scientific leadership, innovation and extensive investigator networks. With staff operating in 15 countries, and with significant operations in the USA, China, India and the broader Asia Pacific region, George Clinical provides the full range of clinical trial services to biopharmaceutical, medical device and diagnostic customers, for all trial phases, registration and post-marketing trials.
GR-CIS provides regulatory strategy, due diligence services and Pharmacovigilance services to life science companies. The Practice, which includes five Quality Practices, has been formed to help pharmaceutical, biotechnology and medtech clients overcome critical regulatory hurdles, devise effective regulatory strategies and provide ongoing, hands-on regulatory support, including assistance with regulatory applications. The team is also supporting companies conducting regulatory due diligence.
GR-CIS has deep preclinical and clinical technological experience, covering biologics, pharmaceuticals, API and generics. By pooling our collective experiences and expertise, the team represents a formidable resource for any life science company needing to supplement its in-house regulatory capability.
Our industry has a 200% drug supply overage problem in clinical trials. Study organizers often supply individually per study, some of which are complex or multi-phase studies. Many study sponsors tend to package “too much” or “too early,” to be on the safe side. Overwhelmingly, these studies often are delayed and have wasted a large quantity of the drugs they’ve already prepared.
Drug pooling can help. In pooling drug supplies across different studies, you are much more able to minimize risk and keep your overage lower, because the forecasted need across multiple studies can be more accurately calculated and stocks at depots can be used more flexibly. In fact, I would expect the overage need on pooled studies to be reduced by 20-50%.
Drug pooling is the common practice of strategically using drugs across different clinical studies to significantly reduce drug overages and maintain drug supplies for study patients. This strategy, used in conjunction with an IRT system, is one Cenduit’s Drug Supply Center of Excellence recommends. Many of our clients are exploring drug pooling in response to the continued modernization and complexity of clinical trials in which a one-size-fits-all approach simply does not work.
When to Use Drug Pooling as a Part of Drug Supply Chain Management
Pooling can be appropriate when the study drug lends itself to being used in the same kind of design across different protocols. Often these protocols are running concurrently, and the drug is packaged in the same way. The more studies you run together, the bigger the benefit of pooling. (However, if the design of the drug is specific to a study, there is typically no point with pooling it with another study.)
Drug pooling has been discussed for over 10 years. This type of modeling is not technically challenging, it has tremendous benefits, and is one of the most under-utilized drug supply management strategies with an IRT system. The main benefit is cost savings. Across numerous industry biopharma conferences, attendees may observe presentations of the great financial savings that pooling can provide across a clinical program. Why does this matter? If you can pool a drug across studies you need less stock, because you can be more flexible with your drug.
Consider this hypothetical scenario: Suppose you have 6 studies in the U.S. with the same drug. Perhaps one study is running slower than expected, and another is running faster than expected. With pooling, a sponsor can elect to send more drug to the study that is running faster. This action will not affect your stock because there is already another study that is running a bit delayed.
Regulatory challenges are a potential issue with drug pooling. Different local regulations, especially across European countries, make sponsors initially reluctant to pool despite the planning benefits. However, there are numerous cases of sponsors who pool that are living with the regulatory pushback, and have become good enough in practice to defend potential hurdles.
Where is Drug Pooling Headed? Cost Savings and Eliminating Drug Overage Challenges
The next natural evolution of drug pooling needs to be a global consensus building of best practices across countries and regions, to reap the benefits and potential efficiency savings. The need for multi-geographical regulatory buy-in will ultimately help sponsors with potential savings as a part of their drug supply chain strategy. On the other hand, if one or more countries won’t accept pooling, the practice would need to be adjusted in certain countries and not in others, and you would lose part of the savings.
It is clear drug pooling offers an important benefit from a logistical and supply chain perspective, and makes it easier to have the drug available for patients. Clinical studies are large and costly. If we can adopt new methods to bring down costs, in the end we can help to bring down the cost of drugs throughout the program and when they’re on the market, as well.
Novotech the largest Asia-Pacific-based CRO has acquired Australasian specialist CRO Clinical Network Services (CNS) as part of a mutual mission to expand services to biopharma for early phase product development and clinical research through to later phase regional and global trials.
Both companies will continue to retain their separate brands and identities.
Early phase CNS clients wishing to advance development into later phase regional trials can tap into Novotech’s Asia-Pacific expertise backed by 10 partnership agreements with leading hospitals and medical institutions that offer access to more than 1.4 billion people living in urban areas in the region.
Novotech has more than 400 staff across Asia-Pacific and business development offices in the USA, and CNS has more than 140 staff in Australia, New Zealand and the USA.
As part of the deal, clients can access leading services from both groups including the CNS BioDesk, that provides early stage product development advice including toxicology, CMC and FDA/EMA regulatory consulting and interactions; and Novotech’s advanced regional IT infrastructure, to support their clinical research programs.
Novotech CEO John Moller said:
“Biopharma clients should know this is a bringing together of the highest quality CROs in the region. Very importantly, we have developed remarkably similar company cultures, and I know the teams are excited about the opportunity to work together.
Novotech and CNS will continue to operate under separate brands with CNS specialising in early phase non-oncology clinical trials across Australia and New Zealand, and Novotech specialising in regional Asia-Pacific and global project delivery across all phases.
Our Asia-Pacific in-country relationships enable a comprehensive understanding of local regulatory requirements and changes, access to leading investigators, strong site connections, and accessible patient populations to deliver success for our clients within timelines and budgets.”
CNS Managing Director, Russ Neal commented:
“Early phase research in Australasia has seen incredible growth over the last 6-7 years and CNS is proud to be a significant part of this proven capability. As our clients have experienced success with us, we have often wished we had the international reach to continue supporting them. This truly complimentary association with Novotech now means that we are able to offer our clients access to Novotech’s Asia-Pacific experience and expertise in later phase regional or global trials. On the other hand, Novotech clients can access our highly regarded global product development and regulatory affairs consultancy team, BioDesk, based out of Washington DC, London and Australia”
CNS COO and Executive Director Gabrielle McKee further added:
“CNS clients will also benefit from many of Novotech’s strengths, including IT infrastructure and specialist functions such as legal, learning and development and marketing and analytics and particularly exciting is that together CNS and Novotech offer our clients one of the most experienced and knowledgeable biometrics teams in the region with about 70 staff in the combined unit.”
About Novotech – https://novotech-cro.com/welcome
Headquartered in Sydney, Novotech is internationally recognized as the leading regional full-service contract research organization (CRO). With a focus on clinical monitoring, Novotech has been instrumental in the success of hundreds of Phase I – IV clinical trials in the Asia-Pacific region.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including: feasibility assessments; ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety services, central lab services, report write-up to ICH requirements, project and vendor management. Novotech’s strong Asia-Pacific presence includes running clinical trials in all key regional markets. Novotech also has worldwide reach through the company’s network of strategic partners.
About Clinical Network Services https://clinical.net.au/
Clinical Network Services (CNS) is an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the USA, who create value for small to medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials or the marketplace sooner. CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical services and biometrics team. CNS’ regional clinical advantage is driven by the extremely pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without prior regulatory approval. CNS offers a uniquely differentiated, customer-orientated, suite of services to clients which enables CNS to guide products efficiently through critical post-discovery development and into initial human trials. Throughout, CNS takes a global development/ regulatory strategic approach to ensure that value is added at every stage of the product development life cycle.
Ongoing uncertainty and concern about Brexit has already cut the number of clinical trials carried out in the UK.
The number of drug trials started in Britain in 2017 was a staggering 25% lower than the average for 2009-2016.
A Fitch analysis showed that 597 trials were initiated in Britain in 2017, against an average of 806 over the previous eight years.
The referendum on whether Britain should stay in the EU was held in 2016 and despite two years of wrangling between and within political parties, no clarity over what Brexit means in real terms has emerged.
Britain is currently due to leave the EU on March 29 next year – less than six months from now.
According to a report by Reuters, the Association of the British Pharmaceutical Industry (ABPI), said the NHS, which has been used for research into groundbreaking and life changing drugs, could suffer through the lack of investment.
Patients could also be deprived of the benefits of new medicines, according to the report.
Speaking to Reuters, Sheuli Porkess, deputy chief scientific officer at the ABPI, said: “We know from our members that Brexit-related uncertainty is a major concern when it comes to decisions about whether to set up trials in the NHS.
“This is why it’s vital that we get a Brexit deal to keep the investment and skills in clinical trials here in the UK.”
If no deal is struck, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) would have to operate as a stand-alone regulator, a possibility that is currently out for industry and public consultation.
And, there is still no transparency over how UK data would be treated by the European Medicines Agency (EMA), although the government says it wants the MHRA to align itself with decisions made by the agency as far as the latest novel drugs are concerned.
Recardio stopped its UK-based drug trials earlier this month, citing uncertainty over Brexit as the reason.
It pulled out of trials for dutogliptin, which is designed to help heal heart tissue post-heart attack, saying the instability caused by Brexit was “very difficult” and was a “significant risk” to the business.
What’s in a name? A lot, according to pharmaceutical companies, many of whom have already launched or are gearing up to introduce new fixed dose combinations (FDCs) by tweaking the compositions but retaining the same brand name as the original product.
For example, in 2016, when popular cough syrup Corex was banned, Pfizer Ltd, the Indian subsidiary of US-based drug maker Pfizer Inc., was quick to discontinue the cough syrup Corex in its then form, changed the composition but decided to retain the brand name for its future respiratory products. The company decided to stop making the Corex cough syrup formulation, a combination of codeine phosphate 10 mg and chlorpheniramine maleate 4mg, changed the formulation and extended the same brand name. The new formulation is now called Corex T (Codeine + Triprolidine) .
According to Pfizer spokesperson “Pfizer discontinued the manufacture of ‘Corex Cough Syrup’ in 2016 as an outcome of a regular review of the product portfolio. However Corex remains an important umbrella brand for Pfizer that has long been associated with a broad range of safe and effective products and continues to be an essential part of our portfolio.”
Likewise, Glenmark Pharmaceuticals Ltd’s pain relief formulation called Vorth TP earlier contained tapentadol and paracetamol. It has now been tweaked to include tramadol and paracetamol. The brand name, however, remains unchanged.
Experts said companies prefer to continue popular brand names for new products containing different ingredients as it becomes easier to market them. “The companies want to retain the brand name as they spend a lot of money in building a name. As long as it is for the same indication by virtue of reformulation to make it a rational combination, the companies prefer to use the same name,” said D.G. Shah, secretary general of Indian Pharmaceutical Alliance, which represents large number of domestic drug makers. Shah said extending the brand names to new products also make it easier for doctors and chemists to remember while dispensing or prescribing the medicines.
“The brands have been in the market for decades and companies invest a lot on these brands. Hence, they would like to save them by moving to combinations that have been approved by the Drug Controller General of India for the same indication with the addition or change of a suffix or prefix to the original name,” said Sunil Attavar, president, Karnataka Drugs and Pharmaceuticals Manufacturers’ Association.
The Union health ministry on 12 September, banned about 328 FDCs after an expert panel formed under the chairmanship of Nilima Kshirsagar, professor of head clinical pharmacology at G.S. Medical College KEM Hospital, Mumbai, to review the safety, efficacy and therapeutic justification of these drugs, found these FDCs “irrational”, citing safety issues and lack of therapeutic justification, recommended the ban. The ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines.
While Glenmark, Wockhardt Ltd, Alkem Laboratories Ltd, Obsurge Biotech, Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate moved the high court against the ministry’s decision, some companies are busy tweaking compositions and launching their new formulations in the market.
Macleods Pharmaceuticals, which makes anti-fungal Panderm Plus is gearing up to launch its new combination called Panderm NM and is awaiting approval from India’s drug regulator.
“Panderm Plus steroid has been fixed with an antibiotic which is never allowed in any country of the world and that is the reason that it has been banned,” Chandra M. Gulhati, editor, Monthly Index of Medical Specialities (MIMS).
An FDC drug contains two or more active ingredients in a fixed dosage ratio. The ban covered about 6,000 brands from top pharma companies, including Pfizer, Wockhardt, Alkem Laboratories, Cipla, Sanofi India and Sun Pharmaceutical Industries Ltd.
Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far.
The analysis, led by University of Oxford researcher Ben Goldacre, found trial sponsors only reported about 51 percent of 7,274 clinical trial results since publication of the European Commission’s guidelines in 2014. Of these, 68 percent of trials with a commercial sponsor posted the results, while only 11 percent of non-sponsored trials shared theirs.
The study found that 32 major universities did not report results for any trials they sponsored. Eleven drugmakers whose trial data the researchers analyzed reported all the trials they sponsored, including Genentech, Gilead and Boehringer Ingelheim. On the other end of the spectrum, Eli Lilly reported only 52 percent of its trials.
“The biggest offenders of not publicly releasing clinical trial data are academic institutions,” says Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest, a nonprofit medical issues research group. “Part of the problem is academic institutions don’t feel the need to abide by the same standards pharmaceutical companies do” when it comes to reporting clinical trials data.
Another problem in reporting trial data is methodological, according to Pitts, because sponsors don’t feel obligated to release early stage data.
“Clearly what’s most important are human trials,” he says, “but oftentimes early studies aren’t released because sponsors don’t think they have any relevance.”
Independent researchers are often unable to verify and build on clinical trial findings without access to this data, but no entity has ever been penalized for failing to fulfill the reporting requirements, according to the study published in BMJ. The EU regulation calls on all trial sponsors to report results one year after a trial concludes, or within six months in the case of research involving children. Trials that miss reporting deadlines by three months or more are to be flagged by the EU, but there is no system in place to flag overdue trials.
“We need to reflect on how we can improve our communication with academic sponsors and smaller sponsor organizations. This study helps to spread the word on how important it is to post trial results once a clinical trial is over,” Fergus Sweeney, head of inspections for the EMA Human Medicines Pharmacovigilance and Committees, said. “We … are firm believers that transparency and public availability and scrutiny of clinical trial information and results are fundamental for the protection and promotion of public health.”